Podcasts about GSK

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Best podcasts about GSK

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Latest podcast episodes about GSK

PeerView Heart, Lung & Blood CME/CNE/CPE Video Podcast
Sagar Lonial, MD, FACP - 4x4 in Multiple Myeloma: Maintaining Momentum for Delivering Innovative Care in Newly Diagnosed and Relapsed Disease

PeerView Heart, Lung & Blood CME/CNE/CPE Video Podcast

Play Episode Listen Later Jul 21, 2025 104:34


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.

PeerView Clinical Pharmacology CME/CNE/CPE Audio Podcast
Sagar Lonial, MD, FACP - 4x4 in Multiple Myeloma: Maintaining Momentum for Delivering Innovative Care in Newly Diagnosed and Relapsed Disease

PeerView Clinical Pharmacology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Jul 21, 2025 104:34


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.

PeerView Oncology & Hematology CME/CNE/CPE Video Podcast
Sagar Lonial, MD, FACP - 4x4 in Multiple Myeloma: Maintaining Momentum for Delivering Innovative Care in Newly Diagnosed and Relapsed Disease

PeerView Oncology & Hematology CME/CNE/CPE Video Podcast

Play Episode Listen Later Jul 21, 2025 104:34


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.

PeerView Oncology & Hematology CME/CNE/CPE Audio Podcast
Sagar Lonial, MD, FACP - 4x4 in Multiple Myeloma: Maintaining Momentum for Delivering Innovative Care in Newly Diagnosed and Relapsed Disease

PeerView Oncology & Hematology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Jul 21, 2025 104:34


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.

PeerView Heart, Lung & Blood CME/CNE/CPE Audio Podcast
Sagar Lonial, MD, FACP - 4x4 in Multiple Myeloma: Maintaining Momentum for Delivering Innovative Care in Newly Diagnosed and Relapsed Disease

PeerView Heart, Lung & Blood CME/CNE/CPE Audio Podcast

Play Episode Listen Later Jul 21, 2025 104:34


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.

PeerView Clinical Pharmacology CME/CNE/CPE Video
Sagar Lonial, MD, FACP - 4x4 in Multiple Myeloma: Maintaining Momentum for Delivering Innovative Care in Newly Diagnosed and Relapsed Disease

PeerView Clinical Pharmacology CME/CNE/CPE Video

Play Episode Listen Later Jul 21, 2025 104:34


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.

Alles auf Aktien
Investieren in mentale Gesundheit und Lieblings-ETFs der Deutschen

Alles auf Aktien

Play Episode Listen Later Jul 18, 2025 24:32


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

MPR Weekly Dose
MPR Weekly Dose #242 — New indication for Kerendia; investigational Tx shows promise for hypertension; Novolog biosimilar; trial results for hormone-free contraceptive; new prefilled Shringrix syringe

MPR Weekly Dose

Play Episode Listen Later Jul 18, 2025 11:31


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.

ESC TV Today – Your Cardiovascular News
Season 3 - Ep.20: ICD indications in primary prevention - Drug treatment of cardiac amyloidosis

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jul 17, 2025 24:48


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.

ESC TV Today – Your Cardiovascular News
Season 3 - Ep.20: Extended interview on ICD Indications in primary prevention

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jul 17, 2025 14:31


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.

Pharma and BioTech Daily
Pharma and Biotech Daily: Insights from the Industry Leaders

Pharma and BioTech Daily

Play Episode Listen Later Jul 17, 2025 1:25


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.

Tell Me Mord
#G wie Genetik: Der Golden State Killer (Teil 2)

Tell Me Mord

Play Episode Listen Later Jul 16, 2025 68:41


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

The EMG GOLD Podcast
Chiesi's Shish Patel on COPD, the climate and improving care

The EMG GOLD Podcast

Play Episode Listen Later Jul 15, 2025 17:09


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.   

A Shot in the Arm Podcast with Ben Plumley
Strengthening the Health Ecosystem with the GLP's Heidi Larson & GSK's Susie Barnes

A Shot in the Arm Podcast with Ben Plumley

Play Episode Listen Later Jul 10, 2025 43:58


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

Inside the Mind of Champions
Mastermind: Shobie Ramakrishnan, GSK's CTO - Leading Tech Transformations

Inside the Mind of Champions

Play Episode Listen Later Jul 9, 2025 39:06


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

Biotech 2050 Podcast
Curran Simpson, President & CEO of REGENXBIO, on Gene Therapy, Strategy & Patient-Centered Impact

Biotech 2050 Podcast

Play Episode Listen Later Jul 8, 2025 28:19


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.

The EMG GOLD Podcast
S10 E06: GSK's Matt Mortimer-Ryan on behaviour-led pharma marketing

The EMG GOLD Podcast

Play Episode Listen Later Jul 8, 2025 23:37


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.  

PeerView Clinical Pharmacology CME/CNE/CPE Audio Podcast
Heinz-Josef Lenz, MD, FACP - Catalysts for Redefined Care in Colorectal Cancer: Adapting Systemic Therapy Regimens Across Disease Settings

PeerView Clinical Pharmacology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Jul 7, 2025 78:15


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.

PeerView Oncology & Hematology CME/CNE/CPE Video Podcast
Heinz-Josef Lenz, MD, FACP - Catalysts for Redefined Care in Colorectal Cancer: Adapting Systemic Therapy Regimens Across Disease Settings

PeerView Oncology & Hematology CME/CNE/CPE Video Podcast

Play Episode Listen Later Jul 7, 2025 78:15


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.

PeerView Oncology & Hematology CME/CNE/CPE Audio Podcast
Heinz-Josef Lenz, MD, FACP - Catalysts for Redefined Care in Colorectal Cancer: Adapting Systemic Therapy Regimens Across Disease Settings

PeerView Oncology & Hematology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Jul 7, 2025 78:15


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.

PeerView Clinical Pharmacology CME/CNE/CPE Video
Heinz-Josef Lenz, MD, FACP - Catalysts for Redefined Care in Colorectal Cancer: Adapting Systemic Therapy Regimens Across Disease Settings

PeerView Clinical Pharmacology CME/CNE/CPE Video

Play Episode Listen Later Jul 7, 2025 78:15


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.

PeerView Gastroenterology CME/CNE/CPE Audio Podcast
Heinz-Josef Lenz, MD, FACP - Catalysts for Redefined Care in Colorectal Cancer: Adapting Systemic Therapy Regimens Across Disease Settings

PeerView Gastroenterology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Jul 7, 2025 78:15


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.

PeerView Gastroenterology CME/CNE/CPE Video Podcast
Heinz-Josef Lenz, MD, FACP - Catalysts for Redefined Care in Colorectal Cancer: Adapting Systemic Therapy Regimens Across Disease Settings

PeerView Gastroenterology CME/CNE/CPE Video Podcast

Play Episode Listen Later Jul 7, 2025 78:15


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.

For our Love of Science
Ep 77: A Bond of Purpose from Academia to Industry - The Journey

For our Love of Science

Play Episode Listen Later Jul 7, 2025 24:00


We are joined again by Christine Vazquez, a viral immunologist and Principal Scientist at GSK, to hear about her journey into science. The earliest memories from her childhood picture Christine sitting with her dad watching educational shows like Stories from the ER and dreaming of growing up to become a medical doctor. Her dad, especially, nurtured her interest in science and reading through books. As an undergraduate at Johns Hopkins University, she was introduced to laboratory research as part of the curriculum and immediately felt a spark. “I think for me, what I became more interested in after exposure to research, was …  I don't necessarily want to treat patients. I want to figure out why they're getting sick and how to help them get better. The broad interest still was the same; the research question changed,” explains Christine. This change in her perspective, and a strong aversion to taking the MCAT, encouraged her to look beyond medical school as the next stage of her journey unfolded. But, Christine didn't really know if graduate school would be the right choice for her. More importantly, the experiences Christine had gained over time also evolved her perception of who is a scientist–some work at the bench and many others apply their knowledge to different fields like science writing and communications. There were endless opportunities for her at this stage; how could she make the right decision? Looking back at her journey, Christine had several influential mentors, especially teachers and guidance counselors who saw something in her that she didn't even see in herself. They encouraged her to participate in extra-curricular activities and opened doors to new opportunities. If she could give one piece of advice to her younger self it would be, breath, it will all work out. Outside of work, Christine enjoys reading, especially literary fiction.Check out the previous episode: https://www.buzzsprout.com/1720419/episodes/17378991 Tune into this episode to learn about Christine's journey:The importance of pivoting for Christine to find her way along her journeyHow her definition of “who is a scientist” evolved with different experiencesWhere Christine sees herself going nextReach out to Christine: https://www.linkedin.com/in/christine-vazquez/ If you enjoyed this episode, also listen to:Ep 61: The Love Language of Organic Chemistry - The JourneyEp 65: Finding Your Fit: How to Navigate the Transition from Academia to Industry – The JourneyVisit our store: WeLoveSciencePodcast.comSuggest a guest Reach out to Fatu:www.linkedin.com/in/fatubmInstagram: @thee_fatu_band LoveSciencePodcast@gmail.com Reach out to Shekerah:www.linkedin.com/in/shekerah-primus and LoveSciencePodcast@gmail.com Music from Pixabay: Future Artificial Intelligence Technology 130 by TimMoorMusic from https://freemusicarchive.org/music/Scott_Holmes: Hotshot by ScottHolmesMusic

ESC TV Today – Your Cardiovascular News
Season 3 - Ep.19: Big data in cardiology - Measuring lipids: what clinicians need to know

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jul 3, 2025 22:14


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.

ESC TV Today – Your Cardiovascular News
Season 3 - Ep.19: Extended interview on Big data in cardiology

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jul 3, 2025 9:17


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."

Pharma and BioTech Daily
Pharma and Biotech Daily: M&A Surge and Regulatory Updates in the Industry

Pharma and BioTech Daily

Play Episode Listen Later Jul 3, 2025 1:29


Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. A judge has suspended mass layoffs at the Department of Health and Human Services, ruling that the staff cuts are likely unlawful as the agency does not have the authority to make such changes without Congress. In other news, private equity firms have recently acquired Bluebird Bio, a gene therapy biotech company, raising questions about their motivations. Additionally, RFK Jr. is advocating for changes to the vaccine injury compensation program to include COVID-19 vaccines, while the FDA is considering regulatory action on Argenx's Vyvgart Hytrulo due to safety concerns. The article also discusses Gilead's plans for dominance in the HIV market with a new drug, and other updates in the pharmaceutical industry.Private equity firms are increasingly targeting biotech companies, with Bluebird Bio recently being acquired by two firms. The first half of the year saw a surge in M&A activity in the pharmaceutical industry, with big pharmas like Eli Lilly and Novartis making multiple deals. Deals related to Alzheimer's disease also saw a significant increase following the approval of new treatments. Gilead is expanding its presence in the HIV market with a new drug, while GSK is also vying for market dominance. Other notable deals include AbbVie's acquisition of Capstan and Novartis' partnership for cardiovascular disease targets. Overall, the industry is seeing increased activity and interest from private equity firms and big pharma companies.

Progress, Potential, and Possibilities
Daniel Schmitt - President & CEO, Actuate Therapeutics - Targeting Hard-To-Treat Cancers

Progress, Potential, and Possibilities

Play Episode Listen Later Jul 2, 2025 54:46


Send us a textDaniel Schmitt is President & Chief Executive Officer of Actuate Therapeutics, Inc. ( https://actuatetherapeutics.com/ ), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β).Mr. Schmitt brings over 30 years of successful industry experience in operations management, new product development, and business development, having held senior executive positions in both large pharmaceutical and small biotechnology companies, including Fujisawa, Searle / Pharmacia, and Ilex Oncology. During his career, Daniel has led and contributed to the successful development and launch of multiple pharmaceutical products, and has constructed and executed numerous high value licensing, acquisition, and development deals for biotech and pharmaceutical companies, totaling nearly $1 billion in upfront and potential milestone payments.Mr. Schmitt received his M.B.A and a B.S. in Chemistry from West Virginia University, and has held research positions affiliated with the National Foundation for Cancer Research and at the University of North Carolina School of Medicine. He has served as an Entrepreneur-in-Residence at Northwestern University, and as an external expert consultant for the University of Chicago and the University of Illinois-Chicago. Mr. Schmitt is also a founding member of Chicago Innovation Mentors.#ActuateTherapeutics #GlycogenSynthaseKinase3Beta #GSK3β #Oncology #Cancer #Elraglusib #PancreaticDuctalAdenocarcinoma #PDAC #EwingSarcoma #Melanoma #ProgressionFreeSurvival #ProgressPotentialAndPossibilities #IraPastor #Podcast #Podcaster #ViralPodcast #STEM #Innovation #Technology #Science #ResearchSupport the show

ASCO Daily News
Immunotherapy at ASCO25: Drug Development, Melanoma Treatment, and More

ASCO Daily News

Play Episode Listen Later Jun 27, 2025 27:01


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

ASCO Daily News
What Lung Cancer Abstracts Stood Out at ASCO25?

ASCO Daily News

Play Episode Listen Later Jun 25, 2025 29:49


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 

ASCO Daily News
GI Cancer Research at ASCO25: Plenary Highlights and More

ASCO Daily News

Play Episode Listen Later Jun 24, 2025 20:47


Dr. Shaalan Beg and Dr. Kristen Ciombor discuss practice-changing studies in GI cancers and other novel treatment approaches that were presented at the 2025 ASCO Annual Meeting. Transcript Dr. Shaalan Beg: Hello, I'm Dr. Shaalan Beg, welcoming you to the ASCO Daily News Podcast. I'm a medical oncologist and an adjunct associate professor at UT Southwestern Medical Center in Dallas, Texas. There were some remarkable advances in gastrointestinal cancers that were presented at the 2025 ASCO Annual Meeting, and I'm delighted to be joined by Dr. Kristen Ciombor to discuss some exciting GI data. Dr. Ciombor is the Ingram Associate Professor of Cancer Research and a co-leader of Translational Research and the Interventional Oncology Research Program at the Vanderbilt Ingram Cancer Center. Our full disclosures are available in the transcript of this episode. Dr. Ciombor, it's great to have you on the podcast today. Dr. Kristen Ciombor: Thanks, Dr Beg. It's great to be here. Dr. Shaalan Beg: Alright, let's kick it off. Big year for GI cancers. We'll start off with LBA1. This was the ATOMIC study sponsored by NCI and the National Clinical Trials Network (NCTN) and the Alliance group. This is a randomized study of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for stage III mismatch repair deficient colorectal cancer. Dr. Kristen Ciombor: I think this study was really definitely practice-changing, as you can tell because it was a Plenary. But I do have some concerns in terms of how we're actually going to implement this and whether this is the final answer in this disease subtype. So, as you said, the patients were enrolled with stage III resected mismatch repair deficient colon cancer, and then they were randomized to either modified FOLFOX6 with or without atezolizumab. And that's where it starts to become interesting because not many of us give FOLFOX for 6 months like was done in this study. Obviously, the study was done over many years, so that was part of that answer, but also the patients received atezolizumab for a total of 12 months. So the question, I think, that comes from this abstract is, is this practical and is this the final answer? I do think that this is practice-changing, and I will be talking to my patients with resected mismatch repair deficient colon cancer about FOLFOX plus atezolizumab. I think the big question is, do these patients need chemotherapy? And can we do a neoadjuvant approach instead? And that's where we don't have all the answers yet. Dr. Shaalan Beg: Yeah, but it has been great to see immunotherapy make its way into the adjuvant space after having made such a big impact in the metastatic space, but still some unanswered questions in terms of the need for chemotherapy and then the duration of therapy, which I guess we'll have to stay tuned in for the next couple of years to to get a lot of those questions answered. Dr. Kristen Ciombor: Yeah, but a big congratulations to the study team, to the NCTN, the NCI. I mean, this is really a great example of federally funded research that needs to continue. So, great job by the study team. The DFS 10% difference is really very large and certainly a practice-changing study. Dr. Shaalan Beg: Yeah, and and sticking with colon cancer, and and this another federally funded study, but this time funded by a Canadian cancer clinical trials group was LBA3510. This is the CHALLENGE study. It's a randomized phase 3 trial of the impact of a structured exercise program on disease-free survival for stage III or high-risk stage II colon cancer. This study got a lot of buzz, a lot of mainstream press coverage, and a lot of discussions on what that means for us for the patients who we're going to be seeing next week in our clinic. What was your takeaway? Dr. Kristen Ciombor: Yeah, this is a really interesting study, and I was so glad to see it presented because this partially answers one of the questions that patients always have for us in clinic, right? You know, once they've completed their standard chemotherapy and surgery, what else can they do to help prevent recurrence? And so we've always known and sort of extrapolated that healthy lifestyle habits are good, but now we have data, particularly in these patients. Most of them were stage III colon cancer patients, those had high-risk stage II cancer. And basically, the goal was to increase their physical activity by at least 10 MET hours per week. So, my big question, of course, as I came into this presentation was, “Okay, what does that mean exactly? How does that translate to real life?” And really what the author presented and explained was that basically most patients could hit their target by adding a 45- to 60-minute brisk walk 3 to 4 times a week. So I think this is very approachable.  Now, in the confines of the study, this was a structured exercise program, so it wasn't just patients doing this on their own. But I do think kind of extrapolating from that, that this is very achievable for most patients. And not only did this prevent recurrence of their prior cancer, but actually the rate of new primary cancer diagnoses, was less, which is really interesting, especially in the breast and prostate cancer. So this was a really interesting, and I think practice-changing study as well, especially given that this is something that most patients can do. Dr. Shaalan Beg: Yeah, and there was a lot of discussion in the hallways after the presentation in terms of how this really changes our existing practice because most folks already recommend exercise as a way for improving outcomes in cancer patients. So we've already been doing that. Now we have some data on how much it can impact the benefit. But there was some discussion about what the actual degree of impact was. There was a drop-off rate in terms of how long folks were able to stick with this exercise regimen. But you've seen this in clinic when someone have their surgery, they have their chemotherapy, they've been so intimately involved with the oncology world, with the oncology practice, and they somehow feel that they're being let loose into this mean, angry world without any guidance and they're looking for something to do. “What more can I do in terms of my lifestyle?” And then here we have very solid data, as solid as can be for an intervention like exercise, showing that there is an impact and you can give a prescription for exercise when someone wraps up their chemotherapy for colon cancer, thanks to the study. Dr. Kristen Ciombor: Yeah. It was a great study. Dr. Shaalan Beg: Moving to gastroesophageal cancer, another late-breaking abstract. This is LBA5. The MATTERHORN trial was a phase 3 trial of durvalumab plus FLOT for resectable GE junction and gastric cancer. And again, another area where immunotherapy has made an impact, and here we're seeing it move closer for earlier-stage disease. What was your take-home for the MATTERHORN trial? Dr. Kristen Ciombor: Yeah, so this study looked at neoadjuvant perioperative durvalumab plus our current standard chemotherapy of FLOT versus placebo plus FLOT. And this was a large study, almost 1,000 patients were randomized. And the primary endpoint was event-free survival, and it was definitely met in favor of the D + FLOT arm, as Dr. Klempner discussed after Dr Janjigian's presentation. I do think there are still some unanswered questions here. Overall survival is not yet mature, so we do have to wait and see how that shakes out. But it's very interesting and kind of is reflective of what, as you said, we're looking at earlier and earlier lines of therapy, particularly with immunotherapy, in these GI cancer spaces. So it makes a lot of sense to test this and and to look at this. So the toxicity was pretty similar to what we would expect. Primary endpoint was met, but again, we'll have to wait and see what the survival data looks like. Dr. Shaalan Beg: Yeah, and in oncology, we know, especially for treatment that does add additional cost, it does add additional potential toxicity that we want to see that overall survival nudged. I did see some polls on social media asking folks whether their practices changed from this, and I think the results were favoring adding durvalumab for this group of patients but understanding that there are caveats to the addition of treatments and the eventual FDA approval in that indication as well. Dr. Kristen Ciombor: Exactly. I completely agree with that. Dr. Shaalan Beg: All right. How about we stick with gastroesophageal cancer? LBA4002 was trastuzumab deruxtecan versus ramucirumab plus paclitaxel for second-line treatment in HER2-positive unresectable or metastatic gastric cancer or GE junction cancer. This was the DESTINY-Gastric04 study. And again, antibody-drug conjugates making a big impact across different diseases. And here we have more data in the HER2-positive gastric cancer space. Your thoughts on this study? Dr. Kristen Ciombor: Yeah, so this is a really important space in gastroesophageal cancer because the HER2 positivity rate is fairly high as compared to some of our other tumor types. So, I do think one of the important things was that patients did have biopsy confirmation of HER2 status, which was very important, and then they were randomized to either T-DXd versus the kind of second-line standard of ramucirumab-paclitaxel. So this was a great practical study and really answers a question that we had for a while in terms of does anti-HER2 therapy in the second-line really impact and improve survival. So we did see a statistically significant improvement favoring T-DXd. I do think it's always important to look at toxicity, though, too. And there was about almost 14% rate of interstitial lung disease, which of course is the most feared toxicity from some of these antibody-drug conjugates, especially T-DXd. So I do think it's important to keep that in mind, but this is definitely a great addition to the armamentarium for these HER2-positive patients. Dr. Shaalan Beg: And pancreas cancer was on the stage after a very long time with a positive clinical trial. This is Abstract 4006. These were preliminary results from a phase 2 study of elraglusib in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel alone for previously untreated metastatic pancreas cancer. This is a frontline clinical trial of gemcitabine/nab-paclitaxel plus/minus the study drug. There were other cohorts in this study as well, but they reported the results of their part 3B arm. And great to see some activity in the pancreas space. And your thoughts? Dr. Kristen Ciombor: Yeah, we definitely need better treatments in pancreas cancer. This was a very welcome presentation to see. The elraglusib is an inhibitor of GSK-3beta, and it's thought that that mediates drug resistance and EMT. And so this is, I think, a perfect setting to test this drug. So patients basically were randomized. Patients with metastatic pancreas cancer were randomized 2: 1 to gemcitabine/nab-paclitaxel plus or minus this elraglusib. So, what we saw was that overall survival was better with the addition of this new drug. And overall, not only the 1-year overall survival, but also median overall survival.  The thing that was interesting, though, was that we saw that the overall survival rates were 9.3 months with the combination versus 7.2 months with just gemcitabine/nab-paclitaxel. And that's a little bit lower than we've seen in other studies. So, not sure what was going on there. Was it the patients that were a bit sicker? Was it a patient selection, you know, thing? I'm not really sure how to explain that so much. Also, the toxicity profile was much higher in terms of visual impairment, with over 60% of patients being treated with the combination versus 9% with gemcitabine/nab-paclitaxel. So these were mild, grade 1 and 2, but still something to be cautious about. Dr. Shaalan Beg: And especially with this being a phase 2 trial, making sure that in a larger study we're able to better evaluate the toxicity and see if the control arm in the larger confirmatory study performs differently will be really important before this compound makes it to the clinic in our space. But very exciting to see these kinds of results for pancreas adenocarcinoma. Dr. Kristen Ciombor: Yeah. Dr. Shaalan Beg: We've talked, it seems, a couple of times on this podcast about the BREAKWATER clinical trial. We did hear PFS and updated OS data, updated overall survival data on first-line encorafenib plus cetuximab plus modified FOLFOX6 for BRAF-mutated colorectal cancer. This was LBA3500. And eagerly anticipated results – we have all previously heard the progression-free survival results – but here we heard updated overall survival results, and very well-received study it seemed from the audience that time. So what are your takeaways on the updated results for BREAKWATER? Dr. Kristen Ciombor: In my opinion, this was one of the most practice-confirming studies. As you mentioned, we've already seen some of the preliminary data of BREAKWATER at prior meetings. But really what was particularly impactful for me was the median overall survival with the BREAKWATER regimen. So, again, patients received FOLFOX, encorafenib cetuximab in the first line if they had BRAF-mutated V600E-mutated colorectal cancer. And the median PFS was 12.8 months, which was actually really remarkable in this traditionally very aggressive, poor prognosis subtype of tumors. So, by seeing a median overall survival of 30.3 months was just incredible, in my opinion. Just a few years ago, that was considered the median overall survival for all comers for metastatic colorectal cancer. And we know the median overall survival was more in the less than 12 months range for BRAF. So this was incredibly impactful, and I think should be absolutely practice-changing for anyone who is eligible for this regimen.  I think again, where the practice meets the study is what's kind of important to think about too, how long did patients get FOLFOX, and certainly it adds toxicity to add a BRAF-targeted regimen on top of FOLFOX already. So, one of the other interesting things about the study, though, was that even though it didn't complete treatment, they actually did look at encorafenib/cetuximab alone and in the first line without chemotherapy. And those preliminary results actually looked okay, especially for patients who might not be able to tolerate chemotherapy, which we certainly see in practice. So, overall, definitely more data. And I agree that it's certainly practice-changing. Dr. Shaalan Beg: And it completely, as you mentioned, changes the outlook for a person who's diagnosed with BRAF-mutated metastatic colon cancer today versus even 7 or 8 years ago. Dr. Kristen Ciombor: And we're seeing this over and over in other subtypes too, but how you choose to treat the patient up front really matters. So really giving the right regimen up front is the key here. Dr. Shaalan Beg: And along the same lines, Abstract 3501 wanted to answer the question on whether people with MSI-high metastatic colorectal cancer need double checkpoint inhibitor therapy or is single therapy enough. So this [CheckMate-8HW] study compared nivo plus ipi with nivo alone, nivo monotherapy for MSI-high metastatic colorectal cancer. And we've known that both of these are fairly active regimens, but we also know the chance of immune-related adverse events is significantly higher with combination therapy. So this was a much-needed study for this group of patients. And what were your takeaways here? Dr. Kristen Ciombor: This, of course, has been really nivo-ipi in the first-line MSI-high metastatic colorectal cancer is now a standard of care. And not everybody is eligible for it, and there could be reasons, toxicity reasons, and other things too. But as we've been seeing for the last couple of years, immunotherapy clearly beats chemo in this space. And now looking at doublet versus single immunotherapy treatment in the first line, I think really nivo-ipi does beat out monotherapy. I will say, however, there is a caveat in that we still haven't seen the nivo-ipi versus nivo in the first line. So what has been presented thus far has been across all lines of therapy, and that does muddy the waters a little bit. So definitely looking forward and and we've asked this many times and based on the statistical plan and and what not, you know, we just haven't seen that data yet. But I do think it's becoming increasingly important to consider doublet immunotherapy for these patients as long as there are no contraindications. With the again, with the caveat that we have to have these toxicity discussions in the clinic with patients because many patients can tolerate it, you know, this regimen fairly well, but there can be very severe toxicities. So, I think an informed discussion should really be had with each patient before moving forward. Dr. Shaalan Beg: Yeah, informed decision, making them aware of the potential of real significant toxicities, immune-related toxicities with double therapy. But I am curious in your practice, how often do you see people choosing doublet therapy as frontline? Dr. Kristen Ciombor: So patients are really savvy, and a lot of times they've heard this data before or have come across it in patient advocacy groups and other things, and it's really nice to be able to have that conversation of the risk versus benefit. So I will say not all of my patients choose doublet, and many of them are still cured with immunotherapy monotherapy. So the big question there is, will we ever understand who actually needs the doublet versus who can still be cured or have very good long-term outcomes with just the single agent? And that has not been answered yet. Dr. Shaalan Beg: What a great point. So the last abstract I was hoping we could talk about is POD1UM-303 or the INTERAACT2 subgroup analysis and impact of delayed retifanlimab treatment for patients with squamous cell carcinoma of the anal canal. What were your thoughts here? Dr. Kristen Ciombor: This was a study, actually we saw at ESMO, we saw the primary data at ESMO last year, and this was an update with some exploratory analyses. But this was really an important study because once again, we're looking at immunotherapy in later lines of therapy. That's how we started looking at and investigating immunotherapy, and now we're moving it up and up in the treatment course. So this was a study of carboplatin/paclitaxel plus or minus retifanlimab. Actually it was retifanlimab versus placebo. And it was a positive study, as we heard last year. This actually led to FDA approval of this regimen last month, just before ASCO, and it has now been incorporated in the NCCN guidelines as the preferred first-line option.  So what I thought was important from the additional data presented at ASCO was looking at the different subgroups, it did not appear that patients with liver mets or not had different outcomes. So that was really good to see because sometimes in colon cancer we see that immunotherapy doesn't work as well when patients have liver mets. And interestingly, because we use immunotherapy in anal cancer without any biomarkers, unlike with colon cancer or some of the other tumor types, also the authors looked at PD-L1 status, and it did look like maybe patients did a little bit better if they had higher PD-L1 expression, but patients still could benefit even if they were PD-L1 negative. So that was important, I think, and we will continue to see further data come out from this study. I want to mention also that EA2176 just completed accrual, so that was carbo-taxol plus or minus nivolumab. And so we should be seeing that data sometime soon, which will hopefully also confirm the ongoing role for immunotherapy in the first-line setting for anal cancer. Dr. Shaalan Beg: That was a fantastic review. Thank you, Dr Ciombor. Thanks for sharing your valuable insights with us today on the ASCO Daily News Podcast. Dr. Kristen Ciombor: Thanks for having me here. Dr. Shaalan Beg: And thank you to our listeners for your time today. You will find links to the abstracts discussed today in the transcript of this episode. And if you value the insights that you hear on the podcast, please take a moment to rate, review, and subscribe, wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and 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. Shaalan Beg  @ShaalanBeg  Dr. Kristen Ciombor @KristenCiombor Follow ASCO on social media:    @ASCO on Twitter   @ASCO on BlueSky  ASCO on Facebook    ASCO on LinkedIn    Disclosures:   Dr. Shaalan Beg:   Consulting or Advisory Role: Ipsen, Cancer Commons, Foundation Medicine, Science37, Nant Health, Lindus Health Speakers' Bureau: Sirtex Research Funding (Inst.): Delfi Diagnostics, Universal Diagnostics, Freenome Dr. Kristen Ciombor: Consulting or Advisory Role: Pfizer, Incyte, Exelixis, Bayer, ALX Oncology, Tempus, Agenus, Taiho Oncology, Merck, BeiGene Research Funding (Inst.): Pfizer, Boston Biomedical, MedImmune, Onyx, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Novartis, Incyte, Amgen, Sanofi, Bristol-Myers Squibb, Array BioPharma, Incyte, Daiichi Sankyo, Nucana, Abbvie, Merck, Pfizer/Calthera, Genentech, Seagen, Syndax Travel, Accommodations, Expenses: Incyte, Tempus

IDEA Collider
Bridging Clinical Practice and Biotech: Paul Peter Tak's Transformative Journey

IDEA Collider

Play Episode Listen Later Jun 22, 2025 49:58


In this episode of Idea Collider, host Mike Rea interviews Paul Peter Tak, CEO of Candel Therapeutics, discussing his remarkable journey from a clinician in Amsterdam to leading cutting-edge biotech companies. Paul shares pivotal moments in his career, the challenges of transitioning from academia to big pharma, and the innovative principles he applied. He dives deep into Candel's promising work in viral immunotherapies for cancers and the unique leadership and management philosophies that have guided his journey. Additionally, Paul Peter touches on his passion for leveraging collective intelligence and his unconventional hobbies that keep him grounded and creative. 00:00 Introduction and Guest Welcome00:59 Early Career and Passion for Medicine02:09 Transition to Industry and GSK Experience04:50 Building Successful Organizations07:42 Innovative Models in Pharma19:03 Joining Candel Therapeutics and Vision for the Future25:15 Transforming Cancer Treatment27:24 Challenges in Biotech Market28:45 Strategic Decisions and Prioritization31:39 Collaborations and External Partnerships33:07 Innovative Approaches and Future Prospects44:23 Leadership and Personal Insights Don't forget to Like, Share, Subscribe, Rate, and Review! Keep up with Paul Peter Tak;LinkedIn: https://www.linkedin.com/in/paul-peter-tak-md-phd-fmedsci-1b44749/ Follow Mike Rea On;Website: https://www.ideapharma.com/X: https://x.com/ideapharmaLinkedIn: https://www.linkedin.com/in/bigidea/ Listen to more fantastic podcast episodes: https://podcast.ideapharma.com/

ESC TV Today – Your Cardiovascular News
Season 3 - Ep.18: Heart disease risk: Framingham Heart Study insights - Sudden death in female athletes

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jun 19, 2025 25:48


This episode covers: Cardiology This Week: A concise summary of recent studies Heart disease risk: Framingham Heart Study insights Sudden death in female athletes Mythbusters: Owning a pet reduces the risk of heart disease Host: Susanna Price Guests: Carlos Aguiar, Sabiha Gati, Vasan Ramachandran Want to watch that episode? Go to: https://esc365.escardio.org/event/1809 Want to watch that extended interview on sudden death in athletes? Go to: https://esc365.escardio.org/event/1809?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. The ESC is not liable for any translated content of this video.The English-language always prevails. 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.   Declarations of interests Stephan Achenbach, Sabiha Gati, Nicolle Kraenkel, Susanna Price and Vasan Ramachandran 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.

ESC TV Today – Your Cardiovascular News
Season 3 - Ep.18: Extended interview on sudden death in athletes

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jun 19, 2025 10:01


Host: Susanna Price Guest: Sabiha Gati Want to watch that extended interview on LDL management? Go to: https://esc365.escardio.org/event/1809?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/1809   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, Sabiha Gati, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. 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.

Notícia no Seu Tempo
CONTEÚDO PATROCINADO - HIV: o que sua saúde sexual tem a ver com isso? com Dr. Vinícius Borges, o Dr Maravilha

Notícia no Seu Tempo

Play Episode Listen Later Jun 11, 2025 12:18


Neste episódio especial da série: Precisamos Falar sobre HIV, uma parceria da GSK com o Estadão Blue Studio, o médico infectologista Dr. Vinícius Borges — mais conhecido como Dr. Maravilha — conduz uma conversa direta, acessível e atualizada sobre HIV, prevenção e saúde sexual. Com ênfase nas novas possibilidades de prevenção, como a PrEP (Profilaxia Pré-Exposição), o Dr. Maravilha explora o que há de mais moderno em estratégias de cuidado e autonomia. Informação de qualidade, sem tabu. Dê o play e venha entender o que sua saúde sexual tem a ver com tudo isso.See omnystudio.com/listener for privacy information.

ESC TV Today – Your Cardiovascular News
Season 3 - Ep.17: Extended interview on strategies to reach LDL cholesterol goals in high-risk patients

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jun 5, 2025 9:15


Host: Susanna Price Guest: J. Wouter Jukema Want to watch that extended interview on LDL management? Go to: https://esc365.escardio.org/event/1807?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/1807 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. Declarations of interests Stephan Achenbach, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. J. Wouter Jukema has declared to have potential conflicts of interest to report: J. Wouter Jukema/his department has received research grants from and/or was speaker (CME accredited) meetings sponsored/supported by Abbott, Amarin, Amgen, Athera, Biotronik, Boston Scientific, Dalcor, Daiichi Sankyo, Edwards Lifesciences, GE Healthcare Johnson and Johnson, Lilly, Medtronic, Merck-Schering-Plough, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi Aventis,Shockwave Medical, the Netherlands Heart Foundation, CardioVascular Research the Netherlands (CVON), the Netherlands Heart Institute and the European Community Framework KP7 Programme. 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.

ESC TV Today – Your Cardiovascular News
Season 3 - Ep.17: Coronary sinus reducer - Strategies to reach LDL cholesterol goals in high-risk patients

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later Jun 5, 2025 21:26


This episode covers:  Cardiology this Week: A concise summary of recent studies Coronary sinus reducer: promise in refractory angina Best strategies to reach LDL cholesterol goals in high-risk patients Snapshots Host: Susanna Price Guests: Carlos Aguiar, Rasha Al-Lamee, J. Wouter Jukema, Steffen Petersen Want to watch that episode? Go to: https://esc365.escardio.org/event/1807 Want to watch that extended interview on LDL management? Go to: https://esc365.escardio.org/event/1807?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. Declarations of interests Stephan Achenbach, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Rasha Al-Lamee has declared to have potential conflicts of interest to report: speaker's fees for Menarini pharmaceuticals, Abbott, Philips, Medtronic, Servier, Shockwave, Elixir. Advisory board: Janssen Pharmaceuticals, Abbott, Philips, Shockwave, CathWorks, Elixir. 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. J. Wouter Jukema has declared to have potential conflicts of interest to report: J. Wouter Jukema/his department has received research grants from and/or was speaker (CME accredited) meetings sponsored/supported by Abbott, Amarin, Amgen, Athera, Biotronik, Boston Scientific, Dalcor, Daiichi Sankyo, Edwards Lifesciences, GE Healthcare Johnson and Johnson, Lilly, Medtronic, Merck-Schering-Plough, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi Aventis, Shockwave Medical, the Netherlands Heart Foundation, CardioVascular Research the Netherlands (CVON), the Netherlands Heart Institute and the European Community Framework KP7 Programme. 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.

NP Pulse: The Voice of the Nurse Practitioner (AANP)
151. Listen Up: Prioritizing RSV Vaccination for Adults (CE)

NP Pulse: The Voice of the Nurse Practitioner (AANP)

Play Episode Listen Later Jun 4, 2025 67:31 Transcription Available


Join expert nurse practitioners Drs. Ruth Carrico and Audrey Stevenson on this engaging podcast episode as they illuminate the critical importance of respiratory syncytial virus (RSV) vaccination for adults. Learn actionable strategies to boost RSV vaccine uptake, address health disparities and protect your most vulnerable patients from this serious respiratory illness. A participation code will be provided at the end of the podcast — make sure to write this code down. Once you have listened to the podcast and have the participation code, return to this activity in the AANP CE Center (aanp.org/cecenter). Click on the "Next Steps" button of the activity and: Enter the participation code that was provided. Complete the post test. Complete the activity evaluation. This will award your continuing education (CE) credit and certificate of completion. 1.25 CE will be available through June 30, 2026. This podcast was supported by an independent medical education grant from GSK. Download the clinical resource handout here: 101199-PCE-AANP-RSV-Vaccine-infographic

The EMG GOLD Podcast
S10 E01: GSK's Dheepa Chari on the evolving sphere of scientific communication

The EMG GOLD Podcast

Play Episode Listen Later Jun 4, 2025 28:11


The EMJ GOLD podcast is back for a new season! In the first episode of season 10, the team are joined by Dheepa Chari, Vice President and Head of Global Scientific Communications, GSK, to discuss the past, present and future of scientific communications. Together, Dheepa and Isabel explore her journey from biostatistics to biopharma leadership — and the lessons learned along the way. They discuss what great science communication looks like, where it's heading next and why storytelling still matters in a digital-first world. Plus, expect practical insights on cross-functional collaboration and the growing role of AI. A little more on EMJ GOLD's guest… Dheepa Chari is the Vice President and Head of Global Scientific Communications at GSK. Here, she leads strategy and execution across Oncology, Vaccines, Specialty Care and General Medicine, driving innovation in how scientific narratives are delivered across channels. Before joining GSK in 2024, Dheepa held senior posts at Pfizer, Amgen and Novartis in both clinical and communications roles. Outside of work, Dheepa brings stories to life in a different way - as a singer-songwriter who regularly performs in New York City.

ACRO's Good Clinical Podcast
S3: E7 The Impact of ICH E6(R3): Sponsor and CRO Perspectives

ACRO's Good Clinical Podcast

Play Episode Listen Later Jun 3, 2025 26:11


In the latest collaboration between ACRO and TransCelerate BioPharma, Cris McDavid (Senior Director, Global Clinical Operations, Parexel) and Tashan Mistree (Senior Director, Business Operations, Office of Chief Medical Officer, GSK) join this week's episode to discuss the impact of ICH E6(R3) from their different vantage points in the clinical research industry. They dive deeper into their experiences implementing the new guidance at their respective companies, the new opportunities that R3 has created in the partnership between CROs and sponsors, and how they envision the future state of R3 once industry has fully embraced the guidance. FIND ACRO & TRANSCELERATE'S ICH E6(R3) TOOLS & RESOURCES HERE: https://www.acrohealth.org/initiatives-hub/interpreting-ich-e6r3/ 

Treating Blood Cancers
Advancing Care in Myeloproliferative Neoplasms (MPNs)

Treating Blood Cancers

Play Episode Listen Later May 29, 2025 32:51


Aaron Gerds, MD, MS, Cleveland Clinic, Cleveland, OH Recorded on May 13, 2025 Aaron Gerds, MD, MS Associate Professor of Medicine Cleveland Clinic Lerner College of Medicine Case Western Reserve University School of Medicine Medical Director Case Comprehensive Cancer Center Clinical Research Office Cleveland, OH In this episode, Dr. Aaron Gerds from the Cleveland Clinic explores the intricacies of Myeloproliferative Neoplasms (MPNs), from diagnosis and monitoring to treatment goals and the latest therapeutic advances. Dr. Gerds discusses emerging therapies, the significance of clinical trials, strategies for managing side effects and long-term effects, and valuable resources for healthcare professionals, patients, and families. Tune in today for expert insights on MPNs! This episode is supported by GSK plc and Karyopharm Therapeutics.

Careers in Discovery
Pascal Lestrate, Vicebio

Careers in Discovery

Play Episode Listen Later May 28, 2025 46:23


After nearly two decades at GSK, Pascal Lestrate took a leap into Biotech, joining Vicebio as Chief Preclinical Science Officer. In this episode of Careers in Discovery, Pascal shares how the shift from big pharma to early-stage Biotech gave him a chance to return to hands-on science - and start with a blank page. We explore the pioneering work Vicebio is doing on multi-pathogen respiratory vaccines using molecular clamp technology, including how their approach could reduce the number of injections needed while improving vaccine stability and access in low-resource settings. Pascal also reflects on his rich and varied career, from molecular biology and immunology to regulatory affairs, quality systems, and digital transformation. Along the way, he shares lessons on navigating major career transitions, leading without deep technical expertise, and how curiosity, values, and a willingness to take up space have shaped his path.

Smarter Podcasting: Making Podcasts Better
MONETIZATION: The Real Value of Podcasting with Charlotte Lewis-West

Smarter Podcasting: Making Podcasts Better

Play Episode Listen Later May 26, 2025 35:04


"There is  more  and more money  going into podcasting advertising every year. Billions and billions now worldwide. So where is it?"Let's be honest—everywhere you turn, you're being told podcasting is a goldmine. Billions of dollars in ad revenue! Massive growth! Side hustle magic! But where is that money really going? Because it's not landing in your inbox—or mine.In this episode of Smarter Podcasting, I'm joined by the brilliant Charlotte Lewis-West, a podcast strategist with a background in broadcast journalism and over a decade working with brands like GSK, Microsoft and Unilever. She's also one of my favourite people to work with at Seven Million Bikes Podcasts.Together, we dig into the real value of podcasting—and why making money through ads and sponsorships isn't the only (or smartest) goal. Charlotte and I get honest about what we've seen in the industry: the hype, the empty promises, and the reality for both indie creators and big-name brands.Here's what we cover:Why most podcast ad money goes to massive networks and the same three sponsors (hello, BetterHelp)Why I've hit over 100,000 downloads and never once had a sponsor approach meWhy brands keep making the same mistakes when launching a show—and how to avoid themThe real return on investment: brand awareness, authority, networking, and trustWhy engagement rate matters more than total downloadsHow to use your podcast to build relationships, not just numbersHow you should actually handle sponsors if they do come knocking (and how not to sell out your voice)We also get into some hard truths about what makes a podcast successful. Spoiler: it's not going viral or chasing trends. It's consistency, knowing your audience, and delivering actual value—week after week.This isn't about crushing dreams. It's about saving you from wasting time, money, and energy on the wrong things—and helping you build a podcast that works for you and your business.Timestamps02:02 – Why I started Smarter Podcasting and what we've achieved03:46 – Charlotte breaks down where the podcast ad money really goes07:00 – Why most shows (even good ones) don't get sponsors09:52 – How many downloads I've had—and why that's not the whole story13:00 – The real reasons to start a podcast (hint: not for ad money)17:30 – The biggest mistakes brands make with podcasts20:10 – “Build it and they will come” is a lie22:32 – The indie podcaster dilemma: doing too much at once24:58 – Monetization beyond sponsorship: smarter ways to get ROI28:10 – What to look for in a sponsor—and how to avoid sounding fake30:45 – Why authentic ads win and scripts usually suckSend us a textThe Podcast Launch LabThe Podcast Makeover Sign up for Descript now! Need a stunning new logo for your brand? Or maybe a short animation?Whatever you need, you can find it on Fiverr.I've been using Fiverr for years for everything from ordering YouTube thumbnails, translation services, keyword research, writing SEO articles to Canva designs and more!

Pharma and BioTech Daily
Pharma and Biotech Daily: Your Daily Dose of What Matters in the Industry

Pharma and BioTech Daily

Play Episode Listen Later May 26, 2025 1:07


Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.A court has halted the Trump administration's plans to reduce and lay off employees in government agencies, citing a lack of authority. Meanwhile, a report called "Make American Healthy Again" criticizes pharmaceutical lobbying, GLP-1s, and vaccines. The report also addresses rising autism rates and over-medication of children. Bio-Rad is redefining antibody discovery with their Pioneer Antibody Discovery Platform.In other news, Merus' bispecific shows promise in head-and-neck cancer, while Congress narrowly passes a tax bill with changes to IRA penalties and negotiation exemptions for orphan drugs. The FDA vaccine advisors agree on a COVID-19 vaccine as a new framework looms, and GSK wins expansion for Nucala after an FDA delay. Lilly expresses concern as CMS leaves obesity drugs out of Medicare coverage, and Sanofi acquires Vigil for $470 million upfront. And that's all for today's updates in the pharmaceutical and biotech world. Stay tuned for more essential news in our next episode.

ESC TV Today – Your Cardiovascular News
Season 3 - Ep.16: The role of cardiac magnetic resonance in myocardial disease - Air pollution and heart disease

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later May 22, 2025 25:29


This episode covers: Cardiology This Week: A concise summary of recent studies The role of cardiac magnetic resonance in myocardial disease Air pollution and heart disease Statistics Made Easy: Quasi-experimental study designs Host: Rick Grobbee Guests: Carlos Aguiar, Steffen Petersen, Mark Miller Want to watch that episode? Go to: https://esc365.escardio.org/event/1806 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. Declarations of interests: Stephan Achenbach, Rick Grobbee, Nicolle Kraenkel and Mark Miller 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.

ESC TV Today – Your Cardiovascular News
Season 3 - Ep.16: Extended interview on The role of cardiac magnetic resonance in myocardial disease 

ESC TV Today – Your Cardiovascular News

Play Episode Listen Later May 22, 2025 11:27


Host: Rick Grobbee Guest: Steffen Petersen Want to watch that extended interview? Go to: https://esc365.escardio.org/event/1806?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. Declarations of interests: Stephan Achenbach, Rick Grobbee 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.

BioCentury This Week
Ep. 297 - European Biotech's Moment? Plus: Biomarin, Boston Deals & Novo Nordisk CEO

BioCentury This Week

Play Episode Listen Later May 20, 2025 35:58


The turbulence that has come with the Trump administration's policies related to the U.S. biopharmaceutical industry is creating an opening for Europe to bolster its life sciences industry. On the latest BioCentury This Week podcast, BioCentury's editors look at how Europe can capitalize on staffing cuts at FDA and NIH and an uncertain policy environment to lure back talent to bolster regulatory agencies and biotech R&D engines and attract assets and partners from China.The editors also discuss two biotech deals driven by former leaders of BD at Roche, Biomarin's James Sabry and Sophie Kornowski at Boston Pharmaceuticals. Under the leadership of Sabry and CEO Alexander Hardy, Biomarin delivered its first takeout in a decade by acquiring Inozyme as it positions itself to take advantage of a regulatory and policy environment that they believe is favorable to their rare disease strategy. CEO Kornowski, meanwhile, executed on a plan to focus her company on a single liver disease asset that GSK acquired for $1.2 billion up front. Finally, BioCentury's editors discuss the management shake-up at obesity company Novo Nordisk, where Lars Fruergaard Jørgensen, the leader who spearheaded Novo Nordisk's transformation into a dominant player in obesity, is stepping down.Chan Zuckerberg Chicago Biohub is hosting an exclusive, invite-only reception on June 3 — the eve of BioCentury's Grand Rounds conference — gathering top voices in biotech innovation and investment to exchange bold ideas, spark new collaborations and channel the energy of Chicago's thriving innovation ecosystem. If you're interested in attending, please register here. This episode was sponsored by Jeito Capital.View full story: https://www.biocentury.com/article/655964#biotech #biopharma #pharma #lifescience #politics #policy #law00:01 - Sponsor Message: Jeito Capital05:05 - European Biotech's Moment?19:00 - Boston Pharma, Biomarin Deals29:41 - Novo Nordisk CEOTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The Great Girlfriends Show
Beyond the Usual Aches- The Surprising Signs Your Body Might Be Battling Lupus

The Great Girlfriends Show

Play Episode Listen Later May 14, 2025 35:19


WALL STREET COLADA
Tregua Comercial Impulsa a Wall Street, Farmacéuticas Bajo Presión por Orden Ejecutiva

WALL STREET COLADA

Play Episode Listen Later May 12, 2025 4:29


En este episodio analizamos las claves del inicio de semana en los mercados: • Wall Street vuela tras tregua EE.UU.–China: Futuros al alza con $SPX +3.1%, $US100 +4% y $INDU +2.4%. EE.UU. y China acordaron reducir aranceles por 90 días: Washington bajará del 145% al 30% y Pekín del 125% al 10%. Las conversaciones en Suiza fueron calificadas como “productivas” y se creará un mecanismo de consultas para seguir negociando. El mercado también espera el CPI de abril mañana. • Acuerdo alivia guerra arancelaria: El pacto cubre la mayoría de tarifas recíprocas recientes. Ambas potencias mantendrán la pausa mientras discuten nuevos términos. Se evalúa una posible reunión en EE.UU., China o un país neutral. Las bolsas globales reaccionan con fuerza al anuncio. • Trump golpea a farmacéuticas con nueva orden: El presidente anunció una orden ejecutiva para reducir precios de medicamentos entre 30%-80%, alineándolos con estándares internacionales. $LLY -2.2%, $AMGN -2.6%, $MRK -2.4%, $PFE -3.3%. En Europa, $AZN -5% y $GSK -2.6%. El sector salud fue el más afectado en Asia. Un episodio donde la diplomacia comercial domina el panorama, pero también se encienden alarmas en el sector farmacéutico global.

Economist Podcasts
Boss Class: Emma Walmsley interview

Economist Podcasts

Play Episode Listen Later Apr 28, 2025 32:19


In 2017 Emma Walmsley became the most powerful woman in corporate Britain. The boss of the drugmaker GSK says leadership is about clearly communicating the what, why and how of your company, and aligning your employees' incentives accordingly. Boss Class season one is free for a limited time. Season two will appear weekly starting May 12th. To hear new episodes, subscribe to Economist Podcasts+. https://subscribenow.economist.com/podcasts-plusIf you're already a subscriber to The Economist, you have full access to all our shows as part of your subscription. For more information about how to access Economist Podcasts+, please visit our FAQs page or watch our video explaining how to link your account. Hosted on Acast. See acast.com/privacy for more information.