Podcast appearances and mentions of Bristol Myers Squibb

La representante de la farmaceutica Bristol-Myers Squibb, pionera en este tipo de tratamiento, ha conversado con Carlos Alsina con motivo del dia mundial de esta enfermedad.

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a myriad of pivotal changes and advancements that have been shaping our industry.The competitive nature of acquisitions within the biopharma sector has been exemplified by recent strategic buyouts. Lundbeck's decision to outbid Alkermes for Avadel Pharmaceuticals highlights how companies are leveraging acquisitions to expand their capabilities and portfolios. Similarly, Pfizer's finalized acquisition of Metsera after a fierce bidding war with Novo Nordisk underscores the importance of securing valuable assets to strengthen positioning in critical therapeutic areas, such as obesity treatment, where demand continues to rise.Regulatory milestones remain at the heart of industry progress. Organon and Henlius's Poherdy recently received FDA approval as a biosimilar to Roche's Perjeta, offering a new treatment avenue for HER2-positive breast cancer patients. This approval is noteworthy as biosimilars play an essential role in oncology by providing similar efficacy to original biologics but at reduced costs, thereby enhancing healthcare affordability and accessibility. In Europe, the EMA's Committee for Medicinal Products for Human Use has endorsed several innovative drugs, including Otsuka's Dawnzera for hereditary angioedema and Lilly's Inluriyo for certain cancer types. These endorsements reflect the growing pipeline of treatments addressing both rare genetic disorders and widespread diseases.Merck & Co.'s acquisition of Cidara Therapeutics for $9.2 billion underscores a strategic pivot towards bolstering its antiviral portfolio. This deal is particularly significant given Cidara's promising influenza antiviral candidate, initially abandoned by Johnson & Johnson. In an era where infectious diseases pose ever-evolving challenges, Merck's investment in antivirals reflects a commitment to advancing therapeutic solutions in this crucial area.However, drug development's inherent uncertainties were highlighted by Bristol Myers Squibb and Johnson & Johnson's joint anticoagulant venture, which faced termination due to a Phase 3 trial failure. This setback emphasizes the challenges and risks entailed in developing novel therapeutics, particularly within high-stakes areas like cardiovascular health.Leadership changes can significantly impact corporate strategy, as seen with Bavarian Nordic following an unsuccessful private equity takeover attempt. Such shifts can influence investor confidence and reshape strategic directions.Investment trends also paint an optimistic picture for innovation within the sector. European life sciences investor Medicxi's successful raising of €500 million signifies robust financial support for biotech ventures. This influx of capital is vital for propelling early-stage research and development efforts across Europe, fostering breakthroughs in chronic and rare disease treatments.In terms of scientific innovation, advancements in bispecific antibody production through AI/ML-driven molecular design promise higher yields and enhanced quality. These technological innovations could revolutionize complex biologics manufacturing, potentially accelerating timelines and expanding therapeutic possibilities.The regulatory landscape is seeing significant activity as well. Notably, FDA officials introduced a novel pathway aimed at accelerating gene editing therapies' development and approval. By facilitating faster market entry for personalized medicines, this regulatory innovation could pave the way for treatments tailored to individual genetic profiles.Kyowa Kirin's collaboration with Kura Oncology reached a milestone with FDA approval for an oral medication targeting acute myeloidSupport the show

La representante de la farmaceutica Bristol-Myers Squibb, pionera en este tipo de tratamiento, ha conversado con Carlos Alsina con motivo del dia mundial de esta enfermedad.

Today's guest is Raul Monroig, People Organization Vice President for the Intercon Region at Bristol Myers Squibb. Bristol Myers Squibb manufactures prescription medicines across oncology, hematology, immunology, cardiovascular disease, and neuroscience. With a truly global footprint, the company's research, manufacturing, and commercial presence spans more than 60 countries, and with such scale, of course, comes the complexity of managing a vast workforce. Raul joins Emerj Editorial Director Matthew DeMello to discuss how global HR teams can embrace AI to tackle critical challenges in workforce development. With AI adoption accelerating at breakneck speed, it may be that focusing on a small set of essential skills like curiosity, agility, and customer service orientation —  rather than training employees on everything all at once — may be the paradigm shift that helps drive organisational success. Learn how brands work with Emerj and other Emerj Media options at emerj.com/ad1.

In this podcast episode, Dr. Dimitrios Coutsinos describes a video capsule series involving three educational videos of lung resections using minimally invasive video-assisted thoracic surgery (VATS) following neoadjuvant immunotherapy in patients with lung cancer. Our Host:Dr. Dimitrios Coutsinos is a thoracic surgeon at Interior Health Authority and a professor at the University of British Columbia. Dr. Coutsinos has received honoraria for advisory board attendance from: AstraZeneca, Bristol Myers Squibb, Intuitive Surgica, Johnson and Johnson, Merck, and Roche.Video Capsule Series:To access the video capsule series, please visit: https://www.impactmedicom.com/video-capsules.This podcast episode and video capsule series was funded by Merck Canada.If you enjoyed our podcast episode, please review and subscribe. For other medical education content, visit our website at: https://www.impactmedicom.com.

Dr. Monty Pal and Dr. Pauline Funchain discuss the latest efforts to diagnose, prevent, and treat the series of immune-related adverse events that have emerged in the era of immunotherapy. TRANSCRIPT Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I am Monty Pal, a medical oncologist, professor and vice chair of medical oncology at the City of Hope Comprehensive Cancer Center in Los Angeles, California. Now, it is probably no surprise to this audience that immunotherapy has transformed the treatment landscape for multiple cancer types. It remains a pillar of modern oncology. Having said that, I think we have all been baffled by certain toxicities that we run into in the clinic. Today, I am delighted to be joined by Dr Pauline Funchain to discuss some of the checkpoint inhibitor toxicities that people struggle with most. And we will also touch on some side effects of immunotherapy beyond checkpoint inhibitors: CAR-T cells, bispecifics, so on and so forth. Dr Funchain is a dear friend, and she is an associate professor and associate director of cancer research training and education at the Stanford Cancer Institute. She is co-director of the Immunotherapy Toxicity Program and the Skin Cancer Genomics Program at Stanford, where she also serves as associate program director of hematology and oncology fellowship. Dr. Funchain is also the co-founder of ASPIRE, and we are going to talk about that a little bit today, the Alliance for the Support and Prevention of Immune-Related Events. FYI for listeners, if you are interested in our disclosures, they are available at the transcript of this episode. Pauline, thanks so much for joining us today. Dr. Pauline Funchain: Monty, thank you for this invitation. It is always great to talk. Dr. Monty Pal: So, for the audience, Pauline and I know each other from my days as a fellow at City of Hope. She was a resident at Harbor UCLA and a stellar resident at that. It has just been amazing to sort of see your career grow and blossom and to witness all the cool things that you are doing. ASPIRE, in particular, sort of caught my eye. So again, for listeners, this is the Alliance for the Support and Prevention of Immune-Related Events. Can you tell us a little bit briefly about the genesis of that, how that came about? Dr. Pauline Funchain: So, there was a bunch of us who were really struggling, I mean, all of us have struggled with these immune-related adverse events, these irAEs. You know, they are new disease states, and even though they look like autoimmune diseases, they tend to need a whole lot more steroid than autoimmune diseases do and they do not totally present in the same way. And in fact, you know, Triple-M, or Triple-M overlap syndrome, is a completely new irAE, a new immune state that we have never had before the advent of checkpoint inhibitor. And so a Triple-M, for those of you who are not as familiar, that is the constellation of myocarditis, myositis, and myasthenia gravis, something that never occurs as a natural autoimmune disease. So we were starting to realize that there were some major differences with these irAEs and autoimmune diseases. We could not treat them the right way. We really needed to learn more about them. And a bunch of us who had interest in this said, "Look, we really need to be all in one space to talk about what we are doing," because all of our treatments were our own little homegrown brews, and we needed to really get together and understand how to treat these things, how to diagnose them, and then learn more about them. So, Dr. Alexa Meara from Ohio State, Dr. Kerry Reynolds from Mass Gen, we put together this research consortium, brought together all of our irAE friends, got our best subspecialists together in a research consortium, which is now only about a year and a half old. And we made this research consortium, the Alliance for Support of Prevention of Immune-Related Events, and we reached out to ASCO, and ASCO was so kind to grant us a [Alliance for Support and Prevention of Immune-Related adverse Events (ASPIRE)] Community of Practice. So we met for the first time as a Community of Practice at the ASCO Annual Meeting just this past June and really got an ASCO community together to really think about how to again, diagnose, prevent, treat irAEs. Dr Monty Pal: This is interesting to me. The ASCO Community of Practice phenomenon is something that I was not super familiar with. Can you explain to our listenership what is the ASCO Community of Practice model? If you have particular interests, how do you sort of get one started? Dr Pauline Funchain: Yeah, so ASCO has an entire page on their Community of Practice. There are multiple Community of Practice groups or COPs. There are ones for Supportive Oncology and Survivorship. There is Women in Oncology. There is a group for International Medical Graduates. And there is about, I think 10 or 12 now that have a physical presence at ASCO but also a virtual presence on the ASCO Community of Practice site. So, if you were interested in any one of these, and you can see them on the ASCO Communities of Practice sites, you would ask to become a member. Once granted membership, then there is a whole webpage of postings and conversations that people can have. You can get email digests of conversations that happen on the website, and then you can anchor it with in-person participation at the Annual Meeting. Dr Monty Pal: That is awesome, and I can think of so many different foci within oncology that really sort of deserve a Community of Practice. This definitely being one of them. You know, it strikes me as being so interesting. I mean, the checkpoint inhibitors have been around for a while now. I think when you and I were in training, gosh, back then, these were just a little bit of a pipe dream, right? But having said that, I would probably say that more than half of my kidney cancer practice is either on checkpoint inhibitors, and the vast majority have been on one at some point in their past, right? With that in mind, you know, we have all treated a lot of patients with these drugs. Why is it that we still struggle to manage the toxicities? And just to take that one step further, what are some of the toxicities that, perhaps through ASPIRE or through your experience, people struggle with the most? Dr Pauline Funchain: So, I think we are still struggling with these because again, they are new disease states, right? This is what we all experienced with COVID, a brand-new virus and a brand-new syndrome. We now have 20-plus of these as irAEs. And what we have realized about them is the immune activation that happens with these is so much more than what we have seen with autoimmune diseases. So for instance, if you have a Crohn's or ulcerative colitis, you will top out at 40 to 60 milligrams of prednisone if a Crohn's flare or ulcerative colitis flare happens. But for our severe IR colitises, you know, it is at least 1 mg per kg, often goes up to 2 mg per kg. We, in some cases, have done 1 gram pulses if we are worried that somebody is going to perforate. So that was sort of like the first 5 years of treating irAE, and then now in the sort of second 5 years of treating irAE, we have realized that that is a lot of immunosuppression, and we might be able to get away with less with the newer biologics that are on board. So, we are struggling to try to get the data for some of these irAEs that we knew, we have known for a while, but to try to get newer treatments that may immunosuppress less so that you may still be able to retain that tumor response. And in fact, some of the preclinical studies suggest that some of these biologics may actually synergize with the immunotherapy and actually make the immunotherapy more effective from a tumor perspective and calm down the irAE as sort of the bystander effect. So we are still trying to optimize those. Getting up trials in the space has been very difficult. That is one of the reasons for the genesis of ASPIRE because we realized we needed to band together to have a bigger voice in that realm. Then there are other things that are brand new. So we talked about Triple-M. So Triple-M, again, with Triple-M or any myocarditis or myasthenia, I mean, there is about a 50% chance of death from irAE based on the literature. I think we are getting better at recognizing this, and so at Stanford we have some data to say that if you serially follow troponin, that maybe your outcomes are better. You can potentially lower the percentage of cases that are fatal because you can catch them early. I mean, this is all preliminary data, but again, these are all things that are evolving, and we do not all have the right answer. I mean, even the serial troponin thing, I think, is pretty controversial. And in fact, at one of our quarterly Zoom meetings that we are doing in ASPIRE in December is going to sort of flush out that controversy about serial troponin measuring and what is the best thing to use? Would you use something like abatacept or would you use ruxolitinib? Which one is better? I think there is a lot of controversy still about these things. Dr Monty Pal: You have really piqued my curiosity here because you think about the cons of treating irAEs, right? And I worry exactly about what you had mentioned, right, which is, "Gosh, what is going on with this tumor in terms of immunosuppression?" But you think about some of the newer agents, you mentioned ruxolitinib, I have heard of dasatinib, for instance, in this setting. Frankly speaking, a lot of these, as you point out, are really thought of as being also anticancer drugs. So you have really got me thinking about the potential synergy between perhaps suppressing an irAE and augmenting antitumor activity, which I think is very interesting. Am I on the right track with that? Dr Pauline Funchain: I think so, but you will find that a lot of people will not even go there because they are worried about how much immunosuppression you are going to cause. I am at heart a geneticist, but I think an immunologist will happily tell you that the immune system is very complex. There are multiple pathways, and these drugs do not all target the same immune pathways. So if we understand a little bit more about the pathways we are targeting and pick apart the pathways that are really, really tumor relevant and the other pathways that are not tumor relevant, you may be able to piece together a better marriage of tumor response and irAE control. Dr Monty Pal: Kind of on this topic, and again, leaning on your background in genetics, where are we in terms of predicting these irAEs? I mean, you would think the holy grail would be picking out a snip or something of this for it, right, that could potentially identify that patient who is going to get Triple-M or, you know, at the very least a significant high-grade irAE event. Are we anywhere closer to that in 2025? Dr Pauline Funchain: There have been data published. There have been some big GWAS studies. All of the effect sizes are pretty small. So there are some prediction algorithms, but none of them are clinically useful. And I think when you look at the odds ratios, they will increase risk by maybe 20%. I think one of the things that we found in a very small series and supported anecdotally is something as easy as family history of autoimmune disease is probably more predictive at this point than any of those types of markers. I think we will get there, but we are not anywhere near where we would like to be. Things like TMB also, actually, there is some good data about higher TMB, higher risk of irAE too. Dr Monty Pal: Interesting. I see all this data coming through, IL-8 polymorphisms, etc. And I just wondered if any of that was ready for prime time. But I mean, this is a good message for the practicing clinician. Sounds like we are not quite there yet. And I could probably keep you on for another entire podcast to talk about this topic, but let us see if we can at least skim the surface. I never thought I would see the day when BiTEs and CAR-Ts were entering into my kidney cancer practice, but in fact, it is really become central to a lot of our clinical trials in RCC these days. I would be lying if I did not say that I was not struggling with the toxicities and so forth associated with these drugs. Can you give us a quick primer, maybe just good resources that people can go to for managing toxicity with BiTEs and with CAR and with some of these novel therapeutic modalities that we are using in the oncology clinics? Dr Pauline Funchain: I know there is a recently published toxicity manual for BiTEs in hematologic malignancies, I think it was in Blood. CAR-T is covered in many irAE guidelines. So ASCO guidelines actually has a CAR-T [cell therapy guideline], and I would be remiss not to point out that actually ASCO has a, I am a little biased, but a wonderful guideline on irAE that is actually being updated as we speak. We are hoping for publication next year. I find the format of that, there are many guidelines out there, actually. There is ASCO, SITC, ESMO has a guideline for irAE, but I find the formatting of the ASCO guideline to be much easier to flip through during clinic, just because of the visual format of the tables. But that is going to be updated next year. And with CAR-T, there is now multiple publications also in terms of guidelines. But what I will say about bispecifics and CAR-T, so they have very similar toxicities in terms of the cytokine release and also with the ICANS, so the neurotoxicity. But what we have been finding that is really interesting with BiTEs and CAR-T, and actually even with TIL, cytokine release is very similar to some of the IL-2 toxicities but not identical that we see with TIL treatment. But now we are starting to see overlap. So patients who have been treated with immunotherapy and then go on to get a bispecific or then go on to get TIL, so I have seen some colitises that have occurred after the fact. Some of the newer CAR-Ts without checkpoint have been causing some really interesting, probably not in a good way, but interesting biologically, colitises that are really refractory. So we are starting to see some overlap, and again, I think this field is just evolving constantly. Dr Monty Pal: Yeah, no, I almost think I need to go back to that fellowship that you and I did together 20 years ago and, you know, and see if I could repeat some coursework on CAR-T management.  You know, Pauline, I could probably keep you on the horn for hours, but this has just been terrific. Thank you so much for sharing all of your insights with us today on the ASCO Daily News Podcast. Dr Pauline Funchain: Thank you for the invitation. It was wonderful to talk about this, and it was wonderful to catch up a little bit, Monty. Dr Monty Pal: Same here, same here. And thanks to our listeners too. If you value the insights you heard today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. 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. Find out more about today's speakers:      Dr. Monty Pal    @montypal   Dr. Pauline Funchain @FunchainMD Follow ASCO on social media:       @ASCO on Twitter      ASCO on Bluesky     ASCO on Facebook       ASCO on LinkedIn     Disclosures: Dr. Monty Pal:     Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview    Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical    Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis    Dr. Pauline Funchain: Consulting or Advisory Role: Merck, Replimune, Sanofi/Regeneron, Immunocore, Tempus Research Funding (Inst.): Pfizer, Bristol-Myers Squibb, IDEAYA Biosciences, Linnaeus Therapeutics Travel, Accommodations, Expenses: Merck

This episode covers: Cardiology this Week: A concise summary of recent studies Lp(a) - What to expect in the very near future Myocardial infarction in older and frail adults Mythbusters: is beetroot good for your heart? Host: Rick Grobbee Guests: JP Carpenter, Vijay Kunadian, Erik Stroes Want to watch that episode? Go to: https://esc365.escardio.org/event/2177 Want to watch that extended interview on Lp(a), go to: https://esc365.escardio.org/event/2177?resource=interview   Disclaimer  ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails.    Declarations of interests Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel, Vijay Kunadian and Erik Stroes have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Rick Grobbee  Guest: Erik Stroes  Want to watch that extended interview on Lp(a), go to: https://esc365.escardio.org/event/2177?resource=interview Want to watch that episode? Go to: https://esc365.escardio.org/event/2177 Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Rick Grobbee and Erik Stroes have declared to have no potential conflicts of interest to report.

In this episode of finding grace I'm joined by Nitika Chopra is the Founder and CEO of Chronicon and The Chronicon Foundation, a pioneering platform and nonprofit uplifting those living with chronic illness through community, advocacy, and education. A seasoned host, speaker, and entrepreneur, she's collaborated with brands like Google, Microsoft, and Bristol-Myers Squibb, hosted a globally distributed talk show, and now leads Truth Talks via substack. Her mission: to create healing spaces where people are empowered to live fully and thrive, on their terms.In this episode you'll discover.Nitika shares what finding grace means to her and journey she's been on.We discussed the continued lack of diversity in the wellness industry, and the importance of using your platforms to create more inclusive, authentic spaces.Nitika shared her powerful story, from being diagnosed with psoriasis at age ten to founding Chronicon, highlighting how resilience, vulnerability, and purpose have shaped her path.We explored the harms of toxic positivity and self-gaslighting, calling for a more compassionate and nuanced approach to healing, especially within chronic illness communities.She touched on the need to bridge the gap between extremes, embracing both struggle and strength, to remove shame and empower others to define their own version of thriving.Nitika spoke about shifting from an illness-based identity toward one rooted in wholeness, seeing healing as an evolving, lifelong practice rather than a fixed destination.Nitika emphasised the healing power of rest and nurturing routines, inviting listeners to reconnect with their inner wisdom and self-love as daily acts of grace.Nitika shares this and so much more.Do reach out to me to continue this conversation.If you want to work with Nitika and find out what she's up to:Instagram @Nitikachopra Substack “The truth today”www.nitikachopra.comYou can find me at : Watch my TEDx talk here Instagram @thehannahwallaceTwitter @hannahwallace_Face book @thehannahwallace Website www.hannah-wallace.com Sign up to my newsletter here Thank you so much for listening please share, subscribe and review it's greatly appreciated and I hope you find grace in your week ahead. Hosted on Acast. See acast.com/privacy for more information.

Many of the top stories of 2025 are currently being written. We're on the edge of our keyboards, watching and waiting as Pfizer and Novo Nordisk duke it out over the right to acquire glittery obesity startup Metsera. In the latest development, Pfizer raised its original bid of around $7.27 billion to about $8.1 billion on Monday—only to be usurped again by the indefatigable Novo, which upped its own bid to a cool $10 billion.  Meanwhile, the unprecedented drama in the uppermost ranks of the FDA—another top story of 2025—continues as CDER Director George Tidmarsh exits the agency. Tidmarsh reportedly resigned Sunday after being placed on administrative leave amid an investigation into his “personal conduct” at the agency. On Monday, however, Tidmarsh told Endpoints News that he was “second-guessing” his decision.  Speaking of the FDA, the regulator appears to have done its own 180—on uniQure's investigational gene therapy for Huntington's disease, three-year data from which sent the biotech's stock into the stratosphere just five weeks ago. Despite previous agreements on protocols and statistical analyses, the agency “no longer agrees” that Phase I/II data for AMT-130 are adequate to provide primary evidence for the application, uniQure said, throwing the timeline for the BLA into question.  Another gene therapy player, Sarepta Therapeutics, took a hit this week, as two of its Duchenne muscular dystrophy drugs, Vyondys 53 and Amondys 45, failed a confirmatory trial. Sarepta still plans to file for full approval of the two exon-skipping therapies, however, based on what it called “encouraging trends” in efficacy. Finally, on the genetic medicine front, CBER director Vinay Prasad teased an upcoming paper that will detail the regulator's thinking and a new approach to gene editing approvals.  On top of all that, Q3 earnings continue to roll in, with Pfizer, Eli Lilly, Vertex, Bristol Myers Squibb, AbbVie, and more reporting results.  One more thing: Have you ever wanted to know more about the inner workings of the Biogen-Eisai Alzheimer's partnership? Check out this profile on BioSpace 40 under 40 honoree Neena Bitritto-Garg, Eisai alum and current CEO of Ensho Therapeutics. 

Bonus Episode for Nov. 4. The weight-loss-drug arms race is only heating up, as Novo Nordisk attempts to snatch drugmaker Metsera away from Pfizer. But can either company compete with Zepbound seller Eli Lilly? WSJ reporter Peter Loftus discusses what earnings from Big Pharma, including AbbVie, Bristol Myers Squibb and Merck, say about the future of the industry and how companies are responding to President Trump's drug-pricing plans, including TrumpRx. WSJ Heard on the Street columnist David Wainer hosts this special bonus episode of What's News in Earnings, where we dig into companies' earnings reports and analyst calls to find out what's going on under the hood of the American economy. Sign up for the WSJ's free Markets A.M. newsletter. Further Reading: Novo Nordisk Sweetens Offer for Metsera - WSJ Pfizer Sues Seeking to Block Novo Nordisk's Effort to Undo Weight-Loss Drug Deal Why Pfizer Can Still Prevail in the Obesity Fight With Novo Nordisk The Day Pharma's Weight-Loss Gold Rush Intensified Pfizer Profit Falls Amid Lower Covid-19 Drug Demand Novo Nordisk Seeks to Outmuscle Pfizer With $9 Billion Bid for Metsera Novo Nordisk to Shake Up Board After Obesity-Market Challenges Mounjaro Powers Eli Lilly to Bumper Quarter of Earnings AbbVie Lifts Profit Outlook as Sales Rise Bristol Myers Squibb Profit Soars, Raises Revenue Guidance Merck Profit Rises on Strong Keytruda Demand GSK Lifts Guidance After Specialty Medicines Boost Sales Novartis Expects to Ride Out Patent Losses With Sales, Profit Growth Ahead Biogen Cuts Full-Year Earnings Guidance, Despite Third-Quarter Profit Rise J&J Lifts Full-Year Sales Outlook, Fueled by Pharma, Med-Device Gains Learn more about your ad choices. Visit megaphone.fm/adchoices

Episode 472 features Dr. Sheila Gujrathi, a biotech entrepreneur, executive, and champion for under represented leaders. Her new book, "The Mirror Effect: A Transformative Approach To Growth For The Next Generation Of Female Leaders" is out now.Chapters:00:00 Introduction and Book Announcement02:15 The Unmet Need: Writing for My Younger Self05:30 Overcoming Challenges: A Personal Journey09:45 The Power of Mentorship and Sponsorship14:00 Spiritual Growth and Finding Purpose18:20 Building a Personal Board of Directors23:10 The Inner Critic and Self-Compassion28:45 The Importance of Storytelling in Leadership33:00 Navigating Negative Work Environments37:15 Conclusion: Embracing Vulnerability and ConnectionFind Sheila Online:Website: ​​https://sheilagujrathimd.com/ TEDxTalk: https://www.youtube.com/watch?v=2DpDx6T3-X4 LinkedIn: https://www.linkedin.com/in/sheila-gujrathi-md/ Instagram: https://www.instagram.com/sheilagujrathimd/ Book: https://sheilagujrathimd.com/book/ About Sheila:Sheila is a biotech entrepreneur, executive, and champion for under represented leaders. Over the past 25 years, she's had the privilege of developing life-changing medicines for patients with serious diseases while building and running private and public biotech companies—including some exciting exits. Today she's a founder, chairwoman, board director, strategic advisor, and consultant to start-up companies and investment funds. Dr. Gujrathi was the co-founder and former CEO of Gossamer Bio and former Chief Medical Officer of Receptos. Her journey started at Northwestern University, where she earned both her M.D. and biomedical engineering degree, and took her from the halls of Harvard, UCSF, and Stanford to the corporate offices of Fortune 500 companies like McKinsey, Genentech, and Bristol-Myers Squibb.Dr. Gujrathi has earned multiple leadership awards, including AIMBE Fellow, BLOC100 Luminary, Healthcare Technology Report Top 25 Women Leaders in Biotechnology, Corporate Directors Forum Director of the Year, and Fiercest Women in Life Sciences. But what really lights her up is creating the inclusive environments she wished she'd had throughout her career. That's why she co-founded the Biotech CEO Sisterhood, a group of trailblazing female CEOs—because we're all better when we support each other.

In der heutigen Folge sprechen die Finanzjournalisten Lea Oetjen und Holger Zschäpitz über das Allzeithoch von Siemens Energy, die Übernahme von Kenvue durch Kimberly-Clark und das große Rätselraten um eine Privatbank. Außerdem geht es um Micron, Alphabet, Biontech, Bristol Myers Squibb, Amazon, OpenAI, Nvidia, Iris Energy, Microsoft, Dell Technologies, Johnson & Johnson, BMW, Continental, Volkswagen, Mercedes-Benz, Aixtron, Deutsche Pfandbriefbank, Lufthansa, Bloom Energy, First Solar, Nextracker, Enphase, Siemens Energy, Linde, Air Liquide, Plug Power, Ballard Power, NEL Asa, Samsung SDI, QuantumScape, GE Vernova, Schneider Electric, Iberdrola, NextEra Energy, Rock Tech Lithium, iShares Global Clean Energy ETF (WKN: A0MW0M), Global X Hydrogen ETF (WKN: A3E40P), Amundi Global Hydrogen ETF (WKN: A1C7AK), WisdomTree Renewable Energy ETF (WKN: A3D7VR), Global X Cleantech ETF (WKN: A2QPB4), Amundi MSCI New Energy ETF (WKN: LYX0CB). Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts und AAA-Newsletter.[ Hier bei WELT.](https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html.) [Hier] (https://open.spotify.com/playlist/6zxjyJpTMunyYCY6F7vHK1?si=8f6cTnkEQnmSrlMU8Vo6uQ) findest Du die Samstagsfolgen Klassiker-Playlist auf Spotify! Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? [**Hier findest du alle Infos & Rabatte!**](https://linktr.ee/alles_auf_aktien) Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/SMF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 7, 2026.Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/SMF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 7, 2026.Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today's focus is on a series of significant advancements that are poised to reshape the landscape of drug development, regulatory standards, and patient care.Eli Lilly has made remarkable strides with its dual-action obesity medications, Zepbound and Mounjaro. Despite being removed from the CVS formulary, these drugs have achieved exceptional sales figures, reaching $10 billion in a single quarter. This success can be attributed to Lilly's innovative direct-to-consumer sales strategy, which exemplifies how modern marketing approaches can overcome traditional market barriers. Additionally, Eli Lilly's partnership with Walmart to expand access to Zepbound through retail pharmacy pickups exemplifies a strategic approach to enhancing patient access to crucial medications. By leveraging Walmart's extensive retail network, this collaboration facilitates easier access to obesity treatments—a significant public health challenge—enhancing both patient convenience and broadening market reach for Lilly's products. These achievements not only highlight the potential of strategic marketing but also underscore a growing demand for effective obesity treatments within the pharmaceutical industry.In another exciting development, Alnylam Pharmaceuticals has reported impressive sales figures for Amvuttra, a treatment for transthyretin amyloid cardiomyopathy. Surpassing analysts' expectations, this success signals a growing market for treatments targeting rare diseases and emphasizes the importance of strategic market expansion to reach underserved patient populations.Meanwhile, Bristol Myers Squibb's anticipated schizophrenia treatment, Cobenfy, has experienced a lukewarm market entry. While meeting initial expectations in its first year, it has yet to create the breakthrough impact investors anticipated. This situation highlights the challenges even well-hyped pharmaceuticals face upon launch and underscores the need for continuous strategic planning to ensure market penetration and sustained growth.A surprising development in mergers and acquisitions comes from Novo Nordisk's $6.5 billion counteroffer to acquire Metsera, an obesity biotech initially targeted by Pfizer. This aggressive move reflects intense competition in the obesity drug market and illustrates the high stakes involved in acquiring promising biotech assets that could potentially transform treatment paradigms for chronic conditions like obesity.The vaccine industry is navigating its own set of challenges with declining sales across the board. However, Merck's adult pneumococcal vaccine Capvaxive has shown promising initial sales figures. As the first pneumococcal vaccine specifically designed for adults, Capvaxive indicates a potential niche market that Merck could successfully capture.On the regulatory front, significant measures are being taken by the FDA to boost biosimilar availability against drug pricing pressures. New draft guidance aims to eliminate clinical testing requirements for biosimilars and categorize all approved biosimilars as "interchangeable." This initiative could significantly reduce biologic medicine costs post-patent expiration and increase competition in the market, potentially making essential medications more accessible to patients. Additionally, the FDA is proposing streamlined biosimilar approval pathways aimed at reducing overall bio-drug costs—a welcome move reflecting concerted efforts to make essential medications more affordable and accessible globally.Argenx has reported positive trial results for Vyvgart in treating generalized myasthenia gravis (gMG), highlighting its commitment to addressing unmet needs within this patient population. These findings could expand treatment options for gMG patients who have been previously overlooked in thSupport the show

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/SMF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 7, 2026.Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/SMF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 7, 2026.Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/SMF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 7, 2026.Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/SMF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 7, 2026.Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

Send us a textDr. Fred Grossman, D.O., FAPA is President and Chief Medical Officer of Coya Therapeutics ( https://coyatherapeutics.com/ ), a clinical-stage company focused on developing multi-modality, Regulatory T Cell (Treg) therapies for neurodegenerative diseases. Coya has already developed strong proof of concept data in Amyotrophic Lateral Sclerosis (ALS) and Alzheimer's, and is also active in the autoimmune and metabolic disease domains.Dr. Grossman brings over 20 years of drug development expertise having held senior executive leadership positions in large and small pharmaceutical companies, leading the development and FDA approval of numerous multi-billion dollar blockbuster drugs addressing significant unmet medical needs particularly across CNS disorders. He has close relationships with thought leaders worldwide and has negotiated directly with the FDA and Global Health Authorities for approval of many drugs across therapeutic areas. Dr. Grossman held executive positions at Eli Lilly, Johnson & Johnson, Bristol Myers Squibb, and Sunovion. He served as President and Chief Medical Officer at Glenmark Pharmaceuticals, a $1.5 Billion per annum global pharmaceutical company based in India, overseeing development of an entire pipeline including generics, complex generics including 505(b)(2) candidates, and next-generation biologics (including bi-specific antibodies). Dr. Grossman also previously served as Chief Medical Officer at Mesoblast, Inc., developing allogeneic cellular therapies for inflammatory diseases. Dr. Grossman is Board-Certified in Psychiatry and a Fellow of the American Psychiatric Association and was a Fellow at the National Institutes of Health (NIH). He has held several academic appointments and authored numerous scientific publications.#RegulatoryTCells #Tregs #AutoimmuneDisorders #ShimonSakaguchi #ImmuneSystem #FredGrossman #CoyaTherapeutics #NeurodegenerativeDiseases #AmyotrophicLateralSclerosis #ALS #Alzheimers #CNSDisorders #StanleyAppel #Immunomodulation #ProInflammatoryCytokines #SelfTolerance #Microglia #Macrophages #CTLA4Ig #LowDoseIl2 #FusionProtein #ImmuneCheckpointModulator #FrontotemporalDementia #ProgressPotentialAndPossibilities #IraPastor #Podcast #Podcaster #ViralPodcast #STEM #Innovation #Technology #Science #ResearchSupport the show

Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Sciences Advisory Council, interview Dr. Andrew Lee, Vice President, Clinical Research at Uniquity Bio, about Thymic Stromal Lymphopoietin (TSLP) and eosinophilic esophagitis (EOE). Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:49] Co-host Ryan Piansky introduces the episode, brought to you thanks to the support of Education Partners Bristol Myers Squibb, GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:13] Holly introduces today's topic, Thymic Stromal Lymphopoietin (TSLP) and eosinophilic esophagitis (EOE), and today's guest, Dr. Andrew Lee, Vice President, Clinical Research at Uniquity Bio.   [1:36] Dr. Lee has nearly 20 years of experience in the clinical development of new vaccines, biologics, and drugs. Holly welcomes Dr. Lee.   [1:52] Dr. Lee trained in internal medicine and infectious diseases.   [1:58] Dr. Lee has been fascinated by the immune system and how it can protect people against infections, what happens when immunity is damaged, as in HIV and AIDS, and how to apply that knowledge to boost immunity with vaccines to prevent infections.   [2:16] Dr. Lee led the clinical development for a pediatric combination vaccine for infants and toddlers. It is approved in the U.S. and the EU.   [2:29] Dr. Lee led the Phase 3 Program for a monoclonal antibody to prevent RSV, a serious infection in infants. That antibody was approved in June 2025 for use in the U.S.   [2:44] In his current company, Dr. Lee leads research into approaches to counteract an overactive immune system. They're looking at anti-inflammatory approaches to diseases like asthma, EoE, and COPD.   [2:58] Dr. Lee directs the ongoing Phase 2 studies that they are running in those areas.   [3:28] Dr. Lee sees drug development as a chance to apply cutting-edge research to benefit people. He trained at Bellevue Hospital in New York City in the 1990s.   [3:40] When Dr. Lee started as an intern, there were dedicated ICU wards for AIDS patients because many of the sickest patients were dying of AIDS and its complications.    [3:52] Before the end of Dr. Lee's residency, they shut down those wards because the patients were on anti-retroviral medications and were doing so well that they were treated as outpatients. They didn't need dedicated ICUs for AIDS patients anymore.   [4:09] For Dr. Lee, that was a powerful example of how pharmaceutical research and drug regimen can impact patients' lives for the better by following the science. That's what drove Dr. Lee to go in the direction of research.   [4:48] Dr. Lee explains Thymic Stromal Lymphopoietin (TSLP). TSLP serves as an alarm signal for Type 2 or TH2 inflammation, a branch of the immune responses responsible for allergic responses and also immunity against parasites.   [5:17] When the cells that line the GI tract and the cells that line the airways in our lungs receive an insult or an injury, they get a danger signal, then they make TSLP.   [5:28] This signal activates other immune cells, like eosinophils and dendritic cells, which make other inflammatory signals or cytokines like IL-4, IL-13, and IL-5.   [5:47] That cascade leads to inflammation, which is designed to protect the body in response to the danger signal, but in some diseases, when there's continued exposure to allergens or irritants, that inflammation goes from being protective to being harmful.   [6:15] That continued inflammation, over the years, can lead to things like the thickened esophagus with EoE, or lungs that are less pliant and less able to expand, in respiratory diseases.   [6:48] Dr. Lee says he thinks of TSLP as being a master switch for this branch of immune responses. If you turn on TSLP, that turns on a lot of steps that lead to generating an allergic type of response.   [7:06] It's also the same type of immune response that can fight off parasite infections. It's the first step in a cascade of other steps generating that type of immune response.   [7:30] Dr. Lee says people have natural genetic variation in the genes that incur TSLP.   [7:38] Observational studies have found that some people with genetic variations that lead to higher levels of TSLP in their bodies had an increased risk for allergic inflammatory diseases like EoE, atopic dermatitis, and asthma.   [8:13] Studies like the one just mentioned point to TSLP being important for increased risk of developing atopic types of diseases like EoE and others. There's been some work done in the laboratory that shows that TSLP is important for activating eosinophils.    [8:38] There's accumulating evidence that TSLP activation leads to eosinophil activation, other immune cells, or white blood cells getting activated.   [9:07] Like a cascade, those cells turn on T-cells and B-cells, which are like vector cells. They lead to direct responses to fight off infections, in case that's the signal that leads to the turning on TSLP.   [9:48] Ryan refers to a paper published in the American Journal of Gastroenterology exploring the role of TSLP in an experimental mouse model of eosinophilic esophagitis. Ryan asks what the researchers were aiming to find.   [10:00] Dr. Lee says the researchers were looking at the genetic studies we talked about, the observational studies that are beginning to link more TSLP with more risk for EoE and those types of diseases.   [10:12] The other type of evidence that's accumulating is from in vitro (in glass) experiments or test tube experiments, where you take a couple of cells that you think are relevant to what's going on.   [10:28] For example, you could get some esophageal cells and a couple of immune cells, and put TSLP into the mix, and you see that TSLP leads to activation of those immune cells and that leads to some effects on the esophageal cells.   [10:42] Those are nice studies, but they're very simplified compared to what you can do in the body. These researchers were interested in extending those initial observations from other studies, but working in the more realistic situation of a mouse model.   [11:00] You have the whole body of the mouse being involved. You can explore what TSLP is doing and model a disease that closely mimics what's happening with EoE in humans.   [12:23] They recreated the situation of what seems to be happening in EoE in people. We haven't identified it specifically, but there's some sort of food allergen in patients with EoE that the immune system is set off by.   [12:55] What researchers are observing in this paper is that in these mice that were treated with oxazolone, there is inflammation in the esophagus, an increase in TSLP levels, and eosinophils going into the esophageal tissues.   [13:15] Dr. Lee says, that's one of the main ways we diagnose EoE; we take a biopsy of the esophagus and count how many eosinophils there are. Researchers saw similar findings. The eosinophil count in the esophageal tissues went way up in these mice.    [13:34] Researchers also saw other findings in these mice that are very similar to EoE in humans, such as the esophageal cells lining the esophagus proliferating. They even saw that new blood vessels were being created in that tissue that's getting inflamed.   [14:00] Dr. Lee thinks it's a very nice paper because it shows that correlation: Increase TSLP and you see these eosinophils going to the esophagus, and these changes that are very reminiscent of what we see in people with EoE.   [14:51] In this paper, the mice made the TSLP, and researchers were able to measure the TSLP in the esophageal tissue. The researchers didn't introduce TSLP into the mice. The mice made the TSLP in response to being repeatedly exposed to oxazolone.   [15:20] That's key to the importance of the laboratory work. The fact that the TSLP is made by the mice is important. It makes it a very realistic model for what we're seeing in people.   [15:41] In science, we like to see correlation. The researchers showed a nice correlation.   [15:46] When TSLP went up in these mice, and the mice were making more TSLP on their own, at the same time, they saw all these changes in the esophagus that look a lot like what EoE looks like in people.    [16:01] They saw the eosinophils coming into the esophagus. They saw the inflammation go up in the esophagus. What Dr. Lee liked about this paper is that they continued the story.   [16:15] The researchers took something that decreases TSLP levels, an antibody that binds to and blocks TSLP, and when they did that, they saw the TSLP levels come down to half the peak level.   [16:35] Then they saw improvement in the inflammation in the esophagus. They saw that the amount of eosinophils decreased, and the multiplication of the esophageal cells went down. The number of new blood vessels went down after the TSLP was reduced.   [16:53] Dr. Lee says, you see correlation. The second part is evidence for causation. When you take TSLP away, things get better. That gives us a lot of confidence that this is a real finding. It's not just observational. There is causation evidence here.   [18:26] Ryan asks if cutting TSLP also help reduce other immune response cells. Dr. Lee says TSLP is the master regulator for this Type 2 inflammation. It definitely touches and influences other cells besides eosinophils.   [18:44] TSLP affects dendritic cells, which are an important type of immune cell, like a coordinating cell that instructs other cells within the immune system what to do. In this paper, they looked at a lot of other effects of TSLP on the tissues of the body.   [19:10] Dr. Lee says, There's a lot of research on TSLP, and one of the reasons we're excited about the promise of TSLP is that it's so far upstream; so much of the beginning, that it's affecting other cells.   [19:29] Its effects could be quite broad. If we're able to successfully block TSLP, we could block a lot of different effects.   [19:40] One treatment for EoE is dupilumab, which blocks IL-4 and IL-13 specifically, and that works well, but TSLP has the potential to have an even greater effect than blocking IL-4 and IL-13, since it is one step before turning on IL-4 and IL-13.    [20:14] That's one of the reasons researchers are excited about the promise of blocking TSLP. There are studies ongoing of TSLP blockers in people with EoE.   [20:34] Ryan asks if there are negative repercussions from blocking TSLP. Dr. Lee says in this study and in people, we are not completely blocking TSLP by any means. There will still be residual TSLP activated, even with very potent drugs.   [21:01] In the study, they block TSLP about 50%‒60%. TSLP is involved in immunity against parasites. In studies with people, they make sure not to include anybody who has an active parasitic infection. A person under treatment should not be in a study.   [21:27] Dr. Lee says we haven't seen any problems with parasitic infections becoming more severe, but that is a theoretical possibility, so for that reason, in studies with TSLP blockers, we generally exclude patients with known parasitic infections.   [22:17] What excited Dr. Lee in this paper was that they showed that when you block TSLP in the mice, then you get real effects in their tissues. Eosinophils went away. The thickening of the basal layers in the esophagus got much better.   [22:38] That kind of real effect reflected in the tissue is super exciting to see. That gives us more confidence that this could work in people, since we're seeing it in a realistic whole-body model in the mice.   [23:12] Dr. Lee says there are ongoing clinical studies on TSLP blockers for EoE. His company is studying an antibody that blocks TSLP in eczema, COPD, and EoE. One of the exciting things about immunology is that it affects many different parts of the body.   [23:42] EoE is associated with other immune-type disorders. There's a high percentage of patients with EoE who have other diseases. EoE coexists with asthma, atopic dermatitis, and chronic rhinitis.   [24:09] It's exciting that if you figure out something that's promising for one disease that TSLP affects, it could have very broad-ranging implications for a variety of diseases.   [24:22] Ryan shares his experience of his doctor talking to him about a TSLP blocker, tezepelumab, as a potential option when it's out of clinical trials. It would target something a little higher up the chain and help with some of his remaining symptoms.   [24:59] Ryan is excited to hear that this research is so encouraging and how it could potentially help treat EoE, asthma, and other conditions, all at once.   [25:16] Dr. Lee says that being in these later-stage studies is super exciting. If these late-stage trials are successful, the next step is to apply for regulatory approval with the various agencies around the world.   [26:40] Dr. Lee shares one takeaway for listeners to remember. Think of TSLP as an alarm that turns on inflammation. He compares TSLP to turning on an alarm during a robbery. There are multiple steps designed to protect the bank and the money.   [27:20] To extend that analogy, with TSLP, once you turn it on, all these other steps are going to happen. Inflammation is designed to protect the body. It's a protective response. If there's an infection, it can clear the infection.   [27:38] If the infection persists, as in HIV, the immune response, which is protective and beneficial, eventually becomes damaging. It becomes dysfunctional. In EoE, if you continually eat the allergic food, the inflammation becomes damaging to the esophagus.   [28:27] Long-term inflammation leads to replacing the normal esophageal tissue with fibrotic tissue, and that's why the esophagus eventually gets hardened and less able to let the food go through.   [28:40] In respiratory diseases, the soft tissue of the lung gets replaced with thicker tissue, and the lung is not able to expand.   [28:54] Dr. Lee says he people to think about TSLP as this master alarm switch. We hope that if you could turn off that TSLP, you could then avoid a lot of the complications that we see with chronic inflammation in these conditions.   [29:14] We're hopeful that you could even take away the symptoms that you see in these diseases, make patients feel better, and with extended treatment, you could begin to reverse some of the damage resulting from inflammation.   [29:32] Ryan likes that analogy and how Dr. Lee has concisely explained these complicated concepts.   [29:51] Dr. Lee thanks Holly and Ryan and adds one more plea to listeners. Please consider getting involved with research. Clinical trials cannot be done without patients. We need patients to advance new treatments.   [30:27] Researchers like Dr. Lee spend a lot of time thinking about how to make the studies not only informative but also fair to patients who decide to become involved. It's a lot of work and a fair amount of time commitment.   [30:44] If you don't want to be in a study, you can help by being on a patient feedback panel and reviewing protocols and informed consents. Follow your interests. Think about getting involved with research, however you can.   [31:06] Ryan and Holly are very grateful for the community, with so many wonderful clinicians and researchers, and so many patients who are willing to volunteer their time and their data to help researchers find better solutions going forward.   [31:26] Ryan thanks Dr. Lee for coming on and putting out that call to action. It's a great reminder for listeners and the patients in the community to look for those opportunities. Chat with your physician. Go to APFED's website. There's a link to active clinical trials.   [31:47] For our listeners who want to learn more about eosinophilic disorders, we encourage you to visit apfed.org and check out the links in the show notes below.   [31:53] For those looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder at apfed.org/specialist.   [32:01] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at apfed.org/connections.   [32:11] Ryan thanks Dr. Andrew Lee for joining us today. We learned a lot. Holly also thanks APFED's Education Partners Bristol Myers Squibb, GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode: Andrew Lee, M.D., VP Clinical Research, Uniquity Bio   "A Mouse Model for Eosinophilic Esophagitis (EoE)" Current Protocols, Wiley Online Library   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.org/specialist apfed.org/connections apfed.org/research/clinical-trials   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of Bristol Myers Squibb, GSK, Sanofi, Regeneron, and Takeda.   Tweetables:   "I see drug development as a chance to apply cutting-edge research to benefit people." — Andrew Lee, M.D.   "When the cells that line the GI tract and the cells that line the airways in our lungs receive an insult or an injury, they get a danger signal, then they make TSLP." — Andrew Lee, M.D.   "Observational studies have found that some people with genetic variations that lead to higher levels of TSLP in their bodies had an increased risk for allergic inflammatory diseases like EoE, atopic dermatitis, and asthma." — Andrew Lee, M.D.   "There's a lot of research on TSLP, and one of the reasons we're excited about the promise of TSLP is that it's so far upstream; so much of the beginning, that it's affecting other cells." — Andrew Lee, M.D.   "Please consider getting involved with research. We can't do these clinical trials without patients. We need patients to advance new treatments for patients." — Andrew Lee, M.D.

This activity was supported by an educational grant from Bristol Myers Squibb. Please go to ⁠ academiccme.com/ccrwestsle⁠ and complete the evaluation to receive your CE/CME Credit. Credit is available through September 19, 2025.

This week on the Power of Owning Your Career Podcast, host Simone Morris welcomes Keith Willis—leadership expert, entrepreneur, and Founder of Core Management Training. Keith's journey is indicative of how careers thrive by intentional design, not by chance. Starting out as a U.S. Army Junior Officer, Keith made the leap to corporate America through the Cameron-Brooks Development & Preparation Program, a pivotal experience that shaped his passion for helping others own their career trajectories. Keith built an impressive resume with award-winning roles in sales and training at industry giants such as Johnson & Johnson, Pfizer, and Bristol Myers Squibb, where he was recognized for his results as both a sales representative and a manager. Inspired by his drive to close the gap between individual performance and transformative leadership, Keith founded Core Management Training, where he equips pharmaceutical and life sciences organizations to turn managers into leaders who drive performance and culture. Today, Keith is also building "Never Look for a Job Again"—an e-zine and course designed to empower professionals to create opportunities rather than wait for them. He believes that anyone can own their career by embracing self-awareness, setting meaningful goals, and building supportive networks. In this candid and practical conversation, Keith shares actionable advice on navigating uncertainty, addressing ageism, and staying true to your authentic self—even when the workplace challenges you to fit in. Listeners will take away Keith's holistic formula for career ownership, practical resources, and the confidence to make bold moves—no matter where they're starting from. Resources Mentioned in the Episode: Never Look for a Job Again (career development guide and upcoming course) PCS to Corporate America by Cameron Brooks Manager Tools & Career Tools podcasts The Long View by Brian Fetherstonhaugh Self-development tools: Audible, LinkedIn Learning, and yes—even ChatGPT! Connect & Learn More: Host Simone E. Morris: LinkedIn | Become a Guest on the Show | 52 Tips for Owning Your Career Keith Willis: Core Management Training | Never Look for a Job Again Follow & Subscribe: Join us on IG at @simonemorrisent for career inspiration Subscribe to our YouTube for inclusive conversations and actionable career strategies Whether you're an aspiring leader, a career changer, or someone looking to unlock your full potential, this episode will inspire you to get behind the wheel of your career and drive your future forward.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/RJP865. CME/MOC/AAPA/IPCE credit will be available until October 27, 2026 .Fine-Tuning Hypertrophic Cardiomyopathy Care in the CMI Era: Redefining Management for the Modern Heart Failure Specialist In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/RJP865. CME/MOC/AAPA/IPCE credit will be available until October 27, 2026 .Fine-Tuning Hypertrophic Cardiomyopathy Care in the CMI Era: Redefining Management for the Modern Heart Failure Specialist In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/RJP865. CME/MOC/AAPA/IPCE credit will be available until October 27, 2026 .Fine-Tuning Hypertrophic Cardiomyopathy Care in the CMI Era: Redefining Management for the Modern Heart Failure Specialist In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/RJP865. CME/MOC/AAPA/IPCE credit will be available until October 27, 2026 .Fine-Tuning Hypertrophic Cardiomyopathy Care in the CMI Era: Redefining Management for the Modern Heart Failure Specialist In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

In der heutigen Folge sprechen die Finanzjournalistinnen Anja Ettel und Lea Oetjen über den Aktientausch zweier einstiger Biotech-Rivalen, die Begnadigung des reichsten US-Häftlings und den Government Shutdown, der zum Risiko für die Amerikaner wird. Außerdem geht es um SAP, Tesla, Chevron, Exxon, Siemens Energy, Deutsche Telekom, T-Mobile, MTU, Beiersdorf, Unilever, Roche, Atoss, Lukoil, Rosneft, Rivian, Biontech, Curevac, Moderna, Bristol Myers Squibb, BlackRock, Solana, Gold, Bitcoin, Ethereum. Wir freuen uns über Feedback an aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts und AAA-Newsletter.[ Hier bei WELT.](https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html.) [Hier] (https://open.spotify.com/playlist/6zxjyJpTMunyYCY6F7vHK1?si=8f6cTnkEQnmSrlMU8Vo6uQ) findest Du die Samstagsfolgen Klassiker-Playlist auf Spotify! Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? [**Hier findest du alle Infos & Rabatte!**](https://linktr.ee/alles_auf_aktien) Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

This episode covers: Cardiology This Week: A concise summary of recent studies Arrhythmias in cardiac amyloidosis Taking the 'O' out of HOCM: managing LVOT obstruction Snapshots Host: Susanna Price Guests: Carlos Aguiar, Stephanie Schwarting, Ahmad Masri Want to watch that episode? Go to: https://esc365.escardio.org/event/2176 Want to watch that extended interview on Arrhythmias in Cardiac Amyloidosis? Go to: https://esc365.escardio.org/event/2176?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Ahmad Masri has declared to have potential conflicts of interest to report: research grants from Pfizer, Ionis, Attralus, Cytokinetics and Janssen. Consulting fees from Cytokinetics, BMS, BridgeBio, Pfizer, Ionis, Lexicon, Attralus, Alnylam, Haya, Alexion, Akros, Edgewise, Rocket, Lexeo, Prothena, BioMarin, AstraZeneca, Avidity, Neurimmune, and Tenaya. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Stephanie Schwarting has declared to have potential conflicts of interest to report: advisory board for Alnylam, Bayer, Pfizer; principal investigator in trials sponsored by Alexion, Novo Nordisk and Intellia. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Susanna Price Guest: Stephanie Schwarting Want to watch the episode? Go to: https://esc365.escardio.org/event/2176 Want to watch the extended interview on Arrhythmias in Cardiac Amyloidosis? Go to: https://esc365.escardio.org/event/2176?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests:  Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Stephanie Schwarting has declared to have potential conflicts of interest to report: advisory board for Alnylam, Bayer, Pfizer; principal investigator in trials sponsored by Alexion, Novo Nordisk and Intellia. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

In this episode, I'm joined by Dr. Burhan Chaudhry, MS neurologist and clinical lead at Bristol Myers Squibb, to discuss CAR-T cell therapy which is an innovative treatment currently enrolling in clinical trials for multiple sclerosis (MS). We dive into how CAR-T cell therapy targets B cells within the central nervous system, offering hope for both relapsing and progressive MS. Dr. Chaudhry explains what sets CAR-T apart from traditional disease modifying therapies, how to get involved in MS clinical trials, and what participants can expect throughout the process. Whether you're newly diagnosed or living with MS for years, join us for empowering strategies, expert advice, and the latest updates on breakthroughs in MS treatment! Bio on Burhan Chaudry: Dr. Burhan Chaudhry is a MS neurologist and clinical lead at Bristol Myers Squibb. His sister was diagnosed with MS when he was in medical school. This inspired him to pursue Neurology. A few years after Burhan was diagnosed with MS as well. After becoming a MS neurologist, Burhan has treated MS patients both in the US and internationally. He is currently clinical lead for a global clinical trial evaluating a novel cell therapy across the MS spectrum. Resources mentioned in this episode: Website to view CAR-T info: https://www.cartautoimmune.com/ ECTRIMS 2025 Results/Report: https://distribute.congrex.com/from.storage?image=rqetJOF1YXChDh_STAPoNpjPhysyG76sohBKnHJhR-TsF3Mvxzx13zdmic5t9umH0 Additional Resources: https://www.doctorgretchenhawley.com/insider Reach out to Me: hello@doctorgretchenhawley.com Website: www.MSingLink.com Social: ★ Facebook: https://www.facebook.com/groups/mswellness ★ Instagram: https://www.instagram.com/doctor.gretchen ★ YouTube: https://www.youtube.com/c/doctorgretchenhawley?sub_confirmation=1 → Game Changers Course: https://www.doctorgretchenhawley.com/GameChangersCourse → Total Core Program: https://www.doctorgretchenhawley.com/TotalCoreProgram → The MSing Link: https://www.doctorgretchenhawley.com/TheMSingLink

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we'll delve into a series of remarkable advancements and strategic movements shaping the landscape of healthcare. Let's start with a recent spotlight on the European Society for Medical Oncology Congress 2025, where key clinical trial outcomes have emerged, potentially reshaping future treatment protocols.AstraZeneca made waves with its Phase 3 trial results for Imfinzi, a PD-L1 inhibitor, in high-risk non-muscle invasive bladder cancer. The findings suggest that Imfinzi stands strong against Pfizer's PD-1 candidate, Sasanlimab. This is particularly noteworthy as bladder cancer has historically had limited non-invasive treatment options. The implications for patient care are substantial, providing hope for improved management of this form of cancer and possibly influencing treatment standards.Meanwhile, Eli Lilly's Verzenio marked another success at the ESMO Congress with its overall survival win in early breast cancer cases. This victory enhances Verzenio's standing within the CDK4/6 inhibitor class, suggesting increased adoption in clinical settings. The demonstration of extended survival benefits not only strengthens Verzenio's competitive position but also contributes to setting a new standard of care in early breast cancer treatment.On the regulatory front, Sanofi encountered mixed outcomes from the European Medicines Agency's Committee for Medicinal Products for Human Use. While Rezurock was not recommended as a third-line treatment for chronic graft-versus-host disease, this decision underscores the stringent regulatory processes companies navigate despite existing market success in other regions like the U.S.In a significant move by the FDA to expedite drug approvals, nine companies including Merck KGaA and Regeneron received priority review vouchers. These vouchers allow a shortened review timeline, reflecting an ongoing trend towards accelerating drug availability to address unmet medical needs swiftly.In terms of strategic developments, EMD Serono—Merck KGaA's U.S. branch—has unveiled a major discount initiative for its IVF treatments on the TrumpRx platform. This aligns with broader efforts to make fertility treatments more accessible amidst rising demand and economic pressures.The metabolic dysfunction-associated steatohepatitis (MASH) arena is also witnessing robust interest with over $10 billion recently reported in mergers and acquisitions. This surge indicates confidence among Big Pharma players in MASH as a lucrative therapeutic field ripe for innovation and development.In response to competitive pressures and operational challenges, Kezar Life Sciences is preparing for layoffs following the FDA's decision to cancel a critical meeting related to its R&D program. This situation illustrates the volatile dynamics within biotech firms where regulatory decisions can significantly impact corporate strategies and workforce stability.Overall, these developments reflect an industry characterized by rapid innovation, strategic realignments, and an evolving regulatory framework. The implications for patient care are substantial as these scientific advancements promise enhanced treatment options across various therapeutic areas.Switching gears to scientific developments, Bristol Myers Squibb has reported promising results from early-stage trials of its EGFRxHER3 antibody-drug conjugate. Demonstrating a 55% overall response rate, this positions BMS to potentially gain a competitive edge in the ADC market—a sector valued for targeting cancer cells while minimizing side effects on healthy tissues.Strategic partnerships continue to shape industry growth and innovation. Roche has secured a deal with Hansoh Pharmaceutical worth up to $1.45 billion for global rights to an experimental ADC outside Greater China. SimilSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Let's dive into the latest news shaping this dynamic industry.Bristol Myers Squibb recently made headlines with their acquisition of Orbital Therapeutics for a remarkable $1.5 billion. This strategic move is aimed at enhancing their in vivo cell therapy capabilities, particularly in treating autoimmune disorders. In vivo cell therapy is a pioneering approach that allows genetic modifications directly within a patient's body, potentially revolutionizing the treatment landscape for numerous conditions. This acquisition underscores Bristol Myers Squibb's commitment to pushing the boundaries of innovative cell therapy technologies and reflects a broader trend in the industry towards personalized medicine.In another significant development, AstraZeneca has aligned with the Trump administration's Most Favored Nation pricing program, agreeing to provide Medicaid drugs at prices competitive on a global scale. This decision marks a strategic shift towards cost reduction, especially in chronic disease management and respiratory therapeutics. The move is indicative of AstraZeneca's efforts to adapt to regulatory pressures and evolving policies that emphasize value-based healthcare delivery.Meanwhile, Ypsomed has announced plans to invest $248 million in establishing a manufacturing facility in North Carolina. This facility will focus on producing auto-injectors, essential for treating diabetes and metabolic disorders. The investment signifies a strategic operational expansion aimed at meeting rising demand in North America, highlighting the growing importance of drug delivery devices in the therapeutic landscape.Turning to clinical trials, Regeneron has unveiled promising Phase 1/2 data for its DB-OTO gene therapy targeting genetic hearing loss in children. By using AAV vectors to address DFNB9-related synaptic transmission deficits, this therapy could mark a breakthrough for those suffering from hereditary hearing conditions. Satellos has also presented encouraging Phase 1 results for SAT-3247, an oral small molecule targeting AAK1 in Duchenne muscular dystrophy, with plans to proceed to Phase 2 trials focused on muscle regeneration.In oncology, Taiho and Cullinan's Phase 2 data on zipalertinib showed efficacy against EGFR-mutated non-small cell lung cancer with brain metastases. This advancement highlights the potential of tyrosine kinase inhibitors in precision oncology. Similarly, Arcus Biosciences reported a median survival of 26.7 months for its combination therapy with domvanalimab and zimberelimab in gastroesophageal adenocarcinoma trials, underscoring the promise of TIGIT-targeted therapies.Assembly Biosciences has shared promising Phase 1b results for its ABI-5366 helicase-primase inhibitor, achieving an impressive 94% reduction in herpes simplex virus shedding. OS Therapies reported significant survival improvement with its OST-HER2 vaccine in recurrent pulmonary metastatic osteosarcoma patients, positioning HER2-targeting immunotherapies as promising cancer treatment interventions.Cabaletta Bio has made strides with its resecabtagene autoleucel CAR-T therapy, demonstrating B cell elimination without preconditioning in pemphigus vulgaris trials. This innovation opens new doors for autoimmune disease management through advanced cell therapies.On the business development front, Roche's out-licensing of its GLP-1/GIP agonist CT-388 to Chugai for diabetes and obesity treatment exemplifies strategic partnerships focused on addressing metabolic disorders through novel small molecules.The sector is also witnessing significant financial activities with Evommune filing an IPO to advance treatments for inflammatory conditions. Meanwhile, Quoin Pharmaceuticals raised $104.5 million through private placement to concentrate on rare disSupport the show

Dr. Hope Rugo and Dr. Giuseppe Curigliano discuss recent developments in the field of bispecific antibodies for hematologic and solid tumors, including strategies to optimize the design and delivery of the immunotherapy. TRANSCRIPT Dr. Hope Rugo: Hello and welcome to By the Book, a podcast series from ASCO that features engaging conversations between editors and authors of the ASCO Educational Book. I am your host, Dr. Hope Rugo. I am the director of the Women's Cancers Program and division chief of breast medical oncology at the City of Hope Cancer Center. I am also the editor-in-chief of the Educational Book. Bispecific antibodies represent an innovative and advanced therapeutic platform in hematologic and solid tumors. And today, I am delighted to be joined by Dr. Giuseppe Curigliano to discuss the current landscape of bispecific antibodies and their potential to reshape the future of precision oncology. Dr. Curigliano was the last author of an ASCO Educational Book piece for 2025 titled, "Bispecific Antibodies in Hematologic and Solid Tumors: Current Landscape and Therapeutic Advances." Dr. Curigliano is a breast medical oncologist and the director of the Early Drug Development Division and chair of the Experimental Therapeutics Program at the European Institute of Oncology in Milan. He is also a full professor of medical oncology at the University of Milan. You can find our disclosures in the transcript of this episode. Dr. Curigliano, Giuseppe, welcome and thanks for being here. Dr. Giuseppe Curigliano: Thanks a lot for the invitation. Dr. Hope Rugo: Giuseppe, I would like to first ask you to provide some context for our listeners on how these novel therapeutics work. And then perhaps you could tell us about recent developments in the field of bispecific antibodies for oncology. We are at a time when antibody-drug conjugates (ADCs) are all the rage and, trying to improve on the targeting of specific antigens, proteins, receptors in the field of oncology is certainly a hot and emerging topic. Dr. Giuseppe Curigliano: So, thanks a lot. I believe really it was very challenging to try to summarize all the bispecific antibodies that are under development in multiple solid tumors. So, the first thing that I would like to highlight is the context and the mechanism of action of bispecific antibodies. Bispecific antibodies represent a groundbreaking advancement in cancer immunotherapy, because these engineered molecules have the unique ability to target and simultaneously bind to two distinct antigens. That is why we call them bispecific. So typically, one antigen is expressed on the tumor cell and the other one is expressed on the immune effectors, like T-cell or natural killer cells. So this dual targeting mechanism offers several key advantages over conventional monoclonal antibodies because you can target at the same time the tumor antigen, downregulating the pathway of proliferation, and you can activate the immune system. So the primary mechanism through which bispecific antibodies exert their therapeutic effects are: First, T-cell redirecting. I mean, many bispecific antibodies are designed to engage tumor-associated antigens like epidermal growth factor receptor, HER2, on the cancer cell and a costimulatory molecule on the surface of T-cell. A typical target antigen on T-cell is CD3. So what does it mean? That you activate the immune system, immune cells will reach the tumor bed, and you have a dual effect. One is downregulating cell proliferation, the other one is activation of the immune system. This is really important in hematological malignancies, where we have a lot of bispecifics already approved, like acute lymphoblastic leukemia or non-Hodgkin lymphoma.  The second, in fact, is the engagement of the tumor microenvironment. So, if you engage immune effector cells like NK cells or macrophages, usually the bispecific antibodies can exploit the immune system's ability to recognize and kill the immune cells, even if there is a lack of optimal antigen presentation.  And finally, the last mechanism of action, this may have a role in the future, maybe in the early cancer setting, is overcoming immune evasion. So bispecific antibodies can overcome some of the immune evasion mechanisms that we see in cancer. For example, bispecific antibodies can target immune checkpoint receptors, like PD-L1 and CTLA-4. Actually, there is a bispecific under development in breast cancer that has a dual targeting on vascular endothelial growth factor receptor and on PD-L1. So you have a dual effect at the same time. So, what is really important, as a comment, is we need to focus first on the optimal format of the bispecific, the optimal half-life, the stability, because of course even if they are very efficient in inducing a response, they may give also a lot of toxicities. So in clinical trials already, we have several bispecifics approved. In solid tumors, very few, specifically amivantamab for non-small cell lung cancer, but we have a pipeline of almost 40 to 50 bispecifics under development in multiple solid tumors, and some of them are in the context of prospective randomized trials. Dr. Hope Rugo: So this is really a fascinating area and it's really exciting to see the expansion of the different targets for bispecific antibodies. One area that has intrigued me also is that some of the bispecifics actually will target different parts of the same receptor or the same protein, but presumably those will be used as a different strategy. It's interesting because we have seen that, for example, in targeting HER2. Dr. Giuseppe Curigliano: Oh, yes, of course. You may consider some bispecifics like margetuximab, I suppose, in which you can target specifically two different epitopes of the same antigen. This is really an example of how a bispecific can potentially be more active and downregulating, let us say, a pathway, by targeting two different domains of a specific target antigen. This is an important point.  Of course, not all the bispecifics work this way, because some of the target antigen may dimerize, and so you have a family of target antigen; an example is epidermal growth factor receptor, in which you have HER1, HER2, HER3, and HER4. So some of them can inhibit the dimerization between one target antigen and the other one, in order to exert a more antiproliferative effect. But to be honest, the new generation of them are more targeting two different antigens, one on the tumor and one on the microenvironment, because according to the clinical data, this is a more efficient way to reduce proliferation and to activate the immune system. Dr. Hope Rugo: Really interesting, and I think it brings us to the next topic, which is really where bispecific antibodies have already shown success, and that is in hematologic malignancies where we have seen very interesting efficacy and these are being used in the clinic already. But the expansion of bispecific antibodies into solid tumors faces some key challenges. It's interesting because the challenges come in different shapes and forms. Tell us about some of those challenges and strategies to optimize bispecific antibody design, delivery, patient selection, and how we are going to use these agents in the right kind of clinical trials. Dr. Giuseppe Curigliano: This is really an excellent question because despite bispecific antibodies having shown a remarkable efficacy in hematological malignancies, their application in solid tumors may have some challenges. The first one is tumor heterogeneity. In hematological malignancy, you have a clear oncogene addiction. Let us say that 90% of the cells may express the same antigen. In solid tumors, it is not the same. Tumor heterogeneity is a typical characteristic of solid tumors, and you have high heterogeneity at the genetic, molecular, and phenotypic levels. So tumor cells can differ significantly from one another, even if within the same tumor. And this heterogeneity sometimes makes it difficult to identify a single target antigen that is universally expressed in an hematological malignancy. So furthermore, sometimes the antigen expressed on a tumor cell can be also present on the normal tissue. And so you may have a cross-targeting. So let's say, if you have a bispecific against epidermal growth factor receptor, this will target the tumor but will target also the skin with a lot of toxicity. The second challenge is the tumor microenvironment. The solid tumor microenvironment is really complex and often immunosuppressive. It is characterized by the presence of immunosuppressor cells like the T regulators, myeloid derived suppressor cells, and of course the extracellular matrix. All these factors hinder immune cell infiltration and also may reduce dramatically the effectiveness of bispecific antibodies. And as you know, there is also an hypoxic condition in the tumor. The other challenge is related to the poor tumor penetration. As you know also with antibody-drug conjugate, only 1 to 3% of the drug will arrive in the tumor bed. Unlike hematological malignancies where tumor cells are dispersed in the blood and easily accessible, the solid tumors have a lot of barriers, and so it means that tumor penetration can be very low. Finally, the vascularity also of the tumor can be different across solid tumors. That is why some bispecifics have a vascular endothelial growth factor receptor or vascular endothelial growth factor as a target. Of course, what do we have to do to overcome these challenges? First, we have to select the optimal antigen. So knowing very well the biology of cancer and the tumor-associated antigens can really select a subgroup of epitopes that are specifically overexpressed in cancer cells. And so we need to design bispecifics according to the tumor type. Second, optimize the antibody format. So there are numerous bispecific antibody formats. We can consider the dual variable domain immunoglobulin, we specified this in our paper. The single chain variable fragments, so FC variable fragments, and the diabodies that can enhance both binding affinity and stability. And finally, the last point, combination therapies. Because bispecific antibodies targeting immune checkpoint, we have many targeting PD-1 or PD-L1 or CTLA-4, combined eventually with other immune checkpoint inhibitors. And so you may have more immunostimulating effect. Dr. Hope Rugo: This is a fascinating field and it is certainly going to go far in the treatment of solid tumors. You know, I think there is some competition with what we have now for antibody-drug conjugates. Do you see that bispecifics will eventually become bispecific ADCs? Are we going to combine these bispecific antibodies with ADCs, with chemotherapy? What is the best combination strategy do you think looking forward? Dr. Giuseppe Curigliano: So, yes, we have a bispecific ADC. We have actually some bispecifics that are conjugated with a payload of chemotherapy. Some others are conjugated with immunoactivation agents like IL-2. One of the most effective strategies for enhancing bispecific activity is the combination therapy. So which type of combination can we do? First, bispecific antibodies plus checkpoint inhibitors. If you combine a bispecific with an immune checkpoint, like anti-PD-1, anti-PD-L1, or anti-CTLA-4, you have more activity because you have activation of T-cells, reduction of immunosuppressive effect, and of course, the capability of this bispecific to potentiate the activity of the immune checkpoint inhibitor. So, in my opinion, in a non-small cell lung cancer with an expression of PD-L1 more than 50%, if you give pembrolizumab plus a bispecific targeting PD-L1, you can really improve both response rate and median progression-free survival.  Another combination is chemotherapy plus bispecific antibodies. Combining chemotherapy with bispecific can enhance the cytotoxic effect because chemotherapy induces immunogenic cell death, and then you boost with a bispecific in order to activate the immune system. Bispecific and CAR T-cells, until now, we believe that these are in competition, but this is not correct. Because CAR T-cells are designed to deliver an activation of the immune system with the same lymphocytes engineered of the patients, with a long-term effect. So I really do not believe that bispecifics are in competition with CAR T-cells because when you have a complete remission induced by CAR T-cell, the effect of this complete remission can last for years. The activity of a bispecific is a little bit different. So there are some studies actually combining CAR T-cells with bispecifics. For example, bispecific antibodies can direct CAR T-cells in the tumor microenvironment, improving their specificity and enhancing their therapeutic effect.  And finally, monoclonal antibody plus bispecific is another next generation activity. Because if you use bispecific antibodies in combination with existing monoclonal antibodies like anti-HER2, you can potentially increase the immune response and enhance tumor cell targeting. In hematological malignancies, this has been already demonstrated and this approach has been particularly effective. Dr. Hope Rugo: That's just so fascinating, the whole idea that we have these monoclonal antibodies and now we are going to add them to bispecifics that we could maybe attach on different toxins to try and improve this, or even give them with different approaches. I suppose giving an ADC with a bispecific would sort of be similar to that idea of giving a monoclonal antibody with the bispecific. So it is certainly intriguing. We also will need to understand the toxicity and cost overall and how we are going to use these, the duration of treatment, the assessment of biomarkers. There are just so many different aspects that still need to be explored.  And then with that idea, can you look ahead five or ten years from now, and tell us how you think bispecific antibodies will shape our next generation cancer therapies, how they will be incorporated into precision oncology, and the new combinations and approaches as we move forward that will help us tailor treatment for patients both with solid tumors and hematologic malignancies? Are we going to be giving these in early-stage disease in solid tumors? So far, the studies are primarily focusing on the metastatic setting, but obviously one of the goals when we have successful treatments is to move them into the early stage setting as quickly as possible. Dr. Giuseppe Curigliano: Let us try to look ahead five years rather than ten years, to be more realistic. So, personally I believe some bispecifics can potentially replace current approaches in specifically T-cell selected population. As we gather more data from ongoing clinical trials and we adopt a deeper understanding of the tumor immuno microenvironment, of course we may have potentially new achievement. A few days ago, we heard that bispecifics in triple negative breast cancer targeting VEGF and PD-L1 demonstrated an improvement in median progression-free survival.  So, how to improve and to impact on clinical practice both in the metastatic and in the early breast cancer setting or solid tumor setting? First, personalized antigen selection. So we need to have the ability to tailor bispecific antibody therapy to the unique tumor profile of individual patients. So the more we understand the biology of cancers, the more we will be able to better target. Second, bispecific antibodies should be combined. I can see in the future a potential trial in which you combine a bispecific anti-PD-L1 and VEGF with immune checkpoint inhibitor selected also to the level of expression of PD-L1, because integration of antibody bispecific with a range of immunotherapies, and this cannot be only immune checkpoint inhibitors, but can be CAR T-cells, oncolytic viruses, also targeted therapy, will likely be a dominant theme in the coming years. This combination will be based on the specific molecular and immuno feature of the cancer of the patient.  Then we need an enhanced delivery system. This is really important because you know now we have a next generation antibody. An example are the bicyclic. So you use FC fragment that are very short, with a low molecular weight, and this short fragment can be bispecific, so can target at the same time a target antigen and improving the immune system. And so the development of this novel delivery system, including also nanoparticles or engineered viral vectors, can enhance the penetration in the tumor bed and the bioavailability of bispecific antibodies. Importantly, we need to reduce toxicity. Until now, bispecifics are very toxic. So the more we are efficient in delivering in the tumor bed, the more we will reduce the risk of toxicity. So it will be mandatory to reduce off-target effects and to minimize toxicity.  And finally, the expansion in new indication. So I really believe you raised an excellent point. We need to design studies in the neoadjuvant setting in order to better understand with multiple biopsies which is the effect on the tumor microenvironment and the tumor itself, and to generate hypotheses for potential trials or in the neoadjuvant setting or in those patients with residual disease.  So, in my opinion, as we refine design, optimize patient selection, and explore new combination, in the future we will have more opportunity to integrate bispecifics in the standard of care. Dr. Hope Rugo: I think it is particularly helpful to hear what we are going to be looking for as we move forward to try and improve efficacy and reduce toxicity. And the ability to engineer these new antibodies and to more specifically target the right proteins and immune effectors is going to be critical, of course, moving forward, as well as individualizing therapy based on a specific tumor biology.  Hearing your insights has been great, and it really has opened up a whole area of insight into the field of bispecifics, together with your excellent contribution to the ASCO Educational Book. Thank you so much for sharing your thoughts and background, as well as what we might see in the future on this podcast today. Dr. Giuseppe Curigliano: Thank you very much for the invitation and for this excellent interview. Dr. Hope Rugo: And thanks to our listeners for joining us today. You will find a link to the Ed Book article we discussed today in the transcript of this episode. It is also, of course, on the ASCO website, as well as on PubMed. Please join us again next month on By the Book for more insightful views on the key issues and innovations that are shaping modern oncology. 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. Hope Rugo  @hope.rugo  Dr. Giuseppe Curigliano @curijoey Follow ASCO on social media:       @ASCO on X (formerly Twitter)       ASCO on Bluesky      ASCO on Facebook       ASCO on LinkedIn       Disclosures:      Dr. Hope Rugo:   Honoraria: Mylan/Viatris, Chugai Pharma  Consulting/Advisory Role: Napo Pharmaceuticals, Sanofi, Bristol Myer  Research Funding (Inst.): OBI Pharma, Pfizer, Novartis, Lilly, Merck, Daiichi Sankyo, AstraZeneca, Gilead Sciences, Hoffman La-Roche AG/Genentech, In., Stemline Therapeutics, Ambryx  Dr. Giuseppe Curigliano: Leadership: European Society for Medical Oncology, European Society of Breast Cancer Specialists, ESMO Open, European Society for Medical Oncology Honoraria: Ellipses Pharma Consulting or Advisory Role: Roche/Genentech, Pfizer, Novartis, Lilly, Foundation Medicine, Bristol-Myers Squibb, Samsung, AstraZeneca, Daiichi-Sankyo, Boerigher, GSK, Seattle Genetics, Guardant Health, Veracyte, Celcuity, Hengrui Therapeutics, Menarini, Merck, Exact Sciences, Blueprint Medicines, Gilead Sciences Speakers' Bureau: Roche/Genentech, Novartis, Pfizer, Lilly, Foundation Medicine, Samsung, Daiichi Sankyo, Seagen, Menarini, Gilead Sciences, Exact Sciences Research Funding: Merck Travel, Accommodations, Expenses: Roche/Genentech, Pfizer, Daiichi Sankyo, AstraZeneca      

This episode covers: Cardiology This Week: A concise summary of recent studies Visceral adiposity: paradigm shift in HFpEF management Artificial Intelligence in echocardiography Milestones: ISIS-2 Host: Susanna Price Guests: Carlos Aguiar, Milton Packer, Rudolf de Boer Want to watch the episode? Go to: https://esc365.escardio.org/event/2175 Want to watch the extended interview on AI in echocardiography? Go to: https://esc365.escardio.org/event/2175?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Rudolf de Boer has declared to have potential conflicts of interest to report: the institution of Rudolf de Boer has received research grants and/or fees from Alnylam, AstraZeneca, Abbott, Bristol-Myers Squibb, NovoNordisk, and Roche; Rudolf de Boer has had speaker engagements with and/or received fees from and/or served on an advisory board for Abbott, AstraZeneca, Bristol Myers Squibb, NovoNordisk, Roche, and Zoll; Rudolf de Boer received travel support from Abbott and NovoNordisk. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Milton Packer has declared to have potential conflicts of interest to report: 89bio, Abbvie, Actavis, Altimmune, Alnylam, Amarin, Amgen, Ardelyx, ARMGO, AstraZeneca, Attralus, Biopeutics, Boehringer Ingelheim, Caladrius, Casana, CSL Behring, Cytokinetics, Daiichi Sankyo, Imara, Lilly, Medtronic, Moderna, Novartis, NovoNordisk, Pharmacocosmos, Regeneron, Roche, Salamandra. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Susanna Price Guest: Rudolf de Boer Want to watch that extended interview on AI in echocardiography? Go to: https://esc365.escardio.org/event/2175?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors.  This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Rudolf de Boer has declared to have potential conflicts of interest to report: the institution of Rudolf de Boer has received research grants and/or fees from Alnylam, AstraZeneca, Abbott, Bristol-Myers Squibb, NovoNordisk, and Roche; Rudolf de Boer has had speaker engagements with and/or received fees from and/or served on an advisory board for Abbott, AstraZeneca, Bristol Myers Squibb, NovoNordisk, Roche, and Zoll; Rudolf de Boer received travel support from Abbott and NovoNordisk. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

In this JCO Article Insights episode, Dr. Ece Cal interviews Dr. Martin Wermke, author of the JCO article, "Phase I Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-Like T-Cell Engager Obrixtamig (BI 764532) in Patients With Delta-Like Ligand 3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas." TRANSCRIPT The disclosures for guests on this podcast can be found in the transcript. Dr. Ece Cali: Welcome to this episode of JCO Article Insights. This is Dr. Ece Cali, JCO editorial fellow, and today I am joined by Dr. Martin Wermke, Professor for Experimental Cancer Therapy at Dresden University of Technology, to discuss the manuscript “Phase 1 Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-like T-Cell Engager Obrixtamig in Patients with DLL3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas.” Obrixtamig is a bispecific T-cell engager that binds to DLL3 on tumor cells and CD3 on T-cells. This manuscript presents the phase 1A dose escalation results of Obrixtamig in patients with DLL3+ small cell lung cancer and neuroendocrine carcinomas. In this study, 168 patients were treated with Obrixtamig across four different dosing regimens. 49% of the patients had small cell lung cancer, 42% had extrapulmonary neuroendocrine carcinoma, and 8% had large cell neuroendocrine carcinoma of the lung. Patients received a median of two prior lines of therapy. 33% of the patients had brain metastases at baseline. Of note, this trial did not mandate baseline brain imaging. Maximum tolerated dose was not reached. 88% of the patients experienced a treatment-related adverse event, however, only 3.6% of the patients had to discontinue treatment due to treatment-related AEs, and dose reduction due to treatment-related AEs was documented in 2.4% of the patient population. Similar to the other DLL3-targeted bi-therapies, the most common adverse events included CRS in 57%, dysgeusia in 23%, and pyrexia in 21% of the patients. CRS events were mostly mild. They occurred more frequently in the first two to three doses. 9% of the patients experienced ICANS, of which 3% were graded as Grade 3 or higher. And let's review the efficacy results. Responses were only seen in patients who received 90 microgram per kg or more once weekly or once every three weeks dosing. The objective response rate in patients who received an effective dose was 28%. If we review by tumor type, 21% of the small cell lung cancer patients, 27% of the extrapulmonary neuroendocrine carcinoma patients, and 70% of the large cell neuroendocrine carcinoma patients had objective response. Median duration of response was 8.5 months, though this data is immature due to short follow-up. Dr. Wermke, DLL3-targeted bispecific T-cell engagers are reshaping the treatment landscape of small cell lung cancer. This trial investigates Obrixtamig in other high-grade neuroendocrine tumors as well. Can you put this trial into context for us and explain why it may represent an important step forward? Dr. Martin Wermke: Yeah, thank you for providing me with the opportunity to discuss our data today. I think the data with Obrixtamig in small cell lung cancer are largely similar to what has been observed with other bispecific T-cell engagers such as tarlatamab with respect to the response rate and duration. It has, however, been to be mentioned that BI 1438001 had a bit more liberal inclusion criteria than other trials around. You already mentioned the fact that we allowed the inclusion of patients without mandatory brain imaging, which led to some patients having their brain mets been diagnosed during the treatment with obrixtamig and then adding to the progressive disease patients. That is something which was not the case with the tarlatamab trials where you really had to have a brain imaging before, and in the Phase 1 trial you were even required to treat the brain mets before you included the patient. So it is a bit different, more poorest patient population. I think the trial adds on existing data by being the first trial to also include non-SCLC neuroendocrine carcinoma of other origin, for example from the gastrointestinal tract, and also by including large cell neuroendocrine carcinoma of the lung, which is a really hard to treat pulmonary neoplasm which currently lacks any standardized treatment. So that is really a step forward which we will build on in the future. Dr. Ece Cali: And one thing I would note in this trial, only patients with tumor expressing DLL3 were enrolled. Can you tell us a little bit more about this target, DLL3 in the context of neuroendocrine tumors, and does DLL3 expression predict clinical outcomes after treatment with DLL3 BiTEs, or do we actually need other predictive biomarkers for these novel agents? Dr. Martin Wermke: Yeah, thank you. That's a pretty interesting question. First of all, DLL3 is an atypical notch ligand, which is expressed by the majority of neuroendocrine carcinomas, virtually absent on healthy adult tissues. Therefore, turning it really into a bona fide target for T-cell engaging therapies, pretty low risk for on-target off-tumor side effects. We found that in all the patients we screened, we had an expression rate of about 94% in small cell lung cancer, 80% of large cell neuroendocrine carcinoma of the lung were positive, and also about 80% of the extrapulmonary neuroendocrine carcinoma. So it's really a high prevalence. So the fact that we only included DLL3+ tumors still means we included most of the patients that presented with these diseases. I think at the moment there are no data suggesting a clear-cut association between DLL3 expression levels and outcome on DLL3 CD3 T-cell engagers. There's also not a lot published. If you want to find this out for tarlatamab, you have to look into their patent to really see the data, but it's not clear-cut and I'm sure we need other markers to complement that. And I think what probably plays a major role is intrinsic T-cell fitness. So the question how really diseased your T-cells are, how old you are, because age also correlates with the fitness of the immune system, and other patient characteristics such as tumor burden, we've seen all across the board that the higher the tumor burden, the lower the rate of prolonged response is in such trials. And I also think we need to focus on other components of the tumor microenvironment. So see how high the T-cell infiltration with obrixtamig is and how abundant suppressive elements like regulatory T-cells or myeloid-derived suppressive cells are. That is work which is currently being done. Data are emerging, but I don't think that at the moment we have any clear biomarker helping us to select who should not receive DLL3 T-cell engagers. Dr. Ece Cali: Those are great points and there is a lot we need to learn about how to use these novel agents in the future. I'd like to highlight the results in large cell neuroendocrine carcinoma of the lung. The response rate in this group was remarkably high at 70%. Though we should note the small sample size of only 14 patients in this trial. After first line chemoimmunotherapy, current approved options for this population have very modest clinical activity. Given these trial results, how do you envision the field moving forward for patients with large cell neuroendocrine carcinoma? Dr. Martin Wermke: Yeah, I think LCNEC is really an area which urgently needs further improvement of therapeutic standards. At the moment, as I said, there is no real standard. We are usually extrapolating from results we have in small cell lung cancer or non-small cell lung cancer, but I don't think we have too many prospective trials really informing this. Of course, 14 patients is a small sample size, but I think it's still fair to say that we can claim that DLL3 T-cell engagers are not doing worse in LCNEC than they do in SCLC. And that's why I think we really need to move forward clinical trials that are specifically targeting this population. Although I fear a bit that, given the rareness of this disease and the aggressiveness of its phenotype, that this is probably not the main focus of the pharmaceutical industry. So I think it's up to us academic investigators to really come up with investigator-initiated trials trying to fill the knowledge gaps we have here. Dr. Ece Cali: And one more thing that I want to talk about is the accessibility for these drugs. These novel agents are showing real promise in improving outcomes for patients with high-grade neuroendocrine tumors, an area where progress has been limited until very recently. However, as DLL3 BiTEs become more widely used, issues of logistics and access come into sharper focus. With unique toxicities and the specialized monitoring, their use is restricted to certain centers. Looking ahead, what kinds of strategies could help mitigate some of these adverse events or make these treatments more broadly available? Dr. Martin Wermke: Yeah, I think if you look at countries like the United States where tarlatamab has already been approved, we can see how the management strategies are evolving. I've heard about a colleague equipping their patients with thermometers and a pill of Dexamethasone, alongside with a temperature control protocol and clearly instructing them, "If you measure a temperature above a certain level then start taking the Dexamethasone and come back to our office and we're going to take care of you." I think that's one way to move forward. I think we are lucky in a way that CRS usually manifests within the first 24 hours. This was the same in our study, like in the tarlatamab studies. So we really know when the time of trouble is for our patients. And in this time, I think we need to instruct the patients to stay close to the hospital. I don't think we need to hospitalize all of them, but we probably need them to stay in a nearby hotel to be able to reach the emergency room if needed in a short period of time. And I think we can also learn in this strategy how to manage bispecific antibodies from the experience our colleagues in hematology had because they have been using bispecific T-cell engagers for quite some years right now and they developed strategies and networks that were able to successfully treat these patients also on an outpatient basis. And I think that is clearly an experience we need to follow, acknowledging that we are talking about diseases which are much more frequent than the standard hematology indications. Dr. Ece Cali: Thank you so much, Dr. Wermke, for this informative discussion and for sharing your perspective on this evolving field. Dr. Martin Wermke: Yeah, thank you for providing me with the opportunity to talk about data. It was really great being able to share that, and I really think that we are just at the beginning of a new exciting area for the treatment of neuroendocrine carcinomas, and I think much improvement is yet to come for our patients. Dr. Ece Cali: Yes, that's really exciting. And thank you everyone for listening to JCO Article Insights. Please come back for more interviews and article summaries and be sure to leave us a rating and review so others can find our show. For more podcasts and episodes from ASCO, please visit asco.org/podcasts. 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 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. Dr. Martin Wermke's Disclosures Honoraria: Lilly, Boehringer Ingelheim, SYNLAB, Janssen, Merck Serono, GWT, Amgen, Novartis, Pfizer,  BMS GmbH & Co. KG, Regeneron, MJH/PER, Takeda Consulting or Advisory Role: Bristol-Myers Squib, Novartis, Lilly, Boehringer Ingelheim, ISA Pharmaceuticals, Amgen, immatics, Bayer, ImCheck therapeutics, AstraZeneca, Tacalyx, Regeneron, Daiichi Sankyo Europe GmbH, Zymeworks, PharmaMar, Iovance Biotherapeutics, T-Knife, Genentech Research Funding: Roche Patents, Royalties, Other Intellectual Property Travel, Accommodations, Expenses: Pfizer, Bristol-Myers Squibb, AstraZeneca,  Amgen,  GEMoaB, Sanofi/Aventis, immatics,  Merck Serono, Janssen Oncology, Iovance Biotherapeutics, Daiichi Sankyo Europe GmbH"

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA information, and to apply for credit, please visit us at PeerView.com/XBK865. CME/MOC/NCPD/CPE/AAPA credit will be available until September 18, 2026.Moving HCM Excellence Into the Fast Lane: Harnessing Technology to Reconfigure Clinical Workflows in an Academic Medical CenterThe University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.This activity is developed in collaboration with our educational partner, PVI, PeerView Institute for Medical Education. In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA information, and to apply for credit, please visit us at PeerView.com/XBK865. CME/MOC/NCPD/CPE/AAPA credit will be available until September 18, 2026.Moving HCM Excellence Into the Fast Lane: Harnessing Technology to Reconfigure Clinical Workflows in an Academic Medical CenterThe University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.This activity is developed in collaboration with our educational partner, PVI, PeerView Institute for Medical Education. In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA information, and to apply for credit, please visit us at PeerView.com/XBK865. CME/MOC/NCPD/CPE/AAPA credit will be available until September 18, 2026.Moving HCM Excellence Into the Fast Lane: Harnessing Technology to Reconfigure Clinical Workflows in an Academic Medical CenterThe University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.This activity is developed in collaboration with our educational partner, PVI, PeerView Institute for Medical Education. In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA information, and to apply for credit, please visit us at PeerView.com/XBK865. CME/MOC/NCPD/CPE/AAPA credit will be available until September 18, 2026.Moving HCM Excellence Into the Fast Lane: Harnessing Technology to Reconfigure Clinical Workflows in an Academic Medical CenterThe University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.This activity is developed in collaboration with our educational partner, PVI, PeerView Institute for Medical Education. In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA information, and to apply for credit, please visit us at PeerView.com/XBK865. CME/MOC/NCPD/CPE/AAPA credit will be available until September 18, 2026.Moving HCM Excellence Into the Fast Lane: Harnessing Technology to Reconfigure Clinical Workflows in an Academic Medical CenterThe University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.This activity is developed in collaboration with our educational partner, PVI, PeerView Institute for Medical Education. In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA information, and to apply for credit, please visit us at PeerView.com/XBK865. CME/MOC/NCPD/CPE/AAPA credit will be available until September 18, 2026.Moving HCM Excellence Into the Fast Lane: Harnessing Technology to Reconfigure Clinical Workflows in an Academic Medical CenterThe University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.This activity is developed in collaboration with our educational partner, PVI, PeerView Institute for Medical Education. In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Sciences Advisory Council, interview three high school students who made less invasive EoE diagnostics the focus of a science fair project. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship that exists between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:51] Co-host Ryan Piansky introduces the episode, brought to you thanks to the support of Education Partners Bristol Myers Squibb, GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:08] Holly introduces today's guests, three high school students from Texas who made EoE diagnostics the focus of a science fair project: Leyna, Nhu, and Jaden.   [1:47] Leyna, Nhu, and Jaden are best friends. Nhu was diagnosed with EoE last summer. Leyna said Nhu told them it took a long time for the doctors to diagnose her because they thought it could be different conditions.   [2:07] Nhu told them about her appointments and her endoscopy procedures. She had to miss school sometimes. Leyna and Jaden were concerned for her.   [2:22] Leyna took AP Bio. Her teacher was a sponsor for the science fair. Leyna thought this would be a meaningful project for the three friends to learn more about Nhu's condition.    [2:45] Holly shares that she wasn't diagnosed until her 20s, but she was sick for much of her childhood.   [3:13] Ryan shares that he was diagnosed when he was two, after two years of his parents taking him to different doctors and undergoing different tests.   [3:31] Nhu says it was hard to find a specialist. They found one and had to wait six months for an appointment. It was a long time, suffering from the effects of EoE with constant symptoms, a lot of heartburn, and painful vomiting.   [4:00] Nhu was diagnosed with EoE in her sophomore year of high school. Her friends have seen her endure a lot, but she's strong. Nhu had to miss an orchestra concert where she had a big solo, because of her EoE.   [4:32] Doctors thought Nhu could have something different, like H. Pylori or cyclic vomiting syndrome. They didn't have clear answers, which was confusing and frustrating for her family.   [4:50] Holly talks about how difficult it was for her to get a diagnosis, and how she was told she was vomiting to get attention. She shared her reaction when diagnosed. She would like someone to do a research study about the pain tolerance of people with EoE.   [5:41] Leyna says junior year is the hardest year of high school. She doesn't know how Nhu survived physics and AP classes with EoE on top of it, and making up late work.   [6:14] Nhu takes a weekly injection. Her symptoms happen almost monthly. Sometimes she misses school for two weeks and has to catch up on work. Leyna and Jaden help her with her schoolwork.   [6:47] Ryan shared how he missed a third of his senior year in high school. He's now on an injectable biologic that has helped him a lot. That treatment option wasn't available when he was in high school. Having supportive friends to send him his schoolwork and keep him up-to-date was very helpful.   [7:11] Ryan explains the esophageal string test (EST). This is a tool that was developed to help monitor eosinophilic esophagitis (EoE). The test works by having the patient swallow a capsule about the size of a Tic Tac that has a string attached.   [7:25] The capsule dissolves in the stomach while the string stays in place in the esophagus. After about an hour, it's gently removed. Along the way, the string collects samples from the lining of the esophagus, which are reviewed, similarly to a biopsy.   [7:37] Holly adds that what makes the string test unique is that it doesn't require an endoscope, anesthesia, or recovery time, things that usually come with a traditional endoscopy and biopsy.   [7:46] It's now being used with patients as young as four years old. While some people might feel some minor discomfort, it's generally much easier for regular monitoring than an endoscopy.   [7:57] Holly explains that she was involved in testing the device and developing a swallowing protocol for it at Children's Hospital of Colorado. We will talk more about this later in the episode.   [8:06] Ryan adds, to learn more about the development of the string test, listen to episode 26 of this podcast.   [8:10] The string test is one of multiple, less-invasive monitoring tools for eosinophilic esophagitis. Others include the sponge test and unsedated trans-nasal endoscopy.   [8:19] To learn more about unsedated transnasal endoscopy, listen to episodes 19 and 20, where we talk to clinicians and patients about this method.   [8:27] During that episode, we talked to the developers of the EST.   [8:38] Jaden tells how he, Leyna, and Nhu brainstormed ideas and decided to base their project specifically on how to diagnose EoE in a less invasive way than endoscopies.   [9:12] Before this project, they were not familiar with the EST. Nhu says her only option for diagnosis was an endoscopy.   [9:21] Holly says it's still like that in Maine. She came from an area of the country where the EST was researched, and it's interesting to her that she doesn't have access to it now.   [9:37] What appealed to the group about the EST as an alternative to endoscopies is that it was so different. There are so many advanced technologies, and the EST is just a capsule taped to a string. It is simple but innovative.   [10:13] Real Talk: Eosinophilic Diseases had Drs. Robin Shandas and Steven Ackerman, who were instrumental in the development of the esophageal string test, as guests on episode 26 of this podcast. Ryan encourages listeners to check out that episode at apfed.org/podcasts.   [10:42] They searched for keywords and analyzed a variety of scholarly literature. They collected a lot of data from Dr. Ackerman's papers.   [11:10] They also reached out to gastroenterologists on social media. A hard thing about science fair projects is coming up with an experiment. They didn't know what they could do just with compiled research, but they had a great sponsor who helped along the way.   [11:56] Leyna says they trusted that the doctors they reached out to on social media were competent in their understanding of different diagnostic methods. She notes that different locations may have different resources and different biases.   [12:14] Leyna says they talked to doctors in the U.S. and from different countries, including India and Mexico. She commented that communities in Mexico might not have the same resources as communities in the U.S. or India. That might change their understanding of the EST.   [12:33] We might have different biases because we don't have the same technology to research and find the same things about the EST.   [13:12] Leyna says they reached out to doctors on social media, but didn't get responses from that many doctors. Reaching out to patients would be a good thing if they want to continue the project.   [14:00] Jaden says most of the data they found was from Dr. Ackerman, including a survey he did comparing the data of the EST and the biopsies.   [14:10] They found that the EST and the biopsies were relatively similar in terms of discovering the eosinophilic count and determining whether the EoE is active or inactive.   [15:30] They found differences between ESTs and biopsies in finding how much of a certain chemical is in the patient's cells.   [14:43] Leyna comments that one of the doctors they reached out to told them about the sponge test, another less invasive method. They didn't research the sponge test, but it sounded interesting.   [15:00] Ryan says there are a lot of cool new techniques that are being researched, like the transnasal endoscopy that goes in through the nose, the string test, and the sponge test.   [15:13] Leyna says the cool thing was hearing about all these methods. They had hypothesized that there are less invasive methods that may be better than endoscopies.   [15:27] They were not able to prove their hypothesis yet. They learned a lot of different things that could be beneficial.   [15:42] Holly points out that the transnasal endoscopy is not scary. It's also known as the unsedated endoscopy. Holly has done both the EST and the unsedated endoscopy,  and they each have pluses and minuses.   [16:15] Nhu explains how the team would meet at one of their houses, usually Leyna's house. One day, they watched Interstellar together, and the “Eureka moment” scene motivated them.   [16:41] They helped each other whenever necessary. When the project board was due, they all went to Leyna's house to work on the project board. They worked together as a team.   [16:51] Jaden analyzed a lot of the data. Leyna reached out to professors. Nhu helped Jaden understand some terms. On the day they presented the project, Nhu was sick in the hospital, which made them sad. They included a photo of her on the project board.   [17:28] Holly says that although Nhu wasn't there, it may have helped people know how sick EoE can make you feel.   [18:28] Leyna says one of the doctors they reached through social media told them that endoscopies have lots of benefits. The biopsy samples give healthcare professionals a clear idea of how many eosinophils per high-powered field, a key indicator in diagnosing EoE.   [18:57] The diagnosis gives a baseline for starting treatment for the patient, monitoring how effective the treatment is. You can't count the number of eosinophils per high-powered field using the string test.   [19:11] The EST is a gelatin capsule attached to a long string that you swallow. It dissolves in the stomach. It's less expensive than an endoscopy.   [19:33] Holly says one of the big differences is that you can't diagnose EoE on a string test. It has to be diagnosed with an endoscopy.   [19:40] Leyna says they learned that from the doctors and medical students who reviewed their project board. You can't diagnose EoE with the EST, but you can monitor it.   [19:52] The string test doesn't provide a direct eosinophil count, but it reflects the level of inflammation in your esophagus, and it can measure the protein biomarkers. That correlates with the eosinophil count from a biopsy. It is good for monitoring EoE.   [20:12] Ryan says that's a great idea. In the show notes, there is a link to the diagnostic consensus guidelines. They specify that you need an endoscopy and 15 eosinophils per high-powered field to be diagnosed with EoE.   [20:28] The EST can monitor the progression of the disorder as you're trying new medicines or an elimination diet. If you need an endoscopy every three to six months, it can be taxing.    [20:49] Ryan comments on the cost. Going through anesthesia for an endoscopy is very expensive, and not everyone has the insurance to cover these diagnostic procedures. The EST is an option you can do in a doctor's office in just over an hour.   [21:16] Holly asks if Nhu has participated in a string test. Nhu has not, but she would love to do a string test if she had the chance. Whenever she sees her doctor, she brings up her condition, and what could be better for her, such as the string test.   [22:06] The science fair is a huge regional fair in Houston, called the Science and Engineering Fair of Houston (SEFH). This was their first year participating. They were regional qualifiers from their district. When they got there, everyone else had six-foot-tall printed boards. It was a shock to them.   [22:56] They hope to level up their board for next year's fair. It was cool and eye-opening to see all these student researchers and get feedback from the people who walked by their booth. They heard some interesting things to use in their next project.   [23:15] One medical student in attendance came by their project board and suggested that while the EST may not diagnose EoE, maybe it could be used as a screening tool [to help identify people who should follow up with a gastroenterologist for a diagnostic work-up]. Interestingly, this was a medical student, and she had recently scheduled an appointment with a gastroenterologist for an endoscopy to see if she has EoE.   [24:04] This student didn't seem to know much about EoE, but felt she was experiencing symptoms that might indicate EoE. She told them she had learned so much from their board. Ryan says it's great that the project was able to help this person.   [24:44] Jaden says that the students at their school didn't know much about EoE, but when they looked at the project board, they were shocked by how incredibly difficult it is to diagnose EoE and how the EST could change a lot of things as a screening method.   [25:11] Jaden says their science teacher came by to see their board and how they were doing. He liked how they included not only the research information but also the stories of why they chose their project and why they were passionate about it.   [25:34] The day of the project, Leyna and Jaden were sad that Nhu couldn't be there with them. Their sponsor, Leyna's biology teacher, was sick, but showed up at the fair to view their presentation. They raised awareness about EoE. People learned about it.   [25:54] When Nhu told Leyna about her EoE, Leyna had no idea what it was. She's glad their project brought the issue to the table. They emphasized that more research needs to be done. There is much we don't know about less invasive methods.   [26:23] Nhu has considered a career in medicine since she has been in many hospitals and talked to a lot of doctors. Jaden sees himself in the engineering field, but he enjoys researching like this and seeing things through a different perspective.   [27:05] Nhu learned a lot about herself with EoE. Leyna loves how much they learned from this project. She is interested in pursuing scientific research. She thinks it's cool that Ryan is a graduate student.   [27:24] Leyna just got back from a five-week summer research program. It was insightful. She doesn't see herself becoming a doctor, but possibly doing research and advocating for different conditions.   [27:43] When Ryan was in high school, with all his hospital time, he had an interest in medicine, then he took a turn into engineering. He enjoys research. He's passionate about engaging in patient advocacy work through APFED.   [28:10] Ryan is glad for Leyna, Nhu, and Jaden that they were able to engage with this research and do it as a group and as friends. He says it's fantastic to hear from the group about the whole process they went through.   [28:23] Holly asks, looking back on everything you guys learned and experienced in this project, what's one question or idea you would still like to explore if you had more time and resources?   [28:38] Nhu wants to research finding more ways to diagnose EoE. Testing for EoE and finding EoE are very interesting for her.   [28:53] Jaden thinks that if they had more time, they would try to create a model of the EST to show how it works. He would possibly try to improve upon the model or develop something new. Instead of just relying on the data we have, he would try to collect data.   [29:26] Leyna agrees. She would like to build a prototype, understand how the capsule works, and find out whether the string down the esophagus is uncomfortable.   [33:41] Ryan suggests there is a doctor who would let them try the string test so they could see how it feels. Holly tried the string test at a major children's hospital while it was being researched. She doesn't want to ask her patients to do something she hasn't done, since she has the diagnosis too.   [30:37] Ryan comments that he enjoyed hearing about the process of the project.   [30:51] Ryan gives a quick recap: The esophageal string test is a tool to help monitor EoE. It is not a tool to diagnose EoE. If you or a loved one has EoE or suspect that you might, ask your clinician about the string test to see if it's an option for you.   [31:03] Holly adds: School science fairs are one way to bring education about eosinophilic disorders to schools. We love hearing about community science fairs and school projects that teach others about these conditions.   [31:13] For those of you looking to learn more about eosinophilic esophagitis, we encourage you to visit apfed.org/EoE.   [31:23] For those looking to find specialists who treat EoE, we encourage you to use APFED's Specialist Finder at apfed.org/specialist.   [31:30] Ryan thanks Leyna, Nhu, and Jaden for joining us today. Holly also thanks APFED's Education Partners Bristol Myers Squibb, GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode: Dr. Robin Shandas Dr. Steven Ackerman “Updated international consensus diagnostic criteria for eosinophilic esophagitis: Proceedings of the AGREE conference”   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.org/specialist apfed.org/connections   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of Bristol Myers Squibb, GSK, Sanofi, Regeneron, and Takeda.   Tweetables:   “Nhu and Jaden are my best friends. Recently, Nhu was diagnosed with EoE. I remember her telling us about the long diagnosis process. It took the doctors quite a long time to diagnose her because they thought it could be different conditions.” — Leyna   “I thought that this would be a meaningful project for us to learn more about Nhu's condition [of EoE].” — Leyna   “The students at our school didn't know much about EoE, but when they looked at the project board, they were shocked by how incredibly difficult it is to diagnose EoE.” — Jaden   “One of the main benefits of the string test is that endoscopies can be quite expensive, especially the anesthesia. It could be beneficial for people who don't have the money for an endoscopy.” — Nhu

This episode covers: Cardiology This Week: A concise summary of recent studies Strategic decisions in valvular heart disease Optimising drug therapy in chronic coronary syndromes Mythbusters: Does wearing a white coat make you smarter? Host: Susanna Price Guests: John-Paul Carpenter, Fabien Praz, Robert Storey Want to watch that episode? Go to: https://esc365.escardio.org/event/2092 Want to watch that extended interview on Optimising drug therapy in chronic coronary syndromes ? Go to: https://esc365.escardio.org/event/2092?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel, Fabien Praz and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Robert Storey has declared to have potential conflicts of interest to report: research grants and personal fees from AstraZeneca and Cytosorbents, and personal fees from Abbott, Afortiori Development/Thrombolytic Science, Boehringer Ingelheim/Lilly, Bristol Myers Squibb/Johnson & Johnson, Chiesi, Idorsia/Viatris, Novo Nordisk, PhaseBio and Tabuk. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Susanna Price Guest: Robert Storey Want to watch that extended interview? Go to: https://esc365.escardio.org/event/2092?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi.  Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Robert Storey has declared to have potential conflicts of interest to report: research grants and personal fees from AstraZeneca and Cytosorbents, and personal fees from Abbott, Afortiori Development/Thrombolytic Science, Boehringer Ingelheim/Lilly, Bristol Myers Squibb/Johnson & Johnson, Chiesi, Idorsia/Viatris, Novo Nordisk, PhaseBio and Tabuk. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

By Adam Turteltaub Being a leader is hard.  Being a compliance leader is harder.  Being a compliance leader in fast-changing times takes it up yet another level, but it's not impossible. Kim Jablonski, Chief Compliance & Ethics Officer at Bristol Myers Squibb shares that with these challenges it's important for leaders not to think in static terms but to recognize that the landscape is constantly changing.  The transformations include not just new laws and regulations but also new expectations for compliance programs, such as when it comes to taking a more data-driven approach. At the same time, though, some things don't change.  For example, you need to communicate with the workforce the importance of acting with integrity, even when there is business pressure to deliver.  That same message should come from leadership as well so that employees see integrity as a part of the culture and behavioral expectations. For their part, compliance leaders, and their teams, need to have a deep understanding of the business and how it works.  They must also be flexible with more than one solution to a problem. She also advocates for a collaborative approach.  Working together with a wide range of internal teams leads to better outcomes, both from a compliance and business perspective. Most notably of all, she shares an insight that is relatable and very eye opening:  We all have obstructed view seats.  As she explains, we all only see a part of the picture and need to be mindful that we benefit from the views of others and that bad decisions are often the product of not being able to see the whole panorama before us. Listen in for more eye-opening insights.

Dr. Sumanta (Monty) Pal and Dr. Petros Grivas discuss innovative new intravesical therapies and other recent advances in the treatment of non-muscle invasive bladder cancer. TRANSCRIPT Dr. Sumanta (Monty) Pal: Hello and welcome. I'm Dr. Monty Pal here at the ASCO Daily News Podcast. I'm a medical oncologist and professor and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. And I'm really delighted to be your new host here. Today's episode is going to really sort of focus on an area near and dear to my heart, something I actually see in the clinics, and that's bladder cancer. We're specifically going to be discussing non-muscle invasive bladder cancer, which actually comprises about 75% of new cases. Now, in recent years, there's been a huge shift towards personalized bladder-preserving strategies, including innovative therapies and new agents that really are reducing reliance on more primitive techniques like radical cystectomy and radiation therapy. And I'm really excited about this new trend. And really at the forefront of this is one of my dear friends and colleagues, Dr. Petros Grivas. He's a professor in the Department of Medicine and Division of Hematology Oncology at the University of Washington. It's going to take a while to get through all these titles. He's taken on a bunch of new roles. He is medical director of the International Program, medical director of the Local and Regional Outreach Program, and also professor in the Clinical Research Division at the Fred Hutch Cancer Center. Petros, welcome to the program. Dr. Petros Grivas: Thank you so much, Monty. It's exciting for me to be here. Dr. Sumanta (Monty) Pal: Just FYI for our audience, our disclosures are available in the transcript of this episode.  We're going to get right into it, Petros. Non-muscle invasive bladder cancer, this is a really, really challenging space. We see a lot of recurrence and progression of the disease over time, about 50% to 70% of patients do have some recurrence after initial treatment, and about 30% are ultimately going to progress on to muscle-invasive or metastatic disease. Now, I will say that when you and I were in training, non-muscle invasive bladder cancer was something that was almost relegated to the domain of the urologist, right? They would use treatments such as BCG (Bacillus Calmette-Guérin) in a serial fashion. It was rare, I think, for you and I to really enter into this clinical space, but that's all changing, isn't it? I mean, can you maybe tell us about some of the new therapies, two or three that you're really excited about in this space? Dr. Petros Grivas: Monty, you're correct. Traditionally and conventionally, our dear friends and colleagues in urology have been managing patients with non-muscle invasive bladder cancer. The previous term was superficial bladder cancer. Now, it has changed, to your point, to non-muscle invasive bladder cancer. And this has to do with the staging of this entity. These tumors in superficial layers of bladder cancer, not invading the muscularis propria, the muscle layer, which makes the bladder contract for urine to be expelled. As you said, these patients have been treated traditionally with intravesical BCG, one of the oldest forms of immunotherapy that was developed back in the 1970s, and this is a big milestone of immunotherapy development. However, over the years, in the last 50 years, there were not many options for patients in whom the cancers had progression or recurrence, came back after this intravesical BCG. Many of those patients were undergoing, and many of them still may be undergoing, what we call radical cystectomy, meaning removal of the bladder and the lymph nodes around the bladder. The development of newer agents over the last several years has given the patients the option of having other intravesical therapies, intravesical meaning the delivery of drugs, medications inside the bladder, aiming to preserve the bladder, keep the bladder in place. And there are many examples of those agents. Just to give you some examples, intravesical chemotherapy, chemotherapy drugs that you and me may be giving intravenously, some of them can be given inside the bladder, intravesical installation. One example of that is a combination of gemcitabine and docetaxel. These drugs are given in sequence one after the other inside the bladder, and they have seen significant efficacy, good results, again, helping patients keeping the bladder when they can for patients with what we call BCG unresponsive non-muscle invasive bladder cancer. And again, there's criteria that the International Bladder Cancer Group and the FDA developed, how to define when BCG fails, when we have BCG unresponsive non-muscle invasive bladder cancer. Dr. Sumanta (Monty) Pal: And we're actually going to get into some of the FDA requirements and development pathways and so forth. What I'm really interested in hearing, and I'm sure our audience is too, are maybe some of the new intravesical treatments that are coming around. I do think it's exciting that the gemcitabine and docetaxel go into the bladder indeed, but what are some of the top new therapies? Pick two or three that you're excited about that people should be looking out for in this intravesical space. Dr. Petros Grivas: For sure, for sure. In terms of the new up-and-coming therapies, there are a couple that come to mind. One of them is called TAR-200, T-A-R 200. This agent is actually a very interesting system. It's an intravesical delivery of a chemotherapy called gemcitabine, the one that I just mentioned a few minutes ago, that is actually being delivered through what we call a pretzel, which is like a rounded [pretzel-shaped] structure working like an osmotic pump, and that is being delivered inside the bladder intravesically by urologists. And this drug is releasing, through the osmotic release mechanism, this chemotherapeutic drug, gemcitabine, inside the bladder. And this can be replaced once every 3 weeks in the beginning. And the data so far from early-phase trials are really, really promising, showing that this agent may be potentially regulatory approved down the road. So TAR-200 is something to keep in mind. And similarly, in the same context, there is a different drug that also uses the same mechanism, and this osmotic release, this pretzel, it's just encoded with a different agent. The different agent is an FGFR inhibitor, a target therapy called erdafitinib, a drug that you and me may give in patients with metastatic urothelial carcinoma if they have an FGFR3 mutation or fusion. And that drug is called TAR-210. Dr. Sumanta (Monty) Pal: And can I ask you, in that setting, do you have to have an FGFR3 mutation to receive it? Or what is the context there? Dr. Petros Grivas: So for TAR-210, TAR-2-1-0, usually there is a checking to see if there is an FGFR3 mutation or fusion. And the big question, Monty, is do we have adequate tissue, right? From a limited tissue on what we call the TURBT, right, that urologists do. And now there is a lot of development in technology, for example, urine circulating tumor DNA to try to detect these mutations in the urine to see whether the patient may be eligible for this TAR-210. Both of those agents are not FDA approved, but there are significant promising clinical trials. Dr. Sumanta (Monty) Pal: So now let's go to a rapid-fire round. Give us two more agents that you're excited about in this intravesical space. What do you think? Dr. Petros Grivas: There is another one called cretostimogene. It's a long name. Dr. Sumanta (Monty) Pal: They really make these names very easy for us, don't they? Dr. Petros Grivas: They are not Greek names, Monty, I can tell you, you know. Even my Greek language is having trouble pronouncing them. The cretostimogene, it's actually almost what we call a growth factor, a GM-CSF. The actual name of this agent is CG0070. This is a replicating mechanism where GM-CSF is replicating in cells. And this agent has shown significant results again, like the TAR-200, in BCG unresponsive non-muscle invasive bladder cancer. I would say very quickly, two agents that actually were recently approved and they're already available in clinical practice, is nadofaragene firadenovec, another long name. That's a non-replicating vector that has the gene of interferon alfa-2b that stimulates the immune system in the bladder. It's given once every 3 months. And the last one that was, as I mentioned, already FDA approved, it's an interleukin-15 superagonist. It's another long name, which is hard to pronounce, but I will give it a try. It's a drug that was recently actually approved also in the UK. The previous name was N-803. It's given together with BCG as a combination for BCG unresponsive non-muscle invasive bladder cancer. Dr. Sumanta (Monty) Pal: This is a huge dilemma, I think, right? Because if you're a practicing, I'm going to say urologist for the moment, I guess the challenge is how do you decide between an IL-15 superagonist? How do you decide between a pretzel-eluting agent? How do you decide between that and maybe something that's ostensibly, I'm going to guess, cheaper, like gemcitabine and docetaxel? What's sort of the current thinking amongst urologists? Dr. Petros Grivas: Multiple factors play into our account when the decision is being made. I discuss with urologists all the time. It's not an easy decision because we do not have head-to-head comparisons between those agents. As you mentioned, intravesical chemotherapy with gemcitabine and docetaxel has been used over the years and this is the lowest cost, I would say, the cheapest option with good efficacy results. Obviously, the nadofaragene firadenovec every 3 months and the interleukin-15 superagonist, N-803, plus BCG have also been approved. The question is availability of those agents, are they available? Are they reimbursed? Cost of those agents can come into play. Frequency of administration, you know, once every 3 months versus more frequent. And of course, the individual efficacy and toxicity data, preference of the patients; sometimes the provider, the urologist, may have something that they may be more familiar with. But we lack this head-to-head comparison. Of course, I want to make sure I mention that radical cystectomy may still be the option for appropriate patients. So that complicates also the decision making and has to be individualized, customized, and personalized, taking into account all those factors. And there is not one size fitting all. Dr. Sumanta (Monty) Pal: So I think we discussed five intravesical therapies. As you point out, and you know, I'm going to get some calls about this: I think I referred to radical cystectomy as being a more primitive procedure. Not true at all. I think it's something that still is, you know, a mainstay of management in this disease space. But I guess it gets even more complicated, am I right, Petros? Because now we have systemic therapies that we can actually apply in this non-muscle invasive setting for at this point, refractory disease. Can you maybe just give us a quick two-minute primer on that? Dr. Petros Grivas: Absolutely, and systemic therapies now come into play, as you said. And a classical example of that, Monty, came from the KEYNOTE-057 trial that we published about 6 years ago. This is intravenous pembrolizumab, given intravascularly, intravenously, as opposed to the previously discussed intravesical administration of agents. Pembrolizumab was tested in that KEYNOTE-057 trial and showed efficacy about, I would say, one out of five patients, about 20%, had a complete response of the tumor in the bladder in a year after starting the treatment. Again, it's hard to compare across different agents, but obviously when we give something intravenously, there is a risk of toxicity, side effects systemically, what we call immune-related adverse events. And this can also play in the decision making, right? When you have intravesical agents versus intravascular agents, there is different toxicity profiles in terms of systemic toxicity. But intravenous pembrolizumab has been an option, FDA approved, since, if I remember, it was early 2020 when this became FDA approved. There are other agents being tested in this disease, but like atezolizumab through the SWOG study that Dr. Black and Dr. Singh led, but atezolizumab is not FDA approved for this indication. Again, this is for BCG unresponsive, high-risk, non-muscle invasive bladder cancer. Dr. Sumanta (Monty) Pal: So maybe teach us how it works, for instance, at an expert center like the Fred Hutch. When you see a patient with non-muscle invasive bladder cancer, there's obviously the option of surgery, there's the intravesical therapies, which I imagine the urology team is still really at the helm of. But then, I guess there has to be consideration of all options. So you've got to bring up systemic therapy with agents like pembrolizumab. In that context, are you involved that early on in the conversation? Dr. Petros Grivas: That's a great discussion, Monty. Paradigm is shifting as we mentioned together. The urologists have been treating these patients and still they are the mainstay of the treaters, the managers in this disease. But medical oncologists come to play more and more, especially with the FDA approval of intravenous pembrolizumab about 5 years ago [GC1]  [KM2] . We have the concept of multidisciplinary bladder cancer clinic here at Fred Hutch and University of Washington. This happens every Tuesday morning, and we're very excited because it's a one-stop shop for the patients. We have the urologist, a medical oncologist, radiation oncologist, and experts from radiology and pathology, and we all review cases specifically with muscle-invasive bladder cancer. But every now and then, we see patients with BCG unresponsive non-muscle invasive bladder cancer. And this is where we discuss and we talk to the patient about pros and cons of all those options. And that's a classic example where medical oncologists may start to see those patients and offer their input and expertise. In addition to that, sometimes we have clinical trials, we may see these patients because there are systemic agents that may be administered in this setting. We have the SunRISe trial program that includes also a systemically administered checkpoint inhibitor. So that's another example where we see patients either in the context of multi-clinic or in individual solo clinics to counsel the patients about the pros and cons of the systemically administered agents in the context of clinical trials. Usually checkpoint inhibitors are the class of agents that are being tested in this particular scenario. Dr. Sumanta (Monty) Pal: I can see a scenario where it's really going to require this sort of deep dive, much in the way that we do for prostate cancer, for instance, where the medical oncologist is involved very early on and planning out any sort of systemic therapy component of treatment or at the very least, at least spelling out those options. I think it's going to be really interesting to see what this space looks like 5 or 10 years down the road. In closing, I wanted to go through something that I think is so different in this space, at least for the time being, and that is the paradigm for FDA approval. When you and I have our fellows in the clinics, we always say, “Look, you know, the paradigm in this disease and that disease and the other disease needs to be phase 3 randomized trials, right? Big thousand patient experiences where you're testing clinical endpoints.” That's tough in non-muscle invasive bladder cancer, right? Because thankfully, outcomes can actually be quite good, you know, in this setting, right? It's tough to actually estimate overall survival in some of these early-stage populations. Tell me what the current regulatory bar is, and this is a tough thing to do in 2 minutes or less but tell me where you see it headed. Dr. Petros Grivas: You alluded to that before, Monty, when I was giving the background and we talked about the regulatory approval. And I have to very quickly go back in time about 10 years ago because it's important for context that can help us in other disease types too. We had workshops with the FDA and the NCI with the help of the International Bladder Cancer Group and other colleagues. And we try to define a framework, what endpoints are meaningful for those patients in this disease. It was a multidisciplinary, multiple stakeholders meeting, where we tried to define what is important for patients. What are the available agents? What are the trial designs we can accept? And what are the meaningful endpoints that the regulatory agencies can accept for regulatory approval? And that was critical in that mission because it allowed us to design clinical trials, for example, single-arm trials in a disease where there was no standard of care. There was intravesical valrubicin and chemotherapy anthracycline that was approved for many years, but was not practically used in clinical practice, despite being approved, the valrubicin. And because of that, the FDA allowed these single-arm trials to happen. And obviously the endpoint was also discussed in that meeting. For example, for carcinoma in situ, complete response, clinical complete response, because the bladder remains intact in many patients, clinical complete response was a meaningful primary endpoint, also duration of response is also very important. So what is the durable clinical complete response in 1 year or 18 months is relevant. And when you have papillary tumors like Ta or T1 with CIS, for papillary tumors, event-free survival becomes one of the key endpoints and you look at it over time, for example, at 12 or 18 months, what is the event-free survival? So clinical complete response, duration of response, event-free survival, depending on the CIS presence or papillary tumors, I think these are endpoints that have allowed us to design those trials, get those agents approved.  Now, the question going forward, Monty, and we can close with that is, since now we have the embarrassment of riches, many more options available compared to where we were 6 and 7 years ago, is now the time to do randomized trials? And if we do randomized trials, which can be the control group? Which of those agents should be allowed to be part of the control group? These are ongoing discussions right now with the NCI, with other agencies, cooperative groups, trying to design those trials and move forward from here.[GC3]  Dr. Sumanta (Monty) Pal: Well, it's awesome to have you here on the program so we can get some early looks into some of these conversations. I mean, clearly, you're at the table at a lot of these discussions, Petros. So I want to thank you for sharing your insights with us today. This was just tremendous. Dr. Petros Grivas: Thank you, Monty. You know, patients in the center, I just came back from the Bladder Cancer Advocacy Network meeting in Washington, D.C., and we discussed all those questions, the topics you very eloquently mentioned and asked me today, and patients gave us great feedback and patients guide us in that effort. Thank you so, so much for having me and congratulations for the amazing podcast you're doing. Dr. Sumanta (Monty) Pal: Oh, cheers, Petros, thanks so much.  And thank you to the listeners who joined us today. If you really like the insights that you heard on this ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Thanks, everyone. 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.   Find out more about today's speakers:      Dr. Sumanta (Monty) Pal  @montypal  Dr. Petros Grivas @PGrivasMDPhD   Follow ASCO on social media:     @ASCO on Twitter    ASCO on Bluesky   ASCO on Facebook     ASCO on LinkedIn     Disclosures:    Dr. Sumanta (Monty) Pal:   Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview  Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical  Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis  Dr. Petros Grivas: Consulting or Advisory Role: Merck, Bristol-Myers Squibb, AstraZeneca, EMD Serono, Pfizer, Janssen, Roche, Astellas Pharma, Gilead Sciences, Strata Oncology, Abbvie, Bicycle Therapeutics Replimune, Daiichi Sankyo, Foundation Medicine, Bicycle Therapeutics, Eli Lilly, Urogen Pharma, Tyra Biosciences Research Funding (Inst.): Bristol-Myers Squibb, Merck, EMD Serono, Gilead Sciences, Acrivon Therapeutics, ALX Oncology, ALX Oncology, Genentech Travel, Accommodations, Expenses: Gilead Sciences

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