Podcasts about GSK

This episode covers: Cardiology This Week: A concise summary of recent studies Oral anticoagulation in atrial fibrillation: answers to frequent questions Smartwatch, heart rate and ECG Milestones: Lyon Diet Heart study Host: Emer Joyce Guests: Carlos Aguiar, Tim Chico, Paulus Kirchhof Want to watch that episode? Go to: https://esc365.escardio.org/event/1811 Want to watch that extended interview on smartwatch, heart rate and ECG? Go to: https://esc365.escardio.org/event/1811?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, Emer Joyce and Nicolle Kraenkel 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Tim Chico has declared to have potential conflicts of interest to report: research funding from Google. Paulus Kirchhof has declared to have potential conflicts of interest to report: partially supported by European Union MAESTRIA (grant agreement 965286), British Heart Foundation (AA/18/2/34218), German Center for Cardiovascular Research supported by the German Ministry of Education and Research (DZHK, grant numbers DZHK FKZ 81X2800182, 81Z0710116, and 81Z0710110), German Research Foundation (Ki 509167694), Dutch Heart Foundation (DHF), the Accelerating Clinical Trials funding stream in Canada, and the Else-Kröner-Fresenius Foundation. Research support for basic, translational, and clinical research projects from German Research Foundation (DFG), European Union, British Heart Foundation, Leducq Foundation, Else-Kröner-Fresenius Foundation, Dutch Heart Foundation (DHF), the Accelerating Clinical Trials funding stream in Canada, Medical Research Council (UK), and German Center for Cardiovascular Research, from several drug and device companies active in atrial fibrillation, and has received honoraria from several such companies in the past, but not in the last five years. Listed as inventor on two issued patents held by University of Hamburg (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). 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: Emer Joyce Guest: Tim Chico Want to watch that extended interview on smartwatch, heart rate and ECG? Go to: https://esc365.escardio.org/event/1811?resource=interview Want to watch that episode? Go to: https://esc365.escardio.org/event/1811   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, Emer Joyce and Nicolle Kraenkel 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Tim Chico has declared to have potential conflicts of interest to report: research funding from Google. 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.

Ready to transform your HR operations?Download Deel's free AI-powered HR guide and discover how to streamline processes, stay compliant, and scale globally with ease: https://shorturl.at/Y1ySBWhy do toxic workplaces thrive, and how can leaders turn them around? In this HR L&D Podcast episode, we're sitting down with Dr Mary-Clare Race, a workplace psychologist and leadership expert, to uncover the psychology of toxic cultures and the strategies that transform them into thriving, inclusive environments.From her PhD research to leading DE&I initiatives for companies like Barclays, GSK, and Unilever, Dr Race explains why harmful behaviors persist, how to rebuild belonging, and why empathy, resilience, and self-awareness are the hallmarks of great leadership. She shares practical ways to hold leaders accountable, strengthen workplace connection, and use AI as a tool to support human-centered coaching.Whether you're in HR or lead a team, this conversation delivers actionable insights for creating healthier, more productive workplaces.Dr Mary-Clare Race's LinkedIn: https://www.linkedin.com/in/dr-mary-clare-race-b59a602/Nick Day's LinkedIn: https://www.linkedin.com/in/nickday/Find your ideal candidate with our job vacancy system: https://jgarecruitment.ck.page/919cf6b9eaSign up to the HR L&D Newsletter - https://jgarecruitment.ck.page/23e7b153e7(00:00) Why Human Resources Matter Most (01:46) Introducing Dr Mary-Clare Race (04:00) The Psychology of Workplace Toxicity (06:06) The “Toxic Triangle” Explained (07:48) Turning Toxic Cultures Into Thriving Ones (10:40) Why DE&I Slips During Economic Pressure (13:16) The Backlash Against DE&I (15:12) Building Belonging Through Human Connection (16:45) Remote Work's Impact on Toxicity (18:27) The Connection Crisis at Work (22:19) Do Playground Bullies Become Business Leaders? (26:25) How Early Experiences Shape Leadership Styles (28:56) Empathy, Resilience & Self-Awareness in Leadership (31:46) Micro-Coaching Moments for Busy Leaders (33:30) Leading Multi-Generational Workforces (36:42) Supporting Caregivers and Working Parents (39:26) AI in Coaching and Leadership Development (43:45) Final Advice for HR Leaders

Sue Norfolk, manager of the Schroder Income Growth Trust, shares how UK companies are adapting their capital distribution strategies with a shift towards share buybacks and stable dividend growth. We also cover the evolving landscape of domestic versus international opportunities, sector-specific insights into financials, consumer discretionary, and industrials, and how geopolitical tensions are factored into portfolio decisions. Finally, we examine the fund's bottom-up stock selection approach, recent adjustments in holdings like AstraZeneca, GSK, and Burberry, and the current valuation-driven opportunities in the market.What's covered in this episode:Schroder Income Growth's dividend hero statusDividends, share buybacks or social dividends?How volatility is factored into the portfolioStaying focused on bottom-up stock pickingThe impact of US politics on the trustRight and wrong tariff callsThe attractive nature of UK mid-capsA closer look at financials and customer discretionaryMaking calls on defence and industrialsWhy this manager favours AstraZeneca over GSKDoubling down on BurberryWhy UK equity is still attractive todayMore about the trust: Launched in 1995, the Schroder Income Growth Trust's principal aim is to provide real growth of income in excess of the rate of inflation. It invests mainly in the shares of UK larger and medium-sized companies, although it can also invest some of the portfolio in the shares of firms listed abroad.Learn more on fundcalibre.comPlease remember, we've been discussing individual companies to bring investing to life for you. It's not a recommendation to buy or sell. The fund may or may not still hold these companies at the time of listening. Elite Ratings are based on FundCalibre's research methodology and are the opinion of FundCalibre's research team only.

Tune in as Isabel and Jade analyse the standout moments from EMJ GOLD's guests this season, uncovering the challenges and opportunities shaping today's pharmaceutical industry. From self-advocacy at work and the future of personalised medicine to disease awareness, market access and making your marketing efforts stand out – they explore the season's core themes, all backed by the latest industry data. Watch our featured guest's full episodes: GSK's Dheepa Chari on the evolving sphere of scientific communication Yacin Marzouki on disrupting the traditional omnichannel model BMS' Anita Gandhi on a decade of change in hematology Pfizer's Richard Maughan on the future of access in the UK GSK's Matt Mortimer-Ryan on behaviour-led pharma marketing Chiesi's Shish Patel on COPD, the climate and improving care AbbVie's Dr Daejin Abidoye on community and compassion in cancer care Bayer's Dr Joana Reis on the promise of AI in breast cancer

In today's episode I was joined by Nolan Polson, Vice President of Quality Assurance and Product Quality at Iovance Biotherapeutics.I really wanted to speak to Nolan because he's one of the few leaders who's built quality teams at every stage – from biologics at Amgen to radiopharma at Janssen, to launching two first-in-class cell therapies at Juno/Celgene/BMS.Nolan's career path is a great example of what it looks like to carry foundational quality principles into fast-paced, high-growth settings. He talks about his early scientific passion, how he transitioned from R&D to Quality Ops, and the leadership mindset required to scale from clinical to commercial.We talk about the following:How Nolan's scientific roots in chemistry shaped his quality mindsetTransitioning from R&D into Quality Ops and building speed with structureWhat Big Pharma taught him about good science, mature systems, and agency collaborationScaling product quality teams from 2 to 45 during two cell therapy launchesBuilding empowered leadership teams and the traits he looks for when hiringHow AI can help quality teams move toward review-by-exception and proactive oversightThe difference between biologics and cell therapy mindsets in a commercial settingCreating a culture of continuous learning and succession planningLessons from moving across Amgen, J&J, GSK, BMS, and IovanceWhy autologous cell therapy still holds massive curative potentialNolan is a thoughtful, experienced quality leader who blends deep scientific expertise with a calm, strategic leadership approach.Thank you Nolan for sharing your incredible journey.Hope everyone enjoys 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 NCPD information, and to apply for credit, please visit us at PeerView.com/ZNS865. NCPD credit will be available until July 29, 2026.Leading the Next Chapter of Myeloma Care: Oncology Nurse Stewardship in the Era of Innovative Antibodies and Cellular Therapies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and HealthTree Foundation for Multiple Myeloma. 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 educational activity is supported by independent medical education grants from AbbVie, GSK, and Johnson & Johnson.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 NCPD information, and to apply for credit, please visit us at PeerView.com/ZNS865. NCPD credit will be available until July 29, 2026.Leading the Next Chapter of Myeloma Care: Oncology Nurse Stewardship in the Era of Innovative Antibodies and Cellular Therapies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and HealthTree Foundation for Multiple Myeloma. 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 educational activity is supported by independent medical education grants from AbbVie, GSK, and Johnson & Johnson.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 NCPD information, and to apply for credit, please visit us at PeerView.com/ZNS865. NCPD credit will be available until July 29, 2026.Leading the Next Chapter of Myeloma Care: Oncology Nurse Stewardship in the Era of Innovative Antibodies and Cellular Therapies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and HealthTree Foundation for Multiple Myeloma. 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 educational activity is supported by independent medical education grants from AbbVie, GSK, and Johnson & Johnson.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 NCPD information, and to apply for credit, please visit us at PeerView.com/ZNS865. NCPD credit will be available until July 29, 2026.Leading the Next Chapter of Myeloma Care: Oncology Nurse Stewardship in the Era of Innovative Antibodies and Cellular Therapies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and HealthTree Foundation for Multiple Myeloma. 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 educational activity is supported by independent medical education grants from AbbVie, GSK, and Johnson & Johnson.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 NCPD information, and to apply for credit, please visit us at PeerView.com/ZNS865. NCPD credit will be available until July 29, 2026.Leading the Next Chapter of Myeloma Care: Oncology Nurse Stewardship in the Era of Innovative Antibodies and Cellular Therapies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and HealthTree Foundation for Multiple Myeloma. 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 educational activity is supported by independent medical education grants from AbbVie, GSK, and Johnson & Johnson.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 NCPD information, and to apply for credit, please visit us at PeerView.com/ZNS865. NCPD credit will be available until July 29, 2026.Leading the Next Chapter of Myeloma Care: Oncology Nurse Stewardship in the Era of Innovative Antibodies and Cellular Therapies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and HealthTree Foundation for Multiple Myeloma. 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 educational activity is supported by independent medical education grants from AbbVie, GSK, and Johnson & Johnson.Disclosure information is available at the beginning of the video presentation.

This episode covers:  Cardiology this Week: A concise summary of recent studies Atrial fibrillation in heart failure Temperature management following cardiac arrest Statistics Made Easy: Collider bias Host: Emer Joyce Guests: Carlos Aguiar, Christian Hassager, Theresa McDonagh Want to watch that episode? Go to: https://esc365.escardio.org/event/1812 Want to watch that extended interview on temperature management following cardiac arrest? Go to: https://esc365.escardio.org/event/1812?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, Emer Joyce, Christian Hassager, Nicolle Kraenkel and Theresa McDonagh 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. 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: Emer Joyce Guest: Christian Hassager Want to watch that extended interview? Go to: https://esc365.escardio.org/event/1812?resource=interview  Want to watch the full episode? Go to: https://esc365.escardio.org/event/1812   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, Emer Joyce, Christian Hassager, Nicolle Kraenkel and Theresa McDonagh 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. 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.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Vinay Prasad's departure from CBER has analysts anticipating a more traditional successor, while GSK streamlines its pipeline and pledges billions in US investments. Susan Monarez is now the confirmed CDC director, and the top biopharma venture capital raises of H1 2025 are summarized. Despite challenges like layoffs and market fluctuations, GSK remains committed to investing in the US despite tariffs. Other headlines include Madrigal's potential $2 billion investment, Biogen and Eisai's Alzheimer's drug update, and Novo Nordisk's new leadership. Trilink Biotechnologies is offering self-amplifying RNA constructs for potential therapeutic advancements.AI biotech companies have secured substantial funding in the first half of 2025, with continued investment pouring into startups within the industry. The top five biopharma venture capital raises of this period are highlighted. There is confusion surrounding Ira's definition of 'drug,' potentially hindering companies from pursuing approval for new formulations and indications. Vinay Prasad's departure from the FDA's Center for Biologics Evaluation and Research, following controversies related to Sarepta, has raised concerns among developers. Despite challenges, four biotech companies are successfully launching their products independently.Over 260 million people are impacted by rare diseases, emphasizing the need for faster evidence generation through global real-world data. GSK's commitment to investing in the US, Merck's cost-cutting measures to support its launch schedule, and Novo Nordisk's new leadership are also highlighted. The FDA has updated regulations regarding Sarepta's DMD gene therapy, making it available for ambulatory patients. Adaptimmune anticipates significant staff reductions following a cell therapy asset sale. Stay tuned for more updates on the latest developments in the biopharma industry.

Wall Street fell from early highs as earnings enthusiasm from Microsoft and Meta waned and Trump's August 1st tariff deadline loomed. S&P 500 down 0.37%, Nasdaq flat. Dow fell steadily throughout the day like the other indices, closing near low. Down 330 points. Most sectors down. Utilities best performer again while Tech was slightly positive. Divergence here – Meta (+11.3%) and Microsoft (+3.9%) rose following their results, Amazon (+1.7%) rose ahead of its, Apple (-0.7%) fell ahead of its, and semiconductors struggled. Healthcare once again struggled, down nearly 3.0%, as Trump sent a letter to the CEOs of 17 major pharmaceutical companies, demanding they lower their prices. Swift and strong reaction – Merck down 4.4%, Pfizer slid 2.3%, AstraZeneca dropped 1.4%, Novo Nordisk fell 3.2%, and GSK dipped 3.0%. REITs and Materials round out the bottom three for the second consecutive day.ASX to fall. SPI futures down 64 points (-0.74%). RMD Results.Want to invest with Marcus Today? The Managed Strategy Portfolio is designed for investors seeking exposure to our strategy while we do the hard work for you. If you're looking for personal financial advice, our friends at Clime Investment Management can help. Their team of licensed advisers operates across most states, offering tailored financial planning services.  Why not sign up for a free trial? Gain access to expert insights, research, and analysis to become a better investor.

US Treasury Secretary Bessent said he will see US President Trump regarding the China tariff pause on Wednesday and some technical details remain on the China tariff pause, while the China tariff extension decision will be up to Trump and if he does not approve tariff pause extension, tariffs on Chinese goods would 'boomerang' back to April 2nd levels, or another level that he chooses.US President Trump said Chinese President Xi wants to meet and he thinks it will happen before the end of the year, while he stated that they will either approve the trade extension or not. Chinese Vice Commerce Minister Li said the US and China have agreed to extend the trade truce; Bessent said China jumped the gun a little on the 90-day pause.Crude futures surged yesterday amid comments from US President Trump who confirmed changing the deadline for Russia to reach a Ukraine ceasefire agreement to 10 days, while there were simultaneous comments from Treasury Secretary Bessent who told Chinese officials that China could face high tariffs if it continues to purchase sanctioned Russian oil due to US secondary tariff legislation.APAC stocks traded mixed following the subdued handover from Wall St; European equity futures indicate a mildly positive cash market open with Euro Stoxx 50 futures up 0.3% after the cash market closed with gains of 0.8% on Tuesday.Looking ahead, highlights include French GDP, Spanish CPI, German GDP & Retail Sales, Italian GDP, ECB Wage Tracker, EZ GDP & Sentiment, US ADP National Employment, GDP Advance (Q2), PCE (Q2), Fed, BoC, BCB Policy Announcements Speakers including Fed Chair Powell, BoC's Macklem & Rogers, Supply from Italy, US Quarterly Treasury Refunding Announcement.Earnings from Hermes, Airbus, Vinci, Danone, Capgemini, HSBC, GSK, Aston Martin, Santander, Caixabank, Telefonica, Intesa Sanpaolo, Leonardo, Mercedes Benz, Siemens Healthineers, BASF, Adidas, Porsche AG, Meta, Microsoft, RobinHood, Carvana, Lam Research, Qualcomm, Ford, Arm, eBay, FMC, Vertiv, Altria, Kraft Heinz, GE Healthcare & VF Corp.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk

On this week's episode, Josh Schimmer, Chris Garabedian, Sam Fazeli, Yaron Werber and guest Adam Feuerstein dive into breaking news, including Sarepta's recent updates -- layoffs, a black box warning, and pipeline reorganization -- and the juxtaposition of Amylyx's post-bariatric hypoglycemia and GLP-1 inhibitor following a webinar update at ENDO 2025. In regulatory news, the group discusses the evolving FDA under Makary's leadership, examining agency morale, rapid review processes for favorable drug pricing, and recent CRLs including Ultragenyx. The discussion then explores what these changes mean for CBER and Peter Marks' accelerated approval pathway for orphan disorders, alongside the ODAC panel for GSK's belantamab for multiple myeloma and the broader space. Market sentiment analysis reveals encouraging signs with the second quarter and first half reports on VC investment showing a clear uptick, along with additional positive feedback from a CEO forum on the FDA's listening tour. The group shares some interesting stats around M&A so far this year, demonstrating strong momentum and a possible trajectory to possibly beat, or at least meet, the 2020 numbers. Data updates include, lung cancer survey insights, DiaMedica's preeclampsia results, obesity updates from Hengrui/Kailera and Chinese biotech. The episode wraps with an overview of Novartis and J&J earnings reports. *This episode aired on July 18, 2025.

This week's deal between GSK and Jiangsu Hengrui is a prime example of how Western biopharmas have begun to recognize the innovation and opportunities being fostered in China — and how it's no longer all about fast followers.On the latest BioCentury This Week podcast, BioCentury's analysts put the collaboration between GSK and Jiangsu Hengrui Pharmaceuticals, two of the most active cross-border dealmakers, into the context of East-West dealmaking over the past 30 months, assessing the innovation that is driving the rush to partner with biotechs in China, Japan, South Korea and beyond, and the types of companies looking to Asia for assets.BioCentury's analysts also discuss Steve Bates' outsized role in building the U.K. biotech hub, as he readies to take on a new role in the U.K. government. They examine new VC funds from Omega Funds and Brandon Capital, FDA's new national priority voucher pilot program, and fallout from how FDA and  Sarepta Therapeutics handled the deaths of four patients who had received the biotech's gene therapies. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656592#biotech #biopharma #pharma #lifescience #EastWestDealmaking #ChinaBiotech #UKBiotech #FDAPolicy00:01 - Sponsor Message: IQVIA Biotech02:48 - Asia Deals Landscape17:32 - Steve Bates & U.K. Biotech25:46 - FDA's New Voucher Pilot31:01 - New VC Funds35:28 - SareptaTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. GSK has entered a partnership with Hengrui worth up to $12 billion, focusing on the COPD candidate HRS-9821. The FDA's new voucher policy has caused confusion among experts, as it lacks clear definition and was announced without public input. The American Medical Association urges RFK Jr. to maintain the preventive task force, and Sarepta denies a patient death is linked to Elevidys as the FDA launches a probe. Biopharma companies are leaning towards holistic treatments for Alzheimer's, while Atai-partnered schizophrenia drug fails in a mid-stage trial. Boehringer partners with Irish startup Re-Vana in a $1 billion+ eye deal.As the Alzheimer's space becomes more competitive, biopharma companies are focusing on holistic treatments beyond disease-modifying drugs like Leqembi and Kisunla. Companies such as Bristol Myers Squibb, Acadia, Otsuka, and Lundbeck are renewing their search for symptomatic treatments. Five upcoming data drops could potentially lead to more effective therapies for Alzheimer's. Sarepta Therapeutics is facing challenges due to safety concerns surrounding its gene therapies, leading to a drop in stock value. The FDA's new voucher program aims to offer accelerated pathways for drugs meeting certain criteria, but experts criticize the lack of transparency and public input in the policy's announcement. Sarepta's future is uncertain as the FDA considers a new study for Elevidys, and the EU issues a negative opinion on the drug. Other news includes delays in the FDA decision on GSK's Blenrep, AstraZeneca's PIII win with nanobody treatment for myasthenia gravis, and the removal of thimerosal from influenza vaccines. George Tidmarsh has been appointed as the new chief of FDA's CDER.

Biophilic design is not just an aesthetic choice, but a critical evolution in workplace design. As work becomes increasingly digital and flexible, the traditional office is transforming into a dynamic, nature-integrated environment. We speak with Jeremy Myerson, design writer and Professor Emeritus in the Helen Hamlyn Centre for Design at the Royal College of Art, who argues that the future workplace must move beyond sterile, industrial spaces to create settings that support human well-being, align with natural rhythms, and enhance productivity. This means incorporating elements like natural light, green spaces, vertical gardens, and designs that connect workers with the natural world. The post-pandemic workplace is no longer about containing workers, but about creating flexible, health-affirming spaces that recognize humans as part of a living ecosystem. Biophilic design, in Jeremy's vision, is the key to reimagining work as an holistic experience that nurtures both human potential and ecological connection. He shares with us highlights from his recent book "Unworking," and traces the fascinating evolution of workplace design and champions biophilic principles as a critical solution to our modern work challenges. The journey begins with agrarian societies, where work was intimately connected to nature - tasks performed on kitchen tables, in fields, and closely aligned with natural rhythms. The industrial revolution dramatically changed this relationship, creating artificial, efficiency-driven environments that systematically separated workers from the natural world. “We created an artificial internal environment in which to work, and the idea of technology, process and industrialisation was very much about conquering nature and resisting nature and separating nature from how we work. We pushed nature back at the end of the 19th century. We kept it at bay during the 20th century. And now we're beginning to think, well, actually, more natural ways of working, outdoor space, access to natural light and clean air, closeness to plants and greenery. All of this helps working life, but we're having to kind of put in a superhuman effort to try and bring back something that was naturally part of our existence. There's a certain irony in that there.” Workplaces became sterile containers designed to maximize productivity, with little consideration for human well-being or natural connections.Jeremy identifies three distinct phases of workplace evolution: the age of efficiency, the age of community, and the age of network. Each phase represents a gradual recognition that workers are not machines, but complex beings who thrive in more holistic environments. Today, we're entering a transformative fourth phase where biophilic design isn't just a nice-to-have, but a fundamental requirement. Digital technologies have liberated work from fixed locations, allowing for more flexible, nature-integrated approaches. For Jeremy, biophilic design extends beyond mere aesthetics. It's about creating environments that support human health, productivity, and well-being. His work with the Healthy City Design Congress emphasizes reconnecting public health with urban planning - a relationship that was intrinsic during the Victorian era but was lost during industrialization. We discuss innovative workplaces like GSK's London headquarters, which features a vertical farm, sit-stand desks, and carefully managed work environments. Booking.com's Amsterdam office demonstrates how biophilic principles can create socially permeable spaces that connect with broader community needs. Biophilia in society extends beyond individual workspaces and places to entire urban landscapes. Jeremy advocates for the "15-minute city" concept, where essential services are accessible within a short walk or cycle, for example Paris design. This approach integrates nature, reduces car dependency, and creates more human-centric urban environments. "We're trying to reconnect something that industrialisation broke," Jeremy says. His magic brush of biophilia would paint cities with more vegetation, slower traffic, and spaces that prioritize human and ecological well-being. The future of work, according to Jeremy, is not about returning to traditional office models but creating diverse, flexible strategies that blend work and life. Hybrid working, technological integration, and biophilic design are key components of this transformation.For Jeremy, biophilic design represents more than an architectural trend. It's a fundamental reimagining of how we interact with our environments, recognising that human productivity and well-being are intrinsically linked to our connection with nature. If we embrace biophilic principles, we can create environments that support human potential, ecological sustainability, and a more holistic approach to work and urban living. Find out more about the Health City Awards 2025, which aim to celebrate and recognise professional and research excellence in the design and planning of healthy and sustainable cities and communities around the world, with entries being accepted until 4 September 2025. https://www.healthycitydesign.global/images/uploads/docs/HCD2025_Awards_Call_for_Entries.pdfTo enter visit: https://www.healthycitydesign.global/awards/submission-processTo learn more about the Worktech academy: https://www.worktechacademy.com If you like this, please subscribe!Have you got a copy of the Journal? You can now subscribe as a member of the Journal of Biophilic Design or purchase a gorgeous coffee table reference copy or PDF download of the Journal journalofbiophilicdesign.comor Amazon and Kindle. Biophilic Design Conference www.biophilicdesignconference.comCredits: with thanks to George Harvey Audio Production for the calming biophilic soundscape that backs all of our podcasts. Listen to our podcast on Audible, Amazon Music, Spotify, iTunes, YouTube and all the RSS feeds.https://www.facebook.com/journalofbiophilicdesign/https://twitter.com/JofBiophilicDsnhttps://www.linkedin.com/company/journalofbiophilicdesign/https://www.instagram.com/journalofbiophilicdesign

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Roche has dropped an early-stage obesity asset, CT-173, citing lack of competitiveness. Novartis has entered into a drug discovery deal with Matchpoint Therapeutics, acquiring global rights on all molecules for several inflammatory diseases. AstraZeneca claims a Phase III win with its nanobody treatment for myasthenia gravis. Second-quarter earnings season is approaching, and biotechs to watch include Sarepta and others facing challenges in the biopharma industry. Genentech downsizes as priorities shift, and GSK's comeback for Blenrep is on pause as the FDA delays its decision. The FDA's lack of transparency has tarnished Sarepta's reputation after patient deaths triggered an FDA battle. Opportunities in the industry include roles like Quality Specialist at CSL and Clinical Research Physician at Eli Lilly and Company.

During the Asia-focused Episode 29 of Biotalk, Geoff shares insights into key trends and developments shaping the biotech landscapes in Japan, China, Korea, Australia, and the broader Asia-Pacific region, as featured in our 2025 Q2 Report: Global Trends in Biopharma Transactions Report. Japan's biotech stocks outperformed broader indices, boosted by regulatory reforms and Shionogi's $1.1B acquisition of Japan Tobacco's pharma units. Licensing slowed, while early-stage financings focused on preclinical firms. China's biotech market surged with four HKEX IPOs raising $1.5B. Venture funding fell as risk aversion grew, but strategic licensing stayed strong at $24.4B, shifting toward later-stage oncology and obesity deals. Korea's biotech index dipped but showed 12-month gains, driven by ABL Bio's $2.8B licensing deal with GSK and key Series B financings. Listen now to gain insights into the evolving global biopharma landscape, explore our report, and we welcome the opportunity to discuss its contents with you. 

Just a few weeks ago, it seemed like Sarepta had weathered a spate of bad news, after two patients died from liver injuries from its Duchenne muscular dystrophy gene therapy Elevidys. Then came news of a third patient death. Last Wednesday, the company announced a major restructuring and 500-person layoff.  Then, in just a few days time, Sarepta Therapeutics went from enjoying a notable stock bump in response to that corporate update to its lowest price in nearly 10 years as it halts shipments of Elevidys. In addition to requesting the shipment hold, the FDA revoked the company's technology platform designation and paused all clinical trials for Sarepta's limb-girdle muscular dystrophy (LGMD) gene therapy. The turmoil was set in motion by media reports that a patient who received the LGMD treatment had died—a fact the company chose not to disclose during an investor call. In other news, the FDA's Center for Drug Evaluation and Research gets a new director in biotech veteran George Tidmarsh, also an adjunct professor of pediatrics and neonatology at Stanford University's School of Medicine. Tidmarsh enters the agency at a time of mass layoffs as well as voluntary departures. Meanwhile, Replimmune and Roche suffer FDA rejections as therapies from Otsuka/Lundbeck and GSK fail to earn adcomm support, as the bar for acceptable controls and demonstrations of efficacy continue to change under FDA commissioner Marty Makary and CBER director Vinay Prasad.  Finally, Big Pharmas continue to pump billions into U.S. manufacturing, with Biogen and AstraZeneca joining the list of companies to have made such pledges, pledging $2 billion and $50 billion, respectively. These latest announcements come as President Donald Trump reiterates that pharma-specific tariffs of up to 200% could come as soon as Aug. 1. 

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.George Tidmarsh, a biopharma veteran and adjunct professor at Stanford's medical school, has been appointed as the new head of the FDA's Center for Drug Evaluation and Research (CDER). His extensive industry experience will be valuable in his new government position. Data secrecy among cell and gene therapy developers is hindering progress in the field, causing fragmentation, stalling innovation, and delaying access to treatments. Meanwhile, Sarepta is facing challenges with its elevidys shipments and has lost platform designation for its technology. At the same time, Roche's phase III trial in COPD has failed, impacting the market path for astegolimab. Layoffs are happening at companies like GSK, Sail, and BioNTech. Experts are exploring new ways to overcome barriers in cell therapy production.Data secrecy among cell and gene therapy developers continues to hinder progress and access to treatments. Acadia has introduced a new team and pipeline with ambitious goals. Patients are fighting for access to Brainstorm's ALS drug after promising real-world data. Moderna's withdrawal of its flu vaccine has left combination flu/COVID-19 vaccines in limbo. In other news, Sarepta is facing challenges with its DMD gene therapy, Ultragenyx's gene therapy for Sanfilippo syndrome is rejected by the FDA, GSK's Blenrep loses an adcomm vote, and BMS' anemia drug Reblozyl fails a Phase III trial. The FDA is experiencing layoffs and employee turnover amid an overhaul. Vinay Prasad overruled reviewers on Moderna's COVID-19 shot for kids. Upcoming events include a webinar on AI for real-world research and job opportunities in the biopharma industry. Readers are encouraged to provide feedback and suggest topics for future coverage.

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/FVK865. CME/MOC/AAPA/IPCE credit will be available until June 30, 2026.4x4 in Multiple Myeloma: Maintaining Momentum for Delivering Innovative Care in Newly Diagnosed and Relapsed Disease In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and HealthTree Foundation for Multiple Myeloma. 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 by independent medical education grants from Bristol Myers Squibb, GSK, Johnson & Johnson, and Regeneron Pharmaceuticals, Inc.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/FVK865. CME/MOC/AAPA/IPCE credit will be available until June 30, 2026.4x4 in Multiple Myeloma: Maintaining Momentum for Delivering Innovative Care in Newly Diagnosed and Relapsed Disease In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and HealthTree Foundation for Multiple Myeloma. 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 by independent medical education grants from Bristol Myers Squibb, GSK, Johnson & Johnson, and Regeneron Pharmaceuticals, Inc.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/FVK865. CME/MOC/AAPA/IPCE credit will be available until June 30, 2026.4x4 in Multiple Myeloma: Maintaining Momentum for Delivering Innovative Care in Newly Diagnosed and Relapsed Disease In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and HealthTree Foundation for Multiple Myeloma. 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 by independent medical education grants from Bristol Myers Squibb, GSK, Johnson & Johnson, and Regeneron Pharmaceuticals, Inc.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/FVK865. CME/MOC/AAPA/IPCE credit will be available until June 30, 2026.4x4 in Multiple Myeloma: Maintaining Momentum for Delivering Innovative Care in Newly Diagnosed and Relapsed Disease In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and HealthTree Foundation for Multiple Myeloma. 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 by independent medical education grants from Bristol Myers Squibb, GSK, Johnson & Johnson, and Regeneron Pharmaceuticals, Inc.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/FVK865. CME/MOC/AAPA/IPCE credit will be available until June 30, 2026.4x4 in Multiple Myeloma: Maintaining Momentum for Delivering Innovative Care in Newly Diagnosed and Relapsed Disease In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and HealthTree Foundation for Multiple Myeloma. 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 by independent medical education grants from Bristol Myers Squibb, GSK, Johnson & Johnson, and Regeneron Pharmaceuticals, Inc.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/FVK865. CME/MOC/AAPA/IPCE credit will be available until June 30, 2026.4x4 in Multiple Myeloma: Maintaining Momentum for Delivering Innovative Care in Newly Diagnosed and Relapsed Disease In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and HealthTree Foundation for Multiple Myeloma. 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 by independent medical education grants from Bristol Myers Squibb, GSK, Johnson & Johnson, and Regeneron Pharmaceuticals, Inc.Disclosure information is available at the beginning of the video presentation.

欢迎收听雪球出品的财经有深度，雪球，国内领先的集投资交流交易一体的综合财富管理平台，聪明的投资者都在这里。今天分享的内容叫从海外并购看国内疫苗的出海价值，来自userfield。国产疫苗标志性品种的预期变化最近几年，度过新冠疫苗繁荣期的国内疫苗行业迎来了低潮期，无论是HPV疫苗还是带状疱疹疫苗，经营表现并没有给行业带来逻辑增量弹性。1、HPV疫苗智飞生物代理的MSD的HPV疫苗系列，4价疫苗已经大幅缩减，而王牌9价HPV疫苗也开始出现滞销，导致智飞生物的库存高企，甚至让MSD在25H1停止了9价HPV疫苗的发货。万泰生物作为国产第一家9价HPV疫苗，市场本来寄予厚望。在1年多前，9价HPV疫苗多轮访视，预期NDA的时候，市值就顶在800亿级别。但没想到的是，2025年9价HPV疫苗滞销让预期逐步回落，甚至在25年6月出获批的时候，玩了一把“见光死”，获批反而股价下跌！最终，这款国产九价HPV疫苗定价为499元/支，价格约为进口九价HPV疫苗的40%。我们拭目以待，在九价HPV疫苗销售周期高点往下走的阶段里，国产获批带来进一步竞争加剧后的市场格局变化！2、带状疱疹疫苗在新生儿出生率下降背景下，大家对疫苗行业的热点开始转到成人疫苗领域。随着HPV疫苗的成功，大家对带状疱疹疫苗的预期也很高。智飞与GSK签了大额订单合同，百克生物的国产减毒带状疱疹疫苗也获批上市。但随着外部消费疲软，带状疱疹疫苗的销售推广也没那么顺利。我们看到第一次智飞与GSK的合同约定24-26年合同额在200亿，但在24年底修订了补充合同，销售期限从2026年底延长至2034年底，重组带状疱疹疫苗的预计采购金额约为216亿元。同时也看到百克生物只有在带状疱疹上市后三个季度内，还保持不错的销售趋势，然后到了2024-2025年，销售颓势明显。全球疫苗市场的变化1、重磅品种进入成熟期全球TOP级别疫苗的增速都下来了。疫苗一哥9价HPV疫苗，可能在2025年会因为中国市场疲软而出现大幅下滑。潜力疫苗品种RSV疫苗有可能出现昙花一现的趋势，GSK和辉瑞都遇到加强针疗效不佳的问题，无法转变成类似流感疫苗的每年都接种的常规疫苗。2、国产疫苗的跟随趋势对标全球疫苗排行榜，国产疫苗已经完成了大部分重磅疫苗的国产化。万泰拿下了第一个9价HPV疫苗；沃森、康泰、康希诺已经让13价肺炎疫苗充分国产化；多联苗领域，康泰做了百白破-Hib四联苗，并且百白破-IPV-Hib五联苗已经进入临床阶段；带状疱疹疫苗：百克第一个国产化，而绿竹的重组带状疱疹疫苗已经申报上市，有望成为第一家重组带状疱疹疫苗国产企业；RSV疫苗：国内重组、RNA等多个技术路线品种齐头并进，艾棣维欣进度最快，已经完成临床2期，安科生物旗下的阿法纳生物，已经把RSV mRNA疫苗推进到临床2期，而三叶草生物已经完成RSV单苗的澳洲临床1期，现在正在做FDA临床1期，同时在澳洲新开了二联苗和三联盟的临床1期。所以，国产疫苗企业正在做的事情，就是把全球重磅疫苗做到国产化。这些疫苗品种中，虽然无法比肩对标疫苗的全球重磅程度，但是万泰9价HPV疫苗、绿竹的重组带状疱疹等品种，我认为仍然有望成为几十亿的大品种。全球疫苗领域重磅并购1、赛诺菲 32 亿美元收购 Translate2021年，赛诺菲以每股 38 美元现金收购 mRNA 技术公司 Translate Bio，总对价约 32 亿美元。后者专注于传染病 mRNA 疫苗开发，其技术平台被用于开发新冠疫苗及其他传染病疫苗。2、GSK 33 亿美元收购 Affinivax2022年，GSK 以 33 亿美元收购细菌性疫苗公司 Affinivax，其核心资产为多抗原呈递系统技术，可开发覆盖 24 种血清型的新一代肺炎球菌疫苗 AFX 3772。3、阿斯利康 11 亿美元收购 Icosavax2023 年，阿斯利康支付 8.38 亿美元预付款收购病毒样颗粒疫苗公司 Icosavax，若达成里程碑条款，总金额可增至 11 亿美元。后者核心资产为针对呼吸道合胞病毒和人偏肺病毒的双价疫苗 IVX-A12，已进入临床 II 期。4、BioNTech 12.5 亿美元收购 CureVac2025 年，BioNTech 以全股票交易方式收购德国 mRNA 公司 CureVac，交易总价值 12.5 亿美元。CureVac 在 mRNA 骨架优化、个性化癌症疫苗及生产技术方面具有核心能力，其 mRNA 疫苗 CV2CoV 曾用于新冠疫苗开发。从上面梳理的几笔10亿美金以上的疫苗领域并购交易，我们发现要么是买技术平台，要么是买重磅产品，未来疫苗领域的潜力重磅并购估计也是围绕这两个方向。国产疫苗企业BD出海可能性除了重磅疫苗国产化逻辑外，在创新药BD出海大时代，国产疫苗企业是否有望对标各种Biotech完成BD出海？我觉得有机会！对标全球疫苗销售TOP排行榜以及近几年重磅并购交易，我看到的机会来自几个逻辑方向：mRNA新技术突破、海外重磅疫苗补强。1、mRNA疫苗mRNA预防疫苗最先在新冠领域突破，国内也批准的石药的mRNA新冠疫苗。近几年，mRNA疫苗探索其他适应症领域，国产疫苗基于mRNA技术的RSV、带状疱疹等多款疫苗已经推进到临床。全球范围内，Moderna 的mRNA技术RSV疫苗 mRESVIA已经获批。mRNA治疗性疫苗，并不局限于传统疫苗企业，而更像biotech领域。国内mRNA肿瘤疫苗赛道近些年崛起趋势明显！上市公司中，云顶新耀的通用型现货 mRNA 肿瘤疫苗EVM14刚刚完成中美双报，成为公司的另一个核心发展板块。所以，mRNA等新技术领域，无论是预防性疫苗，还是治疗性疫苗，国内药企有望对外技术授权，完成BD出海之举。2、海外疫苗补强对于传统疫苗，国内疫苗企业也正在经历从跟随到超越的过程，部分国产疫苗企业有望补强现有海外重磅疫苗短板，甚至疗效优异成为me better产品。RSV疫苗：GSK和辉瑞的RSV疫苗，都出现了间隔重复接种后无法达到第一针的疗效，就是所谓的加强针疗效不佳。从而也导致了商业化第二年，销售额都出现了下降。两家药企最希望的是把RSV疫苗变成类似流感疫苗的每年都重复接种的品种，这样就从一锤子买卖变成了持续购买逻辑，RSV疫苗才能够真正成为超级重磅品种。三叶草生物的重组RSV疫苗的FDA临床1期，用于验证GSK加强针的有效性。如果临床效果明显，有望解决GSK/辉瑞的RSV疫苗加强针问题，重现15亿美元销售额的辉煌。同时然后三叶草生物的两款RSV联苗，在近期也已经启动澳洲临床1期，其中SCB-1022二联疫苗，有望对标阿斯利康8亿美元收购的Icosavax的核心产品，呼吸道合胞病毒和人偏肺病毒的双价疫苗 IVX-A1；而SCB-1033则是全球首家也是独家的RSV三联苗产品。只不过三叶草的三款RSV系列疫苗，都处于临床1期，不确定比较大。我们只能说，如果能够成功，则有望带来潜在超级BD交易。但一切都还要等25年底的数据揭盲情况。带状疱疹疫苗：绿竹生物是国内进展最快的重组带状疱疹疫苗，现在已经处于NDA阶段，2026年有望上市成为第一个国产重组带状疱疹疫苗。绿竹的重组带状疱疹疫苗，与GSK的Shingrix的头对头试验比较结果看，有更强的细胞免疫反应。绿竹生物的LZ901带状疱疹疫苗，佐剂中不含刺激物，副作用大幅低于Shingrix，这也是GSK带状疱疹的痛点。所以，绿竹生物的重组带状疱疹疫苗，经过2.6万人的大样本临床3期数据，充分说明这款产品的保护率和安全性更好，可能成为GSK带状疱疹Shingrix的me better产品。所以，如果说成熟疫苗产品BD出海，还有可能头对头做出优效的产品，我觉得绿竹生物重组带状疱疹疫苗有可能成为第一个吃螃蟹的疫苗产品。毕竟Shingrix年销售额超过40亿美金，替代市场潜力足够有吸引力。总结疫苗领域，虽然国内需求疲软，但是在创新出海背景下，我们发现虽然国内疫苗技术水平提升，有望成为BD出海的新细分领域。无论是基于新技术的mRNA疫苗方向，还是对标海外重磅疫苗，补短板 or me-better，都可能成为突破点！

New indication for Kerendia; investigational therapy shows promise for hypertension; Novolog interchangeable biosimilar gets approval; trial results for hormone-free contraceptive; Shingrix now supplied in a prefilled syringe.

In der heutigen Folge sprechen die Finanzjournalisten Lea Oetjen und Holger Zschäpitz über einen Mega-Deal von Lucid, Billionen-Träume bei Netflix und den Absturz von Jungheinrich. Außerdem geht es um Quantumscape, Bigbear.AI, Aeva Technologies, D-Wave, Archer Aviation, Intuitive Machines, Rocket Lab, AST Spacemobile, Netflix, Disney, ComCast, Warner Brothers Discovery, Uber Technology, Interactive Brokers, TSMC, ASML, PepsiCo, Taiwan Semiconductor, Novartis, Richemont, ABB, Siemens, Salzgitter, Burberry, American Express, Tema Neuroscience and Mental Health ETF (WKN: A408EL), Vertex Pharmaceutical, Eisai, Biogen, Eli Lilly, DexCom, Siemens Healthineers, Johnson&Johnson, Pfizer, Lindbeck, GSK, Atai Life Science, Mind Medicine, iShares Core MSCI World (A0RPWH), Xtrackers MSCI World USD (A1XB5U), Vanguard FTSE All-World USD (A2PKXG), Xtrackers AI & Big Data (A2N6LC), Amundi MSCI World USD (ETF146), Amundi Core Stoxx Europe 600 (LYX0Q0), iShares MSCI ACWI (A1JMDF), Xtrackers II EUR Overnight (DBX0AN), WisdomTree Europe Defence ETF (A40Y9K), HanETF Future of Defence ETF (A3EB9T). Habt Ihr suizidale Gedanken, oder habt Ihr diese bei einem Angehörigen/Bekannten festgestellt? Hilfe bietet die Telefonseelsorge: Anonyme Beratung erhält man rund um die Uhr unter den kostenlosen Nummern 0800 / 111 0 111 und 0800 / 111 0 222. Auch eine Beratung über das Internet ist möglich unter http://www.telefonseelsorge.de. Eine Liste mit bundesweiten Hilfsstellen findet sich auf der Seite der Deutschen Gesellschaft für Suizidprävention. 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

Host: Rick Grobbee Guest: Gerhard Hindricks Want to watch that extended interview? Go to: https://esc365.escardio.org/event/1810?r 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, Rick Grobbee, Gerhard Hindricks and Nicolle Kraenkel 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. 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.

This episode covers: Cardiology This Week: A concise summary of recent studies ICD Indications in primary prevention Drug treatment of cardiac amyloidosis Mythbusters Host: Rick Grobbee Guests: Carlos Aguiar, Gerhard Hindricks, Marianna Fontana Want to watch that episode? Go to: https://esc365.escardio.org/event/1810   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, Rick Grobbee, Gerhard Hindricks and Nicolle Kraenkel 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Marianna Fontana has declared to have potential conflicts of interest to report: consultancy for Alnylam, Alexion/Caelum Biosciences, Astrazeneca, Bridgbio/Eidos, Prothena, Attralus, Intellia Therapeutics, Ionis Pharmaceuticals, Cardior, Lexeo Therapeutics, Janssen Pharmaceuticals, Prothena, Pfizer, Novonordisk, Bayer, Mycardium. Research grants from: Alnylam, Bridgbio, Astrazeneca, Pfizer. Share options in LexeoTherapeutics and shares in Mycardium. 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.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Johnson & Johnson reported second-quarter earnings of $23.7 billion, driven by cancer and neuroscience drugs, exceeding analyst expectations. CEO Joaquin Duato set a target of $50 billion in oncology sales by 2030. Despite challenges in the industry, Johnson & Johnson remains optimistic about its oncology sales target as the biotech industry continues to navigate the evolving landscape of drug development and funding.In a difficult investing environment where IPOs are not guaranteed, AI-focused biotech unicorns are facing challenges in securing funding. GSK's Blenrep is facing setbacks as the FDA questions its efficacy in treating multiple myeloma, while AstraZeneca's amyloidosis asset failed to improve survival in a late-stage trial. The industry is also seeing the rise of women leaders like Audrey Greenberg and the team at Acadia, who are making significant contributions to the field.Biospace is launching a new weekly newsletter focused on critical manufacturing issues in the biopharma industry, covering developments and impacts on companies such as Roche, Sanofi, and Johnson & Johnson. The newsletter aims to provide deep dives, analysis, and roundups of the biggest manufacturing stories of the week every Tuesday. Stay informed with weekly analysis and updates on the changing landscape of manufacturing in the U.S.

In Teil 2 geht es um den entscheidenden Durchbruch im Fall des Golden State Killers. DNA-Spuren führen zu der Erkenntnis, dass ein einziger Täter hinter den Vergewaltigungen, Einbrüchen und Morden steckt. Ahnenforschung und Stammbäume halfen dabei den Täter endlich zu identifizieren. Außerdem sprechen wir über Michelle McNamara, ihr Buch „I'll Be Gone in the Dark“ und wie sie mit ihren Recherchen und Theorien den Fall neu ins Rollen brachte. Zum Schluss blicken wir auf das Leben des GSK und den Prozess, in dem die Opfer und Angehörigen endlich Gehör fanden. +++ Euch gefällt unser Podcast und ihr wollt uns unterstützen? Dann gebt uns gerne einen Kaffee aus: ko-fi.com/tellmemordpodcast Folgt uns gerne auch auf Instagram (@tellmemordpodcast) für mehr Content zu den Fällen! +++ Alle Infos zu unseren Werbepartnern & Rabattcodes unter: https://linktr.ee/tellmemordpodcast

What is the environmental impact of respiratory illness? Find out in this episode of the EMJ GOLD podcast, where Shish Patel, Medical Director, Chiesi UK, joins Isabel to discuss the rising burden of COPD and the impact of respiratory care on the planet.  Together, the two explore the diagnostic gap in COPD, improving the experience of people living with the disease, balancing health innovation with climate concerns and much more.   A little more on EMJ GOLD's guest…  Shish Patel trained as a pharmacist and has worked in the pharmaceutical industry for over 30 years. Currently, he serves as Medical Director at Chiesi UK and Ireland, and he has held senior positions within medical and scientific functions at both affiliate and global level throughout his career. In addition to his significant time at Chiesi, Shish has held positions at GSK and Sanofi. Shish also holds key industry board positions including at the Prescription Medicines Code of Practice Authority and the ABPI.   

Ben Plumley is joined by Professor Heidi Larson, Co-founder and Chair of the Global Listening Project (GLP), and Susie Barnes, Senior Vice President of Global Medical Affairs for the Vaccines Division at GSK to discuss the importance of building trust and motivating awareness about new technologies in global health. The conversation covers the collaboration between the GLP and GSK, insights from their research on trust during COVID-19, and how community engagement and innovative communication strategies play a crucial role in vaccine confidence and public health. They emphasize the need for holistic approaches to prevention and the challenges of addressing vaccine hesitancy in an evolving technological landscape. 00:00 Introduction and Podcast Overview 00:45 Episode Topic: Building Trust in New Technologies 01:09 Meet the Guests: Professor Heidi Larson and Susie Barnes 02:31 The Global Listening Project and GSK Partnership 03:44 Impact of COVID-19 on Trust and Vaccine Confidence 07:22 The Role of General Practitioners and Community Health Workers 14:41 Advancements in Vaccine Technology and Prevention 19:16 Communication Strategies in the 21st Century 28:04 AI and the Need for Multiple Listening Strands 28:42 Engaging Communities in Healthcare 29:21 The Future of Therapeutic Relationships 30:58 Challenges in Vaccine Access and Trust 33:27 Communicating Science Effectively 36:06 Global Listening Project Insights 37:38 Understanding Measles and Immune Amnesia 39:39 Balancing Individual Rights and Societal Responsibilities 42:11 Next Steps for the Global Listening Project 46:43 GSK's Commitment to Prevention and Partnership

Shobie Ramakrishnan is the Chief Digital and Technology Officer at GSK and a true trailblazer in the world of tech and innovation. With decades of experience spanning Silicon Valley and senior roles at global companies like AstraZeneca and Salesforce and Deliveroo, Shobie brings a wealth of insight into leading digital transformation, embracing disruptive change, and building high-performing teams.Shobie dives into what it takes to thrive in ever-evolving environments, whether that's in tech, sport, or business. She unpacks how humility, empathy, and curiosity are at the heart of successful leadership, and shares some practical strategies for harnessing AI, data, and cutting-edge trends to drive organisational growth.To use Sporting Edge's digital content to accelerate your personal and team success, start your free trial here Sporting Edge Mindset ToolkitConnect with JeremyContact hello@sportingedge.com LinkedIn https://www.linkedin.com/in/jeremysnape/ Twitter https://twitter.com/thesportingedgeWebsite https://www.sportingedge.com/ Follow Shobie Ramakrishnan on LinkedIn

Synopsis: When an introverted engineer becomes the President & CEO of REGENXBIO, transformation follows. Curran Simpson joins host Rahul Chaturvedi to unpack his unlikely journey from biotech operations to the C-suite—and how that hands-on experience is reshaping gene therapy's future. They dive into the evolution of REGENXBIO's pipeline, tackling ultra-rare diseases like MPS II, ambitious plans for Duchenne Muscular Dystrophy, and commercial partnerships with giants like AbbVie. Curran offers hard-earned leadership lessons, honest reflections on scaling science, and insights into how one-time gene therapies could revolutionize treatment in both rare and common diseases. From clinical nuance to strategic boldness, this is a masterclass in biotech leadership, platform focus, and staying patient-first—no matter how complex the science or market. Biography: Curran M. Simpson is the President and Chief Executive Officer and member of the Board of Directors at REGENXBIO. Mr. Simpson previously served as the Company's Chief Operating Officer. In that role, he led key business functions including Research & Clinical Development, Corporate Strategy, Manufacturing & Quality, Regulatory, and Commercial Operations. Mr. Simpson joined REGENXBIO in 2015 with extensive leadership experience across biopharmaceutical operations and served as the Company's Chief Technology and Operations Officer before becoming COO. Prior to joining REGENXBIO, he was the Regional Supply Chain Head for North America and Interim Chief Operating Officer at GlaxoSmithKline (GSK). Mr. Simpson earlier served as interim CEO of Human Genome Sciences (HGS), where he led the integration of HGS into GSK, and as Senior Vice President of Operations and Vice President of Manufacturing Operations at HGS. Prior to HGS, Mr. Simpson was Director of Manufacturing Sciences at Biogen. Earlier in his career, Mr. Simpson served in an overseas assignment at Novo-Nordisk Biochem in Denmark and in various senior development and engineer roles at Genentech, working on Herceptin and Avastin, among other roles. Mr. Simpson has an M.S. in surface and colloid science from Clarkson University and a B.S. in chemistry from the Clarkson College of Technology.

In this week's episode of the EMJ GOLD Podcast, Matt Mortimer Ryan, Senior Global Marketing Manager, Vaccines, GSK, shares his perspective on how understanding patients' emotional drivers can unlock more impactful, insight-led disease awareness campaigns.  Matt joins Isabel to discuss what true patient-centric marketing looks like in practice, how to translate behavioural insights into smarter strategies, the advice he'd give his younger self and much more.  A little more on EMJ GOLD's guest…  Matt is a global marketing leader at GSK, driven by a passion for human-centered innovation in the pharmaceutical industry. With more than 20 years of experience at GSK, Pfizer and Danone, he combines his scientific curiosity with strategic creativity to accelerate meaningful outcomes for patients. The views expressed in this interview are Matt Mortimer-Ryan's own and do not necessarily represent those of GSK.  

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/NZA865. CME/MOC/NCPD/AAPA/IPCE credit will be available until June 30, 2026.Catalysts for Redefined Care in Colorectal Cancer: Adapting Systemic Therapy Regimens Across Disease Settings In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Colorectal Cancer Alliance. 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 educational activity is supported through independent medical education grants from Bristol Myers Squibb and GSK.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/NZA865. CME/MOC/NCPD/AAPA/IPCE credit will be available until June 30, 2026.Catalysts for Redefined Care in Colorectal Cancer: Adapting Systemic Therapy Regimens Across Disease Settings In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Colorectal Cancer Alliance. 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 educational activity is supported through independent medical education grants from Bristol Myers Squibb and GSK.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/NZA865. CME/MOC/NCPD/AAPA/IPCE credit will be available until June 30, 2026.Catalysts for Redefined Care in Colorectal Cancer: Adapting Systemic Therapy Regimens Across Disease Settings In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Colorectal Cancer Alliance. 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 educational activity is supported through independent medical education grants from Bristol Myers Squibb and GSK.Disclosure information is available at the beginning of the video presentation.

This episode covers: Cardiology This Week: A concise summary of recent studies Big data in cardiology Measuring lipids: what clinicians need to know Milestones Host: Perry Elliott Guests: Carlos Aguiar, Karim Lekadir, Kostas Koskinas Want to watch that episode? Go to: https://esc365.escardio.org/event/1808 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, Nicolle Kraenkel and Karim Lekadir 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Perry Elliott has declared to have potential conflicts of interest to report: consultancies for Pfizer, BMS, Cytokinetics, AstraZeneca, Forbion. Kostas Koskinas has declared to have potential conflicts of interest to report: speaker fees / honoraria from MSD, Daiichi-Sankyo. 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: Perry Elliott Guest: Karim Lekadir Want to watch that episode? Go to: https://esc365.escardio.org/event/1808?r 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, Nicolle Kraenkel and Karim Lekadir 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Perry Elliott has declared to have potential conflicts of interest to report: consultancies for Pfizer, BMS, Cytokinetics, AstraZeneca, Forbion. 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."

Dr. Diwakar Davar and Dr. Jason Luke discuss novel agents in melanoma and other promising new data in the field of immunotherapy that were presented at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Diwakar Davar: Hello. My name is Diwakar Davar, and I am welcoming you to the ASCO Daily News Podcast. I'm an associate professor of medicine and the clinical director of the Melanoma and Skin Cancer Program at the University of Pittsburgh's Hillman Cancer Center. Today, I'm joined by my colleague and good friend, Dr. Jason Luke. Dr. Luke is a professor of medicine. He is also the associate director of clinical research and the director of the Phase 1 IDDC Program at the University of Pittsburgh's Hillman Cancer Center. He and I are going to be discussing some key advancements in melanoma and skin cancers that were presented at the 2025 ASCO Annual Meeting. Our full disclosures are available in the transcript of this episode.  Jason, it is great to have you back on the podcast. Dr. Jason Luke: Thanks again so much for the opportunity, and I'm really looking forward to it. Dr. Diwakar Davar: Perfect. So we will go ahead and start talking a little bit about a couple of key abstracts in both the drug development immunotherapy space and the melanoma space. The first couple of abstracts, the first two, will cover melanoma. So, the first is LBA9500, which was essentially the primary results of RELATIVITY-098. RELATIVITY-098 was a phase 3 trial that compared nivolumab plus relatlimab in a fixed-dose combination against nivolumab alone for the adjuvant treatment of resected high-risk disease. Jason, do you want to maybe give us a brief context of what this is? Dr. Jason Luke: Yeah, it's great, thanks. So as almost all listeners, of course, will be aware, the use of anti–PD-1 immunotherapies really revolutionized melanoma oncology over the last 10 to 15 years. And it has become a standard of care in the adjuvant setting as well. But to review, in patients with stage III melanoma, treatment can be targeted towards BRAF with BRAF and MEK combination therapy, where that's relevant, or anti–PD-1 with nivolumab or pembrolizumab are a standard of care. And more recently, we've had the development of neoadjuvant approaches for palpable stage III disease. And in that space, if patients present, based on two different studies, either pembrolizumab or nivolumab plus ipilimumab can be given prior to surgery for somewhere in the 6- to 9-week range. And so all of these therapies have improved time-to-event endpoints, such as relapse-free or event-free survival. It's worth noting, however, that despite those advances, we've had a couple different trials now that have actually failed in this adjuvant setting, most high profile being the CheckMate-915 study, which looked at nivolumab plus ipilimumab and unfortunately was a negative study. So, with RELATIVITY-047, which was the trial of nivolumab plus relatlimab that showed an improvement in progression-free survival for metastatic disease, there's a lot of interest, and we've been awaiting these data for a long time for RELATIVITY-098, which, of course, is this adjuvant trial of LAG-3 blockade with relatlimab plus nivolumab. Dr. Diwakar Davar: Great. So with that, let's briefly discuss the trial design and the results. So this was a randomized, phase 3, blinded study, so double-blinded, so neither the investigators knew what the patients were getting, nor did the patients know what they were getting. The treatment investigational arm was nivolumab plus relatlimab in the fixed-dose combination. So that's the nivolumab standard fixed dose with relatlimab that was FDA approved in RELATIVITY-047. And the control arm was nivolumab by itself. The duration of treatment was 1 year. The patient population consisted of resected high-risk stage III or IV patients. The primary endpoint was investigator-assessed RFS. Stage and geography were the standard stratifying factors, and they were included, and most of the criteria were balanced across both arms. What we know at this point is that the 2-year RFS rate was 64% and 62% in the nivolumab and nivolumab-combination arms, respectively. The 2-year DMFS rate was similarly equivalent: 76% with nivolumab monotherapy, 73% with the combination. And similar to what you had talked about with CheckMate 915, unfortunately, the addition of LAG-3 did not appear to improve the RFS or DMFS compared to control in this patient population. So, tell us a little bit about your take on this and what do you think might be the reasons why this trial was negative? Dr. Jason Luke: It's really unfortunate that we have this negative phase 3 trial. There had been a lot of hope that the combination of nivolumab with relatlimab would be a better tolerated combination that increased the efficacy. So in the metastatic setting, we do have 047, the study that demonstrated nivolumab plus relatlimab, but now we have this negative trial in the adjuvant setting. And so as to why exactly, I think is a complicated scenario. You know, when we look at the hazard ratios for relapse-free survival, the primary endpoint, as well as the secondary endpoints for distant metastasis-free survival, we see that the hazard ratio is approximately 1. So there's basically no difference. And that really suggests that relatlimab in this setting had no impact whatsoever on therapeutic outcomes in terms of efficacy. Now, it's worth noting that there was a biomarker subanalysis that was presented in conjunction with these data that looked at some immunophenotyping, both from circulating T cells, CD8 T cells, as well as from the tumor microenvironment from patients who were treated, both in the previous metastatic trial, the RELATIVITY-047 study, and now in this adjuvant study in the RELATIVITY-098 study. And to briefly summarize those, what was identified was that T cells in advanced melanoma seemed to have higher expression levels of LAG-3 relative to T cells that are circulating in patients that are in the adjuvant setting. In addition to that, there was a suggestion that the magnitude of increase is greater in the advanced setting versus adjuvant. And the overall summary of this is that the suggested rationale for why this was a negative trial may have been that the target of LAG-3 is not expressed as highly in the adjuvant setting as it is in the metastatic setting. And so while the data that were presented, I think, support this kind of an idea, I am a little bit cautious that this is actually the reason for why the trial was negative, however. I would say we're not really sure yet as to why the trial was negative, but the fact that the hazard ratios for the major endpoints were essentially 1 suggests that there was no impact whatsoever from relatlimab. And this really makes one wonder whether or not building on anti–PD-1 in the adjuvant setting is feasible because anti–PD-1 works so well. You would think that even if the levels of LAG-3 expression were slightly different, you would have seen a trend in one direction or another by adding a second drug, relatlimab, in this scenario. So overall, I think it's an unfortunate circumstance that the trial is negative. Clearly there's going to be no role for relatlimab in the adjuvant setting. I think this really makes one wonder about the utility of LAG-3 blockade and how powerful it really can be. I think it's probably worth pointing out there's another adjuvant trial ongoing now of a different PD-1 and LAG-3 combination, and that's cemiplimab plus fianlimab, a LAG-3 antibody that's being dosed from another trial sponsor at a much higher dose, and perhaps that may make some level of difference. But certainly, these are unfortunate results that will not advance the field beyond where we were at already. Dr. Diwakar Davar: And to your point about third-generation checkpoint factors that were negative, I guess it's probably worth noting that a trial that you were involved with, KeyVibe-010, that evaluated the PD-1 TIGIT co-formulation of vibostolimab, MK-4280A, was also, unfortunately, similarly negative. So, to your point, it's not clear that all these third-generation receptors are necessarily going to have the same impact in the adjuvant setting, even if they, you know, for example, like TIGIT, and they sometimes may not even have an effect at all in the advanced cancer setting. So, we'll see what the HARMONY phase 3 trial, that's the Regeneron cemiplimab/fianlimab versus pembrolizumab control with cemiplimab with fianlimab at two different doses, we'll see how that reads out. But certainly, as you've said, LAG-3 does not, unfortunately, appear to have an impact in the adjuvant setting. So let's move on to LBA9501. This is the primary analysis of EORTC-2139-MG or the Columbus-AD trial. This was a randomized trial of encorafenib and binimetinib, which we will abbreviate as enco-bini going forward, compared to placebo in high-risk stage II setting in melanoma in patients with BRAF V600E or K mutant disease. So Jason, you know, you happen to know one or two things about the resected stage II setting, so maybe contextualize the stage II setting for us based on the trials that you've led, KEYNOTE-716, as well as CheckMate-76K, set us up to talk about Columbus-AD. Dr. Jason Luke: Thanks for that introduction, and certainly stage II disease has been something I've worked a lot on. The rationale for that has been that building off of the activity of anti–PD-1 in metastatic melanoma and then seeing the activity in stage III, like we just talked about, it was a curious circumstance that dating back about 7 to 8 years ago, there was no availability to use anti–PD-1 for high-risk stage II patients, even though the risk of recurrence and death from melanoma in the context of stage IIB and IIC melanoma is in fact similar or actually higher than in stage IIIA or IIIB, where anti–PD-1 was approved. And in that context, a couple of different trials that you alluded to, the Keynote-716 study that I led, as well as the CheckMate 76K trial, evaluated pembrolizumab and nivolumab, respectively, showing an improvement in relapse-free and distant metastasis-free survival, and both of those agents have subsequently been approved for use in the adjuvant setting by the US FDA as well as the European Medicines Agency.  So bringing then to this abstract, throughout melanoma oncology, we've seen that the impact of anti–PD-1 immunotherapy versus BRAF and MEK-targeted therapy have had very similar outcomes on a sort of comparison basis, both in frontline metastatic and then in adjuvant setting. So it was a totally reasonable question to ask: Could we use adjuvant BRAF and MEK inhibitor therapy? And I think all of us expected the answer would be yes. As we get into the discussion of the trial, I think the unfortunate circumstance was that the timing of this clinical trial being delayed somewhat, unfortunately, made it very difficult to accrue the trial, and so we're going to have to try to read through the tea leaves sort of, based on only a partially complete data set. Dr. Diwakar Davar: So, in terms of the results, they wanted to enroll 815 patients, they only enrolled 110. The RFS and DMFS were marginally improved in the treatment arm but certainly not significantly, which is not surprising because the trial had only accrued 16% to 18% of its complete accrual. As such, we really can't abstract from the stage III COMBI-AD data to stage II patients. And certainly in this setting, one would argue that the primary treatment options certainly remain either anti–PD-1 monotherapy, either with pembrolizumab or nivolumab, based on 716 or 76K, or potentially active surveillance for the patients who are not inclined to get treated.  Can you tell us a little bit about how you foresee drug development going forward in this space because, you know, for example, with HARMONY, certainly IIC disease is a part of HARMONY. We will know at least a little bit about that in this space. So what do you think about the stage IIB/C patient population? Is this a patient population in which future combinations are going to be helpful, and how would you think about where we can go forward from here? Dr. Jason Luke: It is an unfortunate circumstance that this trial could not be accrued at the pace that was necessary. I think all of us believe that the results would have been positive if they'd been able to accrue the trial. In the preliminary data set that they did disclose of that 110 patients, you know, it's clear there is a difference at a, you know, a landmark at a year. They showed a 16% difference, and that would be in line with what has been seen in stage III. And so, you know, I think it's really kind of too bad. There's really going to be no regulatory approach for this consideration. So using BRAF and MEK inhibition in stage II is not going to be part of standard practice moving into the future. To your point, though, about where will the field go? I think what we're already realizing is that in the adjuvant setting, we're really overtreating the total population. And so beyond merely staging by AJCC criteria, we need to move to biomarker selection to help inform which patients truly need the treatment. And in that regard, I don't think we've crystallized together as a field as yet, but the kinds of things that people are thinking about are the integration of molecular biomarkers like ctDNA. When it's positive, it can be very helpful, but in melanoma, we found that, unfortunately, the rates are quite low, you know, in the 10% to 15% range in the adjuvant setting. So then another consideration would be factors in the primary tumor, such as gene expression profiling or other considerations.  And so I think the future of adjuvant clinical trials will be an integration of both the standard AJCC staging system as well as some kind of overlaid molecular biomarker that helps to enrich for a higher-risk population of patients because on a high level, when you abstract out, it's just clearly the case that we're rather substantially overtreating the totality of the population, especially given that in all of our adjuvant studies to date for anti–PD-1, we have not yet shown that there's an overall survival advantage. And so some are even arguing perhaps we should even reserve treatment until patients progress. I think that's a complicated subject, and standard of care at this point is to offer adjuvant therapy, but certainly a lot more to do because many patients, you know, unfortunately, still do progress and move on to metastatic disease. Dr. Diwakar Davar: Let's transition to Abstract 2508. So we're moving on from the melanoma to the novel immunotherapy abstracts. And this is a very, very, very fascinating drug. It's IMA203. So Abstract 2508 is a phase 1 clinical update of IMA203. IMA203 is an autologous TCR-T construct targeting PRAME in patients with heavily pretreated PD-1-refractory metastatic melanoma. So Jason, in the PD-1 and CTLA-4-refractory settings, treatment options are either autologous TIL, response rate, you know, ballpark 29% to 31%, oncolytic viral therapy, RP1 with nivolumab, ORR about 30-ish percent. So new options are needed. Can you tell us a little bit about IMA203? Perhaps tell us for the audience, what is the difference between a TCR-T and traditional autologous TIL? And a little bit about this drug, IMA203, and how it distinguishes itself from the competing TIL products in the landscape. Dr. Jason Luke: I'm extremely enthusiastic about IMA203. I think that it really has transformative potential based on these results and hopefully from the phase 3 trial that's open to accrual now. So, what is IMA203? We said it's a TCR-T cell product. So what that means is that T cells are removed from a patient, and then they can be transduced through various technologies, but inserted into those T cells, we can then add a T-cell receptor that's very specific to a single antigen, and in this case, it's PRAME. So that then is contrasted quite a bit from the TIL process, which includes a surgical resection of a tumor where T cells are removed, but they're not specific necessarily to the cancer, and they're grown up in the lab and then given to the patient. They're both adoptive cell transfer products, but they're very different. One is genetically modified, and the other one is not. And so the process for generating a TCR-T cell is that patients are required to have a new biomarker that some may not be familiar with, which is HLA profiling. So the T-cell receptor requires matching to the concomitant HLA for which the peptide is bound in. And so the classic one that is used in most oncology practices is A*02:01 because approximately 48% of Caucasians have A*02:01, and the frequency of HLA in other ethnicities starts to become highly variable. But in patients who are identified to have A*02:01 genotype, we can then remove blood via leukapheresis or an apheresis product, and then insert via lentiviral transduction this T-cell receptor targeting PRAME. Patients are then brought back to the hospital where they can receive lymphodepleting chemotherapy and then receive the reinfusion of the TCR-T cells. Again, in contrast with the TIL process, however, these T cells are extremely potent, and we do not need to give high-dose interleukin-2, which is administered in the context of TIL. Given that process, we have this clinical trial in front of us now, and at ASCO, the update was from the phase 1 study, which was looking at IMA203 in an efficacy population of melanoma patients who were refractory at checkpoint blockade and actually multiple lines of therapy. So here, there were 33 patients and a response rate of approximately 50% was observed in this population of patients, notably with a duration of response approximately a year in that treatment group. And I realize that these were heavily pretreated patients who had a range of very high-risk features. And approximately half the population had uveal melanoma, which people may be aware is a generally speaking more difficult-to-treat subtype of melanoma that metastasizes to the liver, which again has been a site of resistance to cancer immunotherapy. So these results are extremely promising. To summarize them from what I said, it's easier to make TCR-T cells because we can remove blood from the patient to transduce the T cells, and we don't have to put them through surgery. We can then infuse them, and based on these results, it looks like the response rate to IMA203 is a little bit more than double what we expect from lifileucel. And then, whereas with lifileucel or TILs, we have to give high-dose IL-2, here we do not have to give high-dose IL-2. And so that's pretty promising. And a clinical trial is ongoing now called the SUPREME phase 3 clinical trial, which is hoping to validate these results in a randomized global study. Dr. Diwakar Davar: Now, one thing that I wanted to go over with you, because you know this trial particularly well, is what you think of the likelihood of success, and then we'll talk a little bit about the trial design. But in your mind, do you think that this is a trial that has got a reasonable likelihood of success, maybe even a high likelihood of success? And maybe let's contextualize that to say an alternative trial, such as, for example, the TebeAM trial, which is essentially a T-cell bispecific targeting GP100. It's being compared against SOC, investigator's choice control, also in a similarly heavily pretreated patient population. Dr. Jason Luke: So both trials, I think, have a strong chance of success. They are very different kinds of agents. And so the CD3 bispecific that you referred to, tebentafusp, likely has an effect of delaying progression, which in patients with advanced disease could have a value that might manifest as overall survival. With TCR-T cells, by contrast, we see a very high response rate with some of the patients going into very durable long-term benefit. And so I do think that the SUPREME clinical trial has a very high chance of success. It will be the first clinical trial in solid tumor oncology randomizing patients to receive a cell therapy as compared with a standard of care. And within that standard of care control arm, TILs are allowed as a treatment. And so it will also be the first study that will compare TCR-T cells against TILs in a randomized phase 3. But going back to the data that we've seen in the phase 1 trial, what we observe is that the duration of response is really connected to the quality of the response, meaning if you have more than a 50% tumor shrinkage, those patients do very, very well. But even in patients who have less than 50% tumor shrinkage, the median progression-free survival right now is about 4.5 months. And again, as we think about trial design, standard of care options for patients who are in this situation are unfortunately very bad. And the progression-free survival in that population is probably more like 2 months. So this is a trial that has a very high likelihood of being positive because the possibility of long-term response is there, but even for patients who don't get a durable response, they're likely going to benefit more than they would have based on standard chemotherapy or retreatment with an anti–PD-1 agent. Dr. Diwakar Davar: Really, a very important trial to enroll, a trial that is first in many ways. First of a new generation of TCR-T agents, first trial to look at cell therapy in the control arm, a new standard of efficacy, but potentially also if this trial is successful, it will also be a new standard of trial conduct, a new kind of trial, of a set of trials that will be done in the second-line immunotherapy-refractory space. So let's pivot to the last trial that we were going to discuss, which was Abstract 2501. Abstract 2501 is a first-in-human phase 1/2 trial evaluating BNT142, which is the first-in-class mRNA-encoded bispecific targeting Claudin-6 and CD3 in patients with Claudin-positive tumors. We'll talk a little bit about this, but maybe let's start by talking a little bit about Claudin-6. So Claudin-6 is a very interesting new target. It's a target that's highly expressed in GI and ovarian tumors. There are a whole plethora of Claudin-6-targeting agents, including T-cell bispecifics and Claudin-6-directed CAR-Ts that are being developed. But BNT142 is novel. It's a novel lipid nanoparticle LNP-encapsulated mRNA. The mRNA encodes an anti–Claudin-6 CD3 bispecific termed RiboMAB-021. And it then is administered to the patient. The BNT142-encoding mRNA LNPs are taken up by the liver and translated into the active drug. So Jason, tell us a little bit about this agent. Why you think it's novel, if you think it's novel, and let's talk a little bit then about the results. Dr. Jason Luke: So I certainly think this is a novel agent, and I think this is just the first of what will probably become a new paradigm in oncology drug development. And so you alluded to this, but just to rehash it quickly, the drug is encoded as genetic information that's placed in the lipid nanoparticle and then is infused into the patient. And after the lipid nanoparticles are taken up by the liver, which is the most common place that LNPs are usually taken up, that genetic material in the mRNA starts to be translated into the actual protein, and that protein is the drug. So this is in vivo generation, so the patient is making their own drug inside their body. I think it's a really, really interesting approach. So for any drug that could be encoded as a genetic sequence, and in this case, it's a bispecific, as you mentioned, CD3-Claudin-6 engager, this could have a tremendous impact on how we think about pharmacology and novel drug development moving into the future in oncology. So I think it's an extremely interesting drug, the like of which we'll probably see only more moving forward. Dr. Diwakar Davar: Let's maybe briefly talk about the results. You know, the patient population was heavily pretreated, 65 or so patients, mostly ovarian cancer. Two-thirds of the patients were ovarian cancer, the rest were germ cell and lung cancer patients. But let's talk a little bit about the efficacy. The disease control rate was about 58% in the phase 1 population as a whole, but 75% in the ovarian patient population. Now tell us a little bit about the interesting things about the drug in terms of the pharmacokinetics, and also then maybe we can pivot to the clinical activity by dose level. Dr. Jason Luke: Well, so they did present in their presentation at ASCO a proportionality showing that as higher doses were administered, that greater amounts of the drug were being made inside the patient. And so that's an interesting observation, and it's an important one, right? Suggesting that the pharmacology that we classically think of by administering drugs by IV, for example, would still be in play. And that did translate into some level of efficacy, particularly at the higher dose levels. Now, the caveat that I'll make a note of is that disease control rate is an endpoint that I think we have to be careful about because what that really means is sometimes a little bit unclear. Sometimes patients have slowly growing tumors and so on and so forth. And the clinical relevance of disease control, if it doesn't last at least 6 months, I think is probably pretty questionable. So I think these are extremely interesting data, and there's some preliminary sense that getting the dose up is going to matter because the treatment responses were mostly observed at the highest dose levels. There's also a caveat, however, that across the field of CD3 bispecific molecules like this, there's been quite a bit of heterogeneity in terms of the response rate, with some of them only really generating stable disease responses and other ones having more robust responses. And so I think this is a really interesting initial foray into this space. My best understanding is this molecule is not moving forward further after this, but I think that this really does set it up to be able to chase after multiple different drug targets on a CD3 bispecific backbone, both in ovarian cancer, but then basically across all of oncology. Dr. Diwakar Davar: Perfect. This is a very new sort of exciting arena where we're going to be looking at, in many ways, these programmable constructs, whether we're looking at in vivo-generated, in this case, a T-cell bispecific, but we've also got newer drugs where we are essentially giving drugs where people are generating in vivo CAR T, and also potentially even in vivo TCR-T. But certainly lots of new excitement around this entire class of drugs. And so, what we'd like to do at this point in time is switch to essentially the fact that we've got a very, very exciting set of data at ASCO 2025. You've heard from Dr. Luke regarding the advances in both early drug development but also in advanced cutaneous melanoma. And Jason, as always, thank you so much for sharing your very valuable and great, fantastic insights with us on the ASCO Daily News Podcast. Dr. Jason Luke: Well, thanks again for the opportunity. Dr. Diwakar Davar: And thank you to our listeners for taking your time to listen today. You will find the links to the abstracts that we discussed today in the transcript of this episode. And finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:    Dr. Diwakar Davar    @diwakardavar    Dr. Jason Luke @jasonlukemd Follow ASCO on social media:     @ASCO on Twitter       ASCO on Bluesky   ASCO on Facebook       ASCO on LinkedIn   Disclosures:     Dr. Diwakar Davar:      Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences     Consulting or Advisory Role: Instil Bio, Vedanta Biosciences     Consulting or Advisory Role (Immediate family member): Shionogi     Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences     Research Funding (Inst.): Zucero Therapeutics     Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy     Dr. Jason Luke:     Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical, Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX     Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine     Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure     Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)     Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio

Dr. Vamsi Velcheti and Dr. Nate Pennell discuss novel treatment approaches in small cell and non-small cell lung cancer that were featured at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Vamsi Velcheti: Hello, I'm Dr. Vamsi Velcheti, your guest host of the ASCO Daily News Podcast. I'm a professor of medicine and chief of hematology and oncology at the Mayo Clinic in Jacksonville, Florida. The 2025 ASCO Annual Meeting featured some exciting advancements in small cell lung cancer, targeted therapies for non-small cell lung cancer, and other novel [treatment] approaches. Today, I'm delighted to be joined by Dr. Nate Pennell to discuss some of the key abstracts that are advancing the lung cancer field. Dr. Pennell is the co-director of the Cleveland Clinic Lung Cancer Program and also the vice chair of clinical research at the Taussig Cancer Institute. Our full disclosures are available in the transcript of this episode. Nate, it's great to have you back on the podcast. Thanks so much for being here. Dr. Nate Pennell: Thanks, Vamsi. Always a pleasure. Dr. Vamsi Velcheti: Let's get started, and I think the first abstract that really caught my attention was Abstract 8516, “The Randomized Trial of Relevance of Time of Day of Immunotherapy for Progression-Free and Overall Survival in Patients With Non-Small Cell Lung Cancer.” What are your thoughts about this, Nate? Dr. Nate Pennell: I agree. I thought this was one of the most discussed abstracts, certainly in the lung cancer session, but I think even outside of lung cancer, it got some discussion. So, just to put this in perspective, there have been a number of publications that have all been remarkably consistent, and not just in lung cancer but across multiple cancer types, that immunotherapy, immune checkpoint inhibitors, are commonly used. And all of them have suggested, when looking at retrospective cohorts, that patients who receive immune checkpoint inhibitors earlier in the day – so in the morning or before the early afternoon – for whatever reason, appear to have better outcomes than those who get it later in the day, and this has been repeated. And I think many people just sort of assumed that this was some sort of strange association and that there was something fundamentally different from a prognostic standpoint in people who came in in the morning to get their treatment versus those who came later in the afternoon, and that was probably the explanation. The authors of this randomized trial actually decided to test this concept. And so, about 210 patients with previously untreated advanced non-small cell lung cancer were randomly assigned to get chemo and immune checkpoint inhibitor – either pembrolizumab or sintilimab – and half of them were randomly assigned to get the treatment before 3 PM in the afternoon, and half of them were assigned to get it after 3 PM in the afternoon. And it almost completely recapitulated what was seen in the retrospective cohorts. So, the median progression-free survival in those who got earlier treatment was 13.2 months versus only 6.5 months in those who got it later in the day. So, really enormous difference with a hazard ratio of 0.43, which was statistically significant. And perhaps even more striking, the median overall survival was not reached in the early group versus 17.8 months in the late group with a hazard ratio of 0.43, also highly statistically significant. Even the response rate was 20% higher in the early patients; 75% response rate compared to 56% in the late-time-of-day patients. So very consistent across all measures of efficacy with pretty good matched characteristics across the different groups. And so, I have to tell you, I don't know what to make of this. I certainly was a skeptic about the retrospective series, but now we have a prospective randomized trial that shows essentially the same thing. So, maybe there is a difference between getting treated in the morning, although I have yet to hear someone give a very good mechanistic explanation as to why this would be. What were your thoughts on this? Dr. Vamsi Velcheti: It's indeed fascinating, Nate, and I actually think this was a very interesting abstract. Really, I was caught off guard looking at the data. I mean, if it were a drug, we would be so excited, right? I mean, with those kind of survival benefits. I don't know. I think circadian rhythm probably has something to do with it, like different cytokine profiles at the time of administration. I mean, who knows? But I think it's a randomized trial, and I think I would expect to see a mad rush for treatment appointments early in the morning given this, and at least I want my patients to come in first thing in the morning. It'll be interesting to see. Dr. Nate Pennell: It's important to point out that in this study, everyone got chemo and immunotherapy. And, at least in our cancer center, most patients who are getting platinum-doublet chemotherapy and immunotherapy actually do get treated earlier in the day already, just because of the length of the infusion appointment that's needed. So it really is oftentimes people getting single-agent immunotherapy who are often getting the later, shorter visits. But if you have a choice, I think it would be very reasonable to have people treated earlier in the day. And I do think most of the impressions that I got from people about this is that they would like to see it reproduced but certainly well worth further investigation. And I personally would like to see more investigation into what the rationale would be for this because I still can't quite figure out, yes, if you got it at, say, you know, 5 PM, that's later in the day and I can understand that maybe your immune system is somewhat less receptive at that point than it would be in the morning. But because these checkpoint inhibitors have such long half-lives, it's still in your system the next morning when your immune system is supposedly more receptive. So I don't quite understand why that would be the case. Well, let's move on to the next study. I would like to hear your thoughts on Abstract 8515, “Plasma-Guided, Adaptive First-Line Chemoimmunotherapy for Non-Small Cell Lung Cancer.” Dr. Vamsi Velcheti: Yeah, this was another abstract that seems to be really interesting in my opinion. I think there's kind of a lot of emphasis lately on ctDNA and MRD-based assays to monitor disease. In the lung cancer space, we haven't had a lot of clinical trials looking at this prospectively, and this was one of those pilot studies where they looked at circulating free DNA (cfDNA)-based response-adaptive strategy for frontline patients who are PD-L1 positive. So, patients started with pembrolizumab monotherapy, and based on plasma molecular response after 2 cycles, those patients without response received early treatment intensification with a platinum doublet. So the approach essentially was to reduce the chemotherapy exposure in patients who respond to immunotherapy. And only about 17.5% of the patients on the trial received chemotherapy based on lack of molecular response. So, in this trial, what they found was patients with the cfDNA response had a markedly improved PFS of 16.4 months versus 4.8 months. So essentially, like, this is a really nice study to set a foundation on which we have to do larger studies to incorporate molecular markers trying to look at cfDNA response to inform treatment strategy, either escalation or de-escalation strategies. So, I thought it was a very interesting study. Dr. Nate Pennell: Yeah. I mean, we always have this question for patients, “Should they get immunotherapy alone or combined with chemo?” and I think this certainly is intriguing, suggesting that there may be ways you can monitor people and perhaps rescue those that aren't going to respond to single agent. I'd like to see a randomized trial against, you know, this strategy, perhaps against everyone getting, say, chemoimmunotherapy or make sure that you're not potentially harming people by doing this strategy. But I agree, it's time to move beyond just observing that cell-free DNA is prognostic and important and start using it to actually guide treatment. Dr. Vamsi Velcheti: Yeah, and I would just caution though, like, you know, I think we need more data, but, however, it's certainly a very interesting piece of data to kind of help inform future trials. So, there was another abstract that caught my attention, and I think this would be a very interesting abstract in the EGFR space. Abstract 8506, "Patritumab Deruxtecan (HER3-DXd) in Resistant EGFR-Mutant Advanced Non-Small Cell Lung Cancer Patients After Third-Generation EGFR TKI," it's the HERTHENA-Lung02 study. What do you think about the results of this study? Dr. Nate Pennell: Yeah, this was, I would say, very widely anticipated and ultimately a little disappointing, despite being a positive trial. So, these are patients with EGFR-mutant non-small cell lung cancer who have progressed after a third-generation EGFR TKI like osimertinib. This is really an area of major unmet need. We do have drugs like amivantamab in this space, but still definitely an area where essentially patients move from having a highly effective oral therapy to being in the realm of chemotherapy as their best option. So, this HER3 antibody-drug conjugate, patritumab deruxtecan, had some good single-arm data for this. And we're sort of hoping this would become an available option for patients. This trial was designed against platinum-doublet chemotherapy in this setting and with a primary endpoint of progression-free survival. And it actually was positive for improved progression-free survival compared to chemo with a hazard ratio of 0.77. But when you look at the medians, you can see that the median PFS was only 5.8 versus 5.4 months. It was really a modest difference between the two arms. And on the interim analysis, it appeared that there will not be a difference in overall survival between the two arms. In fact, the hazard ratio at the interim analysis was 0.98 for the two arms. So based on this, unfortunately, the company that developed the HER3-DXd has withdrawn their application to the FDA for approval of the drug, anticipating that they probably wouldn't get past approval without that overall survival endpoint. So, unfortunately, probably not, at least for the near future, going to be a new option for these patients. Dr. Vamsi Velcheti: Yeah, I think this is a space that's clearly an unmet need, and this was a big disappointment, I should say. I think all of us were going into the meeting anticipating some change in the standard of care here. Dr. Nate Pennell: Yeah, I agree. It was something that I was telling patients, honestly, that I was expecting this to be coming, and so now, definitely a bit of a disappointment. But it happens and, hopefully, it will still find perhaps a role or other drugs with a similar target. Certainly an active area. Well, let's leave the EGFR-mutant space and move into small cell. There were a couple of very impactful studies. And one of them was Abstract 8006, “Lurbinectedin Plus Atezolizumab as First-Line Maintenance Treatment in Patients With Extensive-Stage Small Cell Lung Cancer, Primary Results from the Phase III IMforte Trial.” So, what was your impression of this? Dr. Vamsi Velcheti: Yeah, I think this is definitely an interesting study, and small cell, I remember those days when we had barely any studies of small cell at ASCO, and now we have a lot of exciting developments in the small cell space. It's really good to see. The IMforte trial is essentially like a maintenance lurbinectedin trial with atezolizumab maintenance. And the study was a positive trial. The primary endpoint was a PFS, and the study showed improvement in both PFS and OS with the addition of lurbinectedin to atezolizumab maintenance. And definitely, it's a positive trial, met its primary endpoint, but I always am a little skeptical of adding maintenance cytotoxic therapies here in this setting. In my practice, and I'd like to hear your opinion, Nate, most patients with small cell after 4 cycles of a platinum doublet, they're kind of really beaten up. Adding more cytotoxic therapy in the maintenance space is going to be tough, I think, for a lot of patients. But also, most importantly, I think this rapidly evolving landscape for patients with small cell lung cancer with multiple new, exciting agents, actually like some FDA-approved like tarlatamab, also like a lot of these emerging therapeutics like I-DXd and other ADCs in this space. You kind of wonder, is it really optimal strategy to bring on like another cytotoxic agent right after induction chemotherapy, or do you kind of delay that? Or maybe have like a different strategy in terms of maintenance. I know that the tarlatamab maintenance trial is probably going to read out at some point too. I think it's a little challenging. The hazard ratio is also 0.73. As I said, it's a positive trial, but it's just incremental benefit of adding lurbi. And also on the trial, we need to also pay attention to the post-progression second-line treatments, number of patients who received tarlatamab or any other investigational agents.  So I think it's a lot of questions still. I'm not quite sure I'd be able to embrace this completely. I think a vast majority of my patients might not be eligible anyway for cytotoxic chemotherapy maintenance right away, but yeah, it's tough. Dr. Nate Pennell: Yeah. I would call this a single and not a home run. It definitely is real. It was a real overall survival benefit. Certainly not surprising that a maintenance therapy would improve progression-free survival. We've known that for a long time in small cell, but first to really show an overall survival benefit. But I completely agree with you. I mean, many people are not going to want to continue further cytotoxics after 4 cycles of platinum-doublet chemo. So I would say, for those that are young and healthy and fly through chemo without a lot of toxicity, I think certainly something worth mentioning. The problem with small cell, of course, is that so many people get sick so quickly while on that observation period after first-line chemo that they don't make it to second-line treatment. And so, giving everyone maintenance therapy essentially ensures everyone gets that second-line treatment. But they also lose that potentially precious few months where they feel good and normal and are able to be off of treatment. So, I would say this is something where we're really going to have to kind of sit and have that shared decision-making visit with patients and decide what's meaningful to them. Dr. Vamsi Velcheti: Yeah, I agree. The next abstract that was a Late-Breaking Abstract, 8000, “Overall Survival of Neoadjuvant Nivolumab Plus Chemotherapy in Patients With Resectable Non-Small Cell Lung Cancer in CheckMate-816.” This was a highly anticipated read-out of the OS data from 816. What did you make of this abstract? Dr. Nate Pennell: Yeah, I thought this was great. Of course, CheckMate-816 changed practice a number of years ago when it first reported out. So, this was the first of the neoadjuvant or perioperative chemoimmunotherapy studies in resectable non-small cell lung cancer. So, just to review, this was a phase 3 study for patients with what we would now consider stage II or stage IIIA resectable non-small cell lung cancer. And they received three cycles of either chemotherapy or chemotherapy plus nivolumab, and that was it. That was the whole treatment. No adjuvant treatment was given afterwards. They went to resection. And patients who received the chemoimmunotherapy had a much higher pathologic complete response rate and a much better event-free survival. And based on this, this regimen was approved and, I think, at least in the United States, widely adopted.  Now, since the first presentation of CheckMate 816, there have been a number of perioperative studies that have included an adjuvant component of immunotherapy – KEYNOTE-671, the AEGEAN study – and these also have shown improved outcomes. The KEYNOTE study with pembrolizumab also with an overall survival benefit. And I think people forgot a little bit about CheckMate-816. So, this was the 5-year overall survival final analysis. And it did show a statistically and, I think, clinically meaningful difference in overall survival with the 3 cycles of neoadjuvant chemo-nivo compared to chemo with a hazard ratio of 0.72. The 5-year overall survival of 65% in the chemo-IO group versus 55% with the chemo alone. So a meaningful improvement. And interestingly, that hazard ratio of 0.72 is very similar to what was seen in the peri-operative pembro study that included the adjuvant component. So, very much still relevant for people who think that perhaps the value of those neoadjuvant treatments might be really where most of the impact comes from this type of approach. They also gave us an update on those with pathologic complete response, showing really astronomically good outcomes. If you have a pathologic complete response, which was more than a quarter of patients, the long-term survival was just phenomenal. I mean, 95% alive at 5 years if they were in that group and suggesting that in those patients at least, the adjuvant treatment may not be all that important.  So, I think this was an exciting update and still leaves very much the open question about the importance of continuing immunotherapy after surgery after the neoadjuvant component. Dr. Vamsi Velcheti: Yeah, I completely agree, Nate. I think the million-dollar question is: “Is there like a population of patients who don't have complete response but like maybe close to complete response?” So, would you like still consider stopping adjuvant IO? I probably would not be comfortable, but I think sometimes, you know, we all have patients who are like very apprehensive of continuing treatments. So, I think that we really need more studies, especially for those patients who don't achieve a complete CR. I think trying to find strategies for like de-escalation based on MRD or other risk factors. But we need more trials in that space to inform not just de-escalation, but there are some patients who don't respond at all to a neoadjuvant IO. So, there may be an opportunity for escalating adjuvant therapies. So, it is an interesting space to watch out for. Dr. Nate Pennell: No, absolutely. Moving to KRAS-mutant space, so our very common situation in patients with non-small cell lung cancer, we had the results of Abstract 8500, “First-Line Adagrasib With Pembrolizumab in Patients With Advanced or Metastatic KRASG12C-Mutated Non-Small Cell Lung Cancer” from the phase 2 portion of the KRYSTAL-7 study. Why was this an interesting and important study? Dr. Vamsi Velcheti: First of all, there were attempts to kind of combine KRASG12C inhibitors in the past with immune checkpoint inhibitors, notably sotorasib with pembrolizumab. Unfortunately, those trials have led to like a lot of toxicity, with increased especially liver toxicity, which was a major issue. This is a phase 2 study of adagrasib in combination with pembrolizumab, and this is a study in the frontline setting in patients with the G12C-mutant metastatic non-small cell lung cancer. And across all the PD-L1 groups, the ORR was 44%, and the median PFS was 11 months, comparable to the previous data that we have seen with adagrasib in this setting. So it's not like a major improvement in clinical efficacy. However, I think the toxicity profile that we were seeing was slightly better than the previous trials in combination with sotorasib, but you still have a fair amount of transaminitis even in the study. At this point, this is not ready for clinical primetime. I don't think we should be using sotorasib or adagrasib in the frontline or even in the second line in combination with checkpoint inhibitors. Combining these drugs with checkpoint inhibitors in the clinical practice might lead to adverse outcomes. So, we need to wait for more data like newer-generation G12C inhibitors which are also being studied in combination, so we'll have to kind of wait for more data to emerge in this space. Dr. Nate Pennell: I agree, this is not immediately practice changing. This is really an attempt to try to combine targeted treatment with immune checkpoint inhibitor. And I agree with you that, you know, it does appear to be perhaps a little bit better tolerated than some of the prior combinations that have tried in this space. The outcomes overall were not that impressive, although in the PD-L1 greater than 50%, it did have a better response rate perhaps than you would expect with either drug alone. And I do think that the company is focusing on that population for a future randomized trial, which certainly would inform this question better. But in the meantime, I agree with you, there's a lot of newer drugs that are coming along that potentially may be more active and better tolerated. And so, I'd say for now, interesting but we'll wait and see. Dr. Vamsi Velcheti: Yeah, so now moving back again to small cell. So, there was a Late-Breaking Abstract, 8008. This is a study of tarlatamab versus chemotherapy as second-line treatment for small cell lung cancer. They presented the primary analysis of the phase III DeLLphi-304 study. What do you think about this? Dr. Nate Pennell: Yeah, I thought this was really exciting. This was, I would say, perhaps the most important lung study that was presented. Tarlatamab is, of course, the anti-DLL3 bispecific T-cell engager compound, which is already FDA approved based on a prior single-arm phase II study, which showed a very nice response rate as a single agent in previously treated small cell lung cancer and relatively manageable side effects, although somewhat unique to solid tumor docs in the use of these bispecific drugs in things like cytokine release syndrome and ICANS, the neurologic toxicities. So, this trial was important because tarlatamab was approved, but there were also other chemotherapy drugs approved in the previously treated space. And so, this was a head-to-head second-line competition comparison between tarlatamab and either topotecan, lurbinectedin, or amrubicin in previously treated small cell patients with a primary endpoint of overall survival. So, a very well-designed trial. And it did show, I think, a very impressive improvement in overall survival with a median overall survival in the tarlatamab group of 13.6 months compared to 8.3 months with chemotherapy, hazard ratio of 0.6. And progression-free survival was also longer at 4.2 months versus 3.2 months, hazard ratio of 0.72. In addition to showing improvements in cancer-related symptoms that were improved in tarlatamab compared to chemotherapy, there was actually also significantly lower rates of serious treatment-related adverse events with tarlatamab compared to chemotherapy. So, you do still see the cytokine release syndrome, which is seen in most people but is manageable because these patients are admitted to the hospital for the first two cycles, as well as a significant number of patients with neurologic side effects, the so-called ICANS, which also can be treated with steroids. And so, I think based upon the very significant improvement in outcomes, I would expect that this should become our kind of standard second-line treatment since it seems to be much better than chemo. However, tarlatamab is definitely a new drug that a lot of places are not used to using, and I think a lot of cancer centers, especially ones that aren't tied to a hospital, may have questions about how to deal with the CRS. So, I'm curious your thoughts on that. Dr. Vamsi Velcheti: Yeah, thank you, Nate. And I completely agree. I think the data looked really promising, and I've already been using tarlatamab in the second-line space. The durability of response and overall, having used tarlatamab quite a bit - like, I participated in some of the early trials and also used it as standard of care - tarlatamab has unique challenges in terms of like need for hospitalization for monitoring for the first few treatments and make sure, you know, we monitor those patients for CRS and ICANS. But once you get past that initial administration and monitoring of CRS, these patients have a much better quality of life, they're off chemotherapy, and I think it's really about the logistics of actually administering tarlatamab and coordination with the hospital and administration in the outpatient setting. It's definitely challenging, but I think it definitely can be done and should be done given what we are seeing in terms of clinical efficacy here. Dr. Nate Pennell: I agree. I think hospital systems now are just going to have to find a way to be able to get this on formulary and use it because it clearly seems to be more effective and generally better tolerated by patients. So, should move forward, I think. Finally, there's an abstract I wanted to ask you about, Abstract 8001, which is the “Neoadjuvant osimertinib with or without chemotherapy versus chemotherapy alone in resectable epidermal growth factor receptor-mutated non-small cell lung cancer: The NeoADAURA Study”. And this is one that I think was also fairly highly anticipated. So, what are your thoughts? Dr. Vamsi Velcheti: You know, I wasn't probably surprised with the results, and I believe we were all expecting a positive trial, and we certainly were handed a positive trial here. It's a phase III trial of osimertinib and chemotherapy or osimertinib in the neoadjuvant space followed by surgery, followed by osimertinib. It's a global phase 3 trial and very well conducted, and patients with stage II to stage IIIB were enrolled in the study. And in the trial, patients who had a neoadjuvant osimertinib with or without chemotherapy showed a significant improvement in major pathologic response rates over chemotherapy alone. And the EFS was also positive for osimertinib and chemotherapy, osimertinib monotherapy as well compared to chemotherapy alone. So overall, the study met its primary endpoint, and I think it sheds light on how we manage our patients with early-stage lung cancer. I think osimertinib, we know that osimertinib is already FDA approved in the adjuvant space, but what we didn't really know is how was osimertinib going to work in the neoadjuvant space. And there are always situations, especially for stage III patients, where we are on the fence about, are these patients already close to being metastatic? They have, like, almost all these patients have micrometastatic disease, even if they have stage III. As we saw in the LAURA data, when you look at the control arm, it was like a very short PFS. Chemoradiation does nothing for those patients, and I think these patients have systemic mets, either gross or micrometastatic disease at onset. So, it's really important to incorporate osimertinib early in the treatment course. And I think, especially for the locally advanced patients, I think it's even more important to kind of incorporate osimertinib in the neoadjuvant space and get effective local control with surgery and treat them with adjuvant. I'm curious to hear your thoughts, Nate. Dr. Nate Pennell: I am a believer and have long been a believer in targeted adjuvant treatments, and, you know, it has always bothered me somewhat that we're using our far and away most effective systemic therapy; we wait until after they go through all their pre-op treatments, they go through surgery, then they go through chemotherapy, and then finally months later, they get their osimertinib, and it still clearly improves survival in the adjuvant setting. Why not just start the osimertinib as soon as you know that the patient has EGFR-mutant non-small cell lung cancer, and then you can move on to surgery and adjuvant treatment afterwards? And I think what was remarkable about this study is that all of these patients almost - 90% in each arm - went to surgery. So, you weren't harming them with the neoadjuvant treatment. And clearly better major pathologic response, nodal downstaging, event-free survival was better. But I don't know that this trial is ever going to show an overall survival difference between neoadjuvant versus just surgery and adjuvant treatment, given how effective the drug is in the adjuvant setting. Nonetheless, I think the data is compelling enough to consider this, certainly for our N2-positive, stage IIIA patients or a IIIB who might be otherwise surgical candidates. I think based on this, I would certainly consider that. Dr. Vamsi Velcheti: Yeah, and especially for EGFR, like even for stage IIIB patients, in the light of the LAURA study, those patients who do not do too well with chemoradiation. So you're kind of delaying effective systemic therapy, as you said, waiting for the chemoradiation to finish. So I think probably time to revisit how we kind of manage these locally advanced EGFR patients. Dr. Nate Pennell: Yep, I agree. Dr. Vamsi Velcheti: Nate, thank you so much for sharing your fantastic insights today on the ASCO Daily News Podcast. It's been an exciting ASCO again. You know, we've seen a lot of positive trials impacting our care of non-small cell lung cancer and small cell lung cancer patients. Dr. Nate Pennell: Thanks for inviting me, Vamsi. Always a pleasure to discuss these with you. Dr. Vamsi Velcheti: And thanks to our listeners for your time today. You will find links to all of the abstracts discussed today in the transcript of the episode. Finally, if you value the insights that you hear from the ASCO Daily News Podcast, please take a moment to rate, review, subscribe wherever you get your podcast. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. More on today's speakers:    Dr. Vamsi Velcheti   @VamsiVelcheti    Dr. Nathan Pennell   @n8pennell   Follow ASCO on social media:     @ASCO on Twitter     ASCO on Facebook     ASCO on LinkedIn   ASCO on BlueSky   Disclosures:   Dr. Vamsi Velcheti:   Honoraria: ITeos Therapeutics   Consulting or Advisory Role: Bristol-Myers Squibb, Merck, Foundation Medicine, AstraZeneca/MedImmune, Novartis, Lilly, EMD Serono, GSK, Amgen, Elevation Oncology, Taiho Oncology, Merus   Research Funding (Inst.): Genentech, Trovagene, Eisai, OncoPlex Diagnostics, Alkermes, NantOmics, Genoptix, Altor BioScience, Merck, Bristol-Myers Squibb, Atreca, Heat Biologics, Leap Therapeutics, RSIP Vision, GlaxoSmithKline   Dr. Nathan Pennell:     Consulting or Advisory Role: AstraZeneca, Lilly, Cota Healthcare, Merck, Bristol-Myers Squibb, Genentech, Amgen, G1 Therapeutics, Pfizer, Boehringer Ingelheim, Viosera, Xencor, Mirati Therapeutics, Janssen Oncology, Sanofi/Regeneron    Research Funding (Inst): Genentech, AstraZeneca, Merck, Loxo, Altor BioScience, Spectrum Pharmaceuticals, Bristol-Myers Squibb, Jounce Therapeutics, Mirati Therapeutics, Heat Biologics, WindMIL, Sanofi