Podcasts about tigit

On this week's episode, Brad Loncar, Eric Schmidt, and Sam Fazeli kick off with a look at Sanofi's $9 billion acquisition of Blueprint Medicines, highlighting the move as a mature, strategic bet for Sanofi and a positive sign for investment in biotech. On the data front, the group highlights the Phase 3 HARMONi trial from Summit and Akeso in non-small cell lung cancer, which is the first to include both U.S. and Chinese patients in a head-to-head comparison with Keytruda. Vera Therapeutics' positive Phase 3 data in IgA nephropathy was also discussed. The conversation shifts to ASCO 2025, spotlighting early-stage data in targeted protein degraders and novel therapies in breast cancer and myeloma. Despite some volatility in share prices and lack of bold headlines coming out of ASCO, overall sentiment remains optimistic about the pace of innovation in oncology. Next, they dive into TIGIT developments from Roche and AstraZeneca, noting AstraZeneca's ambitious 10 Phase 3 trials. The episode wraps with Bicara Therapeutics' updated data in HPV-negative head and neck cancer, targeting a subgroup identified through translational research. *This episode aired on June 6, 2025.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.At a recent U.S. Senate hearing, Health and Human Services Secretary was questioned about cuts being made to the department and his stance on endorsing the measles vaccine during a growing outbreak. The hearing was tense at times, with RFK Jr. firm on supporting the cuts but wavering on his stance on the MMR vaccine. AbbVie's ADC received accelerated approval for lung cancer treatment, FDA delays decision on Biohaven's application, and chaos ensues at the FDA's advisory committee planning office after workforce cuts. Sino Biological offers solutions for autoimmune disease research, with reagents for nearly 50 diseases. Novo Nordisk has invested $2.4 billion in a new oral obesity drug through a deal with Septerna, aiming to catch up with competitors in the oral weight loss space. AbbVie has committed $335 million upfront in a partnership with Adarx Pharmaceuticals for siRNA research, while GSK has abandoned a TIGIT therapy and instead acquired rights to a liver drug from Boston Pharmaceuticals for potential $2 billion deal. This news highlights the ongoing developments and investments in the pharmaceutical industry.

Donald Trump's tariffs have headlined myriad news stories this week—including at BioSpace, where we reported Pfizer CEO Albert Bourla's claim that his company is prepared to reshore manufacturing if the president makes good on threats made last month. Eli Lilly also appears to be preparing, commiting $27 billion to boost its U.S. manufacturing capacity.   Meanwhile, another regulatory meeting has been canceled under new HHS Secretary Robert F. Kennedy Jr. Reuters revealed last week that an upcoming meeting of the FDA's external advisers for vaccine policy on March 13 has been canceled—just a week after the CDC Vaccine Advisory Board's first meeting of 2025 was postponed. Also on the policy front, BioSpace took a deep dive into priority review vouchers (PRVs) after Congress failed to reauthorize the rare pediatric disease PRV program at the end of 2024. Our reporting shows this will be painful for many biopharma companies who rely on funds from the sale of PRVs.   Speaking of money, AbbVie and Eli Lilly struck a pair of mid-size deals in hot spaces. AbbVie made a late obesity play this week, inking a licensing deal worth up to $2.2 billion with service provider Gubra to bring a long-acting amylin drug to the market, while Lilly hopped onto the hot molecular glue train, paying more than $1.2 billion in a licensing deal with Magnet Biomedicine.  Finally, we examined the somewhat lethargic immuno-oncology space, which has companies, including BMS, Roche, Summit Therapeutics and BeiGene, targeting TIGIT, VEGF, RAS and more in their quest to bring the next Keytruda—which led the way in 2024 as the world's best-selling drug—to the market.  

Clinical-stage drug development offers big rewards—and big risks. To that end, Fierce Biotech recently published its annual roundup of several of the most eye-catching trial failures of the preceding year. The 2024 list includes trial flops from the likes of AbbVie, Novo Nordisk, Pfizer and more, with reports of disappointing results in many tough-to-treat indications, including schizophrenia and Alzheimer's disease. In this week’s episode of The Top Line, we dive into the report. Fierce Biotech’s James Waldron and Gabrielle Masson discuss the entries that stood out for them and ask what lessons the biopharma industry can learn from these setbacks going forward. To learn more about the topics in this episode: 2024's top 10 clinical trial flops AbbVie's $9B schizophrenia prospect flunks phase 2 trials, handing advantage to BMS GSK surrenders HSV vaccine hopes after phase 2 fail, ceding race to Moderna, BioNTech Merck halts phase 3 TIGIT trial after immune-mediated adverse events prompt discontinuations Pfizer's phase 3 gene therapy trial fails to improve function for boys with Duchenne muscular dystrophy See omnystudio.com/listener for privacy information.

This week's podcast from VJOncology brings you the latest updates on novel checkpoint inhibitors that target LAG-3, TIGIT, and TIM3... The post Novel immune checkpoint targets beyond PD-1 and CTLA-4 in solid tumors appeared first on VJOncology.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Amgen's weight loss drug Maritide fell short of expectations, with only a 20% weight loss reported, causing a drop in the company's shares. In other news, Sarepta made a significant commitment of up to $10 billion in a deal with Arrowhead to expand its pipeline with RNA drugs. Roche also made a strategic move by acquiring Poseida for up to $1.5 billion, but faced a setback with a Phase III failure for its TIGIT asset. Alector's Alzheimer's program suffered a setback with a failed Phase II trial, leading to a 17% layoff. Lilly encountered legal challenges related to GLP-1 shortages, while AstraZeneca celebrated success with its Truqap in a Phase III prostate cancer trial.These developments are reshaping the landscape of the biotech industry, offering new opportunities in roles such as manufacturing engineer, associate director of preclinical development, data analyst scientist, and executive director of marketing. Stay informed with more news and updates on Biospace's website.

Audio roundup of selected biopharma industry content from Scrip over the business week ended 25 October 2024. In this episode: Merck & Co's Modifi acquisition; scenarios for new obesity drugs; Astellas gets US approval for claudin drug Vyloy; iTeos builds TIGIT lead; and execs discuss AI in clinical trials. https://insights.citeline.com/scrip/quick-listen-scrips-five-must-know-things-YMAHSAK2FBBKPIPNLZGPGHWPSQ/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

At the recent World Conference on Lung Cancer and European Society for Medical Oncology annual meetings, two packages of lung cancer data from a partnership between Akeso and Summit Therapeutics and another collaboration between iTeos Therapeutics and GSK showed much promise of disrupting the current standard of care. But they also drew some questions and debate.  In this week's episode of “The Top Line,” Angus Liu from Fierce Pharma and Gabrielle Masson from Fierce Biotech discuss the key issues behind those two readouts.    To learn more about the topic in this episode:  iTeos-GSK's TIGIT combo shows 30% more tumor shrinkage than Jemperli, but safety signals scare investors Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer 'Cooking with gas': Regeneron sees its Opdualag rival as next big thing for treating solid tumors ESMO: Bristol Myers moves Opdualag into phase 3 trials in competitive first-line lung cancer field See omnystudio.com/listener for privacy information.

The ESMO Congress yielded another win for cancer immunotherapy target TIGIT, but the readout resurfaced worries about the mechanism's past failures to turn positive earlier stage data into Phase III success. On a special edition of the BioCentury This Week podcast, BioCentury's editors deliver their takeaways from this year's meeting, including analysis of data for TIGIT blocker belrestotug from iTeos Therapeutics, a colorectal cancer readout featuring J&J's Rybrevant and an antibody-drug conjugate from Genmab. The BioCentury team is joined by Gwyn Bebb, who is global franchise head for oncology at podcast sponsor Parexel. Bebb discusses what's changed in the oncology landscape in the 10 years since the approval of the first immunotherapies, observations that COVID-19 vaccines might have a role in treating cancer and developments in the radiopharma field. This episode of BioCentury This Week was sponsored by Parexel Biotech.View full story: https://www.biocentury.com/article/65368100:01 - Sponsor Message: Parexel BioTech01:55 - iTeos' TIGIT Data04:56 - Rybrevant Colorectal07:22 - Gwyn Bebb's Take21:38 - More ESMO HighlightsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

After their groundbreaking approval last year, infusions of Vertex and CRISPR Therapeutics' and bluebird bio's sickle cell gene therapies have begun, bringing hope to patients and the companies closer to realizing revenue. Meanwhile, bispecifics and anti-TIGIT therapies were all the rage at ESMO 2024 as BioNTech, GSK and iTeos, BMS and more reported positive results across multiple cancers. Last week, Moderna announced it would slash its R&D budget by $4 billion as it targets 10 new approvals through 2027. Possibly boding well for this target, the biotech features prominently on our list of 5 late-stage mRNA vaccines to watch. Meanwhile, the oral obesity drug race continues to heat up, with Terns Pharmaceuticals, Roche and Novo Nordisk all reporting new data from their respective trials. And in the equally hot radiopharmaceuticals space, Sanofi inked a $110 million licensing deal with RadioMedix to develop a neuroendocrine tumor candidate. Finally, BioSpace takes a deep dive into the HEALEY ALS Platform Trial, which has so far seen quick failures and small victories as leaders and early participants remain hopeful.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Today's episode covers a range of key topics in the biopharma industry. First, ten-year survival data has revealed the long-term benefits of immunotherapy in melanoma, offering hope for potential cures. Kyverna has announced a CEO swap, appointing Kite veterans to lead the company's next chapter. Sanofi is gearing up to meet the US demand for an RSV antibody as the season approaches. Results from an ESMO trial have shown promising results for Iteos' TIGIT drug in shrinking lung tumors. In other news, Walgreens has settled allegations of fraudulent billing with the Department of Justice, agreeing to pay almost $107 million. Medicare Advantage bonuses are projected to decrease this year, with plans mainly going to UnitedHealthcare and Humana. Healthcare AI startups are raising venture capital funding, and the American Hospital Association is emphasizing regional cybersecurity preparedness. Bristol Myers Squibb (BMS) presented positive Phase III results for its Opdivo-Yervoy combo therapy at ESMO, while AstraZeneca reported success with its perioperative Imfinzi in bladder cancer. Lilly also received FDA approval for an eczema therapy. The Biosecure Act could have significant implications for U.S. biopharmaceutical companies, potentially leading to the termination of contracts with Chinese partners. Efforts in glioblastoma treatment research are ongoing, and strategies for optimizing clinical trial site selection are being explored. The pharmaceutical industry continues to face challenges in expanding patient access and improving cancer research outcomes. Stay tuned for more updates on these and other important developments in the biopharma world.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Evotec is exiting the gene therapy field and cutting jobs due to a slowdown in research spending. Merck has made a $700 million bet on an antibody drug for immune diseases, while Lilly has opened a new R&D hub in Boston. Ovid and Lexicon have laid off staff, and Merck's TIGIT drug has failed another trial. Intellia's therapy for hereditary angioedema has succeeded in a study. The gene therapy market is growing, particularly in cancer care, with companies continuing to invest in improving cell therapies. Cabaletta Bio's shares have sunk on safety concerns, while Vertex has secured reimbursement for Casgev in England. The world's priciest drug may save lives, but there are concerns about whether children can access it in time. Overall, the gene therapy industry is experiencing various developments and challenges as companies navigate the evolving landscape.The Biden administration announced that negotiated drug prices through the IRA program are expected to save Medicare $6 billion in 2026, although the actual savings may not be as significant as claimed. Gilead's investment in CymaBay paid off with FDA approval for a drug to treat autoimmune liver disease. Evotec is the latest biopharma company to announce layoffs in August. In other news, Incyte received a second FDA approval for a drug to treat graft-versus-host disease, while bluebird is experiencing slow uptake of its gene therapies for sickle cell and beta-thalassemia. The role of quality assurance and regulatory affairs (QARA) professionals is evolving, with strategies and best practices being discussed. Various marketing campaigns and strategies are being discussed, including Lobos 1707 casting LeBron James as a spy in new ads, Martha Stewart playing an intern in a Fiverr campaign, and US Bank celebrating black achievement with zines in The New York Times. Additionally, Allbirds' CMO talks about the importance of brand building in the company's turnaround plan. The text also includes information about first-party data strategies, an upcoming webinar on the state of marketing and print projects in 2024, and other relevant industry news and resources.In the healthcare industry, Medicare revealed the results of drug price negotiations, which are expected to save taxpayers $6 billion. Kaiser Permanente has implemented an AI documentation tool from Abridge to summarize medical information from patient-clinician conversations. Meanwhile, Medicaid has surpassed Medicare Advantage as a challenge for health insurers in the second quarter, but many still reported significant earnings. In other news, there are updates on healthcare worker strikes and unsealed court filings detailing a Department of Justice investigation into Prospect Medical for possible false claim act violations.The text discusses the health disparities highlighted by the COVID-19 pandemic, particularly among minority groups, and how these disparities were exacerbated during the crisis. It also explores the importance of building trust among patients of color in the healthcare system despite historical injustices and ongoing disparities. Dr. Reed Tuckson, a leader in public health outreach to people of color, shares lessons learned from the pandemic and discusses how pharma can better serve these communities.The U.S. government has unveiled the prices it will pay for 10 widely used medicines as part of its efforts to lower prescription drug costs through Medicare negotiations. These prices will not take effect until 2026, but the announcement marks a significant step in a process established by the Inflation Reduction Act. Biopharma Dive provides detailed coverage of this development and other industry news, offering insight into topics such as clinical readouts, FDA approvals, gene therapy, druSupport the Show.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.The FDA recently approved Ascendis' drug for a rare endocrine condition, while rejecting MDMA as a therapy aid for PTSD. Pfizer also presented data supporting a case for an RSV shot for immunocompromised adults. Zepbound shortages are starting to ease, but Lilly warns of potential pharmacy availability issues. Galderma has received FDA approval for a skin condition treatment, Nemluvio. In the biotech industry, trends in emerging technologies like gene editing, messenger RNA, and cell therapies are promising new types of medicines. Additionally, there is ongoing progress in cell therapy's impact on cancer care. Despite Merck's TIGIT drug failing another trial, Intellia's therapy succeeded in an HAE study.In other news, Grail plans to cut 350 employees as part of a restructuring effort, while Otsuka Precision Health launches the first digital therapeutic for depression. Globus receives a warning letter over its spine navigation robot, Baxter agrees to sell its kidney care unit to Carlyle for $3.8 billion, and Medtronic wins FDA approval for asleep deep brain stimulation surgery. The medical technology industry is also seeing updates such as FDA approvals for telemonitoring connectivity devices and concerns about undetected bird flu cases.Evotec and Grail have announced job cuts, with Evotec exiting gene therapy and Grail shedding 350 workers. Acelyrin is pivoting away from its main drug and laying off staff to focus on a treatment for thyroid eye disease. Pfizer has appointed an AI chief to expand its digital leadership team. Lilly has opened an R&D hub, while Ovid and Lexicon have laid off staff. The biopharma industry is shifting towards more patient-centric commercialization strategies.Grail is planning to reduce its current workforce by 25% in order to focus on multi-cancer diagnostics. Illumina has outlined a growth roadmap after divesting from Grail, focusing on easier DNA sequencing and improved data analysis for customers. Additionally, companies like Pfizer and Biontech are now shifting their focus to oncology drugs after finding success with COVID-19 vaccines.Experts are analyzing the potential impact of the Inflation Reduction Act (IRA) as the industry awaits the first negotiated drug prices under Medicare. The biotech industry is adapting to a new normal, with M&A activity surging and IPOs making a return. Companies like Lilly and Boundless Bio are making moves in R&D and workforce adjustments.Overall, the biotech industry is navigating a changing business landscape marked by strategic consolidation and renewed investor focus on innovation.Support the Show.

In one of the year's most highly anticipated decisions, the FDA rejected Lykos Therapeutics' MDMA-assisted therapy for post-traumatic stress disorder (PTSD). Reaction from Lykos was swift, with the company stating its intention to “ask for reconsideration of the decision.”   Meanwhile, against the backdrop of the CDC's recent RSV guidelines, Pfizer scored a big Phase III win for its shot in immunocompromised adults. Separately, Merck halted a Phase III trial of its Keytruda, anti-TIGIT, chemo combo in small cell lung cancer but made a splash with the potential $1.3 billion acquisition of Curon's B cell depletion therapy. And AI-focused biotechs Recursion and Exscientia are merging to create a new company that will take Recursion's name. Plus, as we reflect on Q2 earnings, it's becoming clear that Eli Lilly is catching up to Novo Nordisk in the weight loss sphere, while others faced challenges in the vaccine space and the continued COVID cliff. Finally, BioSpace highlights five obesity data readouts to watch in the second half of 2024.

Audio roundup of selected biopharma industry content from Scrip over the business week ended 9 August 2024. In this episode: Amgen positions for obesity and diabetes; BMS returns TIGIT asset in pipeline reshuffle; is Kerendia the next jewel in Bayer's crown?; Japan pharma firms cut jobs; and Sun Pharma seeks GLP-1 partner. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Abbott and Medtronic have announced a partnership to develop diabetes technology, with Abbott creating a glucose sensor that will only connect with Medtronic's insulin delivery technology. Nevro is considering a sale in response to increasing competition in the pain market, while the CMS has finalized a notice on Medicare coverage for breakthrough devices. Inspire has received FDA approval for obstructive sleep apnea neurostimulator therapy, J&J has launched a spine surgical robotics platform, and other notable news includes Big Health receiving FDA approval for its digital therapy for insomnia.CVS has cut its earnings guidance for the third time this year and fired the head of its insurance division, Aetna, due to struggles with high medical utilization in the Medicare Advantage sector. More than 700 rural hospitals are at risk of closing due to reimbursement challenges from private payers. Walgreens is considering selling off VillageMD, a reversal of its previous commitment to expanding healthcare delivery offerings. The 5th Circuit Court handed providers a win in no surprises litigation, vacating instructions that favored insurers over providers. Steward Health will lay off over 1,200 workers in Massachusetts as it prepares to close two hospitals. AI is being used in clinical trials to improve participant retention and KPIs.Pharma companies are currently in a strong position, resulting in smaller upfront payments for biotech startups in drug partnerships. Despite this trend, cell therapies in cancer care are evolving and gaining traction. Lilly resolves shortages of glp-1 medicines, Roche licenses technology for an Alzheimer's drug, and Madrigal sees success with the launch of their new drug. Bristol Myers sends back a TIGIT drug to Agenus, Sarepta reveals lower sales but anticipates growth, and best practices for NDAs and BLAs are outlined. Additionally, the CDC issues guidance on painful IUD insertions, a new strategy to suppress HIV shows promise, and 23andMe's sales miss estimates.Merck has made a significant investment of $1.3 billion to acquire Curon Biopharmaceutical's investigational antibody, which targets B cells and is being studied for non-Hodgkin's lymphoma and B cell acute lymphocytic leukemia. The deal includes an upfront payment of $700 million. In other news, a federal judge dismissed a lawsuit from the U.S. Chamber of Commerce challenging the IRA's drug price negotiation program, while Gilead Sciences reported strong sales in HIV, cancer, and liver disease treatments in the second quarter. Additionally, Lilly is closing the gap in the weight-loss drug market with their product Zepbound, competing with Novo Nordisk's Wegovy.On August 9, Merck made a $700 million bet on an antibody drug with potential in immune diseases. Zepbound shortages have eased, but Lilly warns that pharmacy availability may still be 'choppy.' Merck's TIGIT drug failed another trial, while Intellia's therapy succeeded in a study on hereditary angioedema. Sarepta revealed lower sales for Elevidys but remains optimistic about future opportunities. Biotech companies are receiving smaller upfront payments in drug partnerships, reflecting weaker leverage in deal talks. Cell therapy's impact in cancer care is growing, with ongoing investments to improve it.A district court judge dismissed a lawsuit from the U.S. Chamber of Commerce challenging the Biden administration's drug pricing program that allows Medicare to negotiate prices with pharmaceutical companies. This program aims to lower drug prices starting in 2026, with ten drugs selected for negotiation in the first round. Despite legal challenges from pharma giants like Merck & Co. and AstraZeneca, the judge ruled that the plaintiffs did not have standing to sue. This dSupport the Show.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Steward Health plans to lay off over 1,200 workers in Massachusetts and close two hospitals. Walgreens has reduced its stake in Cencora for $1.1 billion. The cost of healthcare data breaches is nearly $10 million in 2024, making healthcare the most expensive industry for data breaches. Employers are enhancing healthcare benefits despite rising costs, and Medicare has finalized a higher 2.9% inpatient payment rate for 2025. Virtual reality, robotics, and AI are transforming patient engagement, staff burnout, and clinical decision-making in the healthcare industry. Hospitals remain dissatisfied with Medicare's final rule despite the bump in payment rates.On August 5th, J&J launched the Velys spine surgical robotics and navigation platform, while Inspire received FDA approval for obstructive sleep apnea neurostimulator therapy. Philips is suing an independent lab over alleged errors in CPAP foam tests. Compliance hurdles with the FDA's lab developed test rule raise concerns about patient harm. The board of 23andMe rejected CEO Wojcicki's take-private proposal. J&J aims to compete with Stryker and Zimmer Biomet with its new surgical robotics portfolio. Inspire plans to launch its neurostimulator therapy device late in 2024. Philips claims an independent lab overestimated the threat of CPAP foam, leading to unnecessary recall efforts.Bristol Myers has halted Tigit drug research, while Lilly has resolved the shortage of Zepbound and Mounjaro. Biotech IPOs are vital for industry growth, with companies like Os Therapies and Actuate Therapeutics making moves in the market. Cell therapy is advancing in cancer care despite limited uptake, with biotech companies investing in its improvement. Pfizer discontinued late-stage gene therapy development for Duchenne Muscular Dystrophy (DMD), but other companies like RegenxBio and Capricor Therapeutics are making progress with their therapies. Oncology research is introducing new treatments like cell and gene therapies, revolutionizing cancer treatment.BioNTech reported a significant increase in losses in the second quarter of 2024, jumping to nearly $885 million compared to $208.5 million last year. The company is focusing on oncology amidst the impact of COVID-19. Lilly's drugs Mounjaro and Zepbound are no longer in shortage, according to the FDA. Bristol Myers Squibb is backing out of a $1.5 billion deal with Agenus for a bispecific antibody program, while Bayer's finerenone met its primary endpoint in a phase III heart failure trial. The pharmaceutical industry continues to see developments in various therapeutic areas, including Alzheimer's disease and rare diseases.Support the Show.

On this week's episode, hosts Chris Garabedian, Brad Loncar, Tim Opler, Dawn Bell, John Maraganore and Eric Schmidt provide a deep dive into the obesity, diabetes and cardiometabolic space, beginning with an overview of the key findings in Stifel's latest obesity report. The hosts also provide a recap of ADA and EASD abstract highlights and take a look at the next wave of injectable therapies and the trends in consumerization and access. They also discuss Pfizer's update on its once daily oral GLP-1 pill as well as recent reports on patients discontinuing GLP-1 drugs in two years and GLP-1s for obesity-related cancers. Shifting gears, the hosts spotlight a report on the evolving pharma landscape and the future landscape of the blockbuster drug category. In deals of the week, the group discusses Eli Lilly agreeing to buy Morphic for $3.2 billion and Flagship's new $3.6 billion fund. In data news, the hosts cover Roche's setback with its pivotal TIGIT trial, uniQure's positive data for its Huntington's gene therapy and IDEAYA's positive interim phase 2 MAT2a data. *This episode aired on July 12, 2024.

In this episode, we discuss the Dave Smith  @PartOfTheProblem  Chris Cuomo debate on  @VALUETAINMENT  , our predictions for the first presidential debate (see if they came true!) and more!! If you're enjoying the content, please like, subscribe, and comment! Please consider supporting the show! https://anchor.fm/worldxppodcast/support A cancer immunologist by training, Dr. Christopher Nirschl received his PhD from the Johns Hopkins School of Medicine in Immunology in 2015, and completed a postdoctoral fellowship at the Brigham and Women's Hospital in association with Harvard Medical School. He has been studying the interactions between cancer and the immune system for over a decade, and is also one of the inventors of the anti-TIGIT antibody ASP8374/PTZ-201 which is currently in clinical trials. Currently, Dr. Nirschl is an Immunologist at Werewolf Therapeutics in Massachusetts, where he lives with his wife and three children. Find his book, "What the Heck Is A Clinical Trial?", here - https://www.amazon.com/What-Heck-Clinical-Trial-Where-ebook/dp/B09QKG37T7 ______________________ Follow us! @worldxppodcast Instagram - https://bit.ly/3eoBwyr @worldxppodcast Twitter - https://bit.ly/2Oa7Bzm Spotify - http://spoti.fi/3sZAUTG Anchor - http://bit.ly/3qGeaH7 YouTube - http://bit.ly/3rxDvUL #patrickbetdavid #valuetainment #chriscuomo #davesmith #debate #trump #biden #freedom #immunology #covid #fauci #clinicaltrials #immunologist #author #published #life #lifeexperience #politicalnews #unitedstates #rogan #twitterfiles #podcastshow #longformpodcast #longformpodcast #podcasts #podcaster #newpodcast #podcastshow #podcasting #newshow #worldxppodcast --- Support this podcast: https://podcasters.spotify.com/pod/show/worldxppodcast/support

Drs. Shaalan Beg and Rachna Shroff discuss key abstracts on GI cancers that were featured at the 2024 ASCO Gastrointestinal Cancers Symposium, including SKYSCRAPER-08, EMERALD-1, and NEST-1 in esophageal squamous cell carcinoma, hepatocellular carcinoma, and colorectal cancer, respectively. TRANSCRIPT Dr. Shaalan Beg: Hello, and welcome to the ASCO Daily News Podcast. I'm Dr. Shaalan Beg, your guest host of the podcast today. I'm an adjunct associate professor at UT Southwestern's Simmons Comprehensive Cancer Center and vice president of oncology at Science 37. Today, we'll be discussing key abstracts and other exciting highlights from the 2024 ASCO Gastrointestinal Cancers Symposium. Joining me to discuss some key takeaways from the meeting is the chair of this year's Symposium, Dr. Rachna Shroff. Dr. Shroff is the division chief of Hematology Oncology and chief of GI Medical Oncology at the University of Arizona Cancer Center. She also serves as the associate dean for clinical and translational research at the University of Arizona College of Medicine – Tucson. Our full disclosures are available in the transcript of this episode, and disclosures related to all episodes of the podcast are available at asco.org/DNpod.  Dr. Shroff, welcome back to the ASCO Daily News Podcast, and congratulations on a great Symposium. The scientific advances and innovative, multidisciplinary approaches that were featured throughout the meeting were really inspiring and reflect the incredible strides we're making in GI cancer research. Dr. Rachna Shroff: Thank you so much for having me back. I am delighted to be here.  Dr. Shaalan Beg: Dr. Shroff, the theme of this year's symposium was "Taking Personalized Care to the Next Level." I'd love to hear your reflections on the sessions that you found most exciting and really resonated with the attendees.  Dr. Rachna Shroff: Yes, thank you. We were really excited about this theme because we really felt that “Taking Personalized Care to the Next Level” translated to thinking through personalized approaches to patient care, not just in the traditional ways that we think of with precision oncology and genomics driving our care, but also how we can think through multidisciplinary approaches and an individualized care plan. Thinking through how artificial intelligence and novel clinical trial designs can and should be implemented to meet the needs of our individual patients. And so we really highlighted that in what was a somewhat new reboot of a session called “Intersections,” which were every day and were really more cross-tumor; they were tumor agnostic but were thematic focused. As I mentioned, those themes were really based on feedback that we had from prior attendees, as well as from the program committee's feeling on what are really the questions that we are dealing with and that are burning in the clinic today and that includes the emerging role of artificial intelligence and machine learning and how we integrate that into our clinical care, approaches to oligometastatic disease, and it's not really just something that we think of in colorectal cancer but haven't fully used that paradigm to really apply it to other GI malignancies. And then the art and science of clinical trial design where, again, traditional randomized phase 3 trials might not be the best and most innovative and most expedient way of bringing novel therapeutics to our patients. And so, I thought that all of those sessions were really highlighting different important topics that we deal with day to day. Additionally, we had a really fantastic keynote lecture from Dr. Kimmie Ng of the Dana-Farber Cancer Institute. She is a world-renowned expert in the early-onset colorectal cancer space, and the timing of her keynote was perfect with the new cancer statistics that came out literally days before GI ASCO that demonstrated this just dramatic rise in early onset GI malignancies as a whole, not just colorectal. And she spoke really in a comprehensive manner not just on clinical approaches, screening approaches, and how to find these patients at an earlier stage, but also kind of gave us a call to action, if you will, in terms of public health initiatives, as well as like I said, clinical care and really thinking outside of the box for how to reach these patients.  And then, of course, we always have what I think is one of my favorite aspects of the meeting, which are the networking opportunities that include the Trainee and Early Career Networking Luncheon, the Women's Networking Reception, and the Meet the Experts Luncheon where, especially as junior career investigators, you have an opportunity to meet what we think of as the “big names” in GI cancer. Dr. Shaalan Beg: Absolutely, I remember my first couple of GI ASCO meetings and those were probably the most memorable sessions that I attended as junior faculty as well.   So let's take a deeper dive into some key abstracts from the meeting. I'd like to begin with Abstract 245. This is the SKYSCRAPER-08 study. It's first-line tiragolumab and atezolizumab with chemotherapy in an Asian patient population with esophageal squamous cell carcinoma. What are your key takeaways from this study?  Dr. Rachna Shroff: Yeah. This was an exciting study in my opinion in the sense that thinking through how we can build on immunotherapy backbones is obviously a pressing question across the GI cancer space. So this was a phase 3 randomized, double-blinded, placebo-controlled trial that looked specifically at patients with esophageal squamous cell carcinomas. And the study was enrolled fully with an Asian population. It looked at taking the traditional chemotherapy backbone and adding to it an anti-PD-L1 with atezolizumab and an anti-TIGIT with tiragolumab. Again, that proof of principle of using anti-TIGIT and PD-L1 has been looked at across a lot of different GI cancer spaces and we know that the esophageal squamous cell cancers tend to be very immunotherapy responsive. So this was a really important question.  This involved a number of patients, a little over 460 patients, who were randomized one-to-one to receive the tiragolumab with atezolizumab with the standard paclitaxel and cisplatin, that's used for esophageal squamous versus chemotherapy alone with placebo. And the primary endpoint was independent review of progression-free survival, and overall survival. And so, out of the 461 patients randomized, there was at the primary analysis, a median improvement in progression free survival, from 5.4 months in the control arm to 6.2 months with a tira-paclitaxel plus chemo arm with a hazard ratio of 0.56, highly statistically significant. Similarly the median overall survival was also improved from 11.1 months to 15.7 months again with a hazard ratio of 0.7 and some of the other key efficacy endpoints were also improved with the addition of the anti-TIGIT PD-L1 approach. And importantly, there was not really safety signals that jumped out at us.  And so, to me, what this means is that, in our patients with esophageal squamous cell carcinoma, we really should be thinking about chemotherapy with immunotherapy as a backbone and how we can build on it. And, you know, I would imagine that it's hard to argue with both the PFS and OS endpoint that adding anti-TIGIT won't necessarily be kind of the new approach to these patients. And importantly, I'll point out that it seems to be a benefit across the subgroups, including PD-1 status, which is always our big question here. I think the only thing to keep in mind is this was an all-Asian population and whether or not that kind of immune profile of the immune responsiveness is different in those patients, but regardless, a positive phase 3 trial. Dr. Shaalan Beg: It's really exciting to see immune checkpoint inhibitors or immunotherapy beyond PD-1 targeted, CTLA-4 targeted treatments making their way into GI Cancers.  Dr. Rachna Shroff: Absolutely. Dr. Shaalan Beg: Sticking with the immunotherapy theme, let's focus on hepatocellular carcinoma. So LBA432, the EMERALD-1 study of transarterial chemoembolization combined with durva with or without bevacizumab looked at people with unresectable hepatocellular carcinoma eligible for embolization. So really a highly anticipated study, I'm wondering what your thoughts are and whether it'll be practice-changing for this field.  Dr. Rachna Shroff: I was excited to see the press release when it showed that the study was positive, and I think it's because now that we're using immunotherapy in the advanced HCC space, our obvious question is, can we integrate it into multimodality approaches? There are a lot of smaller studies looking at neoadjuvant IO approaches, and in this intermediate stage, unresectable hepatocellular carcinoma patients. We wanted to know if there was a utility to liver directed therapy with immunotherapy.  So, this was a large study. It was a global study looking at unresectable HCC with preserved Child-Pugh function. But it was Child-Pugh A and up to B7, importantly. And there were 616 patients randomized in a 1:1:1 fashion, with the control arm being just TACE alone. But then, there was also an opportunity for durvalumab with TACE, as well as durvalumab plus bevacizumab with TACE. The patients would receive durvalumab during their TACE treatments and could receive up to four TACE treatments and then subsequently were either continued on durvalumab alone, durvalumab plus bevacizumab, or the placebo. The primary endpoint was progression-free survival, powered specifically to look at TACE versus durvalumab plus TACE. In this study, the primary endpoint was met with a significant improvement in PFS. Median PFS was 15 months versus 8.2 months, with a hazard ratio of 0.77. Most prespecified subgroups demonstrated this benefit.  Importantly, there was a secondary endpoint looking at durvalumab plus TACE versus TACE alone, and that actually did not show a statistically significant improvement in median PFS from 8.2 months in the control arm to 10.0 months. The overall response rates were slightly higher with the durvalumab plus bevacizumab approach at 43.6%. And importantly in these patients, who oftentimes have a higher burden of disease in the liver, median time to progression is a really important and clinically meaningful endpoint. That was 22 months with the durvalumab plus bevacizumab and TACE versus 10 months for TACE alone. I would just point out that the overall concern we always have with bevacizumab is the increased risk of bleeding and the treatment-related adverse event profile. Overall, there were no safety signals that emerged from this, with nothing that really, especially in that bleeding risk category, jumped out at us. Of course, we haven't seen the overall survival data yet because we have not seen enough follow-up to really see that number.  I do think that this is potentially practice-changing, and I think it just demonstrates that there's probably some synergy between anti-VEGF with anti-PD-1, and then the liver-directed treatments. The obvious question for us in the United States is that the vast majority of people are moving away from TACE and towards more radioembolization and what can we extrapolate from this? Does this really tell us much if people are using more of a Y90-based approach? I think those are a lot of the burning questions that most of us have.  Dr. Shaalan Beg: Yeah, and it's a very interesting direction that the HCC space is taking because we heard in previous meetings, the role of PD-1 inhibition as adjuvant therapy after resection. Now, we have data for local-regionally advanced disease over local-regional treatments. And of course, you already mentioned the data for more advanced disease. So it sounds like immunotherapy may be impacting the management of anyone diagnosed with hepatocellular carcinoma.  Let's talk about the MONET trial, Abstract 249, which compared thoracoscopic esophagectomy and open esophagectomy for thoracic esophageal cancer. Do you think this is a study which may influence the treatment of patients with thoracic esophageal cancer? Dr. Rachna Shroff: So, this was, again, I think, a really important question. It was a randomized, controlled phase 3 trial comparing a more minimally invasive approach with TE — thoracoscopic esophagectomy — versus an open approach. This had patients with clinical stage 1-3, excluding T4 thoracic esophageal squamous cell carcinomas. They were randomized 1:1 to the open versus the TE approach, with a primary endpoint of overall survival and an important secondary endpoint of relapse-free survival. 300 patients were randomized, and at the second planned interim analysis, the median follow-up was a little over two and a half years. The 3-year overall survival was 82% in the TE group versus 70.9% in the open group. The DSMC of this trial actually recommended early termination based on the non-inferiority, which is what they were specifically looking at. There was a very statistically significant one-sided p-value for non-inferiority.  Importantly, the 3-year recurrence-free survival was also markedly better in the TE group versus the open group, with no real notable differences in R0 resection, or a large percentage of patients who needed to be converted from a TE to an open approach, and really not any significant difference in overall postoperative morbidity. I think this just supports the concept that minimally invasive approaches for our patients with GI malignancies can and should be considered. Again, esophageal squamous because they tend to be seen a lot more in Asia, this study was conducted in Japan, but I think that being said, a lot of our surgeons in Europe and in the U.S. are also very amenable to minimally invasive approaches. And I think this just supports the fact that an open approach is not necessary. So, I would think again, that this is something that is implementable and I think will affect the field.  Dr. Shaalan Beg: Moving on to metastatic cholangiocarcinoma, there have been many FGFR inhibitors that have shown activity and promise and are approved for the management of cholangiocarcinoma with FGFR alteration. But at this ASCO GI, we heard the results of the safety and efficacy of an FGFR1, 2, and 3 inhibitor, tinengotinib, as monotherapy for advanced metastatic cholangiocarcinoma (Abstract 434). How do you see this fitting into the broad picture? Dr. Rachna Shroff: Yeah, so this was highly anticipated data, primarily because at this point, the FGFR space in cholangiocarcinoma is quite crowded. And so a lot of us were getting sick of the "me-too" drugs. What is really unique about tinengotinib is that, not only is it a selective multikinase inhibitor, but it also, in preclinical models as well as in early phase one trials, demonstrated potent inhibition of patients with FGFR2 fusions and rearrangements who had acquired resistance mutations. So, as we better understand the first generation of FGFR inhibitors and note the resistance mechanisms, these drugs are now being developed to try to circumvent or overcome those.  This study looked at 4 different cohorts: 1 cohort with FGFR2 fusion patients who had primary progression who never responded to FGFR inhibitors, a second cohort with FGFR2 fusion patients who had progression after primary response, so those with acquired resistance, and then there was non-fusion FGFR alterations because we do know that a number of cholangiocarcinoma patients have other FGFR alterations that are not fusions, and then those with FGFR wild-type. The primary endpoint was objective response rate, with a total of 48 patients enrolled across the four cohorts. And so the 40 patients who were evaluable in the group that had primary resistance, which was the first cohort, there was a response rate was 9.1% and that was partial response, and 31% had tumor reduction with tinengotinib. And similarly in those with acquired resistance, 37.5%, 3 out of 8 patients had a partial response and tumor reductions were noted with an overall disease control rate between those patients with FGFR2 fusions of 94.7%, between those with primary and secondary resistance.  In the patients who had FGFR alterations, there was 3 out of 9 patients with a partial response and again, tumor reductions were notable across the board and the disease control rate was 88.9%. The FGFR wild-type group, not surprisingly, did not see any partial responses, but interestingly, 75% of these patients had at least disease control, and the median progression-free survival was 5.26 months, again, kind of most notably impressive in the 2 cohorts that included FGFR2 fusions. The toxicity profiles are what we come to expect for FGFR inhibitors and we've gotten better at managing those and mitigating some of those so there was really nothing to jump out there. So there is now an ongoing randomized phase III trial specifically looking at tinengotinib versus physician's choice in patients with FGFR2-altered cholangiocarcinoma after having received prior FGFR inhibitors. So that's where I think it's in is for those of us who know that there are multiple drugs in the space, our big question is can we sequence through that? Can we offer multiple FGFR inhibitors in these patients? And I think we are all eagerly anticipating this data as well as the subsequent data to really justify the use of these novel second generation FGFR inhibitors.  Dr. Shaalan Beg: It's been fantastic to see the evolution of these compounds in precision medicine, or precision oncology at its finest, in terms of understanding mechanisms of resistance and treating refractory disease.   Let's focus on colorectal cancer. I'll tell you, there has been a lot of discussion, Dr. Shroff, on social media, on insurance companies sometimes rejecting one biologic or the other based on tumor sidedness. We have talked about tumor sidedness predicting response on this podcast based on data from previous studies. But this year in GI ASCO, Abstract 207 explored the role of tumor genomics and tumor sidedness and they said that it's tumor genomics, that tumor genomics better explains the differences on outcomes, and it explains it better than sidedness. What does this mean to the field? Because a lot of professional organizations have guidelines that are asking people to now incorporate sidedness. So how does that change based on these results? Dr. Rachna Shroff: I really commend these authors on leveraging real-world data, and I think we're getting better and better at recognizing that real world data actually informs our clinical decision making, possibly better than sometimes some of these studies that lead to the guidelines and algorithms that we develop. So this is a perfect example of a little bit cart before horse in trying to understand the way that sidedness and genomics may interplay.   So this was a study that basically leveraged both the Foundation Medicine and Flatiron Health clinical genomic database and looked at patients with microsatellite stable metastatic colorectal cancer. There were a total of 3,845 patients included in a kind of two-thirds one-third split between left sided and right-sided colorectal cancer. And they found the typical genomic alterations that historically have been thought of more with left-sided colorectal cancer like APC and then more of the RAS BRAF alterations in the right-sided patients. But I think what they really thought and what I think was remarkable is they really looked at the patients and how they received chemotherapy with anti-EGFR or bevacizumab therapies, and they did a multivariate analysis to really see what is driving outcomes. And like you mentioned, what they found was patients in the RAS pathway, those classified as having alterations in the RAS pathway, had less favorable outcomes, while those with APC altered group had more favorable outcomes. And that was regardless of treatment received and sidedness.  And so when they did an analysis of what was called a “likelihood ratio test,” they found that when genomics was added to the sidedness evaluation, there was an improvement in outcome prediction, but not when sidedness was added to genomics. Like you said, it kind of demonstrates, at least in this mining of real-world data from Flatiron that tumor genomics is probably a better driver and a more important driver in determining outcomes than sidedness.  I totally agree with you. I would push for us to really kind of bring a little bit of noise to this and to make insurance companies and other companies that are looking at this to think through this a little bit more and make sure that we're putting all of the data together in a comprehensive passion before making the treatment plans and determinations. Dr. Shaalan Beg: The last abstract I'd like to ask you about is Abstract 117, the NEST-1 trial. This study looked at neoadjuvant botensilimab and balstilimab for resectable mismatch repair proficient and deficient colorectal cancer, both MSS and MSI. What are your key takeaways from this study?  Dr. Rachna Shroff: This is another study that is demonstrating that there may potentially be a role for immunotherapy in microsatellite stable patients. I will make the caveat that this was a single-arm study that really was looking at feasibility safety, with efficacy as a secondary endpoint. The combination of bot-bal in the neoadjuvant space for colorectal cancer patients, they received one dose of boten and two fixed doses of bal two weeks apart and then were taken to surgery. They limited the number of patients and out of the 12 patients that were enrolled, they limited the number of mismatch repair deficient patients. So to your point, they allowed both, but they wanted to make sure it was not just MSI-high patients. What they basically found is that it was safe and did not delay surgery or increase risks of adverse events. But importantly, there was significant regression of tumor noted. And some interesting spatial biology analyses demonstrated potentially novel mechanisms of action, especially in the MSS population, and that ctDNA reductions correlated with pathologic response. There were a lot of different things that they were looking at, basically suggesting that bot-bal is safe and can be used in both mismatch repair–deficient and proficient patients with colorectal cancer. And now importantly, they've added some additional cohorts and expanding the study. As I mentioned, this is right now just 12 patients, but does definitely have a provocative result.  Dr. Shaalan Beg: Thanks so much, Dr. Shroff.  Finally, the role of cell-free DNA (cfDNA) in GI cancers has been an exciting and important development in our field. There's tremendous data that emerged at the GI meeting, and we have decided to do a separate ASCO Daily News Podcast dedicated to ctDNA. So listeners, please look out for our coverage of key studies on ctDNA in GI cancers very soon here on the ASCO Daily News Podcast.  Many thanks, Dr. Shroff, for sharing your insights with us today and for your great work in building a robust GI meeting this year. Thank you very much. Dr. Rachna Shroff: Thank you so much. Dr. Shaalan Beg: And thank you to all our listeners for your time today. You'll find links to the abstracts discussed on the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and inform. It is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Our guests on this podcast express their own opinions, experiences, and conclusions. These statements do not necessarily reflect the views of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an endorsement by ASCO.   Find out more about today's speakers: Dr. Shaalan Beg @ShaalanBeg Dr. Rachna Shroff @rachnatshroff   Follow ASCO on social media:  @ASCO on Twitter  ASCO on Facebook  ASCO on LinkedIn    Disclosures: Dr. Shaalan Beg: Employment: Science 37 Consulting or Advisory Role: Ipsen, Array BioPharma, AstraZeneca/MedImmune, Cancer Commons, Legend Biotech, Foundation Medicine Research Funding (Inst.): Bristol-Myers Squibb, AstraZeneca/MedImmune, Merck Serono, Five Prime Therapeutics, MedImmune, Genentech, Immunesensor, Tolero Pharmaceuticals   Dr. Rachna Shroff: Consulting or Advisory Role: Exelixis, Merck, QED Therapeutics, Incyte, Astra Zeneca, Taiho Pharmaceutical, Boehringer Ingelheim, SERVIER, Genentech, Basilea Research Funding: Pieris Pharmaceuticals, Taiho Pharmaceutical, Merck, Exelixis, QED Therapeutics, Rafael Pharmaceuticals, Bristol-Myers Squibb, Bayer, Immunovaccine, Seagen, Novocure, Nucana, Loxo/Lilly, Faeth Therapeutics

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. Today, we have some exciting news to share with you.## Artificial Intelligence in HealthcareLet's start with a discussion on the benefits of using artificial intelligence (AI) in the healthcare industry. AI has the potential to revolutionize patient care and support in several ways.Firstly, AI can streamline the patient experience by automating processes such as appointment scheduling and prescription refills. This not only improves efficiency but also reduces treatment time.Secondly, AI can relieve the burden on healthcare professionals (HCPs) by assisting them in tasks like data analysis and diagnosis. This allows HCPs to focus on providing personalized care to patients.Lastly, AI can help optimize resource allocation and improve cost-effectiveness in healthcare systems. By leveraging AI tools for patient support, pharmaceutical brands can provide more comprehensive services without significantly increasing costs.Overall, AI has the potential to enhance patient care and support while alleviating the burden on HCPs. It creates better connections between pharma brands and patients and improves treatment outcomes.## Key Developments in BiopharmaMoving on to some key developments in the biopharma industry, we have several exciting updates to share with you.Firstly, there is growing interest in using CAR-T cell therapy to treat autoimmune diseases like lupus. Several drugmakers have initiated clinical trials targeting lupus, indicating the potential of this therapy.Secondly, Vertex has developed a non-opioid drug that has shown positive results in reducing pain. While it fell short compared to a widely prescribed opioid in a secondary goal, this highlights the ongoing challenge of developing effective non-opioid pain treatments.Regeneron is also making strides in the biopharma industry by acquiring 2seventy's cell therapy pipeline. This acquisition reflects their focus on advancing cell therapies and signals the growth of this field.Additionally, Gilead is deepening its investment in Arcus and TIGIT drugs, demonstrating their belief in the potential of the TIGIT pathway.Lastly, a startup called Cour has received significant funding to develop nanoparticle technology for treating autoimmune diseases. This innovative approach aims to "reprogram" the immune system.These developments showcase advancements in cell therapy, non-opioid pain treatments, and autoimmune disease research.## Latest News in BiopharmaIn recent news, there has been a surge in cell therapy trials for lupus following a landmark paper in 2022. This shows promising progress in finding treatments for autoimmune diseases.Furthermore, CG Oncology's successful IPO raised $380 million, indicating positive prospects for other companies planning to go public.Arrivent, a cancer drugmaker, also had a successful IPO, raising $175 million. This highlights strong investor demand for late-stage drugmakers.Accent, a startup working on RNA-targeting cancer drugs, secured funding from pharma giants J&J and Bristol Myers. This further emphasizes the interest and support for innovative therapies.Novo Nordisk has struck a deal with startup Eracal Therapeutics to develop obesity drugs. This collaboration highlights the importance of partnerships in advancing healthcare solutions.Alto Neuroscience and Fractyl Health are preparing for IPOs this week, adding to the momentum of biotech IPOs in the industry.Overall, these developments highlight the ongoing progress and investments in biopharma, particularly in areas such as cell therapy, cancer research, and innovative drug development.That's all for today's episode of Pharma and Biotech Daily. Join us next time for more important news from the world of Pharma and Biotech.

If you're enjoying the content, please like, subscribe, and comment! Please consider supporting the show! https://anchor.fm/worldxppodcast/support A cancer immunologist by training, Dr. Christopher Nirschl received his PhD from the Johns Hopkins School of Medicine in Immunology in 2015, and completed a postdoctoral fellowship at the Brigham and Women's Hospital in association with Harvard Medical School. He has been studying the interactions between cancer and the immune system for over a decade, and is also one of the inventors of the anti-TIGIT antibody ASP8374/PTZ-201 which is currently in clinical trials. Currently, Dr. Nirschl is an Immunologist at Werewolf Therapeutics in Massachusetts, where he lives with his wife and three children. Find his book, "What the Heck Is A Clinical Trial?", here - https://www.amazon.com/What-Heck-Clinical-Trial-Where-ebook/dp/B09QKG37T7 ______________________ Follow us! @worldxppodcast Instagram - https://bit.ly/3eoBwyr @worldxppodcast Twitter - https://bit.ly/2Oa7Bzm Spotify - http://spoti.fi/3sZAUTG Anchor - http://bit.ly/3qGeaH7 YouTube - http://bit.ly/3rxDvUL #health #healthinsurance #insurance #trump #biden #freedom #immunology #covid #fauci #clinicaltrials #immunologist #author #published #life #lifeexperience #boundaries #politicalnews #unitedstates #moderna #pfizer #rogan #twitterfiles #podcastshow #longformpodcast #longformpodcast #podcasts #podcaster #newpodcast #podcastshow #podcasting #newshow #worldxppodcast --- Support this podcast: https://podcasters.spotify.com/pod/show/worldxppodcast/support

ASCO: You're listening to a podcast from Cancer.Net. This cancer information website is produced by the American Society of Clinical Oncology, known as ASCO, the voice of the world's oncology professionals. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guests' statements on this podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Cancer research discussed in this podcast is ongoing, so data described here may change as research progresses. The theme of the 2023 ASCO Annual Meeting was “Partnering With Patients: The Cornerstone of Cancer Care and Research.” From June 2 to 6 in Chicago, Illinois, and online, cancer researchers and clinicians from around the world gathered to discuss the latest cancer research and how to ensure that all people receive the cancer care they need. In the Research Round Up series, members of the Cancer.Net Editorial Board discuss the most exciting and practice-changing research in their field presented at the meeting and explain what it means for people with cancer. In today's episode, our guests will discuss new research in melanoma and health equity. First, Dr. Katy Tsai discusses new research in melanoma. Dr. Tsai is a medical oncologist and Assistant Professor of Medicine in the Division of Hematology and Oncology at the University of California, San Francisco. She is also the 2023 Cancer.Net Associate Editor for Melanoma & Skin Cancer. You can view Dr. Tsai's disclosures at Cancer.Net. Dr. Tsai: Hello. Welcome to the ASCO Cancer.Net Research Round Up. I'm Katy Tsai, an associate professor of medicine and the clinical medical director of the Melanoma and Skin Cancer Program at the University of California, San Francisco. I'm happy to be here today to discuss research on melanoma and skin cancers presented at the 2023 ASCO Annual Meeting. I do not have any disclosures relevant to the studies to be discussed. So, it's always exciting to see the latest research presented at ASCO. One theme in particular that I'd like to highlight in this podcast is recent advances in the field of adjuvant therapy. For the listeners who may not be familiar with this terminology, adjuvant therapy refers to drugs given after surgery to try to decrease the risk of cancer recurrence. Specifically, late-breaking abstract 9505 presented updates from KEYNOTE-716, an adjuvant study of pembrolizumab, or pembro, in patients with resected high-risk stage II melanoma. Late-breaking abstract 9503, which I'll also discuss, presented data from KEYNOTE-942, a pivotal study of a personalized cancer vaccine plus pembrolizumab in patients with resected high-risk stage III and stage IV melanoma. So, let's start with KEYNOTE-716. We've known for some time in our field now that adjuvant pembrolizumab or nivolumab can help decrease the risk of recurrence for patients with resected stage III or IV melanoma. What may not be as well-known, however, is that patients with stage IIB or IIC melanomas, in other words, thicker, ulcerated primary melanomas, even without lymph node spread, actually have a comparable risk of melanoma recurrence compared to patients with early stage III melanomas. KEYNOTE-716 was a large, international phase 3 study that randomized patients with stages IIB and C melanoma to receive either pembro or placebo. The positive results showing improvement in relapse-free survival led to approval of adjuvant pembro in December 2021, but what was presented at ASCO was an update on distant metastasis-free survival. This is obviously an important endpoint for us because ultimately, if someone is going to develop widely metastatic disease, unfortunately, it is a development of these distant metastases that we are concerned about. So what we saw here is that with landmark 36-month follow-up, there was a 41% reduction in the risk of developing distant metastasis in patients who were treated with pembro compared to those who received the placebo. In addition, there was a consistent maintained benefit in relapse-free survival, and importantly, no changes in the side effect profile. These are important data because I believe it is practice-changing in the sense that this is a population of patients who historically might not ever have been referred to medical oncology, maybe just monitored serially with their dermatologists. And this is an option that should be discussed. Ultimately, the risk versus benefit about whether to pursue a year of therapy versus maybe consider treatment only at the time of recurrence is a very personalized discussion between a patient and their treating oncologist, but it is an option that should definitely be offered. So let's move on to KEYNOTE-942. The novel drug being tested in this trial is very exciting. We're calling it “individualized neoantigen therapy.” So this is basically a platform that allows us to develop individualized treatment for someone based on characteristics of their own cancer. This involves taking the actual tumor specimen, genomic sequencing, specifically whole-exome sequencing is performed to try to identify any changes in the DNA. And then through a bioinformatic pipeline, the mutations in the DNA that are thought to be most likely to generate proteins that can be bound within presenting molecules are then identified in the computer program, then synthesized within mRNA. So very similar to the way that COVID vaccines have been made. So this actually becomes the actual drug product. So in this study, patients were randomized to receive either pembrolizumab by itself for a year, which is, as we alluded to earlier, standard adjuvant therapy, but then with the addition of this individualized neoantigen therapy starting with dose 3 and then throughout the rest of the year. So the recurrence-free survival data were actually presented earlier this year at another major conference, AACR [American Association for Cancer Research], and were highly positive. At ASCO 2023, I think what was most impressive about the presented data is that distant metastasis-free survival, so again, a similar important endpoint that we discussed with the other trial, is that the distant metastasis-free survival here was quite impressively maintained. There was a hazard ratio of .35, meaning really a 65% reduction in the risk of recurrence for patients who received the personalized neoantigen therapy plus pembrolizumab. So this is a huge advantage for distant metastasis-free survival in this particular population of patients. What was even more intriguing is that usually when we combine therapies, we tend to see additive toxicity, more side effects. And what was really exciting about this particular trial is that the additive toxicity really wasn't as much as you would expect for giving 2 immunotherapies at the same time. I'll also highlight that even though these results are really exciting within melanoma, that part of the reason this data is so exciting is that it represents a really promising platform for therapeutic development and application in other tumors besides melanoma. So this is definitely super exciting. While perhaps not practice-changing in this moment, it's potentially practice-changing. And I look forward to seeing additional data coming in from planned trials using this particular combination in the metastatic setting in addition to the adjuvant setting. So on the whole, I do think that updates in adjuvant therapy for melanoma were super exciting to see at ASCO 2023. As I mentioned earlier, it's a very large conference. A lot of exciting data being presented. So I do think that other themes to pay attention to as we continue to sort through existing data and look forward to incoming data from forthcoming trials is looking at neoadjuvant therapy. For example, drug given before surgery to try to improve long-term outcomes. For example, at ASCO this year, there was interesting neoadjuvant immunotherapy data presented not for melanoma, but for a different type of skin cancer called squamous cell carcinoma. So that would definitely be another theme to pay attention to in the coming months and years. Thinking about novel combinations, for example, what's new in immune checkpoint inhibitors, we've been used to for a long time referring only to anti-PD1 antibodies, anti-CTLA4 antibodies. What was interesting to see this year were updates in novel combinations, for example, PD1 antibodies combined with LAG3 antibodies. Antibodies against TIGIT. So I think this will be another exciting space to pay attention to both in the metastatic skin cancer setting and in the adjuvant and neoadjuvant settings. Thank you for your time and attention. That concludes my research roundup for melanoma and skin cancers. Thank you. ASCO: Thank you, Dr. Tsai. Next, Dr. Manali Patel discusses new research in health equity. Dr. Patel is a medical oncologist and Assistant Professor of Medicine at Stanford University. She is also the 2023 Cancer.Net Associate Editor for Health Equity. You can view Dr. Patel's disclosures at Cancer.Net. Dr. Patel: Hi, my name is Manali Patel. I'm the Associate Editor for Health Equity for Cancer.Net, and I'm so incredibly excited to present some really amazing work that was presented at our ASCO Annual Meeting this past June in Chicago. Before I start, I do have one disclosure. I will be talking about studies that were presented relating to patient navigation and one study in particular that my group presented looking at community health workers. And so that is a little bit of a disclosure that I would like to address upfront. And now, just to get right started. I thought what was really interesting was the amount of work this year that was presented on disparities in health equity. As in past years, we actually saw quite an influx, probably more so this year than previously, on studies that looked at differing outcomes, inequities in cancer care delivery, describing disparities in terms of receipt of treatment, so if people were receiving treatment. There tended to be a lot of studies that focused on looking at and describing a lot of these disparities. But what I was really impressed by came out from the pediatric colleagues, individuals who are taking care of younger patients, children who are less than the age of 18, and how many of those particular studies were focused on moving from description to actually intervening and making a difference in health equity. And so I want to highlight a couple. There was one that was done out of Dana-Farber, and actually, a multi-site group of authors. So lots of authors from all over the place, but Emily Jones was the lead author. And they described and actually evaluated how they could collect, in the context of clinical trials for children, which is called Children's Oncology Group Trial-- how they could collect social determinants of health data, meaning data that evaluates people's income, transportation, where people live, what kind of work they may do, if they have food and housing insecurity. And what they were able to show is that, by embedding a lot of these data points-- they actually made these data points optional for patients when they came into the clinical trial. And they found high feasibility, meaning lots of people that were signing up to do clinical trials for the Children's Oncology Group Trial were able to complete this extra data, which is extremely important and is a remarkable willingness of individuals to participate in providing this data which is important for their treatment. Along those same lines, Amy Newman from the Children's Hospital of Philadelphia really did a very nice study looking at the feasibility of what they called PediCARE. And it was this intervention that was focused on trying to ensure that people-- again, children less than the age of 18 across 2 different clinics. They evaluated whether PediCARE would help people to receive necessary and important resources as it relates to social and economic needs. And so they screened for food insecurity, for housing insecurity, for people that had difficulties paying for utilities, and transportation security. And then they randomized individuals to either PediCARE or to just usual cancer care. And what they found was that 100% of the people that were randomized to PediCARE successfully received grocery and transportation resources. They felt that it was easier to buy food for their family, and they reported it was easier to get to and from the hospital and that they would be very likely to report and to recommend this intervention to other individuals. And so it really shows how these interventions can move from just describing that housing, food insecurity or problems-- number 1, it starts with the collection of the data, right? What's really important is making sure that we collect this data because we don't currently do that in cancer care. And then number 2, when we actually do collect the data, what are we going to do about it? And it shows that these interventions really do help people to move past their housing and social and economic issues that they may experience into actually receiving care that's important and necessary to improve outcomes. We did see a lot of data reflecting the importance of health insurance and big policies, what I call Big P, which are these national policies, like the Affordable Care Act. And now we've seen, just year after year and including this year, plethora of studies showing how beneficial the Affordable Care Act has been on reducing disparities and improving cancer outcomes overall. We also saw other studies, such as one presented by Dr. Gladys Rodriguez from Northwestern, which looked at disparities in the intensity of care at the end of life amongst patients with gastrointestinal cancers. And the team revealed, across almost 20 years of data in California, that patients were receiving higher rates of what would be considered low-quality care. Now, this is lower hospice use, which we know helps to actually improve survival, lower rates of palliative care use, and greater rates of burdensome hospitalizations. And now, why I think this is particularly important is because this study evaluated what we know is a problem, that there is low-quality care amongst patients from particular racial and ethnic populations, such as Black and Hispanic patient populations, that aren't receiving the right care when they're diagnosed. And then what this reveals is that, even at the end of life, they're perhaps still receiving low-quality care. Another study looked at screening, which I thought was really impressive. It was by Nicole Anne Gay from the UM Sylvester Comprehensive Cancer Center in Miami. And what they evaluated was essentially a quality improvement program to reduce disparities in lung cancer screening. As a lung cancer doctor myself, it's still shocking that fewer than 6% of people that should receive lung cancer screening, meaning a screening test to help us identify and to treat patients with lung cancer-- they aren't receiving lung cancer screening. And so we know that this is a problem overall. They put into place what's called a multi-level, meaning that there were improvements in the electronic health record that they embedded. They also provided patients with navigation, and they also helped clinicians in the primary care clinics obtain information about who should be eligible and which patients should be receiving screening. And what they found was that they were able to move screening rates from 25% improvement completed during the project period from their baseline, which is actually quite impressive. We also saw an interesting study, and actually, just an interesting evaluation, of childhood leukemia survival on the U.S.-Mexico border. And it was a description of how to implement changes by strengthening care partnerships. And so they evaluated and they described the implementation of this program to achieve what they called sustainable high-quality care for children with leukemia. It was done by Paula Aristizabal and was really in a unique border health setting. It was in partnership between the North American and Mexican institutions. And they used what was called the strengthening model developed by the World Health Organization to evaluate specific domains and to try to improve a sustainable program for children with acute lymphoblastic leukemia at a public referral hospital right on the border region. And I thought that that study was particularly interesting because it shows how to be able to use an approach to improve the staffing of a leukemia service, to implement a sustainable training program as well for other clinicians to learn how to provide leukemia care, and then also to try to improve clinical outcomes and funding for patients to receive medications through local partnerships. I thought it was a really fantastic description of how to begin to do this work that is extremely necessary in low- and middle-income nations but also even on our own U.S.-Mexico border. There were also a lot of studies that evaluated the importance of social and economic factors. We know that financial toxicity, which is an unfortunate side effect of cancer treatment and cancer care and a cancer diagnosis overall, is associated with worse outcomes. Financial toxicity means the burdens and costs that arise with having a cancer diagnosis. And now we've seen studies that were presented at ASCO this past year by Dr. Khan, who showed that, within 2 years of diagnosis, are at higher risk for dying after adjusting for many social and also clinical factors. And Dr. Hu also presented data looking at the implications of having a lot of medical debt and death. And what both of these studies showed is that medical debt is associated with having perhaps a lower likelihood of surviving. It does make sense for Dr. Hu's study that one would have a lot of medical debt if they also have a lot of other conditions, but it does begin to shed some light on the fact that there are worse clinical outcomes, meaning people aren't doing as well, depending on how much other medical care expenses they may have. And then finally, one important piece, which I think is really crucial for what's happening now in the way that oncologists may perhaps be able to advocate for payment for services that are important, is looking at navigation studies. Now, this is patient navigators, and that is a very broad topic. And so there were lots and lots of studies that came out at ASCO that evaluated the importance of navigation, including our own work that looked at what happens to veterans after receiving a lay health worker or a navigator to assist with advanced care planning, meaning helping veterans to understand their goals and preferences. And what these studies have shown is that there's actually not only clinical benefit but also, in our own study, that perhaps there may be a survival benefit even 10 years later. It was very wonderful to be at ASCO this past year, and I really hope that you all can look at some of these studies or take away the important and amazing work that's going on in the health equity space. And I thank you for listening to our podcast. ASCO: Thank you, Dr. Patel. You can find more research from recent scientific meetings at www.cancer.net. Cancer.Net Podcasts feature trusted, timely, and compassionate information for people with cancer, survivors, and their families and loved ones. Subscribe wherever you listen to podcasts for expert information and tips on coping with cancer, recaps of the latest research advances, and thoughtful discussions on cancer care. And check out other ASCO Podcasts to hear the latest interviews and insights from thought leaders, innovators, experts, and pioneers in oncology. Cancer.Net is supported by Conquer Cancer, the ASCO Foundation, which funds lifesaving research for every type of cancer, helping people with cancer everywhere. To help fund Cancer.Net and programs like it, donate at CONQUER.ORG/Donate. [music]

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. In today's news, we have some significant leadership changes. Zimmer Biomet CEO Bryan Hanson is leaving the company to join 3M as its new CEO. Ivan Tornos, the current COO of Zimmer Biomet, will take over as the orthopedic device maker's top executive.Moving on to regulatory news, Medtronic's renal denervation device faced a setback at an FDA panel. Outside advisers determined that the risks of the procedure to lower blood pressure outweighed the benefits in a narrow vote. However, Recor's renal denervation system received backing from an FDA panel, with advisers finding it safe and effective, although some expressed concerns about its long-term durability.Next, Tandem's chief commercial officer, Brian Hansen, is resigning as the company prepares to roll out its new Mobi pump. Additionally, Agilent is winding down operations at Resolution Bioscience, a liquid biopsy unit it acquired two years ago for $550 million.In IPO news, brain drug developer Neumora is preparing for an IPO, joining the flurry of biotech companies going public. The IPO filing, along with that of radiopharmaceutical startup Rayzebio, will test the biotech IPO market. Roche's surprise study results suggest that a drug blocking the protein TIGIT may help extend survival in lung cancer patients. The findings have boosted shares of other developers in the space.In other developments, the FDA has partially halted leukemia studies of Gilead's cancer drug, which is the latest setback for the drug that was acquired in 2020. Foundery, a new biotech venture firm, aims to speed up early immune drug research by providing support to researchers working on new immunotherapies. Agenus plans to lay off 25% of its staff and trim its pipeline to preserve cash for potential drug approvals next year. J&J-backed startup Rapport Therapeutics has raised an additional $150 million for brain drug development.Shifting gears to the healthcare industry, CVS Health has announced layoffs in several locations, including Rhode Island, Connecticut, and New York. The layoffs affect 770 employees at CVS's Rhode Island headquarters and around 520 workers at health insurer Aetna's Connecticut hub. The exact reasons for the job cuts have not been disclosed.The Centers for Medicare and Medicaid Services (CMS) has threatened to cut hospices from Medicare if they fail to prove their legitimacy. This crackdown follows reports of fraudulent activity in hospice facilities, including certifying patients for care who were not terminally ill and engaging in fraudulent billing schemes. Cigna, an insurance company, has announced that it will remove prior authorizations for 25% of its services. Additionally, the company plans to eliminate another 500 codes for its Medicare Advantage plans by the end of the year. This move aims to streamline the healthcare process and reduce administrative burden.A report has found that over half of healthcare employees consider themselves inadequately compensated. The survey revealed that almost half of healthcare workers surveyed had less than $1,000 in savings. The divide between professionals who felt fairly compensated and those who didn't was less than 5%. Epic Systems, an electronic health records (EHR) vendor, and Microsoft have expanded their partnership to accelerate generative artificial intelligence (AI) in healthcare. The collaboration aims to deploy tools such as clinical note summarization and coding suggestions to improve patient care.In other industry news, California's medical board is facing financial difficulties, unable to pay its bills. However, proposed fixes to address this issue are being resisted by doctors. Health officials have also laid out plans to cope with the upcoming respiratory virus season. A highly mutated COVID variant has been found in new countries, but officials believe the pandemic i

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.MilliporeSigma has introduced its optimized VirusExpress platform for the development and manufacturing of lentiviral vectors. The platform aims to provide industry-leading titers, robust recovery, streamlined workflows, and reduced development timelines. MilliporeSigma will be showcasing its VirusExpress platform at various events.MilliporeSigma is the U.S. and Canada life science business of Merck KGaA.The FDA panel has rejected Medtronic's renal denervation device, stating that the risks outweigh the benefits. Levita has received 510(k) clearance for its surgeon-controlled arm for magnetic procedures. Draeger's ventilator sound insulation has triggered an FDA class I recall due to concentrations of a potentially carcinogenic foam component being above acceptable levels. Recor has gained FDA panel backing for its high blood pressure device, although there are concerns over the long-term durability of the treatment.Cigna has announced that it will remove prior authorizations for 25% of its services, aiming to reduce administrative burdens and streamline healthcare process for patients.CVS has launched a new venture called Cordavis, which will work directly with manufacturers to market or co-produce low-cost biologic drugs. CMS has threatened to cut hospices from Medicare if they cannot prove their legitimacy.Pharmaceutical companies are preparing for the next wave of COVID-19 infections caused by new variants of the virus. Researchers are concerned about infectious strains like "eris," which have been detected in large cities in the United States. Public health leaders and the pharmaceutical industry are working to develop and distribute vaccines to combat the new variants.Royalty Pharma has made its first gene therapy deal by buying into Ferring's cancer treatment adstiladrin for up to $500 million. Startup Cellares has raised $255 million in funding, with investors pouring cash into cell therapy production. Agenus is set to lay off 25% of its staff and trim its pipeline in a push for cancer drugs. Roche's surprise study results have spurred new optimism for TIGIT drugs.Pharmaceutical companies Pfizer, Moderna, and Novavax are preparing for the next wave of COVID-19 infections caused by new variants of the virus. Public health leaders and the pharmaceutical industry are working to develop and distribute vaccines to combat the new variants.Apellis has discovered faulty needles in its probe of a rare side effect of its eye drug, Syfovre. Boehringer has filed a lawsuit to block Medicare's new power to negotiate certain drug prices, claiming it is unconstitutional. Regeneron has rebounded after winning FDA approval for its longer-lasting vision loss drug, high-dose Eylea. Dexcom and Abbott are ramping up direct-to-consumer marketing in their fight for a larger share of the growing diabetes market. The FDA has approved Pfizer's RSV vaccine, called Abrysvo, for use in pregnancy. Blue Shield of California has dropped CVS Caremark as its pharmacy benefit manager.The FDA panel has given its support to Recor's renal denervation device for the treatment of high blood pressure.

If you're enjoying the content, please like, subscribe, and comment! Please consider supporting the show! https://anchor.fm/worldxppodcast/support A cancer immunologist by training, Dr. Christopher Nirschl received his PhD from the Johns Hopkins School of Medicine in Immunology in 2015, and completed a postdoctoral fellowship at the Brigham and Women's Hospital in association with Harvard Medical School. He has been studying the interactions between cancer and the immune system for over a decade, and is also one of the inventors of the anti-TIGIT antibody ASP8374/PTZ-201 which is currently in clinical trials. Currently, Dr. Nirschl is an Immunologist at Werewolf Therapeutics in Massachusetts, where he lives with his wife and three children. Find his book, "What the Heck Is A Clinical Trial?", here - https://www.amazon.com/What-Heck-Clinical-Trial-Where-ebook/dp/B09QKG37T7 ______________________ Follow us! @worldxppodcast Instagram - https://bit.ly/3eoBwyr @worldxppodcast Twitter - https://bit.ly/2Oa7Bzm Spotify - http://spoti.fi/3sZAUTG Apple Podcasts - http://apple.co/30uGTny Google Podcasts - http://bit.ly/3v8CF2U Anchor - http://bit.ly/3qGeaH7 YouTube - http://bit.ly/3rxDvUL #immunology #covid #fauci #clinicaltrials #immunologist #author #published #life #lifeexperience #boundaries #politicalnews #unitedstates #moderna #pfizer #rogan #twitterfiles #podcastshow #longformpodcast #longformpodcast #podcasts #podcaster #newpodcast #podcastshow #podcasting #newshow #worldxppodcast --- Support this podcast: https://podcasters.spotify.com/pod/show/worldxppodcast/support

In this episode of "The Top Line," we talk with Dr Reanne Moore, an associate professor of psychiatry at the University of California San Diego, about the state of digital phenotyping. We also cover the vaccine patent lawsuits, the smallest insulin pump, and the rest of the week's headlines.  To learn more about the topics in this episode: Nominations for Fierce Biotech's 2023 Fierce 15 close Friday—three more days to submit The Future of Biotech ADC puts Zynlonta study on hold after 7 patient deaths, 5 other severe adverse events Tandem crosses FDA finish line with nod for miniaturized insulin pump Moderna mounts 2 new patent lawsuits against mRNA rivals Pfizer, BioNTech: report Novartis retreats from TIGIT, handing $300M candidate back to BeiGene Illumina receives record €432M fine from EU for false start on Grail deal "The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

Drs. Shaalan Beg and Shiraj Sen discuss notable advances in GI cancers featured at the 2023 ASCO Annual Meeting, including the PROSPECT and PRODIGE-23 trials in rectal adenocarcinoma, the MORPHEUS study in uHCC, and the NORPACT-1 trial in pancreatic head cancer. TRANSCRIPT     Dr. Shaalan Beg: Hello, and welcome to the ASCO Daily News Podcast. I'm Dr. Shaalan Beg, your guest host for the podcast today. I'm the vice president of oncology at Science 37, and I'm an adjunct associate professor at UT Southwestern Medical Center. My guest today is Dr. Shiraj Sen. He is a GI medical oncologist and the director for clinical research at NEXT Oncology in Dallas.   Today, we'll be discussing practice-changing studies and other key advances in GI cancers that were featured at the 2023 ASCO Annual Meeting.   You'll find our full disclosures in the transcript of this episode, and disclosures of all guests on the podcast are available on our transcripts at asco.org/DNpod.   Shiraj, it's great to have you on the podcast today.  Dr. Shiraj Sen: Thanks so much for having me today, Shaalan.  Dr. Shaalan Beg: We saw exciting new data and great progress in GI oncology at the ASCO Annual Meeting. I was hoping we could talk about LBA2. This was the PROSPECT study that was presented during the Plenary Session. It's a randomized, phase 3 trial of neoadjuvant chemoradiation versus neoadjuvant FOLFOX chemo, followed by the selective use of chemoradiation, followed by TME or total mesorectal excision for the treatment of locally advanced rectal cancer. This is the Alliance N1048 trial. What are your thoughts on this study?  Dr. Shiraj Sen: Thanks, Shaalan. It was great to see another GI study presented in a Plenary Session, and I thought this was a great trial that really took us back to thinking about why we do chemoradiation as well as chemotherapy perioperatively in locally advanced rectal cancer. And asking the important question of is there a select patient set or subset where we might be able to safely omit the chemoradiation piece.  To me, the impressive part was this study enrolled from 2012 to 2018. In 2012, when this treatment really started enrolling, the standard of care was long-course chemoradiation for five and a half weeks, followed by surgery, followed by adjuvant chemotherapy with FOLFOX or CAPOX. During this time, a lot of the practices of these patients have shifted from that to giving total neoadjuvant therapy, where we bunch the chemotherapy and chemotherapy upfront prior to the patient undergoing surgery. And this study really asked us to take a look at both practices and ask the question of which one is better and is it possible to de-escalate care for patients who get upfront chemotherapy and omit the chemoradiation and still have similar outcomes.   I thought it was very interesting that this was done in a non-inferiority-type manner, and we can talk more about that in a few minutes as well. But taking that all into context, the fact that in this study, that the non-inferiority endpoints were met for both disease-free survival as well as overall survival in the patients who were able to omit chemoradiation, I think in the big picture sense told us that there truly might be a patient subset where—this is in patients with T2 node-negative disease or T3 node-negative or T3 node-positive disease—where we might be able to safely exclude the chemoradiation and still have similarly effective outcomes for these patients.  Dr. Shaalan Beg: Those are great points, especially when we have started to think about colon cancer and rectal cancer as many different diseases based on their location. And we know that in some instances their biology can be different as well.   Can you talk a little bit about who those patients are that were enrolled on this trial? Because when I think about the German rectal study that led to us using neoadjuvant chemoradiation, the data was really around pelvic control of disease and sphincter preservation. So how did the patients who enrolled in this trial relate to the typical person with rectal cancer who walks through your doors?   Dr. Shiraj Sen: Yeah, great point. I think we should point out the inclusion-exclusion criteria for this study. These patients were only those who were, again, T2 node-positive or T3 node-positive or negative, patients for whom chemoradiation would be indicated in the setting, and patients for whom they'd be good candidates for sphincter-sparing surgeries. So, tumors that are quite up high. These are not for individuals who have tumors requiring an APR. These are not for patients who have clinical T4 tumors. And this is not applied, again, to those high-risk patients who have 4 or more pelvic lymph nodes that are 1 cm in size or larger in the short access. And so, patients who need essentially an APR and the high-risk T4 tumors who are, I think, better suited by something like we'll talk about later in the PRODIGE study.   I think one last point that might be worth making here on the PROSPECT trial is that it was a non-inferiority trial. And in my opinion, this was really a great use of a non-inferiority study. I believe that when there's a new treatment under consideration used in a non-inferiority study, it should be because that therapy or modality of treatment is safer, more cost-effective, or could help increase access to care without compromising efficacy, and ideally maybe more than one of the above. And in this case, I think really all of those checkboxes are met.   In urban settings where we work, we think about access to radiation being quite plentiful, but when we get to more rural areas, or parts of the world where they may not have access to radiation like we may, I think this data can help drive care for a number of patients there. It can certainly be more cost-effective as it allows the omission of radiation. And certainly, from some of the PRO data that they presented, it certainly can be felt to be safer and help omit some toxicities as well.  Dr. Shaalan Beg: Yeah, you mentioned a total neoadjuvant therapy and we seem to be entering this space in rectal cancer where the decision on which modalities an individual person will need for the management of their disease and what sequence they will need is all up for debate, whether that's chemotherapy or radiation, long-form, short-form radiation. And we also heard some results at earlier ASCO meetings around the omission of surgery in people who've had complete clinical responses as well.   And you mentioned total neoadjuvant therapy and at ASCO this year we heard the results from LBA3504, which is a PRODIGE-23 trial. The investigators reported 7-year results of this phase 3 study from the UNICANCER group in France. This study is really pushing the envelope. What are your key takeaways here?   Dr. Shiraj Sen: Great point. I think this study, especially when taken in conjunction with the PROSPECT trial, highlights the fact that these patients really can have heterogeneous diseases and ones that really require careful consideration and discussion at multidisciplinary tumor boards. Unlike the patient population in the PROSPECT trial, the PRODIGE study did treat patients with higher-risk disease. So these were patients with clinical T3, T4 tumors and so higher risk, and asked the question now with more mature 7-year follow-up of, when compared to receiving the standard of care at the time, which was a chemoradiation followed by TME, followed by adjuvant FOLFOX for 12 cycles or the capecitabine, does TNT giving again now modified full FOLFIRINOX for six cycles followed by chemoradiation followed by TME and then adjuvant FOLFOX, do the improvements in both disease-free survival, overall survival, and metastatic relapse rate, do they hold up, and/or are there any differences in local control?   And again, here they demonstrate that even with longer-term follow-up, that the improvements in OFS, DFS, and metastatic relapse rate, really do hold up even with longer-term follow-up. And so, for these patients with higher risk disease, it does seem that giving induction chemotherapy with modified FOLFIRINOX before chemoradiotherapy really might be kind of best practices. The safety profile, even with longer-term follow-up was unchanged. There was not any increase in local recurrences. And again, looking at quality of life metrics there seemed to be similar or maybe improved quality of life for patients who receive the TNT approach. And now again, I think the next step is, as the presenter mentioned, investigating this even in a more tailored fashion, as was done with the PROSPECT study.  Dr. Shaalan Beg: Let's change gears and talk about liver cancer. Abstract 4010 showed the results of the MORPHEUS-liver study. This was a phase 1b/2 randomized trial of tiragolumab in combination with atezolizumab and bevacizumab for people with unresectable locally advanced or metastatic hepatocellular cancer. It's really exciting to see innovations with immune therapy changing how we've managed hepatocellular cancer in the last few years. And here, we're seeing an addition of a third agent to an already approved regimen of atezolizumab and bevacizumab. I was really curious to hear what your take-home message is from this study.   Dr. Shiraj Sen: Yeah, this was another very interesting abstract that was presented at ASCO this year. It's hard to believe that it was only 3 years ago that we first got the approval of atezo plus bev, and that it took more than a decade to really have us as a field improve on outcomes for patients with liver cancer above and beyond giving sorafenib. And here we are just 3 years later, already launching new phase 3 studies from these sorts of early-phase adaptive signal-seeking studies. The investigators as a whole should be commended for the speed at which new drug development has really progressed in liver cancers after, again, quite a lull we had in the pre-I/O days.   It's encouraging to see that in just 3 years that there's another phase 3 study now being launched in HCC on the heels of this data combining the atezo-bev backbone to the anti-TIGIT molecule tiragolumab. Now, I know there was a lot of discussion and some criticism of this study and what the real effects of adding tiragolumab to atezo-bev might be because of the underperformance of the control arm. In this study, the atezo-bev control arm, it should be noted that was only 18 patients, had a response rate of only 11%. And of course, with longer-term follow-up of the IMbrave150 study, we know that with the atezo-bev, we expect a response rate of about 30%. And so how a real-world population of individuals receiving atezo-bev would compare to those receiving tiro-atezo-bev has been discussed. But I think the only real way to answer that question would be with a large, randomized phase III study. And it's encouraging to see that one is being launched to ask that question.    Dr. Shaalan Beg: Absolutely. Let's change gears and talk about pancreatic cancer. LBA4005 explored short-course neoadjuvant FOLFIRINOX versus upfront surgery for people with resectable pancreatic head adenocarcinoma in the NORPACT-1 study. This is a multicenter randomized phase 2 trial and we're starting to see the reporting of clinical trials evaluating the sequencing of systemic therapies for resectable disease. We've heard studies for neoadjuvant therapy for borderline resectable as well as resectable trials in previous meetings. But there's a lot of discussion around the NORPACT-1 trial which may be causing some people to pause on our current understanding of treatment sequencing for resectable disease. I'm curious to hear what your take homes are.   Dr. Shiraj Sen: Thanks. Yes, I thought this was a very interesting study as well. Depending on which institution one practices in, in recent years, many have shifted their practice for individuals with resectable pancreatic cancer from administering full FOLFIRINOX or adjuvant therapy only after surgery to giving it in the neoadjuvant setting based on, again, a number of smaller studies, some that are single institution. This is one of the first studies that in a randomized fashion has asked the question in just resectable pancreatic cancer. So we're not talking about borderline resectable or other patients.    But in resectable pancreatic cancer, whether there are differences now comes if patients receive surgery first, followed by FOLFIRINOX-only adjuvant setting or essentially getting perioperative FOLFIRINOX and so neoadjuvant, followed by surgery, followed by, as tolerated, four cycles of adjuvant FOLFIRINOX. And I was a little surprised by some of the results and to me some of these data were a little intriguing.  Specifically, I think if we take a deeper look like the discussant had after the presentation, there are, I think, some unanswered questions. Specifically, half the patients were randomized to receive neoadjuvant FOLFIRINOX and half of them received upfront surgery. But in the group of individuals who received neoadjuvant FOLFIRINOX, it looked like only half of them completed neoadjuvant chemotherapy. And some answers into kind of why that was, and what it was about those patients then who were in the neoadjuvant arm, is one thing that comes to mind.    Secondly, what I thought was interesting was this study was that it was designed very well to try to take out as much heterogeneity as possible. However, in both arms, there was actually quite a substantial number of individuals who ended up receiving gemcitabine-based chemotherapy. And that's even in the patients who received neoadjuvant FOLFIRINOX, and individuals who received neoadjuvant FOLFIRINOX, only 25% post-op went on to receive adjuvant FOLFIRINOX. And 75% almost received gemcitabine-based therapy. And again, why so many patients received off-protocol adjuvant therapy is something that kind of struck me.  I think the third and final thing that really struck me was, in the patients that received neoadjuvant FOLFIRINOX, there was a higher rate of R0 resections. 56% of patients had an R0 resection compared to those who got upfront surgery, where there was only a 39% rate and similarly kind of higher levels of N0 resection. And yet, despite all of this, again, the authors did show quite clearly that there were not any significant improvements in outcomes for patients that received neoadjuvant therapy, but kind of how improved surgical endpoints do not translate to overall survival and overall endpoints; I think there are still some questions there.    However, I do agree overall that despite these limitations with the conclusions of the author, that at this time at least, it's not clear; the results don't support the widespread use of neoadjuvant FOLFIRINOX as a standard of care for resectable pancreatic cancer. Fortunately, there are studies ongoing, like the Alliance [for Clinical Trials in Oncology] study and the PREOPANC-3 study that hopefully will kind of help settle this verdict.    Dr. Shaalan Beg: Yeah, it's a stark reminder that we need better treatments. I think we've been shifting the sequencing of these treatments and slicing them in as many ways as we can. And the core challenge is in finding better systemic therapies that have been found to be effective in advanced stage as well as in curative stages like this. And one of the points that bothered me about this trial was the drop-off that they saw at the beginning when the biliary system was being drained, or they were getting biopsies because folks who went for surgery upfront didn't always require those procedures. They didn't require histologic diagnosis either. But as is standard practice, before we give systemic therapy, we require psychologic confirmation. And that may have introduced a delay of a couple of days or a couple of weeks, which could have resulted in some imbalances in how survival is measured and how folks were doing. Because, as you know, a lot of times people diagnosed with this disease can be fairly sick, and a matter of a couple of days or weeks can make a big difference in terms of treatment with those.  I'm really excited to wait and hear how the Alliance study and the PREOPANC follow-up trials pan out and as a very important cautionary note for everyone, both the folks who have adopted neoadjuvant therapy and those that have not followed the data. And kudos to the investigators for completing that trial.  Dr. Shiraj Sen: Yeah, I fully agree. I'm glad to see that these trials are being run. I think we should not take anything away from the fact that these are very challenging trials to run. I think we certainly owe a big kudos to the patients who enroll in these studies who have resectable disease, but they're still willing to go through the process of an extra consent form, an extra kind of screening process, additional testing required to go into a clinical trial. And it's only because of them that we're able to run these studies and, as a field, get some answers on how to best take care of our patients.   Dr. Shaalan Beg: Shiraj, thank you so much for coming to the podcast today and sharing your valuable insights on the ASCO Daily News Podcast.   Dr. Shiraj Sen: Thank you so much for having me, and to all of the ASCO staff for having this podcast.  Dr. Shaalan Beg: And thank you to our listeners for your time today. You'll find links to the abstracts discussed today in the transcript of this episode. Finally, if you value the insights that you hear on the podcast, please take a moment to rate, review and subscribe wherever you get your podcasts.    Disclaimer:   The purpose of this podcast is to educate and inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.    Find out more about today's speakers:   Dr. Shaalan Beg  @ShaalanBeg  Dr. Shiraj Sen  @ShirajSenMDPhD     Follow ASCO on social media:   @ASCO on Twitter  ASCO on Facebook  ASCO on LinkedIn     Disclosures:    Dr. Shaalan Beg:   Consulting or Advisory Role:  Ispen, Cancer Commons, Foundation Medicine, Genmab/Seagen   Speakers' Bureau: Sirtex   Research Funding (An Immediate Family Member): ImmuneSensor Therapeutics   Research Funding (Institution): Bristol-Myers Squibb, Tolero Pharmaceuticals, Delfi Diagnostics, Merck, Merck Serono, AstraZeneca/MedImmune     Dr. Shiraj Sen:   Employment: Roche/Genentech  Stock and Other Ownership Interests: Roche/Genentech  Research Funding (Institution): ABM Therapeutics, Zentalis Pharmaceuticals, Parthenon Therapeutics, Pyxis Oncology, Georgiamune Inc.      

    Drs. Diwakar Davar and Jason Luke discuss KEYNOTE-716, KEYNOTE-942, RELATIVITY-047, and other key advances in melanoma, including the promise of mRNA vaccines in melanoma and potentially other cancers, as well exciting advances in neoadjuvant therapies across malignancies featured at the 2023 ASCO Annual Meeting. TRANSCRIPT  Dr. Diwakar Davar: Hello, and welcome to the ASCO Daily News Podcast. I'm your guest host, Dr. Diwakar Davar. I'm an associate professor of medicine and the clinical director of the Melanoma and Skin Cancer Program at the University of Pittsburgh Hillman Cancer Center. I'm delighted to have my colleague and good friend Dr. Jason Luke on the podcast today to discuss some practice-changing studies and other advances in immunotherapy that were featured at the 2023 ASCO Annual Meeting. Dr. Luke is an associate professor of medicine, the director of the Cancer Immunotherapy Center, as well as the associate director of clinical research at the University of Pittsburgh's Hillman Cancer Center.     You can find both of our disclosures in the transcript of this episode, and disclosures of all guests on the ASCO Daily News Podcast are available on our transcripts at asco.org/DNpod.   Jason, there was a lot of exciting data in the immunotherapy space highlighted at the Annual Meeting, and it's great to have you back on the podcast to discuss some of this work.   Dr. Jason Luke: Thanks for having me.    Dr. Diwakar Davar: So, the abstracts that we had selected have several key themes. We'll be covering some of the early advances in melanoma in the stage 2 and stage 2B/C space with KEYNOTE-716. I think this is a study that you know a little bit about seeing you are the presenting author and the principal investigator for the study, as well as the pivotal KEYNOTE-942 trial. And then going on to themes with using third-generation checkpoints, neoadjuvant therapy in non-small-cell lung cancer, and cutaneous squamous cell carcinoma.    But we'll start with KEYNOTE-716. So, this is LBA9505, the study which evaluated pembrolizumab versus placebo as adjuvant therapy in stage 2B and stage 2C melanoma patient population for which historically there was no real effective therapy other than remotely interferon. And these are the final results of the DMFS analysis from this phase 3 trial. So, Jason, what are your thoughts about this, and can you contextualize the results relative to the recent publication?   Dr. Jason Luke: Thanks. I think the important point to level set on this was just a few years ago; this was a population of patients that we didn't treat in clinic. In fact, sometimes they weren't even referred to medical oncology for evaluation. And that was despite the fact that we knew from historical data that the risk of melanoma-specific survival, death from melanoma, was just as high for this population of patients as it was for the patients with stage 3 melanoma, where obviously adjuvant immunotherapy has been a standard for quite some time. And so we launched this clinical trial, KEYNOTE-716. It was a global, randomized phase 3 study of almost 1,000 patients, randomizing patients to either get pembrolizumab or placebo. Importantly, these patients being those with deep primary lesions, stage 2B and 2C with negative sentinel lymph node evaluation.    People will recall that this study hit its primary endpoint on the first protocol-specified analysis at a year. And what we updated at ASCO this year was the final analysis of distant metastasis-free survival. Obviously, an important secondary endpoint because if patients eventually going to develop metastatic disease and pass away, it's the distant metastasis that we worry about. And what we saw in this trial with a landmark 36-month follow-up median of 39 months was that the benefit was increasing. In other words, the magnitude of the hazard ratio change was increasing over time as would be expected, such that at this analysis there was a 41% reduction in the risk of distant metastasis for patients treated with pembrolizumab versus placebo. And we saw a consistent benefit in the recurrence-free survival also out through that same period of time and importantly no change in the safety summary with of course the adverse event profile of pembrolizumab being what it is and well understood across oncology.    So I think these are very important data because they really kind of set the stage for the field. It is now the case that at least discussing adjuvant therapy for patients with stage 2B and 2C is the standard of care; it should be offered to all the patients. Of course, it's always a risk-benefit about whether or not patients want to pursue adjuvant therapy versus consideration of treatment at the time of recurrence. But in my clinic at least, many patients do prefer to try to eliminate the possibility of recurrence and distant metastasis as much as possible.    So I think these are very important data because they really level set the field for what to expect in this population of patients and then they also start to set the table for what's going to come after this. And that's going to be sort of the next step in our conversation here because the next generation of adjuvant studies in melanoma are now going to think about all of melanoma in the adjuvant setting as really one entity, starting from stage 2B going all the way through stage 4 resected. And that'll be relevant actually as we talk about the next abstract that will come in this discussion.   Dr. Diwakar Davar: Just to underscore, positive RFS data, positive DMFS data, and now this therapy has currently got regulatory approval in this investigation and is approved in the United States and certainly in Europe and Australia. One interesting point that we will probably have to contend with, and some of the listeners may be thinking about, is overall survival. So the last adjuvant study that demonstrated overall survival benefit was actually ipilimumab, and increasingly, the Illuminati in melanoma do not believe that we will ever see OS benefit in this disease going forward, even though it has to be an endpoint in all registration phase 3 trials. So, Jason, what are your thoughts about whether or not we'll have a positive OS readout, and even if we don't, why this is still a very important advance in this disease at this time?   Dr. Jason Luke: Your points are well taken. I think it's unclear, probably trending towards unlikely, that we would see an overall survival advantage in this trial given that we have not seen that in the stage 3 adjuvant studies. Now people can debate if, whether or not overall survival is the only meaningful endpoint for patients. I personally do not believe that's true. And to me, preventing recurrence has a value in and of itself, whether or not that's connected to overall survival. And part of the reason that I say that is that for an average patient, the median patient on a trial, of course, we can tell them treatment now, treatment later. It's a wash when you look at the overall study. And yet at the same time, for an individual person who's facing melanoma or cancer, generally they're not going to be the average patient; they're going to be one patient. And it's very possible they could end up with the type of recurrence that in fact is not highly treatable at that time.     So I think that's really the nuance that goes into those adjuvant discussions. The regulatory endpoints have been recurrence in melanoma for a long time. And I think it's important that patients understand the pros and the cons of each. The complexity in adjuvant therapy and neoadjuvant therapy is you don't necessarily know that you had to have it. You're only really going to know whether or not it didn't work if you recur later on. But to me and in my clinic, most patients are willing and interested to want to pursue those therapies in the perioperative setting to try to reduce the possibility of ever developing metastatic disease.    Dr. Diwakar Davar: Excellent. So I think key advance [is] positive DMFS data to add to the earlier reported RFS data and truly practice-changing.     So, moving on to the next study, LBA9503. This is the phase 2 trial of the Moderna vaccine. This is the trial that almost every medical oncologist knows intimately or has been called about by either the press or patients. So what is this study? This essentially is a phase 2 trial evaluating the personalized cancer vaccine PCV Moderna, made by Moderna, the mRNA vaccine, that is being studied in combination with anti-PD-1 pembrolizumab in the stage 3 BCD and stage 4 resected setting. And so there are really two very interesting results here because this is an update of the RFS data that was presented at AACR earlier this year, which was positive. What are your takes on the DMFS results, and maybe a quick blurb on how is this vaccine generated for those who may not be aware of this particular platform?    Dr. Jason Luke: Yeah, certainly. So this individualized neo-antigen therapy, as we're now calling it, is a technology platform that allows us to develop an individualized treatment for each patient based on their own cancer. So taking the actual tumor specimen, whole exome sequencing is performed to try to identify changes in the DNA, and then through a reasonably complex bioinformatic pipeline, those mutations that are likely to generate proteins that can be bound within class 1 MHC molecules are then identified in the computer and then synthesized with an mRNA, very similar to the way that the COVID vaccines were made. And then that becomes the actual drug.    So in the clinical trial, which was KEYNOTE-942, about 160 patients were randomized 2 to 1 to receive either pembrolizumab for a year as per standard adjuvant therapy but then with the addition of the individualized neoantigen therapy starting with dose 3 and throughout the rest of the year versus the control arm of pembrolizumab as the standard of care. As you mentioned, the recurrence-free survival were highly positive in this trial when it was first presented earlier this year, and at the updated ASCO we see the 18-month RFS in which the hazard ratio continues to be maintained. But I think most impressively is that distant metastasis-free survival, where we saw an even greater advantage for distant metastasis-free survival – hazard ratio here being 0.35. And so that's a huge advantage for distant metastasis-free survival in this population of patients.     And very interestingly in the clinical trial, when you follow the Kaplan-Meier plots, what you see over time is that they overlap almost the entire first year. And it's really at about a year, basically after the vaccine has had time to kick in and these neoantigens have been identified, that we then start to see the separation of the curve, which looks very flat over time. And so I think this is a very, very exciting kind of technology platform and very exciting results because there was minimal increase in toxicity – just at the site of the local injection – for the addition of the individualized neoantigen therapy.    And beyond that, hypothetically, this is not necessarily just a melanoma thing. So, of course, based on these phase 2 results, a phase 3 clinical trial called KEYNOTE-V940 is going to be launching later this year to compare pembrolizumab versus pembrolizumab plus this V940 individualized neoantigen therapy. And we're very, very excited in the field to see what those results will look like because the concept here is you could really, really enhance adjuvant therapy with this kind of an approach. Meanwhile, we're just about to talk in a little bit about all the exciting things happening in the neoadjuvant space as well. And with no increase in toxicity, obviously, that looks really good.    Suffice it to say that this technology is not specific to melanoma but rather could be applied almost to any cancer where we think about an adjuvant therapy platform. So I think the results are very, very exciting. It is a phase 2 study and it does have some caveats about not being the largest study and some other things, but you can't help but be impressed by the data that have been presented here so far.   Dr. Diwakar Davar: One important plug, I guess, in addition to that is that you mentioned that there's data using the platform in other diseases. And one really exciting paper that came out recently was Dr. Vinod Balachandran's paper; for those who haven't read it, it's in Nature, and really in a very provocative proof of concept study, they studied the platform, the vaccine plus checkpoint inhibitor therapy plus chemotherapy in a highly adverse tumor patient population. So these are patients with resectable pancreatic cancer who had the vaccine generated from pancreatic cancer that was resected after Whipple surgery. And extraordinarily, out of the 16 patients who had immune responses, 8 of them did not have relapse at a median follow-up of almost a year and a half, which is really quite extraordinary given the lack of really any effective drug outside of chemotherapy in that setting.     So, the point that you're making regarding the benefit of this therapy, suggesting that it could potentially be extended to not just melanoma, potentially other tumors such as highly immunogenic tumors, and potentially even nonimmunogenic tumors such as pancreatic cancer, really suggests that this is going to be a very exciting landscape. And potentially this area, adjuvant therapy and neoadjuvant therapy, like we'll talk about, is potentially an area in which other drugs and potentially combinations will be developed.    So next, we will be discussing 3 abstracts evaluating the theme of combinations, and these abstracts are 9501, 9502, and 4010. Abstract 9501 is an evaluation of the combination of fianlimab and cemiplimab anti-LAG-3 and anti-PD-1, respectively, in advanced melanoma, specifically focusing on the post-PD-1 experience in this disease by Dr. Omid Hamid. 9502 is the updated 2-year survival results from RELATIVITY-047, which evaluated nivolumab and relatlimab against nivolumab alone in frontline metastatic melanoma. And Abstract 4010 are the results from the MORPHEUS platform study, specifically looking at tiragolumab and atezolizumab in patients with advanced unresectable HCC.    But focusing on 9501 and 9502, Jason, what do you make of the combination of fianlimab and cemiplimab post-PD-1 setting?   Dr. Jason Luke: I think the data look very intriguing for this second combination of PD-1 and LAG-3 combination. When nivolumab and relatlimab, the approved LAG-3 inhibitor, kind of burst on the scene a couple of years ago, it was somewhat to the surprise of a lot of people in the community who had really come to think that while PD-1 and CTLA-4 were core molecules for therapeutics and cancer, that we just weren't ever really going to see something else come along in checkpoint blockade. And so nivo and rela got approved. We'll talk about them again in a second. But the data now coming forward for another PD-1 LAG-3 combination, again with cemiplimab PD-1 and fianlimab LAG-3, looks very, very promising.    So in Abstract 9501, they updated a phase 1 expansion cohort, phase 2 cohort looking at patients across the various different settings. And whereas in the treatment naive frontline metastatic setting they had previously described about a 63% response rate, they saw a similar level of response rate in patients who had previously gotten adjuvant anti-PD-1, had a period of time off treatment, and then were treated again. And that was reassuring because it suggested that this is still an active combination even with prior exposure to IO in the past.     Now, the thing that I found to be the most interesting about this combination was whereas with nivo and rela, at least from the RELATIVITY-047 phase 3 trial, it looked like there was less benefit in some of the high-risk population cohorts, at least for this combination in early testing for cemi and fian; like we talk about it sometimes, we saw there was a high response rate even in patients with liver metastases and some other high-risk features. And so I think this combination looks quite potent, and I'm very excited to see what the data will look like. I think it's very unlikely we'll ever actually get a randomized trial of two PD-1 LAG-3 combinations against each other. But suffice it to say that the data we've seen so far for fianlimab LAG-3 with cemiplimab PD-1 looks very intriguing. It certainly justifies the frontline metastatic phase 3 and the adjuvant phase 3 trials that are already in planning or ongoing.   Dr. Diwakar Davar: So one thing to consider is on the RELATIVITY-020 trial – the early trial that was led by Dr. Ascierto that really took a long time to read out – the response rate in patients with prior checkpoint inhibitor therapy was quite low. In fact, the data was quite surprising, as you'd mentioned that we had even seen this movement in the frontline setting because the response rate by BICR was only about 12%. So do you feel like the 2 LAG-3 inhibitors are fundamentally different? And if so, can you speculate as to why that might be? Again, with the caveat to the fact that these are very early data and we don't have enough information. And maybe we can also talk a little bit about the 2 pending trials that are ongoing in the advanced and adjuvant therapy landscapes perspective.   Dr. Jason Luke: I think we don't have enough data yet to truly understand whether or not they're really different. The trials that have been run so far are so different that it's hard to compare things back and forth. You can notice that the dose, the milligram dosage of fianlimab in terms of anti-LAG-3 is quite a bit higher, like a log fold higher almost than with relatlimab. And so there's some question of whether or not just merely more drug-blocking LAG-3 might in fact be more efficacious relative to the dose that's approved for relatlimab in melanoma. But beyond that, I think the data hold up very well for this new combination, again noting all the caveats about cross-trial comparison to, say, it looks to be at least as potent, possibly more potent than the relatlimab combination. But again, I think probably we need to see the data from randomized trials and how that fits into the landscape when the trials actually read out because there's a lot of things going on in melanoma that are likely to change between now and then.   Dr. Diwakar Davar: So just to draw people's attention, there are actually 2 ongoing pivotal phase 3 trials: fian plus cemi versus pembro in patients with advanced metastatic and locally advanced, previously untreated melanoma, as well as an adjuvant trial of the combination against pembrolizumab. Again, highly high-risk resected melanoma. These trials are ongoing. We don't have the results yet and we are looking forward to them.    Now, 9502, a 2-year RELATIVITY-047 result presented by Dr. Hussein Tawbi.    Dr. Jason Luke: So this is the study we were just alluding to before, the randomized phase 3 study of nivolumab versus nivolumab plus for relatlimab. To me, the most useful data sort of updating with this two-year survival follow-up is to show the maintenance of benefit between the 2 arms. And so, consistent with what we saw with nivolumab and ipilimumab, there seems to be a persistent delta between the arms for both progression-free and for overall survival out over that extended period of time, where we can see with that updated data now, at 2 years, that it's 52% of patients still alive on the relatlimab combo versus 42 with nivolumab. And it does seem like this is probably a higher-risk population of patients than participated in CheckMate-067.    So it's a little bit difficult to compare the landmarks except to notice that that difference between the control and experimental groups is consistent over a long period of time and that there were no new safety signals either, and so that was also reassuring. To me, the most interesting nugget of data in the abstract, though, is to look at what happened to patients after they were on the first-line treatment. So one of the big questions in our field is really “If patients get nivolumab and relatlimab upfront, what should they get after that?” Should they then get nivo plus ipi, or vice versa? And I think we don't have an answer clearly to that question just yet.    There was an important letter to the editor of the New England Journal now going on about a year ago by Alex Menzies and colleagues that suggested that the use of ipilimumab was attenuated, the utility of it, after a prior exposure to nivolumab plus relatlimab. They quoted a response rate on the order of only about 10% for patients who got an ipilimumab-containing regimen after initial LAG-3. In the data from Hussein Tawbi at ASCO, however, in a small number of patients, caveat, the response rate was more in sort of the low 20% range, 22% to 25%. And so that would be a much more meaningful and important sort of consideration. If we do have independent activity, then lining up sequential therapies and the toxicities associated with each will become increasingly important as we think about how to maximize these kinds of treatments for our patients, but important longer-term data to show that the benefit is holding up and it's safe, and some new insights into what to do after progression on one of these regimens.    Dr. Diwakar Davar: So, pivoting slightly to combinations, we are going to be discussing a combination of TIGIT plus checkpoints. So tiragolumab is the FC-active TIGIT inhibitor from Regeneron-Roche and this is currently in multiple pivotal phase 3 trials, several of which have been negative, including SKYSCRAPER-01 in non-small cell lung cancer and SKYSCRAPER-03 in small cell lung cancer. The MORPHEUS platform trial essentially is a platform study evaluating multiple different combinations, in this case in liver cancer. And so we have a very interesting Abstract 4010, which is giving us an early readout of the evaluation of tiragolumab plus atezolizumab along with bevacizumab in unresectable, locally advanced or metastatic hepatocellular carcinoma giving us a result that is a little different from what we had seen from the prior negative results of TIGIT. So Jason, what do you make of these early results in the advanced HCC setting?   Dr. Jason Luke: I think these are cautiously intriguing results to really highlight the point is the third checkpoint possibly being LAG-3, now a fourth checkpoint maybe with TIGIT, but with all the caveats that you talked about. In this study, the flow is that there's a continuously accruing control arm which in hepatocellular carcinoma is a combination of atezolizumab plus bevacizumab, and then other arms are added where you add in a third agent. In this case, it's the anti-TIGIT tiragolumab. And in an intriguing fashion, the response rate to the triplet was 42.5% compared to the doublet which was only 11%. So that's a pretty big difference in this population.     Now, it wasn't the largest study, only 58 patients, but it was a randomized clinical trial. And so I think those data really make people kind of open their eyes again. It's worth a little bit of a caveat here that HCC is an unusual cancer in that what is deemed to be unresectable and therefore amendable to systemic therapy is a moving target and that requires multidisciplinary evaluation of patients. And so I think a larger number of patients would really be needed to fully understand this. But certainly, a fourfold increase in the benefit or in terms of response rate looks quite intriguing.    I think the other piece of this is to be just cautious a little bit was when the initial data in non-small cell lung cancer in the CITYSCAPE study came forward, and they looked roughly sort of like this: There was more than a doubling in the PFS and the response rate, which is what triggered all of those phase 3 studies. So to me, this is enough to continue to be very interested in TIGIT as a therapeutic target. And there are many phase 3 trials already ongoing. And so I think, I'm cautiously optimistic that some of those actually will be positive and we could see more movement around TIGIT becoming a standard of care agent.    Dr. Diwakar Davar: To your point about TIGIT being an interesting target, recent data looking at the neoadjuvant landscape in melanoma from Merck, with Merck, also FC-active TIGIT and also some data from authors looking at that TIGIT also presented in this case at ASCO specifically from the ARC-7 study. So very interesting target. Several pivotal trials have been announced. Do you know of any trials that are ongoing in the adjuvant setting in other diseases?   Dr. Jason Luke: Well, as you alluded to, the vibostolimab data in melanoma for TIGIT in the neoadjuvant setting was interesting. And in fact, that has been enough to trigger a global, randomized phase 3 adjuvant study of pembrolizumab and vibostolimab versus pembrolizumab in melanoma. And that sort of takes us back to the beginning of our discussion here, building on the KEYNOTE-716 data. So, yes, TIGIT will be moving forward in the adjuvant space in melanoma and obviously at a static setting for several different tumor types with a PD-1 or PD-L1 backbone.   Dr. Diwakar Davar: So now pivoting towards neoadjuvant therapy and non-small cell lung cancer. The standard of care in this setting was established by the CheckMate-816 trial that essentially established nivolumab plus chemotherapy in the setting of resectable non-small cell lung carcinoma path. Response rate in this setting is approximately 21%. And we have several studies that are essentially looking at novel combinations or in this case, different PD-1 inhibitors in this setting. So Abstract 8500 essentially looked at nivolumab plus relatlimab from a NEOpredict-Lung trial. Jason, do you want to tell us a little bit about this?    Dr. Jason Luke: Yes, I think this is a very interesting study and that this is sort of our first peek at targeting LAG-3 in the context of lung cancer. So obviously we talked about LAG-3 for melanoma. Although the audience is probably aware that there have been neoadjuvant data for LAG-3 with relatlimab in melanoma that substantiated the phase 3 data for the metastatic setting. So one of the questions as we start to apply the LAG-3 in other diseases would be, “Do we see it hold up in both metastatic disease and in the neoadjuvant space?” But in this study, while there were no changes in the safety profile; it didn't impact on whether or not patients could have surgery. There really didn't look to be a big difference in this study between nivolumab and nivolumab plus relatlimab, with the major pathologic response as you alluded to right around 30% for both arms.    Now, it wasn't really the biggest study, but that's certainly quite a bit in contrast with what we've seen in melanoma, where with a PD-1 inhibitor you get again 25%-30%, but with adding on LAG-3, that pushes you up closer to 60%. So I think these were very interesting data that probably put a little bit of an eyebrow raise to say, “Well, let's see what happens in the metastatic setting in lung cancer with the addition of relatlimab LAG-3 on top of a PD-1.” I think it might not be quite so straightforward as what we saw in melanoma, but we'll look forward to those results because those phase 3 trials in metastatic lung cancer should be maturing sometime in the next year or two.   Dr. Diwakar Davar: The theme of neoadjuvant therapy non-small lung cancer, LBA100, which has again previously been discussed in an episode of this podcast by Dr. Jack West and Dr. Velcheti is KEYNOTE-671. And this is a study essentially that looked at pembrolizumab or placebo with platinum-based chemotherapy doublet and followed by resection. So again, a direct parallel to CheckMate-816. What do you make of the results that were reported by our colleagues in this setting, Jason?   Dr. Jason Luke: So not to rehash this, because our colleagues in the lung cancer group have already discussed this at length and obviously they're experts in that disease, but we'll just note that there was a threefold increase in major pathologic response, which turned into a major advantage for event-free survival. And so I think this is at least the third PD-1, PD-L1 combination regimen for neoadjuvant lung cancer that looks very, very promising. It certainly, to me, seems like neoadjuvant consideration really should be the standard of care already moving forward.   To me, what the big question that is left with is “Do we still need the adjuvant component after we give the neoadjuvant?” So, some of the trials are including neoadjuvant and adjuvant, some of them are only neoadjuvant. And I think that's going to be a really important question as we move into the future, both in terms of what is that contribution of the adjuvant component, and then again, going back to earlier in our discussion here, if there could be a major advantage to adding individualized neoantigen therapy, maybe it is important to have both. But I think that's one of the big questions we have to get teased out by the field over the next couple of years.   Dr. Diwakar Davar: And finally pivoting towards cutaneous squamous cell carcinoma. We have 2 abstracts discussing perioperative therapy. So cutaneous squamous cell carcinoma is a high-TMB tumor. The median tumor mutation burden in this disease is threefold that of melanoma. This is a disease in which checkpoint inhibitor therapy is approved as a single agent both with pembrolizumab and cemiplimab on the basis of nonrandomized phase 2 trials. And increasingly, there has been early development in the perioperative setting. The first data in this space came from our colleague Dr. Gross at MD Anderson, who reported in a small, nonrandomized phase 2 trial of 20 patients, a path CR rate with two cycles of cemiplimab at approximately 50%.    A larger multi-institutional phase 2 trial demonstrated that a longer duration of perioperative therapy of four cycles or 3 months of cemiplimab did not particularly improve the path response rates. The response rates were similar at approximately 50% as well. And what we have right now are 2 other trials. The first is the MATISSE trial, Abstract 9507 ,that evaluated nivolumab or nivolumab plus epilimumab in this disease. And the other one was the NEO-CESQ trial, or Abstract 9576, that evaluated neoadjuvant plus adjuvant therapy that's cemiplimab in the high-risk patient population. So we're starting with 9507. Jason, what do you make of the ipi and ipi-nivo data reported in this setting?   Dr. Jason Luke: So I think this is a really interesting study because I think part of the intent is the clinical aspect of how you manage patients with cutaneous squamous cell carcinoma. For those that don't do cutaneous oncology, many of these patients have the development of lesions, which can be actually quite difficult to resect in a way that's not otherwise mutilating or cosmetically quite problematic. And that was part of the impetus for this trial where, again, they looked at either monotherapy PD-1 or a PD-1 plus CTLA-4, and they saw great success. As was predicted based on the other data that you alluded to, response rates are more than 50% near 60%, with actually a substantial number of patients on the trial actually refusing to have surgery after they received their neoadjuvant therapy because they were so certain that they had had a good outcome.    So I think these data are quite reassuring in the context of all of this emerging data around cutaneous squamous cell carcinoma. We'll talk about this NEO-CESQ trial in just a second, but I think it really is emerging to be the standard of care very soon for the use of perioperative PD-1 for cutaneous squamous cell.   Dr. Diwakar Davar: What do you feel about the dose and schedule of checkpoint inhibitor therapy used here? So the dose of ipilimumab used was ipi-1 and not ipi-3, and they waited 4 weeks. So when patients only got two cycles of Q2 weekly nivo, and one cycle of ipilimumab, do you think the responses would have been deeper if they'd waited longer?   Dr. Jason Luke: I think it is possible that they might have been deeper, although I'm not totally sure about that. One of the other abstracts we're not directly mentioning here was a study in Merkel cell carcinoma which suggested that in fact, adding ipi and that also highly immuno-oncology-responsive tumor type did not add to the response rate. So I'm not totally sure about that. I think rather what would be most interesting here is sort of the sort of next generation of biomarker work.    As part of their presentation, the MATISSE trial team showed gene expression profiling that really strongly identified which patients were going to do well on the trial. And I think that's probably eventually going to be how we need to think about this. There are patients in the neoadjuvant setting who are going to do really well with anti-PD-1 alone. And then for those who aren't, that's where we probably really need to think about do we need combos, how long to give the treatment, etc. And I think we're really only on the cusp in the beginning of this, which is exciting as we think about moving into the future.    Dr. Diwakar Davar: Certainly, many combinations are being evaluated in this space and we are very excited for the data that it's about to hopefully come in the next couple of months to years.    So the NEO-CESQ – it's quite a puzzle as to how to pronounce this acronym – and this evaluated cemiplimab in the high-risk setting. So it's worthwhile noting that Dr. Gross's first trial looked at high-risk stage 2, 3, and 4 disease. So the context of cutaneous squamous cell carcinoma that's node-positive disease and distant metastatic disease that is in one location or patients with node-positive disease invention. And his multi-institutional cemiplimab trial of four cycles evaluated included patients with stage 2, 3, and 4 disease.    So here in a study just in stage 3 and 4 diseases, Dr. Ascierto reported the results of 2 cycles of cemiplimab and importantly, these patients had both the neoadjuvant and the adjuvant portion of cemiplimab. So, Jason, you mentioned earlier that one of the key aspects that we start thinking about neoadjuvant therapy is exactly how much do you need. Do you need both the pre-surgical therapy and the post-surgical therapy? Is the presurgical therapy enough? After all, neoadjuvant response equals cure. How much benefit are you getting from post-surgical portions? So what do you make of the results that they've seen here and what is the impact? How do you think we'll be disentangling the impact of the neoadjuvant and the adjuvant portion of the immunotherapy upon response and survival?    Dr. Jason Luke: So just to leverage those comments, I think these data are reassuring because in this higher-risk group of patients, they saw excellent outcomes very similar to what Gross et al had previously reported. So that's good. To your question about how we are going to disentangle this adjuvant versus non-adjuvant question, there's a trial in melanoma called the NADINA trial which is ongoing now in which the use of the adjuvant therapy is actually risk-adapted. So after patients have an initial neoadjuvant treatment they're evaluated, and if they have had a pathologic complete response, they're actually going to stop that treatment and they're not going to give the neoadjuvant therapy. And so I think obviously it's a slightly different disease, but those kinds of data, I think, will be very meaningful to help us sort this out.    And I'm not sure whether or not in cutaneous squamous we would need a different trial than in melanoma, although I think in a different tumor, maybe like, say, lung cancer, you probably would need a dedicated study to try to look at that because I think just the responsiveness to checkpoint blockade is going to vary quite a bit once you get outside of cutaneous oncology. But to summarize, reassuring that a similar pathologic response rate, and I think this question of adjuvant or nonadjuvant, I think that's the next question we've got to answer in the field.    Dr. Diwakar Davar: We have now come to the end of our back-and-forth discussion on these very, very exciting abstracts. So Jason, thank you for highlighting these advances and for engaging in a robust discussion.    Dr. Jason Luke: Thanks for having me.    Dr. Diwakar Davar: And thank you to our listeners today for taking the time to listen to this podcast. You will find the links to the abstracts discussed today in the transcript of this episode. Finally, if you value the insights that you hear in the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcast.    Disclaimer:   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  Follow today's speakers:   Dr. Diwakar Davar   @diwakardavar   Dr. Jason Luke   @jasonlukemd      Follow ASCO on social media:    @ASCO on Twitter   ASCO on Facebook   ASCO on LinkedIn      Disclosures:      Dr. Diwakar Davar:     Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences    Consulting or Advisory Role: Instil Bio, Vedanta Biosciences    Consulting or Advisory Role (Immediate family member): Shionogi    Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences    Research Funding (Inst.): Zucero Therapeutics    Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy    Dr. Jason Luke:      Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical , Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX    Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine    Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure    Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)    Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio        

In this episode of "The Top Line," we talk with Fierce's Max Bayer and Angus Liu about the most important news coming from this year's annual BIO conference. We also cover a COVID lawsuit, an FDA-approved app, and the rest of the week's headlines.  To learn more about the topics in this episode: ASCO: After lung cancer fails, Roche's faith in TIGIT rewarded as tiragolumab shows signs of life in liver cancer Merck ends last Keytruda trial in aggressive prostate cancer campaign, takes separate hit in lung cancer Roche, with HER2 franchise under pressure, pays $70M for breast cancer brain metastases prospect Takeda pledges up to $1.13B for rights to Hutchmed's cancer drug fruquintinib outside of China BIO: Moderna to test mpox vaccine in humans this summer BIO: Jazz is auditioning new bandmates in an M&A market ripe with talent BioNTech to defend itself against COVID-19 vaccine injury claim in Germany Salvation or 'death warrant'? Erytech's war with activist investor rumbles on as merger vote nears RSV vaccine awareness low among older adults, but majority would ask their doc about new shots: survey Huma nabs FDA nod for AI-backed disease management platform Medtronic warns cardioversion can fry some Vanta neurostimulators "The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

In this podcast, Rami Komrokji, MD; María Díez Campelo, MD, PhD; and Amer Zeidan, MBBS, MHS answer questions from an audience of healthcare professionals on topics related to personalized management of myelodysplastic syndromes including:  Practical use of the Molecular International Prognostic Scoring System  Mutational targets and other treatments in ongoing clinical trialsProphylaxis with venetoclax therapyBest practices for bone marrow transplant, including induction and salvage regimensTreatment options for hypoplastic myelodysplastic syndromesPresenters:Rami Komrokji, MDProfessorDepartment of Oncologic SciencesUniversity of South Florida  Vice ChairMalignant Hematology DepartmentMoffitt Cancer CenterTampa, FloridaMaría Díez Campelo, MD, PhDAssociate ProfessorDepartment of MedicineSchool of MedicineUniversity of SalamancaHematologistDepartment of HematologyUniversity Hospital of SalamancaSalamanca, SpainAmer Zeidan, MBBS, MHSAssociate Professor, Internal MedicineHematologyLeader, Leukemia and Myeloid Disease Aligned Research Team (DART)Director, Hematology Early Therapeutics ResearchYale Cancer Center and Smilow Cancer HospitalYale University School of MedicineNew Haven, ConnecticutLink to full program, including downloadable slidesets, expert commentaries, and on-demand webcast:http://bit.ly/3YXgKK3  

Anat Cohen-Dayag is the President and CEO of Compugen, which uses its computational discovery platform to identify new drug targets allowing them to develop new treatments based on these new targets. While most immunotherapies are based on proteins PD-1 or PD-L1, Compugen has discovered two other proteins involved in stimulating the immune system response against cancer. Anat elaborates, "In 2009, we discovered the protein called TIGIT. We discovered it computationally, and we sent it to publication back-to-back with Genentech. And this is the protein that is being now developed by Compugen and by others, Genentech being the leader in this field with phase three studies in the clinic. Their phase two data showed improvement for patients with non-small cell cancer." "Following this TIGIT discovery, we decided that we're not going to compete in the TIGIT space, per se, but that we would like to focus the company on a different type of family of proteins, and we discovered PVRIG. And PVRIG is, again, a protein that we believe has a role in stimulating the immune system response against the cancer. But it is not working only alone. It is a pathway that is working in parallel and in complement to TIGIT and to PD-1."   #Compugen #TIGIT #PVRIG #ImmunoOncology #OvarianCancer #ColonCancer #MachineLearning #ML cgen.com Download the transcript here

Anat Cohen-Dayag is the President and CEO of Compugen, which uses its computational discovery platform to identify new drug targets allowing them to develop new treatments based on these new targets. While most immunotherapies are based on proteins PD-1 or PD-L1, Compugen has discovered two other proteins involved in stimulating the immune system response against cancer. Anat elaborates, "In 2009, we discovered the protein called TIGIT. We discovered it computationally, and we sent it to publication back-to-back with Genentech. And this is the protein that is being now developed by Compugen and by others, Genentech being the leader in this field with phase three studies in the clinic. Their phase two data showed improvement for patients with non-small cell cancer." "Following this TIGIT discovery, we decided that we're not going to compete in the TIGIT space, per se, but that we would like to focus the company on a different type of family of proteins, and we discovered PVRIG. And PVRIG is, again, a protein that we believe has a role in stimulating the immune system response against the cancer. But it is not working only alone. It is a pathway that is working in parallel and in complement to TIGIT and to PD-1."   #Compugen #TIGIT #PVRIG #ImmunoOncology #OvarianCancer #ColonCancer #MachineLearning #ML cgen.com Listen to the podcast here

In this episode we discuss some of the unintended side effects of the covid vaccine, general nutrition, the Great Barrington Declaration, and more!! If you're enjoying the content, please like, subscribe, and comment! Please consider supporting the show! https://anchor.fm/worldxppodcast/support A cancer immunologist by training, Dr. Christopher Nirschl received his PhD from the Johns Hopkins School of Medicine in Immunology in 2015, and completed a postdoctoral fellowship at the Brigham and Women's Hospital in association with Harvard Medical School. He has been studying the interactions between cancer and the immune system for over a decade, and is also one of the inventors of the anti-TIGIT antibody ASP8374/PTZ-201 which is currently in clinical trials. Currently, Dr. Nirschl is an Immunologist at Werewolf Therapeutics in Massachusetts, where he lives with his wife and three children. Find his book, "What the Heck Is A Clinical Trial?", here - https://www.amazon.com/What-Heck-Clinical-Trial-Where-ebook/dp/B09QKG37T7 ______________________ Follow us! @worldxppodcast Instagram - https://bit.ly/3eoBwyr @worldxppodcast Twitter - https://bit.ly/2Oa7Bzm Spotify - http://spoti.fi/3sZAUTG Apple Podcasts - http://apple.co/30uGTny Google Podcasts - http://bit.ly/3v8CF2U Anchor - http://bit.ly/3qGeaH7 YouTube - http://bit.ly/3rxDvUL #immunology #covid #fauci #clinicaltrials #immunologist #author #published #life #lifeexperience #boundaries #politicalnews #unitedstates #moderna #pfizer #rogan #twitterfiles #podcastshow #longformpodcast #longformpodcast #podcasts #podcaster #newpodcast #podcastshow #podcasting #newshow #worldxppodcast --- Support this podcast: https://anchor.fm/worldxppodcast/support

If you're enjoying the content, please like, subscribe, and comment! Please consider supporting the show! https://anchor.fm/worldxppodcast/support Andy is a Project Manager for Donatelli Development. He has over 20 years of development experience and is a licensed professional engineer. Mr. Jennings is a graduate of the Civil Engineering School at the University of Virginia and received a Masters of Science in Civil Engineering from the University of Idaho. He has been registered as a professional engineer in 10 states and has been a member of the American Society of Civil Engineers. A cancer immunologist by training, Dr. Christopher Nirschl received his PhD from the Johns Hopkins School of Medicine in Immunology in 2015, and completed a postdoctoral fellowship at the Brigham and Women's Hospital in association with Harvard Medical School. He has been studying the interactions between cancer and the immune system for over a decade, and is also one of the inventors of the anti-TIGIT antibody ASP8374/PTZ-201 which is currently in clinical trials. Currently, Dr. Nirschl is an Immunologist at Werewolf Therapeutics in Massachusetts, where he lives with his wife and two children. Find his book, "What the Heck Is A Clinical Trial?", here - https://www.amazon.com/What-Heck-Clinical-Trial-Where-ebook/dp/B09QKG37T7 ______________________ Follow us! @worldxppodcast Instagram - https://bit.ly/3eoBwyr @worldxppodcast Twitter - https://bit.ly/2Oa7Bzm Spotify - http://spoti.fi/3sZAUTG Apple Podcasts - http://apple.co/30uGTny Google Podcasts - http://bit.ly/3v8CF2U Anchor - http://bit.ly/3qGeaH7 YouTube - http://bit.ly/3rxDvUL #wxpp #podcast #podcastersofinstagram #podcastlife #podcastshow #longformpodcast #longformpodcast #podcasts #podcaster #newpodcast #podcastshow #podcasting #newshow #worldxppodcast --- Support this podcast: https://anchor.fm/worldxppodcast/support

Medical conferences often are a platform to showcase new clinical trophies. But that wasn't the case for Merck at this year's European Society for Medical Oncology meeting. The Big Pharma presented a series of trial flops for its megablockbuster cancer immunotherapy, Keytruda. We'll discuss if the Merck checkpoint inhibitor has reached a bottleneck or if it was just bad luck.  Also under discussion is the monkeypox test Emergency Use Authorization. Because monkeypox continues to spread in the U.S. and worldwide, the FDA granted its first EUA for a diagnostic test. This regulatory path was also used for COVID-19 tests. But the FDA learned a few lessons from the pandemic and hopes the new guidelines will help avoid the problems seen then.   To learn more about topics in this episode:  ESMO: AstraZeneca, Merck tout Lynparza's 'clinically meaningful' ovarian cancer survival edge but lose one in prostate cancer ESMO: Roche eyes untouched newly diagnosed lung cancer market for solo Tecentriq ESMO: Adding bempeg to Opdivo lowered response rate in Bristol Myers-Nektar failed cancer trial ESMO: GSK keeps the faith in anti-TIGIT plans; it's 'not always about being first' UPDATED ESMO: Amgen's Lumakras confirmatory lung cancer data leave door open for KRAS competitors ESMO: Gilead's Trodelvy makes surprise comeback with above-par breast cancer survival showing Here we go again: FDA opens up emergency authorizations to monkeypox tests Moderna sizes up private COVID vaccine market in US, where shots could cost $100 a pop Sony dives into nascent over-the-counter hearing aid market with WS Audiology partnership OTC birth control could be on the way from Perrigo, as FDA gathers expert panel Altimmune sees phase 1 success in tricky NASH indication with GLP-1 agonist Oramed phase 2 insulin drug data 'paint an exciting picture' in rocky NASH landscape Akero hits endpoints in midphase NASH trial, linking candidate to improvements in fibrosis BMS' preferred drug in its $74B Celgene buy is set to pay dividends, winning its first FDA nod The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/EBJ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The discovery of immune checkpoints that regulate immune responses transformed cancer care, and the impact that the new class of immune checkpoint inhibitors (ICIs) has had in oncology cannot be understated. A proportion of patients achieve remarkable and durable responses and improved overall survival with use of the current ICIs. However, there are a number of limitations associated with the current immunotherapies, patient outcomes are still suboptimal, and new options are needed to maximize the potential of cancer immunotherapy as the fourth treatment pillar in oncology. New rational combinations leveraging synergies between old and new checkpoints have emerged, with inhibitory targeting of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine–based inhibitory motif domains (TIGIT) along with the PD-L1/PD-1 pathway as one potential strategy under extensive investigation across different cancers. To realize the potential of anti-TIGIT checkpoint inhibition, build upon previous advances in cancer immunotherapy, expand into more tumor types and earlier stages of disease, and provide new treatment options in areas of high unmet need to more patients with cancer, it is essential for those involved in the care of patients with solid tumors to become familiar with this novel therapeutic approach and develop competence related to its clinical integration, enabling rapid translation from discovery to the clinic. This educational activity features an expert discussion of the rationale and mechanism of action of agents targeting TIGIT, enhanced with engaging three-dimensional explanations, and provides practical guidance to identify patients most likely to be the best candidates for novel ICI-based treatment approaches. Upon completion of this activity, participants should be better able to: Describe the rationale for use, mechanisms of action, and preclinical and clinical evidence supporting the use of novel ICIs, such as antibodies targeting TIGIT, and synergistic ICI-based combinations showing promise in overcoming the limitations of current immunotherapies and expanding the benefits to more patients with solid tumors, Identify patients who are most likely to be the best candidates for novel ICI-based treatment approaches, including dual-targeted inhibition of TIGIT and anti–PD-L1/PD-1, based on clinical evidence, biomarker status, comorbidities, patient preferences for chemotherapy-free treatment options, and other relevant factors, working collaboratively as a healthcare team.

Go online to PeerView.com/EBJ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The discovery of immune checkpoints that regulate immune responses transformed cancer care, and the impact that the new class of immune checkpoint inhibitors (ICIs) has had in oncology cannot be understated. A proportion of patients achieve remarkable and durable responses and improved overall survival with use of the current ICIs. However, there are a number of limitations associated with the current immunotherapies, patient outcomes are still suboptimal, and new options are needed to maximize the potential of cancer immunotherapy as the fourth treatment pillar in oncology. New rational combinations leveraging synergies between old and new checkpoints have emerged, with inhibitory targeting of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine–based inhibitory motif domains (TIGIT) along with the PD-L1/PD-1 pathway as one potential strategy under extensive investigation across different cancers. To realize the potential of anti-TIGIT checkpoint inhibition, build upon previous advances in cancer immunotherapy, expand into more tumor types and earlier stages of disease, and provide new treatment options in areas of high unmet need to more patients with cancer, it is essential for those involved in the care of patients with solid tumors to become familiar with this novel therapeutic approach and develop competence related to its clinical integration, enabling rapid translation from discovery to the clinic. This educational activity features an expert discussion of the rationale and mechanism of action of agents targeting TIGIT, enhanced with engaging three-dimensional explanations, and provides practical guidance to identify patients most likely to be the best candidates for novel ICI-based treatment approaches. Upon completion of this activity, participants should be better able to: Describe the rationale for use, mechanisms of action, and preclinical and clinical evidence supporting the use of novel ICIs, such as antibodies targeting TIGIT, and synergistic ICI-based combinations showing promise in overcoming the limitations of current immunotherapies and expanding the benefits to more patients with solid tumors, Identify patients who are most likely to be the best candidates for novel ICI-based treatment approaches, including dual-targeted inhibition of TIGIT and anti–PD-L1/PD-1, based on clinical evidence, biomarker status, comorbidities, patient preferences for chemotherapy-free treatment options, and other relevant factors, working collaboratively as a healthcare team.

Go online to PeerView.com/EBJ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The discovery of immune checkpoints that regulate immune responses transformed cancer care, and the impact that the new class of immune checkpoint inhibitors (ICIs) has had in oncology cannot be understated. A proportion of patients achieve remarkable and durable responses and improved overall survival with use of the current ICIs. However, there are a number of limitations associated with the current immunotherapies, patient outcomes are still suboptimal, and new options are needed to maximize the potential of cancer immunotherapy as the fourth treatment pillar in oncology. New rational combinations leveraging synergies between old and new checkpoints have emerged, with inhibitory targeting of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine–based inhibitory motif domains (TIGIT) along with the PD-L1/PD-1 pathway as one potential strategy under extensive investigation across different cancers. To realize the potential of anti-TIGIT checkpoint inhibition, build upon previous advances in cancer immunotherapy, expand into more tumor types and earlier stages of disease, and provide new treatment options in areas of high unmet need to more patients with cancer, it is essential for those involved in the care of patients with solid tumors to become familiar with this novel therapeutic approach and develop competence related to its clinical integration, enabling rapid translation from discovery to the clinic. This educational activity features an expert discussion of the rationale and mechanism of action of agents targeting TIGIT, enhanced with engaging three-dimensional explanations, and provides practical guidance to identify patients most likely to be the best candidates for novel ICI-based treatment approaches. Upon completion of this activity, participants should be better able to: Describe the rationale for use, mechanisms of action, and preclinical and clinical evidence supporting the use of novel ICIs, such as antibodies targeting TIGIT, and synergistic ICI-based combinations showing promise in overcoming the limitations of current immunotherapies and expanding the benefits to more patients with solid tumors, Identify patients who are most likely to be the best candidates for novel ICI-based treatment approaches, including dual-targeted inhibition of TIGIT and anti–PD-L1/PD-1, based on clinical evidence, biomarker status, comorbidities, patient preferences for chemotherapy-free treatment options, and other relevant factors, working collaboratively as a healthcare team.

Go online to PeerView.com/EBJ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The discovery of immune checkpoints that regulate immune responses transformed cancer care, and the impact that the new class of immune checkpoint inhibitors (ICIs) has had in oncology cannot be understated. A proportion of patients achieve remarkable and durable responses and improved overall survival with use of the current ICIs. However, there are a number of limitations associated with the current immunotherapies, patient outcomes are still suboptimal, and new options are needed to maximize the potential of cancer immunotherapy as the fourth treatment pillar in oncology. New rational combinations leveraging synergies between old and new checkpoints have emerged, with inhibitory targeting of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine–based inhibitory motif domains (TIGIT) along with the PD-L1/PD-1 pathway as one potential strategy under extensive investigation across different cancers. To realize the potential of anti-TIGIT checkpoint inhibition, build upon previous advances in cancer immunotherapy, expand into more tumor types and earlier stages of disease, and provide new treatment options in areas of high unmet need to more patients with cancer, it is essential for those involved in the care of patients with solid tumors to become familiar with this novel therapeutic approach and develop competence related to its clinical integration, enabling rapid translation from discovery to the clinic. This educational activity features an expert discussion of the rationale and mechanism of action of agents targeting TIGIT, enhanced with engaging three-dimensional explanations, and provides practical guidance to identify patients most likely to be the best candidates for novel ICI-based treatment approaches. Upon completion of this activity, participants should be better able to: Describe the rationale for use, mechanisms of action, and preclinical and clinical evidence supporting the use of novel ICIs, such as antibodies targeting TIGIT, and synergistic ICI-based combinations showing promise in overcoming the limitations of current immunotherapies and expanding the benefits to more patients with solid tumors, Identify patients who are most likely to be the best candidates for novel ICI-based treatment approaches, including dual-targeted inhibition of TIGIT and anti–PD-L1/PD-1, based on clinical evidence, biomarker status, comorbidities, patient preferences for chemotherapy-free treatment options, and other relevant factors, working collaboratively as a healthcare team.

Go online to PeerView.com/EBJ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The discovery of immune checkpoints that regulate immune responses transformed cancer care, and the impact that the new class of immune checkpoint inhibitors (ICIs) has had in oncology cannot be understated. A proportion of patients achieve remarkable and durable responses and improved overall survival with use of the current ICIs. However, there are a number of limitations associated with the current immunotherapies, patient outcomes are still suboptimal, and new options are needed to maximize the potential of cancer immunotherapy as the fourth treatment pillar in oncology. New rational combinations leveraging synergies between old and new checkpoints have emerged, with inhibitory targeting of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine–based inhibitory motif domains (TIGIT) along with the PD-L1/PD-1 pathway as one potential strategy under extensive investigation across different cancers. To realize the potential of anti-TIGIT checkpoint inhibition, build upon previous advances in cancer immunotherapy, expand into more tumor types and earlier stages of disease, and provide new treatment options in areas of high unmet need to more patients with cancer, it is essential for those involved in the care of patients with solid tumors to become familiar with this novel therapeutic approach and develop competence related to its clinical integration, enabling rapid translation from discovery to the clinic. This educational activity features an expert discussion of the rationale and mechanism of action of agents targeting TIGIT, enhanced with engaging three-dimensional explanations, and provides practical guidance to identify patients most likely to be the best candidates for novel ICI-based treatment approaches. Upon completion of this activity, participants should be better able to: Describe the rationale for use, mechanisms of action, and preclinical and clinical evidence supporting the use of novel ICIs, such as antibodies targeting TIGIT, and synergistic ICI-based combinations showing promise in overcoming the limitations of current immunotherapies and expanding the benefits to more patients with solid tumors, Identify patients who are most likely to be the best candidates for novel ICI-based treatment approaches, including dual-targeted inhibition of TIGIT and anti–PD-L1/PD-1, based on clinical evidence, biomarker status, comorbidities, patient preferences for chemotherapy-free treatment options, and other relevant factors, working collaboratively as a healthcare team.

Go online to PeerView.com/EBJ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The discovery of immune checkpoints that regulate immune responses transformed cancer care, and the impact that the new class of immune checkpoint inhibitors (ICIs) has had in oncology cannot be understated. A proportion of patients achieve remarkable and durable responses and improved overall survival with use of the current ICIs. However, there are a number of limitations associated with the current immunotherapies, patient outcomes are still suboptimal, and new options are needed to maximize the potential of cancer immunotherapy as the fourth treatment pillar in oncology. New rational combinations leveraging synergies between old and new checkpoints have emerged, with inhibitory targeting of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine–based inhibitory motif domains (TIGIT) along with the PD-L1/PD-1 pathway as one potential strategy under extensive investigation across different cancers. To realize the potential of anti-TIGIT checkpoint inhibition, build upon previous advances in cancer immunotherapy, expand into more tumor types and earlier stages of disease, and provide new treatment options in areas of high unmet need to more patients with cancer, it is essential for those involved in the care of patients with solid tumors to become familiar with this novel therapeutic approach and develop competence related to its clinical integration, enabling rapid translation from discovery to the clinic. This educational activity features an expert discussion of the rationale and mechanism of action of agents targeting TIGIT, enhanced with engaging three-dimensional explanations, and provides practical guidance to identify patients most likely to be the best candidates for novel ICI-based treatment approaches. Upon completion of this activity, participants should be better able to: Describe the rationale for use, mechanisms of action, and preclinical and clinical evidence supporting the use of novel ICIs, such as antibodies targeting TIGIT, and synergistic ICI-based combinations showing promise in overcoming the limitations of current immunotherapies and expanding the benefits to more patients with solid tumors, Identify patients who are most likely to be the best candidates for novel ICI-based treatment approaches, including dual-targeted inhibition of TIGIT and anti–PD-L1/PD-1, based on clinical evidence, biomarker status, comorbidities, patient preferences for chemotherapy-free treatment options, and other relevant factors, working collaboratively as a healthcare team.

Go online to PeerView.com/EBJ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The discovery of immune checkpoints that regulate immune responses transformed cancer care, and the impact that the new class of immune checkpoint inhibitors (ICIs) has had in oncology cannot be understated. A proportion of patients achieve remarkable and durable responses and improved overall survival with use of the current ICIs. However, there are a number of limitations associated with the current immunotherapies, patient outcomes are still suboptimal, and new options are needed to maximize the potential of cancer immunotherapy as the fourth treatment pillar in oncology. New rational combinations leveraging synergies between old and new checkpoints have emerged, with inhibitory targeting of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine–based inhibitory motif domains (TIGIT) along with the PD-L1/PD-1 pathway as one potential strategy under extensive investigation across different cancers. To realize the potential of anti-TIGIT checkpoint inhibition, build upon previous advances in cancer immunotherapy, expand into more tumor types and earlier stages of disease, and provide new treatment options in areas of high unmet need to more patients with cancer, it is essential for those involved in the care of patients with solid tumors to become familiar with this novel therapeutic approach and develop competence related to its clinical integration, enabling rapid translation from discovery to the clinic. This educational activity features an expert discussion of the rationale and mechanism of action of agents targeting TIGIT, enhanced with engaging three-dimensional explanations, and provides practical guidance to identify patients most likely to be the best candidates for novel ICI-based treatment approaches. Upon completion of this activity, participants should be better able to: Describe the rationale for use, mechanisms of action, and preclinical and clinical evidence supporting the use of novel ICIs, such as antibodies targeting TIGIT, and synergistic ICI-based combinations showing promise in overcoming the limitations of current immunotherapies and expanding the benefits to more patients with solid tumors, Identify patients who are most likely to be the best candidates for novel ICI-based treatment approaches, including dual-targeted inhibition of TIGIT and anti–PD-L1/PD-1, based on clinical evidence, biomarker status, comorbidities, patient preferences for chemotherapy-free treatment options, and other relevant factors, working collaboratively as a healthcare team.

Go online to PeerView.com/EBJ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The discovery of immune checkpoints that regulate immune responses transformed cancer care, and the impact that the new class of immune checkpoint inhibitors (ICIs) has had in oncology cannot be understated. A proportion of patients achieve remarkable and durable responses and improved overall survival with use of the current ICIs. However, there are a number of limitations associated with the current immunotherapies, patient outcomes are still suboptimal, and new options are needed to maximize the potential of cancer immunotherapy as the fourth treatment pillar in oncology. New rational combinations leveraging synergies between old and new checkpoints have emerged, with inhibitory targeting of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine–based inhibitory motif domains (TIGIT) along with the PD-L1/PD-1 pathway as one potential strategy under extensive investigation across different cancers. To realize the potential of anti-TIGIT checkpoint inhibition, build upon previous advances in cancer immunotherapy, expand into more tumor types and earlier stages of disease, and provide new treatment options in areas of high unmet need to more patients with cancer, it is essential for those involved in the care of patients with solid tumors to become familiar with this novel therapeutic approach and develop competence related to its clinical integration, enabling rapid translation from discovery to the clinic. This educational activity features an expert discussion of the rationale and mechanism of action of agents targeting TIGIT, enhanced with engaging three-dimensional explanations, and provides practical guidance to identify patients most likely to be the best candidates for novel ICI-based treatment approaches. Upon completion of this activity, participants should be better able to: Describe the rationale for use, mechanisms of action, and preclinical and clinical evidence supporting the use of novel ICIs, such as antibodies targeting TIGIT, and synergistic ICI-based combinations showing promise in overcoming the limitations of current immunotherapies and expanding the benefits to more patients with solid tumors, Identify patients who are most likely to be the best candidates for novel ICI-based treatment approaches, including dual-targeted inhibition of TIGIT and anti–PD-L1/PD-1, based on clinical evidence, biomarker status, comorbidities, patient preferences for chemotherapy-free treatment options, and other relevant factors, working collaboratively as a healthcare team.

Go online to PeerView.com/EBJ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The discovery of immune checkpoints that regulate immune responses transformed cancer care, and the impact that the new class of immune checkpoint inhibitors (ICIs) has had in oncology cannot be understated. A proportion of patients achieve remarkable and durable responses and improved overall survival with use of the current ICIs. However, there are a number of limitations associated with the current immunotherapies, patient outcomes are still suboptimal, and new options are needed to maximize the potential of cancer immunotherapy as the fourth treatment pillar in oncology. New rational combinations leveraging synergies between old and new checkpoints have emerged, with inhibitory targeting of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine–based inhibitory motif domains (TIGIT) along with the PD-L1/PD-1 pathway as one potential strategy under extensive investigation across different cancers. To realize the potential of anti-TIGIT checkpoint inhibition, build upon previous advances in cancer immunotherapy, expand into more tumor types and earlier stages of disease, and provide new treatment options in areas of high unmet need to more patients with cancer, it is essential for those involved in the care of patients with solid tumors to become familiar with this novel therapeutic approach and develop competence related to its clinical integration, enabling rapid translation from discovery to the clinic. This educational activity features an expert discussion of the rationale and mechanism of action of agents targeting TIGIT, enhanced with engaging three-dimensional explanations, and provides practical guidance to identify patients most likely to be the best candidates for novel ICI-based treatment approaches. Upon completion of this activity, participants should be better able to: Describe the rationale for use, mechanisms of action, and preclinical and clinical evidence supporting the use of novel ICIs, such as antibodies targeting TIGIT, and synergistic ICI-based combinations showing promise in overcoming the limitations of current immunotherapies and expanding the benefits to more patients with solid tumors, Identify patients who are most likely to be the best candidates for novel ICI-based treatment approaches, including dual-targeted inhibition of TIGIT and anti–PD-L1/PD-1, based on clinical evidence, biomarker status, comorbidities, patient preferences for chemotherapy-free treatment options, and other relevant factors, working collaboratively as a healthcare team.

Go online to PeerView.com/EBJ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. The discovery of immune checkpoints that regulate immune responses transformed cancer care, and the impact that the new class of immune checkpoint inhibitors (ICIs) has had in oncology cannot be understated. A proportion of patients achieve remarkable and durable responses and improved overall survival with use of the current ICIs. However, there are a number of limitations associated with the current immunotherapies, patient outcomes are still suboptimal, and new options are needed to maximize the potential of cancer immunotherapy as the fourth treatment pillar in oncology. New rational combinations leveraging synergies between old and new checkpoints have emerged, with inhibitory targeting of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine–based inhibitory motif domains (TIGIT) along with the PD-L1/PD-1 pathway as one potential strategy under extensive investigation across different cancers. To realize the potential of anti-TIGIT checkpoint inhibition, build upon previous advances in cancer immunotherapy, expand into more tumor types and earlier stages of disease, and provide new treatment options in areas of high unmet need to more patients with cancer, it is essential for those involved in the care of patients with solid tumors to become familiar with this novel therapeutic approach and develop competence related to its clinical integration, enabling rapid translation from discovery to the clinic. This educational activity features an expert discussion of the rationale and mechanism of action of agents targeting TIGIT, enhanced with engaging three-dimensional explanations, and provides practical guidance to identify patients most likely to be the best candidates for novel ICI-based treatment approaches. Upon completion of this activity, participants should be better able to: Describe the rationale for use, mechanisms of action, and preclinical and clinical evidence supporting the use of novel ICIs, such as antibodies targeting TIGIT, and synergistic ICI-based combinations showing promise in overcoming the limitations of current immunotherapies and expanding the benefits to more patients with solid tumors, Identify patients who are most likely to be the best candidates for novel ICI-based treatment approaches, including dual-targeted inhibition of TIGIT and anti–PD-L1/PD-1, based on clinical evidence, biomarker status, comorbidities, patient preferences for chemotherapy-free treatment options, and other relevant factors, working collaboratively as a healthcare team.

If you're enjoying the content, please drop a like, comment, and subscribe! Check out our new clips channel here: https://www.youtube.com/channel/UC9KPTBSzEkPmwCmo9FL_ulg A cancer immunologist by training, Dr. Christopher Nirschl received his PhD from the Johns Hopkins School of Medicine in Immunology in 2015, and completed a postdoctoral fellowship at the Brigham and Women's Hospital in association with Harvard Medical School. He has been studying the interactions between cancer and the immune system for over a decade, and is also one of the inventors of the anti-TIGIT antibody ASP8374/PTZ-201 which is currently in clinical trials. Currently, Dr. Nirschl is an Immunologist at Werewolf Therapeutics in Massachusetts, where he lives with his wife and two children. Find his book, "What the Heck Is A Clinical Trial?", here - https://www.amazon.com/What-Heck-Clinical-Trial-Where-ebook/dp/B09QKG37T7 ______________________ Follow us! @worldxppodcast Instagram - https://bit.ly/3eoBwyr @worldxppodcast Twitter - https://bit.ly/2Oa7Bzm Spotify - http://spoti.fi/3sZAUTG Apple Podcasts - http://apple.co/30uGTny Google Podcasts - http://bit.ly/3v8CF2U Anchor - http://bit.ly/3qGeaH7 YouTube - http://bit.ly/3rxDvUL #immunology #immunologist #author #published #life #lifeexperience #boundaries #politicalnews #unitedstates #military #roevwade #podcastshow #longformpodcast #longformpodcast #podcasts #podcaster #newpodcast #podcastshow #podcasting #newshow #worldxppodcast --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app Support this podcast: https://anchor.fm/worldxppodcast/support

On this week's episode, Agustin discusses the failures of targeting TIGIT antibodies, the competitive race for KRAS superiority, and the pitfalls of Caribou Biosciences and their allogeneic CAR-T cell therapy. If you are a fan of this show make sure to like, comment, subscribe and follow me on Twitter @biotech_bros. If you have any questions regarding the product offerings feel free to explore my website biotechbros.com

Welche Neuigkeiten es im Bereich der Pneumo-Onkologie gibt, ordnet Harald Müller-Huesmann gemeinsam mit Florian Fuchs (Erlangen) ein.In der fünften Folge aus Chicago geht es noch einmal richtig rund: TIGIT-Studie, aktueller Stand in puncto Immuntherapien, Antibody Drug Conjugates (ADC's), Adagrasib-Studiendaten, Erstlinien-Therapie, Practice Changing beim Lungenkarzinom - ja oder nein? – und, und, und… Vor dem Mikrofon werden Fakten und Highlights aus pneumo-onkologischer Sicht auf den Punkt gebracht. Und am Ende: haben sich die vier Stunden Wartezeit in der „Immigration-Line“ nun gelohnt oder nicht? Alle Antworten gibt es in der neuesten Podcast-Episode.  --Über Onkologe Overseas - Sonderfolgen aus Chicago:Harald Müller-Huesmann serviert Ihnen die wichtigsten Neuigkeiten aus Chicago in ca. 10 Minuten, pünktlich zum Frühstück. Der amerikanische Krebskongress ist für eine Fülle an brandaktuellen und hochrelevanten Studienpublikationen bekannt. Zusätzlich zu Daten-fokussierten Formaten (Onkologie VirtuOS) möchten wir Ihnen dieses Jahr in unserem Podcast auch emotionale, persönliche und praxisnahe Einblicke eines behandelnden Onkologen anbieten.

Go online to PeerView.com/KCV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapy in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 monoclonal antibodies is swiftly expanding from metastatic to early-stage, curative-intent settings in an increasing number of solid tumors. Furthermore, it's on the cusp of further explosive growth as other novel agents, including inhibitors of new checkpoints such as LAG-3 and TIGIT, are starting to emerge. Pathologists and oncologists play a crucial role in identifying patients who would benefit the most from the broadening arsenal of immunotherapies and assessing response to these therapies. While there are substantial gaps in biomarker testing, pathologic response assessment, and the use of immunotherapies in current practice, things will only become more complicated. This PeerView Live educational activity, based on a recent symposium, will help you refine your current best practices and prepare you for what's to come next. Top experts convene to provide a visual exploration of the most important recent advances in immuno-oncology, conduct demonstrations of representative and challenging real-world cases, and walk you through practical exercises on operationalizing biomarker testing and pathologic response assessment in different laboratory and clinical settings. Upon completion of this activity, participants should be better able to: Discuss the rationale, recommendations, and practical considerations related to cancer immunotherapy biomarker testing and pathologic response assessment in different tumors and treatment settings, Use appropriate immunotherapy biomarker testing and pathologic response assessment to cancer immunotherapies according to the latest evidence, requirements, and best practice recommendations across different tumors and treatment settings, Implement effective strategies for multidisciplinary communication, collaboration, and coordination among pathologists, oncologists, and other care team professionals regarding selection and interpretation of immunotherapy biomarker tests and pathologic response assessment to guide clinical decision-making regarding cancer immunotherapies across different tumors and treatment settings.

Go online to PeerView.com/KCV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapy in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 monoclonal antibodies is swiftly expanding from metastatic to early-stage, curative-intent settings in an increasing number of solid tumors. Furthermore, it's on the cusp of further explosive growth as other novel agents, including inhibitors of new checkpoints such as LAG-3 and TIGIT, are starting to emerge. Pathologists and oncologists play a crucial role in identifying patients who would benefit the most from the broadening arsenal of immunotherapies and assessing response to these therapies. While there are substantial gaps in biomarker testing, pathologic response assessment, and the use of immunotherapies in current practice, things will only become more complicated. This PeerView Live educational activity, based on a recent symposium, will help you refine your current best practices and prepare you for what's to come next. Top experts convene to provide a visual exploration of the most important recent advances in immuno-oncology, conduct demonstrations of representative and challenging real-world cases, and walk you through practical exercises on operationalizing biomarker testing and pathologic response assessment in different laboratory and clinical settings. Upon completion of this activity, participants should be better able to: Discuss the rationale, recommendations, and practical considerations related to cancer immunotherapy biomarker testing and pathologic response assessment in different tumors and treatment settings, Use appropriate immunotherapy biomarker testing and pathologic response assessment to cancer immunotherapies according to the latest evidence, requirements, and best practice recommendations across different tumors and treatment settings, Implement effective strategies for multidisciplinary communication, collaboration, and coordination among pathologists, oncologists, and other care team professionals regarding selection and interpretation of immunotherapy biomarker tests and pathologic response assessment to guide clinical decision-making regarding cancer immunotherapies across different tumors and treatment settings.

Go online to PeerView.com/KCV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapy in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 monoclonal antibodies is swiftly expanding from metastatic to early-stage, curative-intent settings in an increasing number of solid tumors. Furthermore, it's on the cusp of further explosive growth as other novel agents, including inhibitors of new checkpoints such as LAG-3 and TIGIT, are starting to emerge. Pathologists and oncologists play a crucial role in identifying patients who would benefit the most from the broadening arsenal of immunotherapies and assessing response to these therapies. While there are substantial gaps in biomarker testing, pathologic response assessment, and the use of immunotherapies in current practice, things will only become more complicated. This PeerView Live educational activity, based on a recent symposium, will help you refine your current best practices and prepare you for what's to come next. Top experts convene to provide a visual exploration of the most important recent advances in immuno-oncology, conduct demonstrations of representative and challenging real-world cases, and walk you through practical exercises on operationalizing biomarker testing and pathologic response assessment in different laboratory and clinical settings. Upon completion of this activity, participants should be better able to: Discuss the rationale, recommendations, and practical considerations related to cancer immunotherapy biomarker testing and pathologic response assessment in different tumors and treatment settings, Use appropriate immunotherapy biomarker testing and pathologic response assessment to cancer immunotherapies according to the latest evidence, requirements, and best practice recommendations across different tumors and treatment settings, Implement effective strategies for multidisciplinary communication, collaboration, and coordination among pathologists, oncologists, and other care team professionals regarding selection and interpretation of immunotherapy biomarker tests and pathologic response assessment to guide clinical decision-making regarding cancer immunotherapies across different tumors and treatment settings.

Go online to PeerView.com/KCV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapy in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 monoclonal antibodies is swiftly expanding from metastatic to early-stage, curative-intent settings in an increasing number of solid tumors. Furthermore, it's on the cusp of further explosive growth as other novel agents, including inhibitors of new checkpoints such as LAG-3 and TIGIT, are starting to emerge. Pathologists and oncologists play a crucial role in identifying patients who would benefit the most from the broadening arsenal of immunotherapies and assessing response to these therapies. While there are substantial gaps in biomarker testing, pathologic response assessment, and the use of immunotherapies in current practice, things will only become more complicated. This PeerView Live educational activity, based on a recent symposium, will help you refine your current best practices and prepare you for what's to come next. Top experts convene to provide a visual exploration of the most important recent advances in immuno-oncology, conduct demonstrations of representative and challenging real-world cases, and walk you through practical exercises on operationalizing biomarker testing and pathologic response assessment in different laboratory and clinical settings. Upon completion of this activity, participants should be better able to: Discuss the rationale, recommendations, and practical considerations related to cancer immunotherapy biomarker testing and pathologic response assessment in different tumors and treatment settings, Use appropriate immunotherapy biomarker testing and pathologic response assessment to cancer immunotherapies according to the latest evidence, requirements, and best practice recommendations across different tumors and treatment settings, Implement effective strategies for multidisciplinary communication, collaboration, and coordination among pathologists, oncologists, and other care team professionals regarding selection and interpretation of immunotherapy biomarker tests and pathologic response assessment to guide clinical decision-making regarding cancer immunotherapies across different tumors and treatment settings.

Go online to PeerView.com/KCV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapy in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 monoclonal antibodies is swiftly expanding from metastatic to early-stage, curative-intent settings in an increasing number of solid tumors. Furthermore, it's on the cusp of further explosive growth as other novel agents, including inhibitors of new checkpoints such as LAG-3 and TIGIT, are starting to emerge. Pathologists and oncologists play a crucial role in identifying patients who would benefit the most from the broadening arsenal of immunotherapies and assessing response to these therapies. While there are substantial gaps in biomarker testing, pathologic response assessment, and the use of immunotherapies in current practice, things will only become more complicated. This PeerView Live educational activity, based on a recent symposium, will help you refine your current best practices and prepare you for what's to come next. Top experts convene to provide a visual exploration of the most important recent advances in immuno-oncology, conduct demonstrations of representative and challenging real-world cases, and walk you through practical exercises on operationalizing biomarker testing and pathologic response assessment in different laboratory and clinical settings. Upon completion of this activity, participants should be better able to: Discuss the rationale, recommendations, and practical considerations related to cancer immunotherapy biomarker testing and pathologic response assessment in different tumors and treatment settings, Use appropriate immunotherapy biomarker testing and pathologic response assessment to cancer immunotherapies according to the latest evidence, requirements, and best practice recommendations across different tumors and treatment settings, Implement effective strategies for multidisciplinary communication, collaboration, and coordination among pathologists, oncologists, and other care team professionals regarding selection and interpretation of immunotherapy biomarker tests and pathologic response assessment to guide clinical decision-making regarding cancer immunotherapies across different tumors and treatment settings.

Go online to PeerView.com/KCV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapy in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 monoclonal antibodies is swiftly expanding from metastatic to early-stage, curative-intent settings in an increasing number of solid tumors. Furthermore, it's on the cusp of further explosive growth as other novel agents, including inhibitors of new checkpoints such as LAG-3 and TIGIT, are starting to emerge. Pathologists and oncologists play a crucial role in identifying patients who would benefit the most from the broadening arsenal of immunotherapies and assessing response to these therapies. While there are substantial gaps in biomarker testing, pathologic response assessment, and the use of immunotherapies in current practice, things will only become more complicated. This PeerView Live educational activity, based on a recent symposium, will help you refine your current best practices and prepare you for what's to come next. Top experts convene to provide a visual exploration of the most important recent advances in immuno-oncology, conduct demonstrations of representative and challenging real-world cases, and walk you through practical exercises on operationalizing biomarker testing and pathologic response assessment in different laboratory and clinical settings. Upon completion of this activity, participants should be better able to: Discuss the rationale, recommendations, and practical considerations related to cancer immunotherapy biomarker testing and pathologic response assessment in different tumors and treatment settings, Use appropriate immunotherapy biomarker testing and pathologic response assessment to cancer immunotherapies according to the latest evidence, requirements, and best practice recommendations across different tumors and treatment settings, Implement effective strategies for multidisciplinary communication, collaboration, and coordination among pathologists, oncologists, and other care team professionals regarding selection and interpretation of immunotherapy biomarker tests and pathologic response assessment to guide clinical decision-making regarding cancer immunotherapies across different tumors and treatment settings.

Go online to PeerView.com/KCV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapy in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 monoclonal antibodies is swiftly expanding from metastatic to early-stage, curative-intent settings in an increasing number of solid tumors. Furthermore, it's on the cusp of further explosive growth as other novel agents, including inhibitors of new checkpoints such as LAG-3 and TIGIT, are starting to emerge. Pathologists and oncologists play a crucial role in identifying patients who would benefit the most from the broadening arsenal of immunotherapies and assessing response to these therapies. While there are substantial gaps in biomarker testing, pathologic response assessment, and the use of immunotherapies in current practice, things will only become more complicated. This PeerView Live educational activity, based on a recent symposium, will help you refine your current best practices and prepare you for what's to come next. Top experts convene to provide a visual exploration of the most important recent advances in immuno-oncology, conduct demonstrations of representative and challenging real-world cases, and walk you through practical exercises on operationalizing biomarker testing and pathologic response assessment in different laboratory and clinical settings. Upon completion of this activity, participants should be better able to: Discuss the rationale, recommendations, and practical considerations related to cancer immunotherapy biomarker testing and pathologic response assessment in different tumors and treatment settings, Use appropriate immunotherapy biomarker testing and pathologic response assessment to cancer immunotherapies according to the latest evidence, requirements, and best practice recommendations across different tumors and treatment settings, Implement effective strategies for multidisciplinary communication, collaboration, and coordination among pathologists, oncologists, and other care team professionals regarding selection and interpretation of immunotherapy biomarker tests and pathologic response assessment to guide clinical decision-making regarding cancer immunotherapies across different tumors and treatment settings.

Go online to PeerView.com/KCV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapy in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 monoclonal antibodies is swiftly expanding from metastatic to early-stage, curative-intent settings in an increasing number of solid tumors. Furthermore, it's on the cusp of further explosive growth as other novel agents, including inhibitors of new checkpoints such as LAG-3 and TIGIT, are starting to emerge. Pathologists and oncologists play a crucial role in identifying patients who would benefit the most from the broadening arsenal of immunotherapies and assessing response to these therapies. While there are substantial gaps in biomarker testing, pathologic response assessment, and the use of immunotherapies in current practice, things will only become more complicated. This PeerView Live educational activity, based on a recent symposium, will help you refine your current best practices and prepare you for what's to come next. Top experts convene to provide a visual exploration of the most important recent advances in immuno-oncology, conduct demonstrations of representative and challenging real-world cases, and walk you through practical exercises on operationalizing biomarker testing and pathologic response assessment in different laboratory and clinical settings. Upon completion of this activity, participants should be better able to: Discuss the rationale, recommendations, and practical considerations related to cancer immunotherapy biomarker testing and pathologic response assessment in different tumors and treatment settings, Use appropriate immunotherapy biomarker testing and pathologic response assessment to cancer immunotherapies according to the latest evidence, requirements, and best practice recommendations across different tumors and treatment settings, Implement effective strategies for multidisciplinary communication, collaboration, and coordination among pathologists, oncologists, and other care team professionals regarding selection and interpretation of immunotherapy biomarker tests and pathologic response assessment to guide clinical decision-making regarding cancer immunotherapies across different tumors and treatment settings.

Go online to PeerView.com/KCV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapy in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 monoclonal antibodies is swiftly expanding from metastatic to early-stage, curative-intent settings in an increasing number of solid tumors. Furthermore, it's on the cusp of further explosive growth as other novel agents, including inhibitors of new checkpoints such as LAG-3 and TIGIT, are starting to emerge. Pathologists and oncologists play a crucial role in identifying patients who would benefit the most from the broadening arsenal of immunotherapies and assessing response to these therapies. While there are substantial gaps in biomarker testing, pathologic response assessment, and the use of immunotherapies in current practice, things will only become more complicated. This PeerView Live educational activity, based on a recent symposium, will help you refine your current best practices and prepare you for what's to come next. Top experts convene to provide a visual exploration of the most important recent advances in immuno-oncology, conduct demonstrations of representative and challenging real-world cases, and walk you through practical exercises on operationalizing biomarker testing and pathologic response assessment in different laboratory and clinical settings. Upon completion of this activity, participants should be better able to: Discuss the rationale, recommendations, and practical considerations related to cancer immunotherapy biomarker testing and pathologic response assessment in different tumors and treatment settings, Use appropriate immunotherapy biomarker testing and pathologic response assessment to cancer immunotherapies according to the latest evidence, requirements, and best practice recommendations across different tumors and treatment settings, Implement effective strategies for multidisciplinary communication, collaboration, and coordination among pathologists, oncologists, and other care team professionals regarding selection and interpretation of immunotherapy biomarker tests and pathologic response assessment to guide clinical decision-making regarding cancer immunotherapies across different tumors and treatment settings.

Go online to PeerView.com/KCV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapy in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 monoclonal antibodies is swiftly expanding from metastatic to early-stage, curative-intent settings in an increasing number of solid tumors. Furthermore, it's on the cusp of further explosive growth as other novel agents, including inhibitors of new checkpoints such as LAG-3 and TIGIT, are starting to emerge. Pathologists and oncologists play a crucial role in identifying patients who would benefit the most from the broadening arsenal of immunotherapies and assessing response to these therapies. While there are substantial gaps in biomarker testing, pathologic response assessment, and the use of immunotherapies in current practice, things will only become more complicated. This PeerView Live educational activity, based on a recent symposium, will help you refine your current best practices and prepare you for what's to come next. Top experts convene to provide a visual exploration of the most important recent advances in immuno-oncology, conduct demonstrations of representative and challenging real-world cases, and walk you through practical exercises on operationalizing biomarker testing and pathologic response assessment in different laboratory and clinical settings. Upon completion of this activity, participants should be better able to: Discuss the rationale, recommendations, and practical considerations related to cancer immunotherapy biomarker testing and pathologic response assessment in different tumors and treatment settings, Use appropriate immunotherapy biomarker testing and pathologic response assessment to cancer immunotherapies according to the latest evidence, requirements, and best practice recommendations across different tumors and treatment settings, Implement effective strategies for multidisciplinary communication, collaboration, and coordination among pathologists, oncologists, and other care team professionals regarding selection and interpretation of immunotherapy biomarker tests and pathologic response assessment to guide clinical decision-making regarding cancer immunotherapies across different tumors and treatment settings.

Anti-TIGIT drugs were once hailed as the future of immuno-oncology. But Roche's two recent clinical trial failures for tiragolumab are raising questions about whether Big Pharmas bet on the wrong horse. Also under discussion is the sector's impressive first-quarter revenue growth. Out of nearly two dozen biopharma companies, more than half generated double-digit growth, including eye-popping increases from mRNA stars Moderna and BioNTech. And Fierce journalists finally got together in person after more than two years. They share what it was like to be in a newsroom once again. To learn more about the topics in this episode: To TIGIT or not to TIGIT? Roche's latest trial flop casts shadow on Big Pharma's $6B bet Roche's TIGIT flop prompts GSK, iTeos to reevaluate next steps for rival drug Strike 2: Roche flunks another phase 3 lung cancer test to leave TIGIT space reeling Pfizer, Merck and AstraZeneca led Big Pharma's growth in Q1 but they couldn't match mRNA hotshots Labcorp's combo COVID, flu, RSV test nabs first green light for direct-to-consumer Pfizer holding on tight to supplies of COVID-19 drug Paxlovid, limiting the prospect of combination research: report GlaxoSmithKline is no more: Meet the scaled down 'GSK' Avanos Medical faces Class I recall for feeding tube system linked to 23 deaths since 2015 Lilly's highly anticipated diabetes drug Mounjaro wins FDA blessing The Top Line is produced by senior multimedia producer Teresa Carey, with editor-in-chief Tracy Staton, managing editor Querida Anderson, senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. See omnystudio.com/listener for privacy information.

Dr. Hossein Borghaei, Fox Chase Cancer Center, joins Hafiz and Mahim today to discuss updates in TIGIT, Immunotherapy, and more.

In this episode, Jyoti D. Patel, MD, and Ani Balmanoukian, MD, discuss several studies investigating agents targeting TIGIT, an emerging immune checkpoint target with promising results in PD-L1-positive NSCLC. The episode includes a review of phase II data on the use of tiragolumab plus atezolizumab in NSCLC, the use of PD-L1 as a marker of response, the potential role of anti-TIGIT therapies in solid tumors, and ongoing trials in lung cancer including SKYSCRAPER-01, SKYSCRAPER-02, SKYSCRAPER-03, and SKYSCRAPER-05. Presenters:Jyoti D. Patel, MDProfessor of MedicineDivision of Hematology and OncologyMedical Director for Thoracic OncologyAssistant Director for Clinical ResearchAssociate Vice Chair of Clinical ResearchDepartment of MedicineRobert H. Lurie Comprehensive Cancer CenterNorthwestern UniversityChicago, Illinois Ani  Balmanoukian, MDDirector of Thoracic OncologyMedical OncologyThe Angeles Clinic and Research Institute, a Cedars-Sinai AffiliateLos Angeles, CaliforniaLink to the complete program, including an online text module with downloadable slidesets, ClinicalThought commentaries, and an additional podcast on this topic:https://bit.ly/38qVCH7

In this episode, Jyoti D. Patel, MD, and Diwakar Davar, MD, discuss several studies investigating agents targeting TIGIT, an emerging immune checkpoint target with promising early-phase clinical trial results. The episode includes a comprehensive explanation of TIGIT, how the TIGIT pathway functions, and the potential role of TIGIT inhibition for the treatment of cancer, including analyses from ongoing clinical trials such as CITYSCAPE, PACIFIC-8, ARC-7, and SKYSCRAPER-01.Presenters:Jyoti D. Patel, MDProfessor of MedicineDivision of Hematology and OncologyMedical Director for Thoracic OncologyAssistant Director for Clinical ResearchAssociate Vice Chair of Clinical ResearchDepartment of MedicineRobert H. Lurie Comprehensive Cancer CenterNorthwestern UniversityChicago, IllinoisDiwakar Davar, MDAssistant Professor, Melanoma and Phase I TherapeuticsDivision of Hematology/OncologyDepartment of MedicineUniversity of Pittsburgh Hillman Cancer CenterPittsburgh, PennsylvaniaLink to the complete program, including an online text module with downloadable slidesets, ClinicalThought commentaries, and an additional podcast on this topic:https://bit.ly/3r9BLmB

On this week's episode Virginia Li discusses the closely watched FDA AdCom meeting for Amylyx's ALS therapy AMX0035, which saw experts vote narrowly against Amylyx having shown sufficient efficacy for the drug from a single clinical study. Simon King looks at two major clinical data announcements – for Almirall and Eli Lilly's atopic dermatitis drug lebrikizumab and Roche's potential cancer therapy tiragolumab. And FirstWord HealthTech's Tina Tan highlights some notable trends in health tech venture capitalist investments during the first quarter of 2022, ahead of an exclusive live event for FirstWord HealthTech PLUS subscribers next week where she will provide a more comprehensive overview of VC activity.

If you're enjoying the content, please drop a like, comment, and subscribe! A cancer immunologist by training, Dr. Christopher Nirschl received his PhD from the Johns Hopkins School of Medicine in Immunology in 2015, and completed a postdoctoral fellowship at the Brigham and Women's Hospital in association with Harvard Medical School. He has been studying the interactions between cancer and the immune system for over a decade, and is also one of the inventors of the anti-TIGIT antibody ASP8374/PTZ-201 which is currently in clinical trials. Currently, Dr. Nirschl is an Immunologist at Werewolf Therapeutics in Massachusetts, where he lives with his wife and two children. Find his book, "What the Heck Is A Clinical Trial?", here - https://www.amazon.com/What-Heck-Clinical-Trial-Where-ebook/dp/B09QKG37T7 @worldxppodcast Instagram - https://bit.ly/3eoBwyr @worldxppodcast Twitter - https://bit.ly/2Oa7Bzm Spotify - http://spoti.fi/3sZAUTG Apple Podcasts - http://apple.co/30uGTny Google Podcasts - http://bit.ly/3v8CF2U Anchor - http://bit.ly/3qGeaH7YouTube - http://bit.ly/3rxD

A cancer immunologist by training, Dr. Christopher Nirschl received his PhD from the Johns Hopkins School of Medicine in Immunology in 2015, and completed a postdoctoral fellowship at the Brigham and Women's Hospital in association with Harvard Medical School. He has been studying the interactions between cancer and the immune system for over a decade, and is also one of the inventors of the anti-TIGIT antibody ASP8374/PTZ-201 which is currently in clinical trials. Currently, Dr. Nirschl is an Immunologist at Werewolf Therapeutics in Massachusetts, where he lives with his wife and two children. Be on the lookout for his book, "What the Heck Is A Clinical Trial?", out this coming winter! @worldxppodcast Instagram - https://bit.ly/3eoBwyr@worldxppodcast Twitter - https://bit.ly/2Oa7Bzm Spotify - http://spoti.fi/3sZAUTGApple Podcasts - http://apple.co/30uGTnyGoogle Podcasts - http://bit.ly/3v8CF2UAnchor - http://bit.ly/3qGeaH7YouTube - http://bit.ly/3rxD

To the oncologist, human physiology is a riot of redundancies, and treating cancer is a game of whack-a-mole – target one mechanism, another pops up. Anat Cohen-Dayag, scientist and CEO of Compugen has known this for years. However, to bring her expertise into the clinical realm, she needed to transform her company from a service provider of computational target discovery, into a savvy team of scientists/clinicians poised to enter the blockbuster field of cancer immunotherapy checkpoints.

  Vidcast:  https://youtu.be/LsH7UZN_Fz4   Today's medical discoveries that point to future therapy: Ultrasonic Patch Warns Of Strokes and Heart Attacks Electromagnetic Helmet Helps Shrink Brain Tumor Copper Tranporter Gene Triggers Blood Vessel Repair New Cancer Immunotherapy Emerging Nanodressing Turbocharges Wound Healing   UC-San Diego have developed a soft, flexible ultrasound generating patch that, when worn on the skin of the neck or chest, can report blood flow problems major arteries feeding the brain and heart.  The phased array of ultrasound transducers in the patch work continuously to measure blood flow in vessels as deep as 6 inches within the body.  The ultrasound beam may also be electronically tilted for measurements of vessels not directly beneath the patch.   An oscillating magnetic field generated within a wearable helmet has driven shrinkage of an otherwise untreatable brain tumor by 30%.  Neurosurgical investigators at the Houston Methodist Research Institute report the case of a 53 year old man with an end-stage, recurrent frontal lobe glioblastoma given this electromagnetic therapy for 5 weeks.  Looks for more work in this arena.   Medical College of Georgia cardiologists report that the gene responsible for copper transport and utilization also promotes the healing of ailing blood vessels.  In a biochemical cascade, the product of this gene, ATP7A, triggers activity of the blood vessel growth factor VEGFR2.  Acquiring control over this process could help halt vascular deterioration in diabetics and others with chronic vascular disease.   There are new cancer immunotherapy agents in town called anti-TIGIT antibodies, and they prevent TIGIT from dialing down killer T cell activity against cancer cells.  The major drug companies are all battling to get their hands on these experimental agents.  GlaxoSmithKline just bought rights to EOS-448, BristolMyersSquibb bought AGEN1777, Gilead  AB154, and Roche has already tested its tiragolumab in combination with another checkpoint inhibitor in phase 2 trials.  Stay tuned on this one.   A wound nanodressing composed of thin threads of natural materials including collagen as well as wound healing promotion agents may provide a cost effective means of helping diabetics and others with chronic vascular disease.  Michigan State bioengineers helmed a multinational group that has developed these dressings aiming to keep the eventual cost as low as $20 per unit by employing readily available biopolymers.   These and other cutting edge solutions are coming to your doctor's office and our hospitals…….some day soon!   https://www.nature.com/articles/s41551-021-00763-4 https://www.frontiersin.org/articles/10.3389/fonc.2021.708017/full https://www.nature.com/articles/s41467-021-23408-1 https://cen.acs.org/pharmaceuticals/biologics/GSK-buy-iTeosanti-TIGIT-antibody/99/i23 https://pubmed.ncbi.nlm.nih.gov/31828774/ https://pubs.acs.org/doi/10.1021/acs.molpharmaceut.1c00400   #ultrasoundpatch #oncomagnetictherapy #glioblastoma #TIGIT #antitigit #checkpointinhbitor #wounds #diabetes  

FirstWord Pharma PLUS editors Becky Simon, Michael Flanagan and Simon King discuss Eli Lilly's decision to file its investigational Alzheimer's disease treatment donanemab for accelerated approval with the FDA, take a closer look at Intellia Therapeutics' pivot into CAR-T, question whether momentum is building for Big Pharma in-licensing deals and break down expert feedback on Sage Therapeutics depression drug zuranolone.

Earlier this week GlaxoSmithKline announced it will pay iTeos Therapeutics $625 million dollars upfront to gain exclusive co-marketing rights for the latter's anti-TIGIT monoclonal antibody EOS-448, as part of a deal potentially worth over $2 billion. The drug is currently in Phase I development for advanced solid tumours and this collaboration represents the latest move by GlaxoSmithKline to build out its cancer pipeline. FirstWord Pharma PLUS executive editor Simon King spoke to Jo Jenkins, chief medical officer at iTeos about the deal, EOS-448 and the competitive anti-TIGIT field where the likes of Roche, Merck & Co. and Bristol Myers Squibb are all active.

Iteos Therapeutics inc. has come a long way in the past year. The company went public in July 2020 and this week inked a deal with Glaxosmithkline plc (GSK) that could top $2 billion. Iteos brings GSK a human monoclonal antibody targeting TIGIT, the third of the known CD226 checkpoints that the company wanted for its cancer therapy program. The two companies plan to split U.S. profits, something that Iteos insisted upon as part of the deal. Iteos is receiving $625 million as an up-front payment and up to $1.45 billion in potential milestone payments.In this episode, BioWorld Staff Writer Lee Landenberger caught up with Michel Detheux, president and CEO of Iteos, who said the company was in a strong financial position and didn't need a deal this size, but the cash infusion will significantly boost its PD-1 development programs. See acast.com/privacy for privacy and opt-out information.