Podcasts about Daiichi Sankyo

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/KFF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 21, 2026.Turning the Tide in Gastric Cancer Management: Integrating Modern Systemic Therapies Across the Disease Continuum for Community-Based Clinicians In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca and Daiichi Sankyo, Inc.Disclosure information is available at the beginning of the video presentation.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In the ever-evolving landscape of pharmaceuticals and biotechnology, a series of strategic transactions and scientific advancements are reshaping the industry.BioMarin's acquisition of Amicus Therapeutics for $4.8 billion is a significant highlight, marking the company's largest transaction to date. This move signifies a strategic pivot towards enhancing its capabilities in the rare disease sector, leveraging Amicus's expertise and robust pipeline to potentially improve patient outcomes in this highly specialized area. This acquisition is expected to enrich BioMarin's portfolio significantly with promising assets from Amicus, reflecting a strategic shift under new leadership towards rare disease treatments.Regulatory affairs have seen considerable activity as well, with the FDA raising concerns over manufacturing practices at Catalent's gene therapy facility. These issues, documented in a Form 483 following inspections, particularly pertain to the production of Elevidys. Such regulatory scrutiny emphasizes the critical importance of maintaining compliance with manufacturing standards in gene therapy—a burgeoning field within biotech that holds immense promise for treating genetically-driven conditions.The FDA's oversight extends beyond manufacturing practices to advertising, as evidenced by an untitled letter issued to Bristol Myers Squibb regarding their Cobenfy TV ad. This action is part of the FDA's broader initiative to ensure that direct-to-consumer marketing materials accurately portray drug benefits and risks, thereby protecting public health.In another strategic move, Alvotech and Teva are gearing up for the 2026 U.S. launch of an Eylea biosimilar following a settlement with Regeneron. This development highlights the competitive dynamics within the biosimilar market—a segment poised for growth as patents on major biologics expire, offering more cost-effective alternatives and expanding treatment access.Meanwhile, Clovis Oncology has achieved a milestone with Rubraca, which transitioned from accelerated approval to full FDA endorsement for prostate cancer treatment after five years. This progression underscores Rubraca's demonstrated efficacy and safety profile in addressing advanced prostate cancer—a notable achievement amid an increasingly competitive oncology market.Policy changes proposed by Health and Human Services Secretary Robert F. Kennedy Jr. could have profound implications by disrupting funding streams for hospitals providing gender-affirming care to minors. The potential impact on healthcare providers and patients who rely on these services is significant.Turning to clinical trials, Daiichi Sankyo has seen success with Enhertu receiving FDA approval for first-line HER2-positive breast cancer treatment. Nonetheless, challenges persist as a separate phase 3 trial for another antibody-drug conjugate was paused due to unexpected patient deaths. Meanwhile, Takeda plans to seek FDA approval for its TYK2 inhibitor following successful phase 3 trials in psoriasis—indicating promising potential in autoimmune disease therapies.Strategic shifts are evident across organizations as well, highlighted by Kathy Fernando's departure from Pfizer to join Replicate Bioscience as Chief Business Officer. Her new role focuses on advancing Replicate's self-replicating RNA technology platform—an area gaining traction due to its implications for vaccine development and therapeutic applications.On the clinical trials front, Altimmune reported encouraging results from a 48-week study on metabolic dysfunction-associated steatohepatitis (MASH). Their GLP-1/glucagon dual receptor agonist demonstrated sustained weight loss and improvements in non-invasive liver fibrosis measures—offering new hope for MASH patients who face limited treSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant updates that are shaping the future of healthcare, patient care, and drug development.The U.S. Food and Drug Administration has been particularly active recently, granting Johnson & Johnson a National Priority Review Voucher for its multiple myeloma drug combination. This move highlights the importance of J&J's treatment in addressing unmet needs within oncology, a field continuously striving for innovative solutions. These vouchers expedite the review process, reflecting a broader commitment to accelerating the availability of critical therapies for patients who need them most.Continuing with regulatory advancements, AstraZeneca and Daiichi Sankyo's Enhertu, in combination with Roche's Perjeta, has gained FDA approval as a first-line treatment for unresectable or metastatic HER2-positive breast cancer. This breakthrough is supported by late-stage study results demonstrating a 44% reduction in disease progression or death compared to standard care. The approval signifies not only progress in breast cancer therapeutics but also underscores the potential benefits of strategic collaborations in drug development. Such partnerships are increasingly vital as they aim to optimize therapeutic efficacy through shared expertise and resources.In contrast to these advancements, Pfizer is facing financial recalibrations with projected revenues for 2026 estimated to decline due to diminishing COVID-19 vaccine sales and patent expirations. This situation reflects broader industry challenges as companies navigate post-pandemic market dynamics and patent cliffs, forcing reevaluations of long-term strategies.On another front, Gilead Sciences continues to push boundaries in HIV treatment with a promising single-tablet regimen combining bictegravir and lenacapavir. This innovation targets underserved segments within the HIV market, offering streamlined treatment options that could enhance patient adherence and outcomes significantly.Shifting focus to obesity management, Novo Nordisk's oral semaglutide is emerging as a highly anticipated medication among primary care providers. This trend highlights a growing preference for oral GLP-1 therapies as convenient alternatives to injectable formulations, marking a shift in how obesity—a major public health concern—is managed.The importance of regulatory compliance remains evident as Novo Nordisk received an FDA warning letter concerning manufacturing issues at an Indiana site previously owned by Catalent. This incident underscores the necessity for rigorous quality control in pharmaceutical manufacturing, which can have far-reaching implications on operational dynamics and supply chains.The FDA is also pioneering efforts to incorporate real-world evidence into medical device submissions by opening pathways for extensive deidentified datasets from sources like national cancer registries and electronic health records. This policy shift aims to integrate diverse data sources into the evidentiary foundation for medical device evaluations, potentially fostering innovation within this sector.In line with collaborative efforts, Genentech has partnered with Caris Life Sciences in a multi-year agreement valued at up to $1.1 billion, emphasizing the strategic importance of integrating diagnostic advancements with therapeutic developments to achieve precision medicine goals.Meanwhile, Yarrow Bioscience has acquired an autoimmune thyroid disease drug from China's Gensci, exemplifying a growing trend of cross-border collaborations aimed at leveraging global innovation ecosystems to address diverse therapeutic areas. This acquisition is part of a $1.37 billion deal, reinforcing the globalization of biotech partnerships as companies seek access to novel therapeutics andSupport the show

Eli Lilly is wrapping up 2025 with record-breaking weight loss in a late-stage trial for its triple hormone receptor agonist retatrutide. Results from the Phase III TRIUMPH-4 trial exceeded analyst expectations, leading BMO Capital markets to cleverly dub it “a true TRIUMPH.” Also in the weight loss arena, Zealand Pharma inked a deal with China's OTR Therapeutics worth up to $2.5 billion to collaborate on next-gen drugs for obesity and other metabolic diseases, and Rhythm Pharmaceuticals awaits a Dec. 20 FDA verdict for Imcivree in hypothalamic obesity.   Turning to the FDA, reports broke late last week that the agency was considering slapping a black box label—its strictest warning—on COVID-19 vaccines. Commissioner Marty Makary denied those reports on Monday, stating on Bloomberg TV that the FDA has “no plans” to make such a move. This follows an internal memo from Vinay Prasad leaked over Thanksgiving in which the CBER director claimed that “at least” 10 children have died “because of” COVID-19 vaccines. An internal safety review published last week refuted this conclusion, instead concluding that between zero and seven deaths could be linked to the shots.   Pfizer CEO Albert Bourla, for one, is tired of the recent rhetoric from HHS on vaccines and hopes they are “an anomaly” that will be corrected soon. With strong words about the administration's sentiment on vaccines, Bourla prominsed Pfizer's continued investment in vaccines despite declining revenue. Pfizer this week lowered its 2026 guidance to $62.5 billion in revenue, missing analyst consensus.  The FDA has also granted several approvals in the past week, to Amgen, Milestone Pharmaceuticals and AstraZeneca and Daiichi Sankyo. USAntibiotics also snagged a greenlight, for Augmentin XR, the first approval to be given under the agency's new Commissioner's National Priority Voucher (CNPV) program. Also this week, Johnson & Johnson scored a CNPV ticket—without even having to apply—for its investigational combo of Tecvayli plus Darzalex for relapsed or refractory multiple myeloma after the FDA was impressed by Phase III data.   In ClinicaSpace this week, we highlighted 5 of 2025's Defining Clinical Wins and The 5 Most Painful Clinical Trial Failures of 2025. This past week provided a few more on each front. In the winner's circle, Immunome's desmoid tumor drug and and Kyverna's CAR T for stiff person syndrome both aced pivotal trials, while Sanofi's MS drug tolebrutinib and Gilead and Arcus' TIGIT therapy domvanalimab each failed Phase III tests.   And in BioPharm Executive, we highlight 6 Biotechs That Could Be Big Pharma's Next M&A Target, and more M&A predictions for 2026.  

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we dive into a series of pivotal events shaping the landscape of drug development and patient care. The interplay between scientific advancements, regulatory shifts, and strategic partnerships is setting the stage for significant transformations within the industry.A highlight of recent developments is the legal challenge faced by Merck & Co. regarding its new subcutaneous version of Keytruda. This immunotherapy, already a breakthrough in cancer treatment, has encountered a hurdle in Germany where Halozyme, known for its drug-delivery technologies, has secured a preliminary injunction. This move by a German court halts Merck's activities related to Keytruda SC in Germany and underscores the intricate web of intellectual property rights in drug launches across international markets. The outcome of this case could establish crucial precedents for future commercialization efforts involving advanced drug delivery technologies.Meanwhile, there's promising news from Bristol Myers Squibb as their CAR-T therapy, Breyanzi, receives its fifth FDA approval, this time for marginal zone lymphoma. This approval is particularly noteworthy as it marks Breyanzi as the first CAR-T treatment sanctioned for this specific indication and extends its use across five different types of blood cancers. CAR-T therapies continue to represent a frontier in cancer treatment by leveraging the body's immune system to combat malignancies more effectively. This success story from Bristol Myers Squibb highlights the expanding potential of CAR-T therapies in tackling various hematological cancers, offering renewed hope for patients with limited treatment avenues.On the regulatory front, the FDA's proposal to consider single-trial approvals for certain drugs has sparked considerable debate. While some industry voices express concerns about potential compromises to safety and efficacy standards, others see it as an opportunity to invigorate research and development investments by reducing both time and costs associated with bringing new therapies to market. This shift could indeed accelerate innovation but will necessitate a careful balance to uphold rigorous safety standards.In parallel regulatory news, Daiichi Sankyo has received an "untitled letter" from the FDA over its patient ambassador video for Turalio, indicating ongoing challenges in navigating drug promotion guidelines and patient engagement strategies. Such interactions emphasize the complexities pharmaceutical companies face within regulatory frameworks.Shifting focus to corporate strategies, Mark Cuban's Cost Plus Drugs is exploring a partnership with Humana aimed at addressing prescription drug costs for employers. This collaboration seeks to reduce healthcare expenses through innovative pricing models and distribution channels, reflecting a broader industry trend toward cost containment and value-based care delivery.In another development affecting public health policy, the CDC's Advisory Committee on Immunization Practices has postponed its vote on changes to newborn hepatitis B vaccine policies due to ongoing debates and confusion surrounding the topic. This delay highlights the intricate nature of updating long-standing public health policies, especially those impacting vaccination schedules.From an investment perspective, Freenome's decision to go public through a $330 million SPAC deal stands out. Specializing in developing blood tests for early cancer detection using machine learning technologies, Freenome's move aims to secure capital necessary for advancing its diagnostic tools—potentially transforming cancer screening practices by enabling earlier detection and intervention.In clinical trial news, Praxis Precision Medicines reported positive efficacy results from a Phase 2 trialSupport the show

This episode covers: Cardiology This Week: A concise summary of recent studies DAPT: how short is too short Obesity and atrial fibrillation Milestones: COURAGE  Host: Emer Joyce Guests: Carlos Aguiar, Steffen Massberg, Prash Sanders Want to watch that episode? Go to: https://esc365.escardio.org/event/2178 Want to watch that extended interview on dual antiplatelet therapy (DAPT) and shortening its optimal duration, go to: https://esc365.escardio.org/event/2178?resource=interview   Disclaimer  ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails.   Declarations of interests Stephan Achenbach, Yasmina Bououdina, Emer Joyce, Nicolle Kraenkel and Steffen Massberg have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Prashanthan Sanders has declared to have potential conflicts of interest to report: advisory board representative University of Adelaide, Medtronic, Boston Scientific, CathRx, Abbott and Pacemate as well as research grants for University of Adelaide: Medtronic, Abbott, Boston Scientific, Becton Dickson. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of pivotal events and breakthroughs shaping the future of this dynamic industry.The pharmaceutical and biotech sectors are experiencing a wave of significant advancements, regulatory shifts, and strategic maneuvers. Recently, Bristol Myers Squibb faced a delay in their Alzheimer's psychosis treatment, Cobenfy, due to site irregularities detected in the ADEPT-2 study. This highlights the critical importance of rigorous clinical trial management. The postponement could influence stakeholders' confidence in timelines for breakthrough treatments in neuropsychiatric disorders.Richard Pazdur, M.D., is preparing to retire from his leadership role at the FDA's Center for Drug Evaluation and Research. This transition period could have profound implications for how new therapies are evaluated, potentially altering approval processes and timelines. His departure marks a significant shift within an agency renowned for its role in drug approvals and regulatory oversight.On the scientific front, Cosmo Pharmaceuticals has reported promising results from two Phase 3 trials of clascoterone, a topical cream designed to treat male-pattern hair loss. The findings suggest that clascoterone could become a transformative treatment by offering a novel mechanism to address androgenetic alopecia through the inhibition of dihydrotestosterone activity at the follicular level. This development underscores an expanding focus on dermatological conditions within biopharma research and offers new hope to millions affected by hair loss.In legal developments, Daiichi Sankyo's successful appeal in its antibody-drug conjugate (ADC) patent dispute with Seagen marks a significant victory with substantial financial implications. The overturning of a $41.8 million verdict illustrates the competitive dynamics in ADC technology, which plays a crucial role in targeted cancer therapies. This case emphasizes the importance of robust intellectual property strategies in maintaining competitive advantages in innovative therapeutic modalities.On the funding front, Excelsior Sciences has secured $95 million to enhance its "smart bloccs" platform for small molecule discovery and production. This investment aims to support advancements in chemical synthesis technologies crucial for accelerating drug development pipelines and fostering collaborations across therapeutics and materials science sectors. Such initiatives underscore the growing emphasis on technological innovation to streamline drug discovery processes.The European Union is making strides toward bolstering supply chain resilience with new regulations aimed at preventing drug shortages. By diversifying local biopharma supply chains and encouraging domestic production, these measures address vulnerabilities exposed by recent global disruptions. This policy shift could lead to more sustainable drug manufacturing practices within Europe, ensuring better preparedness against future crises.Pharvaris has achieved a significant milestone with its Phase 3 trial of deucrictibant meeting primary endpoints. This sets the stage for regulatory filings as a competitor to KalVista Pharmaceuticals' Ekterly in hereditary angioedema treatment. This progress highlights ongoing innovation in addressing rare genetic diseases and fostering competitive therapeutic landscapes.The FDA's approval of Cleveland Diagnostics' IsoPSA test marks a notable advancement in prostate cancer diagnostics. By detecting specific PSA protein variants associated with malignancy risk, IsoPSA represents a step forward in precision medicine. It offers enhanced diagnostic accuracy and potentially improves patient outcomes through early intervention strategies.Overall, these developments reflect the dynamic nature of the pharmacSupport the show

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/UAD865. CME/MOC/AAPA credit will be available until November 20, 2026.Harnessing the Power of ADCs in Gynecologic Cancers: Expert Insights for Practice Integration In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/UAD865. CME/MOC/AAPA credit will be available until November 20, 2026.Harnessing the Power of ADCs in Gynecologic Cancers: Expert Insights for Practice Integration In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/UAD865. CME/MOC/AAPA credit will be available until November 20, 2026.Harnessing the Power of ADCs in Gynecologic Cancers: Expert Insights for Practice Integration In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/UAD865. CME/MOC/AAPA credit will be available until November 20, 2026.Harnessing the Power of ADCs in Gynecologic Cancers: Expert Insights for Practice Integration In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/UAD865. CME/MOC/AAPA credit will be available until November 20, 2026.Harnessing the Power of ADCs in Gynecologic Cancers: Expert Insights for Practice Integration In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/UAD865. CME/MOC/AAPA credit will be available until November 20, 2026.Harnessing the Power of ADCs in Gynecologic Cancers: Expert Insights for Practice Integration In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

Daiichi Sankyo has been pioneering ADCs since 2010, with a pipeline targeting over 30 indications and potentially reaching 400,000 patients.In today's episode I'm joined by Dr. Markus Kosch, Head of the EU Oncology Business Division at Daiichi Sankyo. A physician by training with a deep academic background in oncology, Markus has spent over two decades advancing cancer care, from clinical practice to leadership roles shaping strategy across Europe and Canada. Since joining Daiichi Sankyo in 2021, he has been at the forefront of one of the industry's most ambitious ADC pipelines, overseeing more than 60 clinical trials across 24 countries and driving landmark approvals that are redefining treatment in breast, lung, and gastric cancers.This week's episode is brought to you with the support of Kadans. Looking for the perfect space to grow your Life Sciences company? Kadans Science Partner is Europe's leading provider of cutting-edge lab and offices spaces, tailored to your needs. Kadans puts you at the centre of innovation, giving you the chance to connect with top researchers, universities, and investors through its international network. Here, you'll join a vibrant community of innovators driving real change. Are you ready to take your research to the next level? Learn more at kadans.com – where innovation thrives. 01:45.         Meet Markus Kosch03:12.         Clinical background shaping an industry role04:46.         Daiichi Sankyo's 40-year oncology legacy06:19.         European investments and Munich hub10:34.         ADC platform strengths explained14:20.         Key ESMO 2025 trial dataClarification: The reference to ‘TB01' at 16:24 refers to the TROPION-Breast02 clinical trial, not TB01.19:43.         Managing risks and partnerships23:35.         Patient advocacy in trial design33:59.         Future of oncology and ADCsInterested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletterTo dive deeper into the topic: 10 oncology deals in 2025 spotlight where industry leaders are betting bigAstraZeneca and Daiichi Sankyo's Enhertu recommended for approvalTen drugs to watch in 2025: will these therapies become blockbusters?

This episode covers: Cardiology This Week: A concise summary of recent studies 'ChatGPT, MD?' - Large Language Models at the Bedside Management decisions in myocarditis Statistics Made Easy: Mendelian randomisation Host: Emer Joyce Guests: Carlos Aguiar, Folkert Asselbergs, Massimo Imazio Want to watch that episode? Go to: https://esc365.escardio.org/event/2179 Want to watch that extended interview on 'ChatGPT, MD?': Large Language Models at the Bedside? Go to: https://esc365.escardio.org/event/2179?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Folkert Asselbergs, Yasmina Bououdina, Massimo Imazio, Emer Joyce, and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Emer Joyce Guest: Folkert Asselbergs Want to watch that episode? Go to: https://esc365.escardio.org/event/2179 Want to watch that extended interview on 'ChatGPT, MD?': Large Language Models at the Bedside? Go to: https://esc365.escardio.org/event/2179?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails.  Declarations of interests: Stephan Achenbach, Folkert Asselbergs, Yasmina Bououdina, Emer Joyce, and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. E mma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson. Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

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

In this Bright Spots in Healthcare episode, host Eric Glazer sits down with three leaders reshaping one of healthcare's most overlooked — yet mission-critical — functions: provider credentialing. Credentialing is the quiet infrastructure of trust in healthcare. When it's done right, patients get timely access to high-quality care, providers get paid faster, and health plans stay compliant. When it fails, backlogs grow, compliance risk skyrockets, provider satisfaction plummets, and member access suffers. Joining Eric for this discussion: Sandra Clarke, Former CFO & COO, Blue Shield of California Brett Dooies, Head of Product, Verifiable Janan Dave, VP of Operations, Verifiable Together, they explore how AI and automation are transforming credentialing from a slow, manual compliance task into a strategic capability that improves efficiency, trust, and network readiness. In this episode, you'll learn: Why credentialing sits at the intersection of compliance, provider experience, and member access How legacy processes, staffing limits, and messy data create hidden risk, and why backlogs can grow like quicksand Practical ways health plans are applying AI to reduce verification time, speed onboarding, and triage high-risk cases Why the most successful plans treat credentialing as infrastructure, not paperwork Key metrics to track when modernizing credentialing, including turnaround time, backlog clearance, audit readiness, and provider experience What to automate first,  and why humans still play a critical oversight role Bright Spots include: 97% automated verification in seconds across millions of records monthly New staffing and automation models that increase speed without compromising compliance Real-world examples where AI prevented risk exposure and accelerated network growth Leadership lessons in adopting AI responsibly and avoiding the "lift-and-shift" trap   This conversation offers payer leaders a real-world playbook to modernize credentialing and strengthen the foundation of your healthcare organization. Panelist Bios: Sandra Clarke is a healthcare executive and board advisor with over 25 years of experience leading finance, operations, and large-scale transformation across payer, provider, and life sciences organizations. As former CFO and COO of Blue Shield of California, she oversaw $25B in annual revenue and spearheaded initiatives delivering $700M in annualized savings while reimagining the company's pharmacy care model. Clarke has also held senior leadership roles at Daiichi Sankyo and Philips Healthcare and serves on multiple healthcare boards. She holds degrees from MIT, Bentley University, and Seton Hall University School of Law. Janan Dave is the VP of Operations at Verifiable, a start-up offering software and services solutions for healthcare organizations to ease the challenges surrounding provider network management. Janan has a background in public health and health policy, and has spent the last decade helping scale operations at various healthcare startups. She is passionate about building smart solutions to reduce waste in the healthcare system, and promote better care especially for the aging population, family caregivers, and women. Janan studied public health at the University of Pennsylvania, and lives in Brooklyn, NY. Brett Dooies is the Head of Product at Verifiable, where he leads the development of AI-powered solutions to simplify healthcare credentialing and monitoring. With a decade of experience building enterprise software, he specializes in applying advanced AI and analytics to enhance the customer experience and deliver transformative solutions. Drawing on his background in modernizing banking software, Brett is dedicated to creating products that drive operational excellence, uphold regulatory compliance, and improve data accuracy for Verifiable's partners, helping them scale with confidence in a complex ecosystem. Resources: MIT Sloan "Internet of AI Agents: State of AI in Business 2025" report finds that although over 80 % of organizations have piloted generative AI tools, only around 5 % have achieved meaningful business transformation—a gap dubbed the "GenAI Divide". It highlights that the primary barrier isn't model technology or regulation, but rather the failure of AI systems to integrate deeply into workflows, learn from feedback, and scale beyond the pilot stage. https://mlq.ai/media/quarterly_decks/v0.1_State_of_AI_in_Business_2025_Report.pdf Thank you to our Episode Partner, Verifiable: Verifiable is a credentialing and network monitoring platform built to help healthcare organizations optimize operations with error-free, fast verifications and to stay compliant with ease. Backed by their in-house NCQA certified credentialing team that bring a combined 60+ years of experience, Verifiable's innovation supports managing trusted networks at scale through 97% verification automation in seconds with millions processing each month. Verifiable works with leading healthcare organizations such as Humana Dental, Zelis, Talkspace, Headway, Empower Pharmacy, and many others.   Learn more about them at https://verifiable.com/ Want to go deeper or schedule a briefing with Verifiable? Email hkrish@brightspotsventures.com and we'll coordinate time with the Verifiable team to discuss how their approach can help your plan reduce costs, accelerate onboarding, and strengthen network integrity. About Bright Spots Ventures: Bright Spots Ventures is a healthcare strategy and engagement company that creates content, communities, and connections to accelerate innovation.   We help healthcare leaders discover what's working, and how to scale it. By bringing together health plan, hospital, and solution leaders, we facilitate the exchange of ideas that lead to measurable impact. Through our podcast, executive councils, private events, and go-to-market strategy work, we surface and amplify the "bright spots" in healthcare, proven innovations others can learn from and replicate. At our core, we exist to create trusted relationships that make real progress possible. Visit our website at www.brightspotsinhealthcare.com.  

This episode of the Scope of Things features an exclusive panel at SCOPE Europe 2025 covering regulatory requirements for AI literacy training, featuring industry executives Jonathan Crowther, head of the operational design center at Merck KGaA; Janie Hansen, global development information management, business systems transformation at Daiichi Sankyo; Francis Kendall, head of statistical programming, digital and data sciences at Biogen; and James Weatherall, vice president and chief data scientist of biopharmaceuticals R&D at AstraZeneca. Plus, host Deborah Borfitz gives the latest news on efforts to reduce excess data collection in studies, whole genome sequencing of breast cancer, a virus cocktail to combat superbugs, and more. Show Notes News Roundup   Collaborative study on data collection in trials News posted on the TransCelerate website Heart benefits of semaglutide Study in The Lancet Whole genome sequencing of breast cancers Study in The Lancet Oncology Pan-cancer immunotherapy heads to trials Research article in Cell Article in Bio-IT World Promising NAD+ “youth molecule” Review article in Nature Aging  Virus cocktail to combat superbugs Article in Nature Microbiology AI annotates medical images News posted on the MIT website Fitbits aid precision health American Life in Realtime study in PNAS Nexus Latest from the Human Epilepsy Project Study in JAMA Neurology Imposter study participants Editorial in The BMJ Guests Jonathan Crowther, Ph.D., Head, Operational Design Center, Merck KGaA, Darmstadt, Germany Janie Hansen, Global Development Information Management, Business Systems Transformation, Daiichi Sankyo Francis Kendall, Head of Statistical Programming, Digital and Data Sciences, Biogen James Weatherall, Ph.D., Vice President & Chief Data Scientist, BioPharmaceuticals R&D, AstraZeneca  The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider's look at clinical research today.

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/EVZ865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 29, 2026.Making Precision Decisions for Patients With EGFRm NSCLC: Success Strategies With Targeted Options, Potent Combinations, and Emerging Agents In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Johnson & Johnson.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/EVZ865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 29, 2026.Making Precision Decisions for Patients With EGFRm NSCLC: Success Strategies With Targeted Options, Potent Combinations, and Emerging Agents In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Johnson & Johnson.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/EVZ865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 29, 2026.Making Precision Decisions for Patients With EGFRm NSCLC: Success Strategies With Targeted Options, Potent Combinations, and Emerging Agents In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Johnson & Johnson.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/EVZ865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 29, 2026.Making Precision Decisions for Patients With EGFRm NSCLC: Success Strategies With Targeted Options, Potent Combinations, and Emerging Agents In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Johnson & Johnson.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/EVZ865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 29, 2026.Making Precision Decisions for Patients With EGFRm NSCLC: Success Strategies With Targeted Options, Potent Combinations, and Emerging Agents In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Johnson & Johnson.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/EVZ865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 29, 2026.Making Precision Decisions for Patients With EGFRm NSCLC: Success Strategies With Targeted Options, Potent Combinations, and Emerging Agents In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Johnson & Johnson.Disclosure information is available at the beginning of the video presentation.

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

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

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Recent developments in these industries underscore a period of significant scientific progress, regulatory maneuvers, and strategic investments.One notable event was AstraZeneca and Daiichi Sankyo's success at the European Society for Medical Oncology Congress 2025. Their antibody-drug conjugate, Datroway, demonstrated superior efficacy compared to Gilead's Trodelvy in the first global head-to-head trial involving Trop2-targeted therapies. This reflects the increasing focus on antibody-drug conjugates as precision medicine tools that offer targeted treatment options with potentially improved outcomes over traditional chemotherapy.In a move highlighting the ongoing trend of bolstering domestic production capacities, Merck is making a substantial $3 billion investment in a small molecule drug plant in Virginia. This is part of a broader $70 billion commitment to expand manufacturing and R&D capabilities in the U.S. Such strategic investments are crucial for maintaining competitive advantage and ensuring drug availability while meeting rising demands and streamlining supply chains.Turning to regulatory updates, the FDA has approved Amgen and AstraZeneca's Tezspire for chronic rhinosinusitis with nasal polyps. This marks Tezspire's second indication, following its initial approval for severe asthma in 2021. The expanded approval showcases the drug's versatility and represents a strategic push to enhance its market presence against competitors like Dupixent.In oncology, Merck's Keytruda and Astellas/Pfizer's Padcev have made headlines with compelling results in muscle-invasive bladder cancer. The combination therapy reduced the risk of death by 50%, reinforcing Keytruda's position as a cornerstone immunotherapy across multiple cancer types. This result not only augments treatment options but also signifies the potential for combination regimens to enhance patient outcomes.Roche has expanded the indication of its aging oncology drug Gazyva to treat lupus nephritis, demonstrating strategic repurposing efforts to extend the lifecycle of existing therapies. While this expansion into autoimmune diseases comes late in Gazyva's lifecycle, it highlights a growing trend of capitalizing on established drugs for new therapeutic areas.AstraZeneca and Daiichi Sankyo's Enhertu showed robust efficacy in early breast cancer treatment, potentially reshaping therapeutic strategies by offering new hope for early intervention. Similarly, Novartis' Pluvicto demonstrated promise in slowing hormone-sensitive prostate cancer progression, underscoring the potential of radioligand therapies in oncology.However, not all developments have been positive. AstraZeneca faced setbacks when its Imfinzi and Lynparza combination failed to meet survival goals in ovarian cancer, underscoring the challenges inherent in oncology drug development and the stringent benchmarks set by regulatory authorities like the FDA.The industry is also witnessing significant advancements in next-generation ADCs, as evidenced by Tubulis' 59% response rate in early clinical trials, which has attracted substantial investor interest. Additionally, Grail's Galleri cancer blood test is progressing towards FDA review with enhanced performance data, potentially revolutionizing cancer screening and early detection practices.These scientific and regulatory milestones are complemented by strategic investments in bioconjugation technologies. Cohance Life Sciences' $10 million investment in NJ Bio to enhance GMP bioconjugation capabilities exemplifies this trend. Such investments are crucial for advancing ADC development, which remains a focal point for innovative cancer therapies.Overall, these developments reflect a dynamic phase for the pharmaceutical and biotech sectors characterized by signSupport the show

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

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

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

In today's episode, we're unpacking an important yet often misunderstood component of effective publication planning: the Publication Steering Committee (PSC).We're joined by industry leaders Cindy Toste, Senior Director of Publications at GlaxoSmithKline, and Paul Ricigliano, Senior Director and Head of Oncology Global Publications at Daiichi Sankyo, Inc.Together, we explore what makes a PSC truly successful, from establishing clear governance and managing cross-functional dynamics to defining roles across medical affairs and clinical teams. Cindy and Paul also share real-world lessons on how to navigate disagreement, maintain momentum, and ensure decisions don't stall progress.Whether you're forming your first PSC or optimizing an existing one, this episode offers practical guidance on turning conflict into collaboration, and collaboration into meaningful publication outcomes.To join ISMPP, visit our website at https://www.ismpp.org/This episode is generously sponsored by Avalere Health.

This week, the American FDA announced it's set to review a new breast cancer drug, Enhertu, developed by AstraZeneca (AZN) and its Japanese partner, Daiichi Sankyo. Julian Hofmann and Dan Jones unpack what this did to Astra's shares, the wider issues facing pharmaceutical companies, plus an update on GSK's (GSK) newest CEO.Next, our Big Read on the ways to effectively pass on your wealth. In the UK, estimates suggest up to £7tn could be transferred from older to younger generations over the next 30 years. Val Cipriani, author of the piece, explains what the “Great Wealth Transfer” means for investors, the trade-off gifters need to consider, and more. Last up, results from Ceres Power (CWR) came in lower than expected. Mark Robinson unpacks the reasons behind it, German shareholder Bosch's departure, and where the valuation stands.Timestamps1:23 AstraZeneca14:53 Passing on wealth 27:40 Ceres PowerRead more on these topics:A pharma giant with star quality How to pass on wealth to your childrenCeres Power cuts revenue guidance for 2025 Hosted on Acast. See acast.com/privacy for more information.

Dr. Monty Pal and Dr. Matteo Lambertini discuss a compelling global study on the clinical behavior of breast cancer in young BRCA1 and BRCA2 carriers, the association of pre-diagnostic awareness of BRCA status with prognosis, and the importance of identifying healthy people who are at risk of carrying the BRCA1/2 pathogenic variants. TRANSCRIPT Dr. Monty Pal: Well, hello everyone, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist, professor, and vice chair of medical oncology at the City of Hope Comprehensive Cancer Center in Los Angeles. Now, when we think about genetic testing, whether for patients diagnosed with breast cancer or for other family members of them, it seems to be widely underutilized. Today, we're going to be discussing a recently published study in the Journal of Clinical Oncology that reported on the clinical behavior of breast cancer and specifically young BRCA1 and BRCA2 carriers, and the association of pre-diagnostic awareness of BRCA status with prognosis. I thought this was just a fascinating piece, and I honestly couldn't wait to have this conversation. It's a really compelling paper that highlights the importance of identifying healthy people who are at risk of carrying the BRCA1/2 pathogenic variants, and really the need for genetic counseling and testing to inform people about early detection that could lead to a better prognosis. I'm really delighted to welcome the study's lead author, Dr. Matteo Lambertini. He really needs no introduction. He's very well known in the breast cancer world for his amazing contributions to fertility in the context of breast cancer, to pregnancy in the context of breast cancer, and genetic testing. He's an associate professor at the University of Genova, and a breast cancer medical oncologist at the San Martino Polyclinic Hospital in Genova, Italy.  Dr. Lambertini, thank you so much for joining us today. Dr. Matteo Lambertini: Thank you very much, Dr. Pal. It's a great pleasure. Dr. Monty Pal: Oh, thanks. And just FYI, if you're listening in and you want to hear our disclosures, they're all listed at the transcript of this podcast.  So, I poured through this paper [Clinical Behavior of Breast Cancer in Young BRCA Carriers and Prediagnostic Awareness of Germline BRCA Status] yesterday, Dr. Lambertini, and first of all, congratulations on this study. This was a huge international multicenter effort, 4,752 patients. How did you pool all these patients with young breast cancer? Dr. Matteo Lambertini: Thanks a lot for the question. Yes, this was an effort made by several centers all over the world. The main idea behind the creation of this network that we have named as BRCA BCY Collaboration, was to get as many data as possible in a sort of niche patient population in the breast cancer field, meaning women diagnosed with breast cancer at the age of 40 years or younger, and all of them being BRCA carriers. We know that around, in the Western world, around 5% of breast cancer cases are being diagnosed under the age of 40 years, and among them around 10-15% are BRCA carriers. So, I would say it's a relatively rare patient population where we did not have a lot of evidence to support our choices in terms of counseling on treatment, prevention, and oncofertility as well. That was the idea behind the creation of this network that includes many centers. Dr. Monty Pal: Yeah. You know, what's so interesting about this is that you sort of draw this line between patients who have BRCA testing at the time of diagnosis and then BRCA testing earlier in their course and then leading to a diagnosis perhaps. And I think that's where really sort of the dichotomy in outcome sits. Can you maybe elaborate on this and tell us about timing of genetic testing in this study and what that meant ultimately in terms of prognosis? Dr. Matteo Lambertini: In this specific analysis from this large network, including almost 5,000 women with breast cancer diagnosed at the age of 40 years or younger and being a BRCA carrier, we looked specifically into the timing of genetic testing because this is a retrospective study and the criteria for inclusion are those that I have just mentioned, so diagnosis at a young age plus carrying germline BRCA pathogenic or likely pathogenic variant. In this analysis, we have looked into the time the patient has got the genetic testing and particular we focused on two populations: those that were diagnosed, knowing already to be a BRCA carrier, and those that got tested after being diagnosed with breast cancer. And the main findings from this analysis have been that knowing to be a BRCA carrier was associated with a lower stage at the time of diagnosis, meaning more T1 tumors, so a tumor less than 2 cm, more node-negative disease, and this translated into less aggressive treatment, so less often axillary dissection, less often use of chemotherapy and anthracycline-based chemotherapy. And even more importantly, we have seen a better overall survival for those patients that were diagnosed already knowing to be BRCA carriers as compared to those tested after breast cancer diagnosis. These results after adjusting for all the confounding, stage, treatment and so on, there was not significant anymore, meaning that it's not the timing of test per se that is probably leading to a better survival, but it is the fact that knowing to be a BRCA carrier would likely translate into having access to all the preventive measures that we have in this setting and this will translate into an overall survival benefit, so in terms of saving more lives in young BRCA carriers. Dr. Monty Pal: I think it's such an important point, and it's one that I think might sound implicit, right, but it needs to be proven, I think, through a study like this. You know, the fact that finding this early, identifying the mutation, doing enhanced screening, and so forth, is really going to lead to superior clinical outcomes. One of the things that I think many people puzzle over, including myself, is what to do? I personally occasionally will see BRCA altered patients in the context of prostate cancer. But that's a very different population of individuals, right? Typically older men. In young females with BRCA mutation, I guess there's a specific set of considerations around reproductive health. You'd already highlighted preventive strategies, but what sorts of things should we be talking about in the clinics once a patient's diagnosed and once perhaps their breast cancer diagnosis is established? Dr. Matteo Lambertini: Yes, exactly. Knowing to be a BRCA carrier has a lot of implications from prevention to treatment to survivorship issues including reproductive counseling. And this is important not only for the patient that has been diagnosed with breast cancer but also for all the family members that will get tested and maybe identify with this sort of genetic alteration before diagnosis of cancer. Why this is important is because we have access to very effective preventive measures, a few examples: MRI screening, which starts at a very young age and normally young women don't have an effective screening strategy outside the BRCA field. Also, primary preventive measures, for example, risk-reducing surgery. These women are known to have a high risk of breast cancer and high risk of ovarian cancer. So the guidelines are suggesting to undergo risk-reducing salpingo-oophorectomy at a young age, so 35 to 40 years in BRCA1 carrier, 40 to 45 years in BRCA2 carrier. And also risk-reducing mastectomy should be discussed because it is a very effective way to prevent the occurrence of breast cancer. And in some situations, including the setting that we are talking about, so young women with breast cancer, BRCA carrier, also risk-reducing mastectomy has shown to improve overall survival.  On the other side, once diagnosed with breast cancer, nowadays knowing to be or not a BRCA carrier can make a difference in terms of treatment. We have PARP inhibitors in the early setting, in the adjuvant setting as well as in the metastatic setting. And in terms of survivorship implication, one of the critical aspects for young women is the oncofertility care which is even more complicated when we talk about BRCA carriers that are women candidates for gynecological surgery at a very young age. So this sort of counseling is even more complicated. Dr. Monty Pal: One of the other things, and this is subtle in your paper and I hope you don't mind me bringing it up, is the difference between BRCA1 and BRCA2. It really got me thinking about that because there are differences in phenotype and manifestation. Do you mind just expanding on that a little bit for the audience because I think that's a really important reminder that you brought up in the discussion? Dr. Matteo Lambertini: The difference between BRCA1 and BRCA2 carriers has been known that there are different phenotypes of breast cancer that are more often diagnosed in these two different populations. Normally BRCA1 carriers have a higher likelihood to develop a triple negative breast cancer as compared to BRCA2 carriers, more likely to develop a hormone receptor-positive HER2-negative disease. In this study, again, a specific population of young women with breast cancer, we have seen the same findings, mostly triple negative disease in BRCA1 carrier, mostly luminal-like disease in BRCA2 carrier. But what's novel or interesting from this study is to look also at the age at the time of diagnosis of this disease. And particularly in BRCA1 carriers, we should be sort of more careful about diagnosis of breast cancer and also other primary tumors including ovarian cancer because the risk of developing these malignancies is higher even at a younger age as compared to BRCA2 carriers. And this has implications also in the primary and secondary prevention that we were talking about earlier. Dr. Monty Pal: Oh, interesting. I guess the fundamental question then from your paper becomes, how do we get at the right patients for screening for BRCA1 and BRCA2? And I realize our audience here is largely oncologists who are going to be listening to this podcast, oncology providers, MDs, nurses, etc. But maybe speak for a moment to the general practitioner. Are there things that, for instance, a general practitioner should be looking for to say, “Wait a minute, this patient's high risk, we should consider BRCA1, BRCA2 testing or germline screening”? Dr. Matteo Lambertini: Yes, it's a very important question for the breast cancer community. After the updated ASCO guideline, the counseling is way easier because right now the age cutoff goes up to 65 years, meaning that all the patients diagnosed with breast cancer below the age of 65 years should be tested these days. And then above the age of 65, there are different criteria like triple-negative disease or family history. From a general practitioner standpoint, it's of course a bit more difficult, but knowing particularly the family history of the person that they have in front will be crucial to know if there are cases of breast cancer diagnosed at a young age, maybe triple-negative cases, knowing cases of ovarian cancer in first-degree relatives or pancreatic cancer in first-degree relatives, and of course cases of prostate cancer as well. So, I would say probably mostly the family side will be important from a general practitioner perspective.  From an oncology one, the other point that I think is important to stress also based on the data that we have shown in this publication is that having a case of breast cancer known to carry a BRCA pathogenic or likely pathogenic variant. It means that all the people around this case should get tested and if found to be BRCA carrier and healthy carrier, these people should also undergo the primary and secondary prevention strategies because this is very critical also to improve their outcomes and try to avoid the developing of breast or ovarian cancer, but also in the case of diagnosis of this disease, a diagnosis at an earlier stage, as we have seen in this paper. Dr. Monty Pal: Brilliant. I'm going to diverge from our list of questions here and close by asking a question that I have at the top of my mind. You're very young. I know our podcast listeners can't see you, but you're very, very young. Dr. Matteo Lambertini: Thank you. Thank you for that. Not so young but yeah. Dr. Monty Pal: You have nearly 300 papers. Your H-index is 67. You've already made these seminal contributions, as I outlined it from the outset, regarding fertility, regarding use of GnRH analogs, regarding pregnancy and breast cancer. What are you studying now? What are you really excited about right now that you're doing that you think might potentially be practice changing? Give us a little teaser. Dr. Matteo Lambertini: Yeah. Thanks a lot, Dr. Pal. Receiving this compliment from you is fantastic. So, thanks a lot for that. From my side, in terms of my research, I've been interested in the field of breast cancer in young women since the start of my training. I've had very good mentors from Italy, from Europe, from the U.S. I'm still interested in this field, so I think we still have a lot to learn to try to improve the care of young women with breast cancer. For example, the oncofertility care, which is something I worked a lot over the past years. Now with all the new treatment options, there's a sort of new chapter of oncofertility counseling. So, what's the impact of immunotherapy? What's the impact of the new targeted agents?  More on the genetic aspects, now we know that there's not only BRCA1 or BRCA2. There are a lot of other different genes that may increase the risk of breast cancer and other malignancies. And also for these genes, we really don't have a lot of evidence to counsel women on prognosis, treatment, prevention strategy. So we need to learn way more for this special patient population that are quite rare, and so we really need a multicenter academic effort to try to give some evidence in this field. Dr. Monty Pal: Yeah. It's tough because these are rare circumstances, but, you know, I think that you've done really well to sort of define some collective experiences that I think really define therapy. I mean, I just remember when I was in training 25 years ago, just reading through textbooks where all the experience around breast cancer and pregnancy was really just very sort of anecdotal almost, you know? And so it's great to see that the state of the science has moved forward.  Well, gosh, I really enjoyed our conversation today. I think your study really reminds us how powerful genetic information is in terms of improving outcomes. And, you know, hopefully this will lead some individuals to perhaps test more broadly in appropriate settings. So, thank you so much, Matteo, for joining us today with your fantastic insights on the ASCO Daily News Podcast. Dr. Matteo Lambertini: Thank you very much, Dr. Pal. It's a real pleasure. Dr. Monty Pal: And thanks to our listeners too. You'll find a link to Dr. Lambertini's study in the transcript of this episode. Finally, if you value the insights that you heard today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Thanks a ton. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers:    Dr. Sumanta (Monty) Pal  @montypal  Dr. Matteo Lambertini @matteolambe   Follow ASCO on social media:     @ASCO on Twitter    ASCO on Bluesky   ASCO on Facebook     ASCO on LinkedIn     Disclosures:    Dr. Monty Pal:   Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview  Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical  Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis  Dr. Matteo Lambertini: Consulting or Advisory Role: Roche, Novartis, Lilly, AstraZeneca, Pfizer, MSD, Exact Sciences, Gilead Sciences, Seagen, Menarini, Nordic Pharma Speakers' Bureau: Takeda, Roche, Lilly, Novartis, Pfizer, Sandoz, Ipsen, Knight Therapeutics, Libbs, Daiichi Sankyo, Gilead Sciences, AstraZeneca, Menarini, AstraZeneca, Menarini Research Funding (Inst.): Gilead Sciences Travel, Accommodations, Expenses: Gilead Sciences, Daiichi Sankyo Europe GmbH, Roche

Alex Natskovich is the Founder and CEO of MEV, LLC, a technology services firm that builds custom software and modernizes digital systems for life sciences, real estate, and pharma companies. With over 20 years in software engineering, he has led 200+ projects across diverse industries and specializes in distributed systems, cloud computing, and large-scale data processing. Under his leadership, MEV has delivered major projects for clients such as Cartier, Novo Nordisk, and Daiichi Sankyo. In this episode… Surviving economic chaos can forge an entrepreneurial spirit that thrives in uncertainty. What lessons can be drawn from growing up in a place where scarcity and improvisation are part of daily life, and how do those lessons translate into building successful teams and technology today? Alex Natskovich, a veteran software engineer and product leader, believes resilience and resourcefulness are the foundation of innovation. He shares how early hardships taught him to adapt quickly, think creatively, and focus on core values when hiring talent. From avoiding common product pitfalls, like untested assumptions and weak data privacy, to embracing AI tools such as GitHub Copilot and Fireflies for smarter development, his insights reveal how to build scalable, market-ready products. These experiences underscore the importance of aligning strategy, technology, and culture to win in competitive markets. In this episode of the Inspired Insider Podcast, Dr. Jeremy Weisz sits down with Alex Natskovich, Founder and CEO of MEV, to discuss how early-life resilience shaped his leadership in software development. He explores hiring based on core values over technical skills, lessons from guiding Hawaii Information Service's MLS platform overhaul, and the impact of AI on client expectations and product development.

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

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

In this episode, Melissa sits down with Erin Bradshaw, EVP for Patient Services & Navigation at the Patient Advocate Foundation, to explore the complex world of insurance denials and step therapy. Together, they discuss the surprising ways AI is already impacting patient advocacy, from helping navigate appeals to streamlining the process of getting the care you need. They explore whether AI is a helpful ally, a potential challenge, or a true game changer for patients navigating insurance barriers. Erin shares expert insights, clarifies common misconceptions about AI in healthcare, and highlights the resources and strategies that can make a real difference for patients facing these obstacles. Thank you to Amgen Oncology and Daiichi Sankyo for making this episode possible.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Novartis and Monte Rosa have entered into their second molecular glue deal worth up to $5.7 billion, with Novartis putting $120 million upfront for more of the biotech's AI-discovered degraders. The myasthenia gravis market, once sparse, is now flourishing with new treatments approved and promising late-stage trial results from companies like Argenx and Regeneron. In other news, AstraZeneca has suspended its $270 million commitment in the UK, the FDA has flip-flopped on scrapping advisory committee meetings, and Sino Biological has developed a high-throughput platform for AI-driven antibody discovery. The myasthenia gravis space is heating up with targeted therapies, with several companies releasing promising late-stage trial results. Biogen is developing a pipeline for lupus, with investors showing interest in their programs. The FDA has several actions scheduled for September, including Merck's proposed subcutaneous formulation of Keytruda. Eli Lilly's obesity pill, Orforglipron, is in focus at the European Association for the Study of Diabetes meeting. In the cancer news, Merck's Keytruda challenger faces consistency problems, while other companies like Daiichi Sankyo and Biontech report positive data. Capsida reports a patient death in a gene therapy trial, while Alkermes shows promise in narcolepsy treatment. FDA is looking to streamline the development of non-opioid painkillers. Various webinars and events are upcoming in the pharma industry. Job opportunities are available at companies like Moderna, Abbvie, and Regeneron. Overall, the biopharma industry is seeing advancements and progress in various therapeutic areas.

Detecting the Often Undetectable One family's insight into ovarian and uterine cancer, finding support, cherishing family and making change through philanthropy. Diane Trounson-Chaiken, PsyD Diane was born and raised in Long Island City, NY and as a true New Yorker did all of her schooling in NYC. She received her BA in Psychology and Education from Barnard College, Columbia University in 1988 then traveled downtown to New York University where she received her MA and Doctor of Psychology in Child Clinical Psychology in 1994. For many years she worked in early intervention with developmentally delayed preschoolers and their families. She also taught psychology graduate courses to Masters and Doctoral students at several universities, most notably Philadelphia College of Osteopathic Medicine.  Diane met her husband Warren in 1989. They were married in 1993 and moved to the Philadelphia area in 1994. They have two sons, Ben (27 years) and Josh (23 years). Ben graduated from Colgate University in 2020 and lives in Manhattan. Josh graduated from Wake Forest University in 2024 and currently lives in Chicago. Spending time with her husband and sons is what Diane loves most in life. Whether traveling the world, a passion they all share, or sitting on the beach at the Jersey shore, it's all about being together. In April 2023, Diane was diagnosed with Stage 3B Clear Cell Ovarian Cancer & Stage 1 Uterine Cancer. She is treated at Fox Chase Cancer Center in Philadelphia, recognized as a nationally leading cancer center for both clinical care and research. After surgery and chemotherapy Diane achieved remission in October 2023. A year later in November 2024 she suffered a recurrence that resulted in surgery.  Again, this summer in June 2025 she had a more significant recurrence with several areas of metasteses. Diane is currently undergoing chemotherapy which will be followed by surgery and continued chemo. She has learned that this journey is not a sprint but much more of a marathon and is so grateful for the love and support of  her family and many dear friends.  Following are several organizations and programs the Chaiken family supports philanthropically.  -Fox Chase Cancer Center, Ovarian cancer research -Unite for Her, a national organization that provides free services and support for breast and ovarian cancer patients -We Are Wake, a campus wide program at Wake Forest University that supports students' mental health. -Her Health Compass -Crohn's & Colitis Foundation of America  Warren Chaiken is a seasoned executive with over two decades of experience leading complex organizations and driving growth through strategic innovation, operational excellence, and customer-centric leadership. Most recently, Warren served as President & CEO of Almo Corporation, a leading national distributor of appliances, consumer electronics, and professional A/V equipment. Under his leadership, Almo experienced significant expansion, culminating in its successful acquisition by DCC Technology, a division of DCC plc. Warren began his career in accounting and finance before joining Almo, where he held progressive leadership roles across operations, logistics, and sales. As CEO, he championed a culture of service, integrity, and continuous improvement while fostering key partnerships and launching new business units, including Almo Professional A/V. His functional expertise spans strategic planning, mergers and acquisitions, supply chain management, and go-to-market strategy. He is also recognized for his ability to build high-performing teams, guide family-owned businesses through transformational growth, and lead with vision in dynamic markets. Warren and Diane Chaiken are committed philanthropists. Together, they support the Philadelphia Board of the Crohn's & Colitis Foundation of America, Unite for HER, Committee to Benefit the Children, and Swim With Purpose. They also endowed The Chaiken Family Ovarian Cancer Visiting Professorship at Fox Chase Cancer Center. In addition, they founded the Chaiken Cares Foundation to promote health and provide assistance for a variety of children's needs. Their past involvement includes serving on the Parents Committees of both Wake Forest University and Colgate University. Warren and Diane have been married for 32 years and are proud parents of two sons—Ben, 27, and Josh, 23. Warren holds a B.A. from Lafayette College and an MBA from Penn State University. He currently advises companies in the distribution and technology sectors. Sue Weldon, Founder/Chief Executive Officer of Unite for HER, founded the organization in 2009 following her breast cancer diagnosis at age 39. Her vision for accessible integrative cancer care has transformed the organization from serving 23 patients to helping thousands annually. A nationally recognized leader in health equity, Sue serves as a patient advocate advisor to the American Cancer Society, Lilly, AstraZeneca, Deloitte, Daiichi-Sankyo, Pfizer, Novartis, and AbbVie. She holds a BA from West Chester University and has received numerous honors, including AstraZeneca's Catalyst for Care Award and West Chester University's Distinguished Alumni Award. She has three grown children, Taylor, Evan and Corrine and resides with her husband, Chip in West Chester, PA Find Yonni & Heather here https://www.herhealthcompass.com/

Dr. Pedro Barata and Dr. Rana McKay discuss the integration of innovative advances in molecular imaging and therapeutics to personalize treatment for patients with renal cell and urothelial carcinomas. TRANSCRIPT Dr. Pedro Barata: Hello, I'm Dr. Pedro Barata, your guest host of By the Book, a podcast series featuring insightful conversations between authors and editors of the ASCO Educational Book. I'm a medical oncologist at University Hospitals Seidman Cancer Center and an associate professor of medicine at Case Western Reserve University in Cleveland, Ohio. I'm also an associate editor of the ASCO Educational Book. Now, we all know the field of genitourinary cancers (GU) is evolving quite rapidly, and we have new innovations in molecular imaging as well as targeted therapeutics. Today's episode will be exploring novel approaches that are transforming the management of renal cell and urothelial carcinomas and also their potential to offer a more personalized treatment to patients. For that, joining for today's discussion is Dr. Rana McKay, a GU medical oncologist and professor at University of California San Diego. Dr. McKay will discuss her recently published article titled, “Emerging Paradigms in Genitourinary Cancers: Integrating Molecular Imaging, Hypoxia-Inducible Factor-Targeted Therapies, and Antibody-Drug Conjugates in Renal Cell and Urothelial Carcinomas.”  Our full disclosures are available in the transcript of this episode.  And with that, Rana McKay, great to have you on the podcast today. Dr. Rana McKay: Oh, thank you so much, Dr. Barata. It's really wonderful to be here with you. So, thanks for hosting. Dr. Pedro Barata: No, thanks for taking the time, and I'm looking forward to this conversation. And by the way, let me start by saying congrats on a great article in the Educational Book. Really super helpful paper. I'm recommending it to a lot of the residents and fellows at my own institution. I would like to first ask you to kind of give our listeners some context of how novel approaches in the molecular imaging as well as targeted therapeutics are actually changing the way we're managing patients with GU, but specifically with renal cell carcinoma and urothelial carcinoma. So, what are the areas you would call out as like being big areas for innovation in this context, and why are they important? Dr. Rana McKay: Very good question. And I think this is really what this article highlights. It highlights where are we going from an imaging diagnostics standpoint? Where are we going from a therapeutic standpoint? And I think if we have to step back, from the standpoint of diagnostics, we've seen PET imaging really transform diagnostics in prostate cancer with the advent of PSMA PET imaging, and now PSMA PET imaging is used as a biomarker for selection for theranostics therapy. And so, we're starting to see that enter into the RCC landscape, enter into the urothelial cancer landscape to a lesser extent. And I think it's going to potentially be transformative as these tools get more refined. I think when we think about therapeutics, what's been transformative most recently in the renal cell carcinoma landscape has been the advent of HIF2α inhibition to improve outcomes for patients. And we have seen the approval of belzutifan most recently that has reshaped the landscape. And now there's other HIF2α inhibitors that are being developed that are going to be further important as they get refined. And lastly, I think when we think about urothelial carcinoma, the greatest transformation to treatment in that context has been the displacement of cisplatin and platinum-based chemotherapy as a frontline standard with the combination of enfortumab vedotin plus pembrolizumab. And we've seen antibody-drug conjugates really reshape treatment and tremendously improve outcomes for patients. So, I think those are the three key areas of interest. Dr. Pedro Barata: So with that, let's focus first on the imaging and then we'll get to the therapeutic area. So, we know there's been a paradigm shift, really, when prostate-specific targets emerged as tracers for PET scanning. And so, we now commonly use prostate-specific membrane antigen, or PSMA-based PET scanning, and really transform how we manage prostate cancer. Now, it appears that we're kind of seeing a similar wave in renal cell carcinoma with the new radiotracer against the target carbonic anhydrase IX. What can you tell us about this? And is this going to be available to us anytime soon? And how do you think that might potentially change the way we're managing patients with RCC today? Dr. Rana McKay: First, I'll step back and say that in the context of PSMA PET imaging, we have actually been able to better understand RCC as well. So, we know that PSMA is expressed in the neovasculature of tumors, and it can actually be used to detect renal cell carcinoma tumors. It has a detection rate of about 84% when used for detection. And so, you know, I don't think it's just restricted to carbonic anhydrase IX, but we will talk about that. So, PSMA expressed in the neovasculature has a detection rate of around 84%, particularly if we're looking at clear cell RCC. CAlX is overexpressed in clear cell RCC, and it's actually used in diagnosing renal cell carcinoma when we think of CAlX IHC for diagnosing clear cell RCC. And now there are CAlX PET tracers. The first foray was with the ZIRCON study that was actually an interestingly designed study because it was designed to detect the likelihood of PET imaging to identify clear cell RCC. So, it was actually used in the early diagnostics setting when somebody presents with a renal mass to discriminate that renal mass from a clear cell versus a non-clear cell, and it was a positive study. But when I think about the potential application for these agents, you know, I think about the entire landscape of renal cell carcinoma. This is a disease that we do treat with metastasis-directed therapy. We have certainly seen patients who've undergone metastasectomy have long, durable remissions from such an approach. And I think if we can detect very early onset oligometastatic disease where a metastasis-directed therapy or SABR could be introduced - obviously tested in a trial to demonstrate its efficacy - I think it could potentially be transformative. Dr. Pedro Barata: Wonderful. It's a great summary, and I should highlight you are involved in some of those ongoing studies testing the performance of this specific PET scanning for RCC against conventional imaging, right? And to remind the listeners, thus far, for the most part, we don't really do FDG-PET for RCC. There are some specific cases we do, but in general, they're not a standard scanning. But maybe that will change in the future. Maybe RCC will have their own PSMA-PET. And to your point, there's also emerging data about the role of PSMA-PET scanning in RCC as well, as you very elegantly summarized. Wonderful. So, let me shift gears a little bit because you did, in your introduction, you did highlight a novel MOA that we have in renal cell carcinoma, approved for use, initially for VHL disease, and after that for sporadic clear cell renal cell carcinoma. We're talking about hypoxia-inducible factor 2-alpha inhibitors, or HIF2α inhibitors, such as belzutifan. But there's also others coming up. So, as a way to kind of summarize that, what can you tell us about this breakthrough in terms of therapeutic class, this MOA that got to our toolbox of options for patients with advanced RCC? Tell us a little bit what is being utilized currently in the management of advanced RCC. And where do you see the future going, as far as, is it moving early on? Is it getting monotherapy versus combinations? Maybe other therapies? What are your thoughts about that? What can you tell us about it? Dr. Rana McKay: Belzutifan is a first-in-class HIF2α inhibitor that really established clinical validation for HIF2α as a therapeutic target. When we think about the activity of this agent, the pivotal LITESPARK-005 trial really led to the approval of belzutifan in patients who were really heavily pretreated. It was patients who had received prior IO therapy, patients who had received prior VEGF-targeted therapy. And in the context of this study, we saw a median PFS of 5.6 months, and there did seem to be a tail on the curve when you looked at the 12-month PFS rate with belzutifan. It was 33.7% compared to 17.6% with everolimus. And then when we look at the response rate, it was higher with belzutifan on the order of 22-23%, and very low with everolimus, as we've previously seen. I think one of the Achilles heels of this regimen is the primary PD rate, which was 34% when used in later line. There are multiple studies that are testing belzutifan in combination across the treatment landscape. So, we have LITESPARK-011, which is looking at the combination of belzutifan plus lenvatinib in the second-line setting. We've got the MK-012 [LITESPARK-012] study, which is looking at belzutifan in various combinations in the frontline setting. So there is a combination with IO plus belzutifan. And so this is also being looked at in that context. And then we also have the LITESPARK-022 study, which is looking at pembrolizumab with belzutifan in the adjuvant setting. So there's a series of studies that will be exploring belzutifan really across the treatment landscape. Many of these studies in combination. Additionally, there are other HIF2α inhibitors that are being developed. We have casdatifan, which is another very potent HIF2α inhibitor. You know, I think pharmacologically, these are different agents. There's a different half-life, different dosing. What is going to be the recommended phase 3 dose for both agents, the EPO suppression levels, the degree of EPO suppression, and sustainability of EPO suppression is very different. So, I think we've seen data from casdatifan from the ARC-20 trial from monotherapy with a respectable response rate, over 30%, primary PD rate hovering just around 10%.  And then we've also seen data of the combination of casdatifan with cabozantinib as well that were recently presented this year. And that agent is also being tested across the spectrum of RCC. It's being looked at in combination with cabozantinib in the PEAK-1 study, and actually just at the KCRS (Kidney Cancer Research Summit), we saw the unveiling of the eVOLVE-RCC trial, which is going to be looking at a volrustomig, which is a PD-1/CTLA-4 inhibitor plus casdatifan compared to nivo-ipi in the frontline setting.  So, we're going to see some competition in this space of the HIF2α inhibitors. I think when we think of mechanism of action in that these are very potent, not a lot of off-target activity, and they target a driver mutation in the disease. And that driver mutation happens very early in the pathogenesis. These are going to be positioned much earlier in the treatment landscape. Dr. Pedro Barata: All these studies, as you're saying, look really promising. And when we talk about them, you mentioned a lot of combinations. And to me, when I think of these agents, it makes a lot of sense to combine because there's not a lot of overlapping toxicities, if you will. But perhaps for some of our listeners, who have not used HIF2α inhibitors in practice yet, and they might be thinking about that, what can you tell us about the safety profile? How do you present it to your patients, and how do you handle things like hypoxia or anemia? How do you walk through the safety profile and tolerability profile of those agents like belzutifan? Dr. Rana McKay: I think these drugs are very different than your traditional TKIs, and they don't cause the classic symptoms that are associated with traditional TKIs that many of us are very familiar with like the rash, hand-foot syndrome, hypertension, diarrhea. And honestly, these are very nuanced symptoms that patients really struggle with the chronicity of being on a chronic daily TKI. The three key side effects that I warn patients about with HIF2α inhibitors are: (1) fatigue; (2) anemia; and (3) hypoxia and dysregulation in the ability to sense oxygen levels. And so, many of these side effects - actually, all of them - are very dose-dependent. They can be very well-managed. So, we can start off with the anemia. I think it's critically important before you even start somebody on belzutifan that you are optimizing their hemoglobin and bone marrow function. Make sure they don't have an underlying iron deficiency anemia. Make sure they don't have B12 or folate deficiency. Check for these parameters. Many patients who have kidney cancer may have some hematuria, other things where there could be some low-level blood loss. So, make sure that those are resolved or you're at least addressing them and supplementing people appropriately. I monitor anemia very closely every 3 to 4 weeks, at least, when people start on these medications. And I do initiate EPO, erythropoietin, should the anemia start to worsen. And I typically use a threshold of around 10g/dL  for implementing utilization of an EPO agent, and that's been done very safely in the context of the early studies and phase 3 studies as well. Now, with regards to the hypoxia, I think it's also important to make sure that you're selecting the appropriate individual for this treatment. People who have underlying COPD, or even those individuals who have just a very high burden of disease in their lung, lymphangitic spread, pleural effusions, maybe they're already on oxygen - that's not an ideal candidate for belzutifan. Something that very easily can be done in the clinic before you think about initiating somebody on this treatment, and has certainly been integrated into some of the trials, is just a 6-minute walk test. You know, have the patient walk around the clinic with one of the MAs, one of the nurses, put the O2 sat on [measuring oxygen saturation], make sure they're doing okay. But these side effects, like I said, are very dose-dependent. Typically, if a patient requires, if the symptoms are severe, the therapy can be discontinued and dose reduced. The standing dose is 120 mg daily, and there's two dose reductions to 80 mg and 40 mg should somebody warrant that dose modification. Dr. Pedro Barata: This is relatively new, right? Like, it was not that we're used to checking oxygen levels, right? In general, we're treating these patients, so I certainly think there's a learning curve there, and some of the points that you highlight are truly critical. And I do share many of those as well in our practice. Since I have you, I want to make sure we touch base on antibody-drug conjugates as well. It's also been a hot area, a lot of developments there. When I think of urothelial carcinoma and renal cell carcinoma, I see it a little bit different. I think perhaps in urothelial carcinoma, antibody-drug conjugates, or ADCs, are somewhat established already. You already mentioned enfortumab vedotin. I might ask you to expand a little bit on that. And then in renal cell carcinoma, we have some ADCs as well that you include in your chapter, and that I would like you to tell us what's coming from that perspective. So, tell us a little bit about how do you see ADCs in general for GU tumors, particularly UC and RCC? Tell us a little bit about the complexity or perhaps the challenges you still see. At the same time, tell us about the successes. Dr. Rana McKay: Stepping back, let's just talk about like the principles and design of ADCs. So, most ADCs have three components. There's a monoclonal antibody that typically targets a cell surface antigen, which is conjugated by a linker, which is the second component, to a payload drug. And typically, that payload drug has been chemotherapy, whether it be topoisomerase or whether it be MMAE or other chemotherapeutic. We can start in the RCC space. There's been multiple antibody-drug conjugates that have been tested. There's antibody-drug conjugates to CD70, which is expressed on clear cell RCC. There's been antibody-drug conjugates to ENPP3, which is also expressed on RCC. There's antibody-drug conjugates to CDH6. And they have different payloads, like I said, whether it be topoisomerase I or other microtubule inhibitors. Now, when we think about kidney cancer, we don't treat this disease with chemotherapy. This disease is treated with immunotherapy. It is treated with treatments that target the VEGF pathway and historically has not been sensitive to chemo. So, I think even though the targets have been very exciting, we've seen very underwhelming data regarding activity, and in some context, seen increased toxicity with the ADCs. So, I think we need to tread lightly in the context of the integration and the testing of ADCs in RCC. We just came back from the KCRS meeting, and there was some very intriguing data about a c-Kit ADC that's being developed for chromophobe RCC, which is, you know, a huge unmet need, these variant tumors that really lack appropriate therapeutics. But I just caution us to tread lightly around how can we optimize the payload to make sure that the tumor that we're treating is actually sensitive to the agent that's targeting the cell kill. So, that's a little bit on the ADCs in RCC. I still think we have a long way to go and still in early testing. Now, ADCs for UC are now the standard of care. I think the prototypical agent, enfortumab vedotin, is a nectin-4-directed ADC that's conjugated to an MMAE payload and was the first ADC approved for advanced urothelial, received accelerated approval following the EV-201 trial, which was basically a multicenter, single-arm study that was investigating EV in cisplatin-ineligible patients with advanced urothelial carcinoma, and then ultimately confirmed in the EV-301 study as well. And so, that study ended up demonstrating the support superiority of EV from an overall survival standpoint, even PFS standpoint. Building on that backbone is the EV-302 study, which tested EV in combination with pembrolizumab versus platinum-based chemotherapy in the frontline setting. And that was a pivotal, landmark study that, like I said, has displaced platinum therapy as a frontline treatment for people with advanced urothelial carcinoma. And when we think about that study and the median overall survival and just how far we've come in urothelial cancer, the median OS with EV-pembro from that trial was 31 and a half months. I mean, that's just incredible. The control arm survival was 16 and a half months. The hazard ratio for OS, 0.47. I mean this is why when this data was presented, it was literally a standing ovation that lasted for several minutes because we just haven't seen data that have looked that good. And there are other antibody-drug conjugates that are being tested. We've all been involved in the saga with sacituzumab govitecan, which is a trophoblast cell surface antigen 2 (Trop-2) targeted ADC with a topoisomerase I payload. It was the second ADC to receive approval, but then that approval was subsequently withdrawn when the confirmatory phase 3 was negative, the TROPiCS-04 trial. So, approval was granted based off of the TROPHY-U-01, single-arm, phase 2 study, demonstrating a response rate of around 28% and a PFS of, you know, about 5 and a half months. But then failure to show any benefit from an OS standpoint. And I think there's a lot of controversy in the field around whether this agent still has a role in advanced urothelial carcinoma. And I think particularly for individuals who do not have molecular targets, like they're not HER2-amplified or have HER2-positivity or FGFR or other things like that. Dr. Pedro Barata: Fantastic summary, Rana. You were talking about the EV, and it came to mind that it might not be over, right, for the number of ADCs we use in clinical practice in the near future. I mean, we've seen very promising data for ADC against the HER2, right, and over-expression. It also can create some challenges, right, in the clinics because we're asking to test for HER2 expression. It's almost like, it's not exactly the same to do it in breast cancer, but it looks one more time that we're a little bit behind the breast cancer field in a lot of angles. And also has vedotin as a payload. Of course, I'm referring to disitamab vedotin, and there's very elegant data described by you in your review chapter as well. And it's going to be very interesting to see how we sequence the different ADCs, to your point as well. So, before we wrap it up, I just want to give you the opportunity to tell us if there's any area that we have not touched, any take-home points you'd like to bring up for our listeners before we call it a day. Dr. Rana McKay: Thank you so much. I have to say, you know, I was so excited at ASCO this year looking at the GU program. It was fantastic to see the progress being made, novel therapeutics that really there's a tremendous excitement about, not just in RCC and in UC, but also in prostate cancer, thinking about the integration of therapies, not just for people with refractory disease that, even though our goal is to improve survival, our likelihood of cure is low, but also thinking about how do we integrate these therapies early in the treatment landscape to enhance cure rates for patients, which is just really spectacular. We're seeing many of these agents move into the perioperative setting or in combination with radiation for localized disease. And then the special symposium on biomarkers, I mean, we've really come a long, long way. And I think that we're going to continue to evolve over the next several years. I'm super excited about where the field is going in the treatment of genitourinary malignancies. Dr. Pedro Barata: Oh, absolutely true. And I would say within the Annual Meeting, we have outstanding Educational Sessions. And just a reminder to the listeners that actually that's where the different teams or topics for the Educational Book chapters come from, from actually the educational sessions from ASCO. And your fantastic chapter is an example of that, right, focusing on advanced GU tumors. So, thank you so much, Rana, for taking the time, sharing your insights with us today on the podcast. It was a fantastic conversation as always. Dr. Rana McKay: My pleasure. Thanks so much for having me, Dr. Barata. Dr. Pedro Barata: Of course.  And thank you to our listeners for your time today. You will find the link to the article discussed today in the transcript of this episode. I also encourage you to check out the 2025 ASCO Educational Book. You'll find an incredible wealth of information there. It's free, available online, and you'll find, hopefully, super, super important information on the key science and issues that are shaping modern oncology, as we've heard from Dr. McKay and many other outstanding authors. So, thank you, everyone, and I hope to see you soon. 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. Pedro Barata @PBarataMD Dr. Rana McKay @DrRanaMcKay Follow ASCO on social media:        @ASCO on X (formerly Twitter)        ASCO on Bluesky       ASCO on Facebook        ASCO on LinkedIn        Disclosures:     Dr. Pedro Barata: Stock and Other Ownership Interests: Luminate Medical Honoraria: UroToday Consulting or Advisory Role: Bayer, BMS, Pfizer, EMD Serono, Eisai, Caris Life Sciences, AstraZeneca, Exelixis, AVEO, Merck, Ipson, Astellas Medivation, Novartis, Dendreon Speakers' Bureau: AstraZeneca, Merck, Caris Life Sciences, Bayer, Pfizer/Astellas Research Funding (Inst.): Exelixis, Blue Earth, AVEO, Pfizer, Merck  Dr. Rana McKay: Consulting or Advisory Role: Janssen, Novartis, Tempus, Pfizer, Astellas Medivation, Dendreon, Bayer, Sanofi, Vividion, Calithera, Caris Life Sciences, Sorrento Therapeutics, AVEO, Seattle Genetics, Telix, Eli Lilly, Blue Earth Diagnostics, Ambrx, Sumitomo Pharma Oncology, Esiai, NeoMorph, Arcus Biosciences, Daiichi Sankyo, Exelixis, Bristol Myers Squibb, Merck, Astrazeneca, Myovant Research Funding (Inst.): Bayer, Tempus, AstraZeneca, Exelixis, Bristol Myers Squibb, Oncternal Therapeutics, Artera    

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

In today's episode, supported by Daiichi-Sankyo, we spoke with Ronan J. Kelly, MD, MBA, FASCO; and Michelle Shiller, DO, AP/CP, MGP, about HER2 immunohistochemistry (IHC) testing in non–small cell lung cancer (NSCLC). Kelly is director of the Charles A. Sammons Cancer Center and chief science officer at Baylor University Medical Center in Dallas, Texas; the W.W. Caruth Jr. Endowed Chair of Immunology at Baylor University Medical Center; chief of Oncology at Baylor Scott & White Health System; founder and medical director of the Texas Cancer Interception Institute; a clinical professor at the Texas A&M University College of Medicine; an adjunct associate professor of oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland; and a professor in the Clinical Sciences Division at the Translational Genomics Research Institute in Phoenix, Arizona. Shiller is a molecular genetic pathologist at Baylor University Medical Center.  In our conversation, Drs Kelly and Shiller discussed the importance of performing IHC testing for HER2 in NSCLC, how IHC results may influence treatment decision-making beyond the scope of next-generation sequencing results, and recommendations for more efficient and collaborative IHC testing implementation in clinical practice. 

This episode covers: Cardiology This Week: A concise summary of recent studies Oral anticoagulation in atrial fibrillation: answers to frequent questions Smartwatch, heart rate and ECG Milestones: Lyon Diet Heart study Host: Emer Joyce Guests: Carlos Aguiar, Tim Chico, Paulus Kirchhof Want to watch that episode? Go to: https://esc365.escardio.org/event/1811 Want to watch that extended interview on smartwatch, heart rate and ECG? Go to: https://esc365.escardio.org/event/1811?resource=interview   Disclaimer ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors.  This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails.   Declarations of interests Stephan Achenbach, Emer Joyce and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Tim Chico has declared to have potential conflicts of interest to report: research funding from Google. Paulus Kirchhof has declared to have potential conflicts of interest to report: partially supported by European Union MAESTRIA (grant agreement 965286), British Heart Foundation (AA/18/2/34218), German Center for Cardiovascular Research supported by the German Ministry of Education and Research (DZHK, grant numbers DZHK FKZ 81X2800182, 81Z0710116, and 81Z0710110), German Research Foundation (Ki 509167694), Dutch Heart Foundation (DHF), the Accelerating Clinical Trials funding stream in Canada, and the Else-Kröner-Fresenius Foundation. Research support for basic, translational, and clinical research projects from German Research Foundation (DFG), European Union, British Heart Foundation, Leducq Foundation, Else-Kröner-Fresenius Foundation, Dutch Heart Foundation (DHF), the Accelerating Clinical Trials funding stream in Canada, Medical Research Council (UK), and German Center for Cardiovascular Research, from several drug and device companies active in atrial fibrillation, and has received honoraria from several such companies in the past, but not in the last five years. Listed as inventor on two issued patents held by University of Hamburg (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Emer Joyce Guest: Tim Chico Want to watch that extended interview on smartwatch, heart rate and ECG? Go to: https://esc365.escardio.org/event/1811?resource=interview Want to watch that episode? Go to: https://esc365.escardio.org/event/1811   Disclaimer  ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors.  This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails.   Declarations of interests Stephan Achenbach, Emer Joyce and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Tim Chico has declared to have potential conflicts of interest to report: research funding from Google. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Dr. Hope Rugo and Dr. Kamaria Lee discuss the prevalence of financial toxicity in cancer care in the United States and globally, focusing on breast cancer, and highlight key interventions to mitigate financial hardship. TRANSCRIPT  Dr. Hope Rugo: Hello, and welcome to By the Book, a podcast series from ASCO that features engaging conversations between editors and authors of the ASCO Educational Book. I'm your host, Dr. Hope Rugo. I'm the director of the Women's Cancer Program and division chief of breast medical oncology at the City of Hope Cancer Center, and I'm also the editor-in-chief of the Educational Book. Rising healthcare costs are causing financial distress for patients and their families across the globe. Patients with cancer report financial toxicity as a major impediment to their quality of life, and its association with worse outcomes is well documented. Today, we'll be discussing how patients with breast cancer are uniquely at risk for financial toxicity. Joining me for this discussion is Dr. Kamaria Lee, a fourth-year radiation oncology resident and health equity researcher at MD Anderson Cancer Center and a co-author of the recently published article titled, "Financial Toxicity in Breast Cancer: Why Does It Matter, Who Is at Risk, and How Do We Intervene?" Our full disclosures are available in the transcript of this episode.  Dr. Lee, it's great to have you on this podcast. Dr. Kamaria Lee: Hey, Dr. Rugo. Thank you so much for having me. I'm excited to be here today. I also would like to recognize my co-authors, Dr. Alexandru Eniu, Dr. Christopher Booth, Molly MacDonald, and Dr. Fumiko Chino, who worked on this book chapter with me and did a fantastic presentation on the topic at ASCO this past year. Dr. Hope Rugo: Thanks very much. We'll now just jump into the questions. We know that rising medical costs contribute to a growing financial burden on patients, which has [GC1]  [JG2]  been documented to contribute to lower quality-of-life, compromised clinical care, and worse health outcomes. How are patients with breast cancer uniquely at risk for financial toxicity? How does the problem vary within the breast cancer population in terms of age, racial and ethnic groups, and those who have metastatic disease? Dr. Kamaria Lee: Breast cancer patients are uniquely at risk of financial toxicity for several reasons. Three key reasons are that breast cancer often requires multimodal treatment. So this means patients are receiving surgery, many receive systemic therapies, including hormonal therapies, as well as radiation. And so this requires care coordination and multiple visits that can increase costs. Secondly, another key reason that patients with breast cancer are uniquely at risk for financial toxicity is that there's often a long survivorship period that includes long-term care for toxicities and continued follow-ups, and patients might also be involved in activities regarding advocacy, but also physical therapy and mental health appointments during their prolonged survivorship, which can also add costs. And a third key reason that patients with breast cancer are uniquely at risk for financial toxicity is that the patient population is primarily women. And we know that women are more likely to have increased caregiver responsibilities while also potentially working and managing their treatments, and so this is another contributor. Within the breast cancer population, those who are younger and those who are from marginalized racial/ethnic groups and those with metastatic disease have been shown to be at an increased risk. Those who are younger may be more likely to need childcare during treatment if they have kids, or they're more likely to be employed and not yet retired, which can be disrupted while receiving treatment. And those who are racial/ethnic minorities may have increased financial toxicity due to reasons that exist even after controlling for socioeconomic factors. And some of these reasons have been shown to be increased risk of job or income loss or transportation barriers during treatment. And lastly, for those with metastatic breast cancer, there can be ongoing financial distress due to the long-term care that is needed for treatment, and this can include parking, transportation, and medications while managing their metastatic disease. Dr. Hope Rugo: I think it is really important to understand these issues as you just outlined. There has been a lot of focus on financial toxicity research in recent years, and that has led to novel approaches in screening for financial hardship. Can you tell us about the new screening tools and interventions and how you can easily apply that to clinical practice, keeping in mind that people aren't at MD Anderson with a bunch of support and information on this but are in clinical practice and seeing many, many patients a day with lots of different cancers? Dr. Kamaria Lee: You're exactly right that there is incredible nuance needed in understanding how to best screen for financial hardship in different types of practices. There are multiple financial toxicity tools. The most commonly used tool is the Comprehensive Score for Financial Toxicity, also known as the COST tool. In its full form, it's an 11-item survey. There's also a summary question as well. And these questions look at objective and subjective financial burden, and it uses a five-point Likert scale. For example, one question on the full form is, "I know that I have enough money in savings, retirement, or assets to cover the cost of my treatment," and then patients are able to respond "not at all" to "very much" with a threshold score for financial toxicity risk. Of course, as you noted, one critique of having an 11-item survey is that there's limited time in patient encounters with their providers. And so recently, Thom et al validated an abbreviated two-question version of the COST tool. This validation was done in an urban comprehensive cancer center, and it was found to have a high predictive value to the full measure. We note which two questions are specifically pulled from the full measure within the book chapter. And this is one way that it can be easier for clinicians who are in a busier setting to still screen for financial toxicity with fewer questions. I also do recommend that clinicians who know their clinic's workflow the best, work with their team of nurses, financial navigators, and others to best integrate the tool into their workflow. For some, this may mean sending the two-item survey as a portal message so that patients can answer it before consults. Other times, it could mean having it on the tablet that can be done in the clinic waiting room. And so there are different ways that screening can be done, even in a busy setting, and acknowledging that different practices have different amounts of resources and time. Dr. Hope Rugo: And where would people access that easily? I recognize that that information is in your chapter, or your article that's on PubMed that will be linked to this podcast, but it is nice to just know where people could easily access that online. Dr. Kamaria Lee: Yes, and so you should be able to Google ‘the COST measure', and then there is a website that also has the forms as well. So it's also beyond the book chapter, Googling ‘the COST measure', and then online they would be able to find access to the form. Dr. Hope Rugo: And how often would you do that screening? Dr. Kamaria Lee: So, I think it's definitely important that we are as proactive as possible. And so initially, I recommend that the screening happens at the time of diagnosis, and so if it's done through the portal, it can be sent before the initial consult, or again, however, is best in the workflow. So at the time of diagnosis and then at regular intervals, so throughout the treatment process, but then also into the follow-up period as well to best understand if there's still a financial burden even after the treatments have been completed. Dr. Hope Rugo: I wonder if in the metastatic setting, you could do it at the change of treatment, you know, a month after somebody's changed treatment, because people may not be as aware of the financial constraints when they first get prescribed a drug. It's more when you hear back from how much it's going to cost. And leading into that, I think it's, what do you do with this? So, you know, this cost conversation is really important. You're going to be talking to the patient about the cost considerations when you, for example, see that there are financial issues, you're prescribing treatments. How do we implement impactful structured cost conversations with our breast cancer patients, help identify financial issues, and intervene? How do we intervene? I mean, as physicians often we aren't really all that aware, or providers, of how to address the cost. Dr. Kamaria Lee: Yes, I agree fully that another key time when to screen for financial toxicity is at that transition between treatments to best understand where they're at based off of what they've received previously for care, and then to anticipate needs when changing regimens, such as like you said in the metastatic setting. As we're collecting this information, you're right, we screen, we get this information, and what do we do? I do agree that there is a lack of knowledge among us clinicians of how do we manage this information. What is insurance? How do we manage insurance and help patients with insurance concerns? How do we help them navigate out-of-pocket costs or even the indirect costs of transportation? Those are a lot of things that are not covered in-depth in traditional medical training. And so it can be overwhelming for a lot of clinicians, not only due to time limitations in clinic, but also just having those conversations within their visit. And so what I would say, a key thing to note, is that this is another area for multidisciplinary care. So just as we're treating patients in a multidisciplinary way within oncology as we work with our medical oncology, surgical colleagues across the board, it's knowing that this is another area for multidisciplinary care. So the team members include all of the different oncologists, but it also includes team members such as financial counselors and navigators and social workers and even understanding nonprofit partners who we have who have money that can be set aside to help reduce costs for certain different aspects of treatment. Another thing I will note is that most patients with breast cancer often say they do want to have these conversations still with their clinicians. So they do still see a clinician as someone that can weigh in on the costs of their treatment or can weigh in on this other aspect of their care, even if it's not the actual medication or the radiation. And so patients do desire to hear from their clinicians about this topic, and so I think another way to make it feel less overwhelming for clinicians like ourselves is to know that even small conversations are helpful and then being knowledgeable about within your institution or, like I said, outside of it with nonprofits, being aware of who can I refer this patient to for continued follow-up and for more detailed information and resources. Dr. Hope Rugo: Are those the successful interventions? It's really referring to financial navigators? How do people identify? You know, in an academic center, we often will sort of punt this to social workers or our nurse navigators. What about in the community? What's a successful intervention example of mitigating financial toxicity? Dr. Kamaria Lee: I agree completely that the context at which people are practicing is important to note. So as you alluded to, in some bigger systems, we do have financial navigators and this has been seen to be successful in providing applications and assisting with applications for things such as pharmaceutical assistance, insurance applications, discount opportunities.  Another successful intervention are financial toxicity tumor boards, which I acknowledge might not be able to exist everywhere. But where this is possible, multidisciplinary tumor boards that include both doctors and nurses and social workers and any other members of the care team have been able to effectively decrease patients' personal spending on care costs and decrease co-pays through having a dedicated time to discuss concerns as they arise or even proactively. Otherwise, I think in the community, there are other interventions in regards to understanding different aspects of government programs that might be available for patients that are not, you know, limited to an institution, but that are more nationally available, and then again, also having the nonprofit, you know, partnerships to see other resources that patients can have access to.  And then I would also say that the indirect costs are a significant burden for many patients. So by that, I mean even parking costs, transportation, childcare. And so even though those aren't interventions necessarily with someone who is a financial navigator, I would recommend that even if it's a community practice, they discuss ways that they can help offset those indirect costs with patients with parking or if there are ways to help offset transportation costs or at least educate patients on other centers that may be closer to them or they can still receive wonderful care, and then also making sure that patients are able to even have appointments scheduled in ways that are easier for them financially.  So even if someone's receiving care out in the community where there's not a financial navigator, as clinicians or our scheduling teams, sometimes there are options to make sure if a patient wants, visits are more so on one day than throughout the week or many hours apart that can really cause loss of income due to missed work. And so there are also kind of more nuanced interventions that can happen even without a financial navigation system in place. Dr. Hope Rugo: I think that those are really good points and it is interesting when you think about financial toxicity. I mean, we worry a lot when patients can't take the drugs because they can't afford them, but there are obviously many other non-treatment, direct treatment-related issues that come up like the parking, childcare, tolls, you know, having a working car, all those kinds of things, and the unexpected things like school is out or something like that that really play a big role where they don't have alternatives. And I think that if we think about just drug costs, I think those are a big issue in the global setting. And your article did address financial toxicity in the global setting. International financial toxicity rates range from 25% of patients with breast cancer in high-income countries to nearly 80% in low- and middle-income countries or LMICs. You had cited a recent meta-analysis of the global burnout from cancer, and that article found that over half of patients faced catastrophic health expenditures. And of course, I travel internationally and have a lot of colleagues who are working in oncology in many countries, and it is really often kind of shocking from our perspective to see what people can get coverage for and how much they have to pay out-of-pocket and how much that changes, that causes a lot of disparity in access to healthcare options, even those that improve survival. Can you comment on the global impact of this problem? Dr. Kamaria Lee: I am glad that you brought this up for discussion as well. Financial toxicity is something that is a significant global issue. As you mentioned, as high as 80% of patients with breast cancer in low- and middle-income countries have had significant financial toxicity. And it's particularly notable that even when looking at breast cancer compared to other malignancies around the world, the burden appears to be worse. This has been seen even in countries with free universal healthcare. One example is Sri Lanka, where they saw high financial toxicity for their patients with breast cancer, even with this free universal healthcare. But there were also those travel costs and just additional out-of-hospital tests that were not covered. Also, literature in low- and middle-income countries shows that patients might also be borrowing money from their social networks, so from their family and their friends, to help cover their treatment costs, and in some cases, people are making daily food compromises to help offset the cost of their care. So there is a really large burden of financial toxicity generally for cancer globally, but also specifically in breast cancer, it warrants specific discussion. In the meta-analysis that you mentioned, they identified key risk factors of financial toxicity globally that included people who had a larger family size, a lower income, a lack of insurance, longer disease duration, so again, the accumulation of visits and costs and co-pay over time, and those who had multiple treatments. And so in the global setting, there is this significant burden, but then I will also note that there is a lack of literature in low-income countries on financial toxicity. So where we suspect that there is a higher burden and where we need to better understand how it's distributed and what interventions can be applied, especially culturally specific interventions for each country and community, there's less research on this topic. So there is definitely an increased need for research in financial toxicity, particularly in the global setting. Dr. Hope Rugo: Yes, and I think that goes on to how we hope that financial toxicity researchers will have approaches to large-scale multi-institutional interventions to improve financial toxicity. I think this is an enormous challenge, but one of the SWOG organizations has done some great work in this area, and a randomized trial addressing cancer-related financial hardship through the delivery of a proactive financial navigation intervention is one area that SWOG has focused on, which I think is really interesting. Of course, that's going to be US-based, which is how we might find our best paths starting. Do you think that's a good path forward, maybe that being able to provide something like that across institutions that are independent of being a cancer only academic center, or more general academic center, or a community practice? You know, is finding ways to help patients with breast cancer and their families understand and better manage financial aspects of cancer care on a national basis the next approach? Dr. Kamaria Lee: Yes, I agree that that is a good approach, and I think the proactive component is also key. We know that patients that are coming to us with any cancer, but including breast cancer, some of them have already experienced a financial burden or have recently had a job loss before even coming to us and having the added distress of our direct costs and our indirect costs. So I think being proactive when they come to us in regards to the additional burden that their cancer treatments may cause is key to try to get ahead of things as much as we can, knowing that even before they've seen us, there might be many financial concerns that they've been navigating.  I think at the national level, that allows us to try to understand things at what might be a higher level of evidence and make sure that we're able to address this for a diverse cohort of patients. I know that sometimes the enrollment can be challenging at the national level when looking at financial toxicity, as then we're involving many different types of financial navigation partners and programs, and so that can maybe make it more complex to understand the best approaches, but I think that it can be done and can really bring our understanding of important financial toxicity interventions to the next level. And then the benefit to families with the proactive component is just allowing them to feel more informed, which can help decrease anticipation, anxiety related to anticipation, and allow them to help plan things moving forward for themselves and for the whole family. Dr. Hope Rugo: Those are really good points and I wonder, I was just thinking as you were talking, that having some kind of a process where you could attach to the electronic health record, you could click on the financial toxicity survey questions that somebody filled out, and then there would be a drop-down menu for interventions or connecting you to people within your clinic or even more broadly that would be potential approaches to manage that toxicity issue so that it doesn't impact care, you know, that people aren't going to decide not to take their medication or not to come in or not to get their labs because of the cost or the transportation or the home care issues that often are a big problem, even parking, as you pointed out, at the cancer center. And actually, we had a philanthropic donor when I was at UCSF who donated a large sum of money for patient assistance, and it was interesting to then have these sequential meetings with all the stakeholders to try and decide how you would use that money. You need a big program, you need to have a way of assessing the things you can intervene with, which is really tough. In that general vein, you know, what are the governmental, institutional, and provider-level actions that are required to help clinicians do our best to do no financial harm, given the fact that we're prescribing really expensive drugs that require a lot of visits when caring for our patients with breast cancer in the curative and in the metastatic setting? Dr. Kamaria Lee: At the governmental level, there are patient assistant programs that do exist, and I think that those can continue and can become more robust. But I also think one element of those is oftentimes the programs that we have at the government level or even institutional levels might have a lot of paperwork or be harder for people with lower literacy levels to complete. And so I think the government can really try to make sure that the paperwork that is given, within reason, with all the information they need, but that the paperwork can be minimized and that there can be clear instructions, as well as increased health insurance options and, you know, medical debt forgiveness as more broad just overall interventions that are needed. I think additionally, institutions that have clinical trials can help ensure that enrollment can be at geographically diverse locations. Some trials do reimburse for travel costs, of course, but sometimes then patients need the reimbursement sooner than it comes. And so I think there's also those considerations of more so upfront funds for patients involved in clinical trials if they're going to have to travel far to be enrolled in that type of care or trying to, again, make clinical trials more available at diverse locations.  I would also say that it's important that those who design clinical trials use what is known as the “Common Sense Oncology” approach of making sure that they're designed in minimizing the use of outcomes that might have a smaller clinical benefit but may have a high financial toxicity. And that also goes to what providers can do, of understanding what's most important to a particular patient in front of them, what outcomes and what benefit, or you know, how many additional months of progression-free survival or things like that might be important to a particular patient and then also educating them and discussing what the associated financial burden is just so that they have the full picture as they make an informed decision. Dr. Hope Rugo: As much as we know. I mean, I think that that's one of the big challenges is that as we prescribe these expensive drugs and often require multiple visits, even, you know, really outside of the clinical trial setting, trying to balance the benefit versus the financial toxicity can be a huge challenge. And that's a big area, I think, that we still need help with, you know. As we have more drugs approved in the early-stage setting and treatments that could be expensive, oral medications, for example, in our Medicare population where the share of cost may be substantial upfront, you know, with an upfront cost, how do we balance the benefits versus the risk? And I think you make an important point that discussing this individually with patients after we found out what the cost is. I think warning patients about the potential for large out-of-pocket cost and asking them to contact us when they know is one way around this. You know, patients feeling like they're sort of out there with a prescription, a recommendation from their doctor, they're scared of their cancer, and they have this huge share of cost that we didn't know about. That's one challenge, and I don't know if there's any suggestions you have about how one should approach that communication with the patient. Dr. Kamaria Lee: Yes, I think part of it is truly looking at each patient as an individual and asking how much they want to know, right? So we all know that patients, some who want more information, some want less, and so I think one way to approach that is asking them about how much information do they want to know, what is most helpful to them. And then also, knowing that if you're in a well-resourced setting that does have the social workers and financial navigators, also making sure it's integrated in the multidisciplinary setting and so that they know who they can go to for what, but also know that as a clinician, you're always happy for them to bring up their concerns and that if it's something that you're not aware of, that you will connect them to the correct multidisciplinary team members who can accurately provide that additional information. Dr. Hope Rugo: Do you have any other additional comments that you'd like to mention that we haven't covered? I think the idea of a financial toxicity screen with two questions that could be implemented at change of therapy or just periodically throughout the course of treatment would be a really great thing, but I think we do need as much information on potential interventions as possible because that's really what challenges people. It's like finding out information that you can't handle. Your article provides a lot of strategies there, which I think are great and can be discussed on a practice and institutional level and applied. Dr. Kamaria Lee: Yeah, I would just like to thank you for the opportunity to discuss such an important topic within oncology and specifically for our patients with breast cancer. I agree that it can feel overwhelming, both for clinicians and patients, to navigate this topic that many of us are not as familiar with, but I would just say that the area of financial toxicity is continuing to evolve as we gather more information on most successful interventions and that our patients can often inform us on, you know, what interventions are most needed as we see them. And so you can have your thinking about it as you see individual patients of, "This person mentioned this could be more useful to them." And so I think also learning from our patients in this space that can seem overwhelming and that maybe we weren't all trained on in medical school to best understand how to approach it and how to give our patients the best care, not just medically, but also financially. Dr. Hope Rugo: Thank you, Dr. Lee, for sharing your insights with us today. Our listeners will find a link, as I mentioned earlier, to the Ed Book article we discussed today in the transcript of this episode. I think it's very useful, a useful resource, and not just for providers, but for clinic staff overall. I think this can be of great value and help open the discussion as well. Dr. Kamaria Lee: Thank you so much, Dr. Rugo. Dr. Hope Rugo: And thanks to our listeners for joining us today. Please join us again next month on By the Book for more insightful views on topics you'll be hearing at Education Sessions from ASCO meetings and our deep dives into new approaches that are shaping modern oncology. Thank you. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:       Dr. Hope Rugo  @hope.rugo  Dr. Kamaria Lee @ lee_kamaria Follow ASCO on social media:       @ASCO on X (formerly Twitter)       ASCO on Bluesky      ASCO on Facebook       ASCO on LinkedIn       Disclosures:      Dr. Hope Rugo:   Honoraria: Mylan/Viatris, Chugai Pharma  Consulting/Advisory Role: Napo Pharmaceuticals, Sanofi, Bristol Myer  Research Funding (Inst.): OBI Pharma, Pfizer, Novartis, Lilly, Merck, Daiichi Sankyo, AstraZeneca, Gilead Sciences, Hoffman La-Roche AG/Genentech, In., Stemline Therapeutics, Ambryx    Dr. Kamaria Lee: No relationships to disclose  

This episode covers:  Cardiology this Week: A concise summary of recent studies Atrial fibrillation in heart failure Temperature management following cardiac arrest Statistics Made Easy: Collider bias Host: Emer Joyce Guests: Carlos Aguiar, Christian Hassager, Theresa McDonagh Want to watch that episode? Go to: https://esc365.escardio.org/event/1812 Want to watch that extended interview on temperature management following cardiac arrest? Go to: https://esc365.escardio.org/event/1812?resource=interview   Disclaimer ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails.   Declarations of interests Stephan Achenbach, Emer Joyce, Christian Hassager, Nicolle Kraenkel and Theresa McDonagh have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Emer Joyce Guest: Christian Hassager Want to watch that extended interview? Go to: https://esc365.escardio.org/event/1812?resource=interview  Want to watch the full episode? Go to: https://esc365.escardio.org/event/1812   Disclaimer ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English-language always prevails.   Declarations of interests Stephan Achenbach, Emer Joyce, Christian Hassager, Nicolle Kraenkel and Theresa McDonagh have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

In this episode of, “Your Voice. Your Health”, we take a closer look at step therapy but this time through a financial lens. I sat down with Monica Bryant, Esq., Chief Mission Officer of Triage Cancer, to talk about how step therapy can create unexpected financial obstacles—from rising co-pays and delayed treatment to challenges with insurance coverage and staying employed during treatment in  your health plans, navigating appeals, and accessing financial aid. She also shares practical tips for choosing insurance plans, minimizing out-of-pocket costs, and using tools like Triage Cancer's new health insurance comparison calculator to make informed, cost-conscious decisions. If you or a loved one is facing treatment delays or financial stress related to step therapy, this episode offers clear, actionable guidance to help you take control. Special thanks to Amgen and Daiichi-Sankyo for making this episode possible.  

Today's guest is Michael Zaiac, Head of Medical Oncology for Europe and Canada at Daiichi Sankyo. Michael joins the platform in a special episode focused on how AI is driving measurable ROI in clinical trials—particularly in patient recruitment and eligibility. Their conversation explores how life sciences teams are applying advanced analytics to accelerate enrollment, improve diversity in study populations, and reduce time to trial completion. Michael also shares where generative AI is beginning to play a role in patient-facing materials, including simplified consent forms and study summaries. Throughout the episode, Michael emphasizes the importance of early stakeholder alignment, regulatory transparency, and the discipline required to deploy AI responsibly in high-risk clinical environments. This episode is sponsored by Medable. Learn how brands work with Emerj and other Emerj Media options at emerj.com/ad1. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on the ‘AI in Business' podcast!