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This episode is sponsored by Gilead Sciences. Gilead had no involvement or input in the podcast content. Gilead is working to transform how cancer is treated. We are innovating with next-generation therapies, combinations, and technologies to deliver improved outcomes for people with cancer. From antibody drug conjugates and small molecules to cell therapy-based approaches, our portfolio and pipeline assets are creating new possibilities for people with cancer.Recorded on location at the San Antonio Breast Cancer Symposium, December 2025.Metastatic triple-negative breast cancer remains the breast cancer subtype with the fewest targetable biomarkers and the shortest treatment algorithm. When a trial reports a double-digit progression-free survival in the first-line setting, it is worth understanding what that actually changes and how the trial was designed with patient outcomes at the center.This episode was recorded in December 2025, before regulatory action. On June 24, 2026, the FDA approved sacituzumab govitecan-hziy for two first-line indications in triple-negative breast cancer: as a single agent for adults with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor-based therapy supported by ASCENT-0, and in combination with pembrolizumab for adults whose tumors express PD-L1 with a CPS of 10 or greater supported by ASCENT-04. Janice's speculation in this episode about how PD-L1 status might factor into the guidelines has since been answered by the label.ASCENT-04/KEYNOTE-D19 NCT05382286 was a phase 3, open-label, randomized trial of 443 patients with previously untreated locally advanced unresectable or metastatic TNBC whose tumors expressed PD-L1 at a CPS of 10 or greater by the 22C3 assay. Participants were randomized 1:1 to sacituzumab govitecan plus pembrolizumab or to physician's choice of chemotherapy plus pembrolizumab. Patients in the control arm with centrally confirmed progression were offered crossover to sacituzumab govitecan.0:00 Live from the San Antonio Breast Cancer Symposium0:30 The METAvivor ribbon and what the pink ribbon leaves out1:35 Diagnosed in 2016 with a median overall survival of 9 to 15 months2:26 Nine years later3:20 From pediatric nursing to research advocacy4:30 What has changed since 2017, and what has not5:26 2011: when chemotherapy was the only option5:55 On not knowing a relevant clinical trial existed6:47 Why metastatic TNBC still has no maintenance therapy7:25 What first-line treatment looks like today8:25 Inside ASCENT-049:09 Progression-free survival, defined9:59 Why a double-digit PFS is notable in this subtype11:20 Why each subsequent line of treatment works for less time11:52 How many patients never reach second line12:50 The case for a stronger first-line option13:21 Crossover design, and why it matters to patients14:33 What crossover means in a randomized trial15:56 Patient advocates in clinical trial design18:59 Quality of life versus quantity of life21:48 Rapid fire: metastatic breast cancer and metastatic TNBC23:06 Rapid fire: first line, second line, progression-free survival24:00 Rapid fire: immunotherapy and antibody-drug conjugates24:59 Advice for the newly diagnosed26:04 What she wants next: a biomarker26:52 On ADCs, tolerability, and the need for novel targetsJanice Cowden, RN is a research patient advocate living with metastatic triple-negative breast cancer. She practiced as a registered nurse for approximately 22 years, primarily in pediatrics, and later worked as a pharmaceutical sales representative. She was diagnosed with stage I triple-negative breast cancer in 2011 and with metastatic disease in 2016, and completed the Living Beyond Breast Cancer advocacy training program in 2017.This podcast is intended for educational and informational purposes only and should not be considered medical advice.
In this episode of Oncology Unplugged, host Chandler Park, MD, a medical oncologist at Norton Cancer Institute in Louisville, Kentucky, was joined by Joshua Brody, MD, the director of the Lymphoma Immunotherapy Program at the Mount Sinai Tisch Cancer Center and a faculty member of the Icahn Genomics Institute in New York, New York.Their discussion centered on the evolving frontline and relapsed treatment landscape in Hodgkin lymphoma, highlighting the field's decades-long shift away from intensive chemotherapy and radiation toward better-tolerated, biologically targeted regimens. Drs Park and Brody framed Hodgkin lymphoma as a rare success story in oncology, noting that a once-uniformly fatal disease is now curable in more than 90% of patients, and emphasized that the modern treatment goal has moved from maximizing efficacy at any cost to preserving efficacy and minimize long-term toxicity, particularly given the disease's young patient population and correspondingly long survivorship horizon.A major focus of the conversation was the retirement of bleomycin from frontline regimens. Dr Brody explained that bleomycin carried substantial risk of pneumonitis and pulmonary fibrosis without strong single-agent antitumor activity and traced its decline to the phase 3 RATHL trial (NCT00678327), which established that patients with a clean interim PET scan after 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) could safely omit bleomycin from subsequent cycles. He noted that this PET-adapted approach helped set the stage for the 2 trials that have since reshaped frontline advanced-stage therapy: the phase 3 ECHELON-1 trial (NCT01712490), which showed that brentuximab vedotin (Adcetris) plus doxorubicin, vinblastine, and dacarbazine (AVD) outperformed standard ABVD, and the phase 3 SWOG S1826 (NCT03907488) trial, in which nivolumab (Opdivo) plus AVD produced a significantly lower relapse rate than brentuximab vedotin plus AVD, with durable benefit confirmed at the 2025 ASH Annual Meeting. Dr Brody described nivolumab plus AVD as the current standard of care for most patients with advanced-stage disease in the United States, citing both its efficacy and its more favorable toxicity profile relative to brentuximab vedotin, which carries a meaningful risk of peripheral neuropathy.The discussion then turned to the underlying biology that makes Hodgkin lymphoma so responsive to PD-1 blockade. Dr Brody explained that the malignant Reed-Sternberg cell relies heavily on PD-L1 overexpression, frequently driven by 9p24 amplifications or translocations, to evade T-cell surveillance, leaving the tumor unusually vulnerable once that mechanism is blocked pharmacologically. He noted that this single dominant immune-evasion pathway helps explain why response rates to anti–PD-1 therapy in Hodgkin lymphoma exceed those seen in melanoma and non–small cell lung cancer.Drs Park and Brody also explored treatment selection in early-stage disease, where Dr Brody noted that multiple regimens now achieve cure rates exceeding 90%, leaving no single clear standard. Options include traditional ABVD with low-dose radiation, radiation-free approaches with intensified chemotherapy, and emerging nivolumab-inclusive regimens, with selection often individualized based on disease location and patient-specific factors, such as the feasibility of giving radiation to sensitive anatomic sites.On relapsed disease, Dr Brody emphasized that outcomes remain favorable even after treatment failure, with second-line therapy typically incorporating whichever novel agent, anti–PD-1 or brentuximab vedotin, was not used in the frontline setting, often combined with chemotherapy. He noted that some patients achieve durable remission without proceeding to autologous stem cell transplant, though transplant remains an option for appropriate candidates, and flagged older patients as an ongoing unmet need given poorer transplant tolerability in this population.The conversation concluded with a look at emerging therapies beyond current CD30- and PD-1-targeted approaches, including CD70-directed antibody-drug conjugates and CD30-directed CAR T-cell therapy, both still early in development. Dr Brody highlighted new data presented at the 2026 ASCO Annual Meeting on an investigational PRMT5 inhibitor among heavily pretreated patients. He described the finding as unexpected and among the most promising developments on the horizon for relapsed and refractory disease.
Two Onc Docs, hosted by Samantha A. Armstrong, MD, and Karine Tawagi, MD, is a podcast dedicated to providing current and future oncologists and hematologists with the knowledge they need to ace their boards and deliver quality patient care. Dr Armstrong is a hematologist/oncologist and assistant professor of clinical medicine at Indiana University Health in Indianapolis. Dr Tawagi is a hematologist/oncologist and assistant professor of clinical medicine at the University of Illinois in Chicago.In this episode, OncLive On Air® partnered with Two Onc Docs to deliver a comprehensive, board-focused review of metastatic non–small cell lung cancer (NSCLC) diagnosis and management for 2026, reflecting the rapidly expanding treatment landscape that is growing to include chemotherapy, immunotherapy, and targeted agents.The discussion began with molecular workup, emphasizing the importance of conducting upfront multigene next-generation sequencing plus PD-L1 testing by immunohistochemistry (IHC) for all nonsquamous disease, with HER2 and c-MET IHC now part of routine evaluation. Drs Armstrong and Tawagi stressed that circulating tumor DNA complements but does not replace tissue biospy, and that a targetable driver generally prompts the initiation of first-line targeted therapy, except in the case of KRAS G12C and NRG1 fusions.Regarding EGFR-mutated disease, they reviewed 3 category 1 first-line options: osimertinib (Tagrisso) monotherapy, osimertinib plus chemotherapy, and amivantamab (Rybrevant) plus lazertinib (Lazcluze), cautioning against overlapping immunotherapy. They detailed post-osimertinib resistance testing and EGFR exon 20 insertions, then addressed ALK, ROS1, BRAF V600E, RET, MET exon 14, NTRK, and NRG1 alterations, noting preferred agents and characteristic toxicities, such as lorlatinib (Lorbrena)–associated hyperlipidemia.Drs Armstrong and Tawagi also covered HER2-directed therapies, including fam-trastuzumab deruxtecan-nxki (Enhertu), as well as antibody-drug conjugates for EGFR-mutated and c-MET–high disease. For driver-negative disease, they stratified first-line therapy by PD-L1 status and histology, discussing immunotherapy monotherapy, chemoimmunotherapy, and dual checkpoint blockade, before reviewing second-line options for patients with or without prior immunotherapy.
In this special WCLC 2026 episode of Lung Cancer Considered, hosts Dr. Narjust Florez and Dr. Stephen Liu discuss daily highlights from the conference and ask what changes in clinic on Monday. A ROS1 drug that protects the brain and a first line combination that could not beat a decade old standard. Dr. Alexander Drilon brings the first line ARROS-1 data on zidesamtinib, and Dr. Giannis Mountzios walks us through EVOKE-03, sacituzumab govitecan plus pembrolizumab in PD-L1 high lung cancer. Guests: Alexander Drilon, MD Chief, Early Drug Development Service Memorial Sloan Kettering Cancer Center Professor, Weill Cornell Medical College Attending Physician, Thoracic Oncology Service Giannis Mountzios, MD, MSc, PhD Medical Oncologist and Director at the 4th Oncology Department and Clinical Trials Unit Henry Dunant Hospital Center Athens, Greece,
Send us Fan MailIn this episode, the Oncology Journal Club team take a whistle-stop tour through some of the latest evidence in breast, colorectal, lung and thyroid cancer, with plenty to discuss around AI pathology, access to palliative care and the ever-changing world of ASCO Guidelines.We kick things off with a lively deep dive into SERENA-6 and the idea of switching treatment when an ESR1 mutation emerges — before the cancer has actually progressed — in first-line treatment of hormone receptor-positive advanced breast cancer. The team get into the biology behind the approach, the potential benefits for patients and, importantly, what we're really measuring when treatment changes halfway through the journey.Next up is a deceptively simple question with potentially big implications: could aspirin have a role as adjuvant treatment after colorectal cancer surgery? The ASCOLT translational work, alongside signals from other trials, raises the possibility that benefit may be concentrated in patients with particular PIK3CA mutations rather than applying to everyone. But that leads to a very real-world question: if the treatment is cheap but the testing isn't, how do we make precision prevention accessible — and when should we start?We then turn to PD-L1-high advanced non-small cell lung cancer, where a systematic review and meta-analysis suggests that chemoimmunotherapy may offer better survival than PD-1/PD-L1 inhibitor monotherapy. But, as always, the numbers are only part of the story — particularly when we're treating older or less-fit patients in the real world.And in our Quick Bites, we look at why so many patients never receive systemic treatment, why early palliative care is still underused, the potential of faster respiratory pathways to improve access, AI-powered pathology, and new ASCO Guidelines.If you enjoy sharp takes on new oncology papers — and what they actually mean for patients and practice — subscribe, share the episode with a colleague and leave us a review to help others find the show.The Oncology Journal Club Podcast is hosted by Professor Craig Underhill, Dr Kate Clarke and Professor Chris Jackson, and proudly produced by The Oncology Network.Visit oncologynetwork.com.au for Show Notes, to send us Voice Notes and more information.
This episode kicks off Season 5 of the Believe Big podcast, and Ivelisse welcomes back Dr. Lucas Tims of Root Causes Medical Clinic to untangle the confusing world of cancer testing. Dr. Tims unpacks chemosensitivity tests like RGCC and Datar/OncoStat, including real criticisms around consistency and a key blind spot: lab dishes can't recreate the body's tumor microenvironment, so immune-modulating therapies like mistletoe or IV vitamin C can look ineffective even when they're not. He explains where these tests still shine, especially for narrowing down later-line chemo or targeted options. He then draws a clear line between monitoring and treatment selection: Signatera tracks ctDNA/MRD after surgery to watch for recurrence, while Tempus profiles tumor genomics to surface druggable targets like PD-L1 for immunotherapy. He also introduces Astron Health as a second-opinion, tumor-board-style review, and Celcuity for pinpointing true driver pathways, with relevance reaching beyond solid tumors into blood cancers. Throughout, Dr. Tims returns to one grounding principle: no single test tells the whole story. He encourages listeners to work with their clinicians and pair tumor testing with integrative "terrain" testing, inflammation, immune function, toxins, hormones, gut health, and stress, for the fullest picture of their cancer.Learn more about Dr. Lucas Tims and Root Causes Medical Clinic here.Substack: rootcauses.substack.comThe SEED Program White Papers >Suggested Resources:BOOK: The Metabolic Approach to Cancer by Dr. Nasha Winters and Jess Higgins KelleyAbout RGCC Cancer Testing and OncostatDatar Cancer Genetics website, home pageSignateraTempusAstron HealthYour donations power our podcast's mission to support cancer patients with hope, insights, and resources. Every contribution fuels our ability to uplift and empower. Join us in making a lasting impact. Donate now!
Two Onc Docs, hosted by Samantha A. Armstrong, MD, and Karine Tawagi, MD, is a podcast dedicated to providing current and future oncologists and hematologists with the knowledge they need to ace their boards and deliver quality patient care. Dr Armstrong is a hematologist/oncologist and assistant professor of clinical medicine at Indiana University Health in Indianapolis. Dr Tawagi is a hematologist/oncologist and assistant professor of clinical medicine at the University of Illinois in Chicago.In this episode, OncLive On Air® partnered with Two Onc Docs to deliver a comprehensive, board-focused review of early-stage and locally advanced non–small cell lung cancer (NSCLC) for 2026, reflecting recent shifts in staging and perioperative therapy.The discussion began with histology, distinguishing adenocarcinoma (positive for TTF-1 and CK7) from squamous cell carcinoma (positive for p63 and p40). Turning to staging, Drs Armstrong and Tawagi emphasized the 9th edition of the lung cancer TNM staging system, noting that T categories are unchanged but N2 is now split into N2a and N2b, and M1c is now split into M1c1 and M1c2. They also stressed the importance of biomarker testing for PD-L1, EGFR, ALK, and RET.Regarding treatment, they explained that stage IA disease warrants surgery or stereotactic body radiation therapy without systemic therapy. In resectable disease that is 4 cm or larger or node-positive disease, driver mutations guide management: osimertinib (Tagrisso) for EGFR-mutated disease, alectinib (Alecensa) for ALK-positive disease, and selpercatinib (Retevmo) for RET-mutated disease, with immunotherapy avoided in EGFR-mutated or ALK-positive tumors. For driver-negative disease, they reviewed 4 category 1 regimens, including neoadjuvant nivolumab (Opdivo) and perioperative pembrolizumab (Keytruda) or nivolumab, cautioning against switching agents in the middle of a treatment course.Drs Armstrong and Tawagi then addressed adjuvant immunotherapy, unresectable stage III disease management with concurrent chemoradiation followed by consolidative durvalumab (Imfinzi) or osimertinib, surgical candidacy, adjuvant chemotherapy regimens, postoperative radiation, and special circumstances, including superior sulcus tumors.
In today's episode, we spoke with Michael K. Wong, MD, PhD, FRPC. Dr Wong is a physician at Roswell Park Comprehensive Cancer Center in Buffalo, New York.In our exclusive interview, Dr Wong discussed the significance of the FDA's accelerated approval of vusolimogene oderparepvec-wtpg (Tudriqev; RP1) in combination with nivolumab (Opdivo) for adult patients with unresectable advanced cutaneous melanoma whose disease progressed on a prior PD-1–blocking antibody–based regimen. He noted that this approval followed a lengthy regulatory trajectory, including two prior complete response letters, before a third biologics license application was accepted in June 2026 and a positive advisory committee vote paved the way for approval.Dr Wong contextualized the evidentiary basis for the approval, drawing on data from the single-arm, phase 1/2 IGNYTE trial (NCT03767348), in which the efficacy-evaluable population achieved an objective response rate of 24.2% (95% CI, 15.8%-34.3%) and a median duration of response of 14.1 months (95% CI, 10.7-not reached). He emphasized that the trial enrolled a genuinely high-risk population, including patients with elevated lactate dehydrogenase, more than 55% with PD-L1–negative tumors by immunohistochemistry, 44% who had failed prior ipilimumab (Yervoy) plus nivolumab, and 66% with primary resistance to anti–PD-1 therapy, making the results clinically meaningful in the context of a setting where no robust options previously existed. He also addressed the distinction between RP1 and talimogene laherparepvec (Imlygic), the prior herpes-based oncolytic agent, explaining that RP1 is a fundamentally reengineered particle with distinct genetic modifications, enhanced oncolytic activity, and an expanded injection approach that includes visceral lesions such as those in the liver and lung. From an operational standpoint, Dr Wong outlined key considerations for community and academic practices looking to integrate RP1, including room setup, pharmacy handling of live agents, personal protective equipment protocols, and the importance of partnering with interventional radiology to inject a diversity of lesions across nodal basins for optimal response.Finally, Dr Wong positioned RP1 plus nivolumab within the broader post–PD-1 treatment landscape alongside tumor-infiltrating lymphocyte (TIL) therapy, noting that although both options now occupy this space, RP1 plus nivolumab offers a more broadly accessible treatment approach given the logistical demands of TIL therapy.
BUFFALO, NY – August 28, 2026 – A new #research paper was published in Volume 17 of Oncotarget on August 19, 2026, titled “Incidence of KRAS G12C mutations in genitourinary malignancies; emerging target in precision medicine.” The study was led by first author Kelly Crane from the Department of Urology at SUNY Upstate Medical University. The corresponding author is K. R. Seetharam Bhat, who is affiliated with the Department of Urology at SUNY Upstate Medical University and Upstate Urology at MVHS. KRAS is one of the most extensively studied oncogenes in cancer, and the G12C variant has become clinically important following the development of mutation-specific inhibitors. Although KRAS G12C-targeted therapy is established in other malignancies, its frequency and genomic characteristics in genitourinary cancers have remained less well defined. To address this gap, the researchers performed comprehensive genomic profiling of 13,654 tumor specimens from patients with metastatic disease, including 1,453 renal clear cell carcinomas, 3,879 urothelial bladder carcinomas, and 8,322 prostate acinar adenocarcinomas. Tumor mutational burden, microsatellite instability, and PD-L1 expression were also evaluated. Across the full cohort, KRAS alterations were detected in 367 tumors, or 2.7%, while KRAS G12C was identified in only 25 tumors, representing approximately 0.2% of all specimens. No G12C variants were found among the renal clear cell carcinomas. In urothelial bladder carcinoma, 24 of 202 KRAS-altered tumors, or 12%, carried G12C, while only one of 158 KRAS-altered prostate tumors contained the variant. Full press release - https://www.oncotarget.com/news/pr/kras-g12c-mutation-identified-as-a-rare-potential-target-in-genitourinary-cancers/ DOI - https://doi.org/10.18632/oncotarget.28912 Correspondence to - K. R. Seetharam Bhat - bhatkuls@upstate.edu Abstract video - https://www.youtube.com/watch?v=me9HXtnDmp4 Sign up for free Altmetric alerts about this article - https://oncotarget.altmetric.com/details/email_updates?id=10.18632%2Foncotarget.28912 Subscribe for free publication alerts from Oncotarget - https://www.oncotarget.com/subscribe/ Keywords - cancer, KRAS mutation, genitourinary malignancy, precision medicine, emerging target To learn more about the journal, please visit https://www.oncotarget.com and connect with us on social media: Facebook - https://www.facebook.com/Oncotarget/ X - https://twitter.com/oncotarget Instagram - https://www.instagram.com/oncotargetjrnl/ YouTube - https://www.youtube.com/@OncotargetJournal LinkedIn - https://www.linkedin.com/company/oncotarget Pinterest - https://www.pinterest.com/oncotarget/ Reddit - https://www.reddit.com/user/Oncotarget/ Spotify - https://open.spotify.com/show/0gRwT6BqYWJzxzmjPJwtVh MEDIA@IMPACTJOURNALS.COM
We had a chance to dive into one of the most significant advancements in the treatment of HER2-positive gastroesophageal junction (GEJ) and gastric adenocarcinoma. In this episode, we discussed the groundbreaking HERIZON-GEA-01 study that led to the approval of zanidatamab, a novel bispecific HER2-directed antibody. We welcomed Dr. Nataliya Uboha, a GI medical oncologist from the University of Wisconsin, who shared her insights on the study's design, findings, and the implications for clinical practice. Learn about the importance of biomarker testing, the mechanism of action of zanidatamab, and how it compares to traditional therapies like trastuzumab. Key topics covered in this episode: Overview of the HERIZON-GEA-01 study and its findings Mechanism of action of zanidatamab Comparison of treatment regimens and overall survival benefits Management of side effects, including diarrhea and infusion reactions The role of PD-L1 testing in treatment decisions Whether you're a healthcare professional or simply interested in the latest in oncology, this episode provides valuable insights into the evolving landscape of treatment for HER2-positive upper GI malignancies. Listen us on: Spotify: https://open.spotify.com/show/31BXhY9FM4gPWG10WgE11o Follow us on social media: X/Twitter: https://x.com/oncbrothers Instagram: https://www.instagram.com/oncbrothers Website: https://oncbrothers.com/ Don't forget to like, subscribe, and check out our other discussions on FDA approvals, treatment algorithms, and challenging cases! #GastricCancer, #HER2positive, #Zanidatamab, #HERIZONGEA01, #OncologyBrothers
En este episodio del podcast GineLink: Expertos en Oncología Ginecológica, la Dra. Laura Venegas modera una sesión de análisis junto a la Dra. Ainhoa Madariaga, oncóloga médica del Hospital Universitario 12 de Octubre en Madrid, y el Dr. Giuseppe Caruso, oncólogo ginecólogo del Instituto Europeo de Oncología en Milán. La discusión se centra en el cambio de paradigma en el tratamiento del cáncer de ovario resistente a platino, un escenario históricamente asociado a expectativas terapéuticas limitadas y que actualmente experimenta una transición hacia mejoras significativas en la supervivencia global gracias a la integración de terapias dirigidas.Los expertos hablan sobre la evolución de los conjugados anticuerpo-fármaco (ADC), destacando el uso de mirvetuximab soravtansina en pacientes con alta expresión del receptor de folato alfa (FRα). A partir de los resultados del ensayo de fase 3 MIRASOL, se discute el impacto de este agente frente a la quimioterapia convencional, así como el racional clínico para trasladar su uso a líneas de tratamiento más tempranas o estrategias de combinación (con carboplatino o bevacizumab), evidenciadas en estudios como PICCOLO, IMGN853-0420 y MIROVA.Finalmente, los expertos examinan los datos del estudio KEYNOTE-B96, abordando la incorporación de pembrolizumab junto a paclitaxel semanal, lo que suscita un debate sobre el papel del PD-L1 como biomarcador predictivo exclusivo en esta patología. La conversación concluye con el análisis del ensayo ROSELLA, el cual introduce el uso de relacorilant, un antagonista selectivo del receptor de glucocorticoides. La combinación de este agente con nab-paclitaxel presenta un mecanismo de acción innovador diseñado para modular la vía del cortisol y revertir la quimiorresistencia celular, ofreciendo beneficios clínicamente significativos en la supervivencia global de pacientes altamente pretratadas.Referencias:Este contenido se basa en la interpretación crítica de la evidencia científica disponible, así como en la experiencia clínica del o los ponentes como profesionales de la salud en instituciones de referencia.Para profundizar en los conceptos discutidos, se recomienda al profesional de la salud consultar literatura científica vigente, guías clínicas internacionales y la normatividad aplicable en su país.
This episode is sponsored by Gilead Sciences. Gilead had no involvement or input in the podcast content. Gilead is working to transform how cancer is treated. We are innovating with next-generation therapies, combinations, and technologies to deliver improved outcomes for people with cancer. From antibody drug conjugates and small molecules to cell therapy-based approaches, our portfolio and pipeline assets are creating new possibilities for people with cancer.Dr. Sara Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, returns to Patient From Hell to explain the ASCENT-04/KEYNOTE-D19 study, the phase 3 trial she led as principal investigator, and what it changes for people living with metastatic triple-negative breast cancer.For years, the most effective drugs for metastatic TNBC were only available after first-line chemotherapy had already failed. The problem, as Dr. Tolaney puts it plainly, is that many patients never reach a second line of treatment at all. ASCENT-04 asked whether moving an antibody-drug conjugate to the front, paired with immunotherapy, would change that. Median progression-free survival improved from 7.8 months to 11.2 months, and treatment responses lasted significantly longer.UPDATE: Since this recorded conversation, the FDA has acted on the data discussed in this episode. On May 22, 2026, Datopotamab Deruxtecan was approved for first-line metastatic TNBC in patients who are not candidates for immunotherapy. On June 24, 2026, Sacituzumab Govitecan was approved for first-line use both as a single agent and in combination with pembrolizumab for PD-L1-positive disease (CPS ≥10). Consult with your care team for the most recent indications and availability of these treatment options.00:00 The trial that moves the best drugs first 00:31 Welcome back, Dr. Sara Tolaney 00:40 What ASCENT-04 set out to solve 02:00 Why many patients never reach second-line treatment 02:50 What PD-L1 status means for your treatment 04:12 The result: 7.8 to 11.2 months 05:29 What is an antibody-drug conjugate (ADC)? 06:33 Why TROP-2 is the target in triple-negative breast cancer 07:24 How immunotherapy works: taking the brakes off the T cell 09:01 Who was eligible for the trial 10:05 What "controlling" cancer actually means 11:44 Progression-free survival vs. duration of response 13:37 Dr. Tolaney reconsiders: what ASCENT-03 showed 15:51 How trial data reaches your oncologist's office 18:21 The testing checklist after a metastatic diagnosis 19:59 First-line treatment options today 22:27 The new paradigm: ADCs as the first-line backbone 23:51 What comes second line 25:29 Why tumor sequencing matters: somatic BRCA, TMB, trials 27:24 Twenty years of change in triple-negative breast cancer 29:28 Advice for a newly diagnosed patientSara M. Tolaney, MD, MPH is Chief of the Division of Breast Oncology and Associate Director of the Susan F. Smith Center for Women's Cancers at Dana-Farber Cancer Institute, and Associate Professor of Medicine at Harvard Medical School. She trained at Princeton University, UC San Francisco, Johns Hopkins University, and Dana-Farber Cancer Institute, and holds a Masters in Public Health (MPH) from Harvard University. She serves on the National Cancer Institute (NCI) Breast Cancer Steering Committee and is Vice Chair for Late-Stage Development in Breast Cancer for the Alliance for Clinical Trials in Oncology. She was principal investigator of ASCENT-04.
Featuring perspectives from Dr Terence Friedlander, Dr Matthew Galsky, Dr Shilpa Gupta and Prof Andrea Necchi, moderated by Dr Friedlander, including the following topics: Case: A woman in her late 60s with T3N0 upper tract urothelial carcinoma that was resected has no evidence of disease on imaging, receives negative circulating tumor DNA results and elects observation instead of adjuvant treatment (0:00) Case: A man in his late 70s with PD-L1-negative high-grade muscle-invasive bladder cancer who is ineligible for cisplatin because of poor renal function undergoes cystectomy (10:12) CME information and select publications
EVA CAST - o podcast do Grupo Brasileiro de Tumores Ginecológicos
O episódio 46 do EVA CAST, o podcast do Grupo Brasileiro de Tumores Ginecológicos, discute como a imunoterapia vem transformando o tratamento dos tumores ginecológicos e quais caminhos podem ampliar seus benefícios nos próximos anos. Já incorporada à prática clínica em diferentes cenários do câncer do colo do útero e do endométrio, essa estratégia ainda apresenta resultados mais restritos no câncer de ovário e abre novas frentes de pesquisa, especialmente em combinação com outras modalidades de tratamento. Participam da conversa Fernanda Cano Casarotto, oncologista clínica, membro da Diretoria do Grupo Brasileiro de Tumores Ginecológicos (EVA), líder em Gineco-oncologia do Hospital Nora Teixeira/Santa Casa de Porto Alegre e coordenadora do Comitê de Rastreamento e Prevenção da SBOC; e Pedro Zanúncio, médico radio-oncologista da Beneficência Portuguesa de São Paulo e Grupo Oncoclínicas. Ao longo do episódio, os especialistas explicam como a imunoterapia atua sobre o sistema imunológico e por que biomarcadores e características da biologia tumoral são importantes para identificar as pacientes com maior possibilidade de benefício. Entre os temas abordados estão os avanços da imunoterapia nos cânceres do colo do útero e do endométrio, a classificação molecular, a deficiência do sistema de reparo do DNA, a expressão de PD-L1 e outros biomarcadores que ajudam a orientar decisões terapêuticas. A conversa também analisa por que o câncer de ovário tem apresentado respostas mais modestas à imunoterapia e quais evidências recentes começam a apontar novas possibilidades para pacientes com doença resistente aos tratamentos já utilizados. Outro destaque é a combinação entre imunoterapia e radioterapia. O episódio explica como a radiação, além de atuar diretamente sobre o tumor, pode modificar seu microambiente e estimular uma resposta do sistema imunológico. Os convidados discutem conceitos como tumores “frios” e “quentes”, efeito abscopal, momento ideal para combinar os tratamentos, dose e fracionamento da radioterapia e as evidências que vêm consolidando essa integração, especialmente no câncer do colo do útero. A conversa aborda ainda a evolução tecnológica da radioterapia, com técnicas que permitem direcionar o tratamento com maior precisão e reduzir a exposição de estruturas saudáveis. Os especialistas discutem como esses avanços contribuem para incorporar novas terapias com maior segurança, buscando melhorar o controle da doença sem perder de vista as toxicidades e a qualidade de vida das pacientes. Também entram no debate os desafios dos tumores ginecológicos raros, a importância dos estudos clínicos e as barreiras de acesso à imunoterapia no Brasil, tanto na saúde suplementar quanto no SUS. Na reta final, Fernanda Cano Casarotto e Pedro Zanúncio reforçam que o avanço da imunoterapia e da radio-oncologia passa por uma seleção cada vez mais individualizada das pacientes. O objetivo é identificar quem realmente precisa de intensificação do tratamento, quem pode ser poupada de terapias desnecessárias e como biomarcadores e novas evidências podem ajudar a equilibrar eficácia, segurança e qualidade de vida.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into recent transformative events that are shaping this dynamic industry, from strategic mergers to groundbreaking drug approvals. Starting with the merger between Supernus Pharmaceuticals and Indivior Pharmaceuticals, this all-stock deal valued at $2.2 billion is set to create a powerhouse focused on central nervous system (CNS) disorders. By combining their resources, the new entity is expected to enhance its capabilities in neurological disorders with a robust portfolio of approved drugs. This merger allows the companies to leverage economies of scale, optimize research and development, and expand their market presence, offering promising prospects for advancements in treating CNS-related conditions. In regulatory news, Novartis has secured FDA approval for an expanded indication of Pluvicto (lutetium vipivotide tetraxetan), a radioligand therapy originally approved for PSMA-positive metastatic castration-resistant prostate cancer. This therapy can now be used for metastatic hormone-sensitive prostate cancer, marking a significant step forward in prostate cancer treatment. By targeting prostate-specific membrane antigen (PSMA) with precision, Pluvicto offers the potential for improved patient outcomes and highlights the growing role of radioligand therapies in oncology. Globally, Pharmamar's Zepzelca (lurbinectedin) has been approved in Canada, Qatar, and South Korea as a first-line maintenance therapy for extensive-stage small cell lung cancer. This approval signifies a potential shift in how aggressive cancer types are treated, particularly when combined with PD-L1 inhibitors, opening new avenues for effective combination therapies. Industry partnerships continue to drive innovation, as seen with Fujifilm and Taiho Pharmaceutical's collaboration to develop next-generation antibody-drug conjugate (ADC) manufacturing technologies using the Aralinq platform. With ADCs becoming increasingly pivotal in targeted cancer therapies due to their precision in delivering cytotoxic drugs to tumor cells, advancements in manufacturing could significantly enhance production capabilities and therapeutic efficacy. Financial dynamics within the industry remain robust. AbbVie has raised its 2026 revenue forecast to $67.6 billion, citing strong performances from its immunology drugs Skyrizi and Rinvoq. These therapies have shown substantial success in treating autoimmune conditions, reflecting their impact on AbbVie's financial health and reinforcing confidence in their commercial viability. On the clinical trial front, Ratio Therapeutics has successfully closed a $70 million Series C funding round to support its radiotherapeutics pipeline and initiate the ATLAS trial. This infusion of funds underscores the continued interest and investment in radiopharmaceuticals with promising applications in oncology. The landscape of mergers and acquisitions remains active as AstraZeneca and Bristol Myers Squibb reportedly engage in early-stage merger discussions. Such a merger could create an oncology giant valued at approximately $400 billion, potentially reshaping competitive dynamics and accelerating innovation across therapeutic areas. Regulatory changes are also underway with HRSA advancing a revised 340B rebate model pilot program despite hospital opposition. The implications for healthcare providers are significant as this could affect operational efficiencies and financial strategies within participating entities. Overall, these developments reflect ongoing trends toward industry consolidation and strategic partnerships that foster innovation in drug manufacturing technologies. Regulatory approvals continue to advance precision medicine through targeted therapies, showcasing the sector's dynamic nature as it addresses unmet medical needs while navigating complex regulatory environments. Meanwhile, Sandoz's settlement of nearly $500 million for antitrust claims in the U.S. highlights ongoing scrutiny of industry competition practices. This settlement signals potential shifts in market dynamics as companies seek to resolve legal challenges while maintaining operational integrity. Cybersecurity has emerged as a critical concern following Amgen's reported breach compromising sensitive patient data. This incident amplifies the need for enhanced data protection measures to safeguard information integral to patient trust and competitive integrity. In leadership news, BioNTech has appointed Guido Oelkers as CEO amid its continued innovation in mRNA technology post-COVID-19. This strategic move underscores BioNTech's commitment to leadership capable of navigating advances in mRNA therapeutics. Lastly, Novo Nordisk faced setbacks with its investigational therapy ziltivekimab failing a phase 3 trial targeting inflammatory pathways for cardiovascular outcomes. Despite such challenges, these high-stakes trials highlight both risks and opportunities inherent in pharmaceutical innovation. As we reflect on these stories, it's clear that scientific advancements, regulatory developments, and strategic business moves continue to shape the trajectory of the pharmaceutical and biotech sectors. These efforts promise significant implications for future drug development and patient care as companies strive to harness breakthroughs while adapting to evolving industry landscapes.Support the show
In today's episode, we spoke with Solange Peters, MD, PhD. Dr Peters is a full professor, and chair of medical oncology and the thoracic malignancies programme in the Department of Oncology at the University Hospital of Lausanne in Switzerland. In our exclusive interview, Dr Peters discussed the rationale for pairing antiangiogenic activity with checkpoint inhibition upfront in non–small cell lung cancer (NSCLC), rather than sequencing them. She noted that prior attempts to combine or sequence bevacizumab (Avastin) with checkpoint inhibitors yielded only modest signals, hampered by bevacizumab's long half-life and class-specific toxicities including bleeding risk that historically excluded patients with squamous cell carcinoma. By contrast, PD-L1/VEGF bispecifics such as pumitamig carry a significantly shorter half-life of approximately 5 to 6 days, resulting in a similar toxicity category but with lower rates of high-grade events and a broadened eligible population.She highlighted the mechanistic rationale for this combination, explaining that VEGF and PD-L1 co-targeting appears to remodel the tumor microenvironment cooperatively, bringing cancer cells into closer proximity with T cells. In the case of PD-L1/VEGF bispecifics, a macromolecular structure forms in the tumor microenvironment that leads to internalization of PD-L1, creating a dual blockade of the PD-1/PD-L1 pathway beyond simple receptor occupancy.Dr Peters then discussed data presented at the 2026 ASCO Annual Meeting from the phase 2/3 ROSETTA Lung-02 trial (NCT06712316) evaluating pumitamig plus chemotherapy in the first-line setting. She described the activity observed across all PD-L1 expression strata, including in PD-L1–negative patients, who comprised up to 70% of the nonsquamous population and achieved response rates above 50% as particularly compelling. She also addressed the dose selection rationale, noting that the 1500-mg dose demonstrated the optimal pharmacodynamic activity and favorable risk-benefit profile for phase 3 advancement.Finally, Dr Peters offered broader perspective on the increasingly competitive PD-L1/VEGF bispecific landscape, including the parallel development of ivonescimab. She suggested that differences in clinical trial design including patient population, inclusion and exclusion criteria, and end point ambition may ultimately differentiate agents more than mechanism alone, and emphasized that global data will be essential to shaping regulatory and clinical practice decisions.
In today's episode, we spoke with Sara M. Tolaney, MD, MPH, about the FDA approval of sacituzumab govitecan plus pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 as determined by an FDA-authorized test. Dr Tolaney is chief of the Division of Breast Oncology and associate director of the Susan F. Smith Center for Women's Cancers and a senior physician at Dana-Farber Cancer Institute, as well as an associate professor of medicine at Harvard Medical School in Boston, Massachusetts.This regulatory decision was backed by findings from the phase 3 ASCENT-04/KEYNOTE-D19 trial (NCT05382286), in which the median progression-free survival among patients in the sacituzumab govitecan arm was 11.2 months (95% CI, 9.3-16.7) vs 7.8 months (95% CI, 7.3-9.3) among patients who received physician's choice of chemotherapy plus pembrolizumab (HR, 0.65; 95% CI, 0.51-0.84; P = .0009).In our exclusive interview, Dr Tolaney highlighted the significance of this approval, key data from ASCENT-04, and how the TNBC paradigm is shifting to accommodate this new regimen.
Immune checkpoint inhibitors have rapidly reshaped care for triple-negative breast cancer (TNBC)—but surgical teams increasingly encounter their downstream perioperative consequences. In this episode, we define immunotherapy through the lens of checkpoint biology, review the landmark evidence supporting pembrolizumab in metastatic PD‑L1–positive TNBC (KEYNOTE‑355) and curative-intent stage II–III TNBC (KEYNOTE‑522), and translate immune-related adverse events (irAEs) into practical periop recognition, triage, and timing decisions—especially for endocrine, pulmonary, hepatic, dermatologic, and GI toxicities. Hosts:- Rashmi Kumar, MD, PhDResident, University of Michigan General Surgery Residency Program Twitter/X: @RashmiJKumar- Melissa Pilewskie, MDAttending Breast Surgical Oncologist, Co-Director of the Weiser Family Center for Breast Cancer, Michigan MedicineTwitter/X: @MPilewskie- Stephanie Downs-Canner, MDAttending Breast Surgical Oncologist & Physician-Scientist, Memorial Sloan Kettering Cancer Center, Program Director of the Breast Surgical Oncology Fellowship Training ProgramTwitter/X: @SDownsCannerLearning Objectives: Define immunotherapy and immune checkpoint inhibition in breast cancer Summarize current clinical indications and pivotal evidence for pembrolizumab in TNBC Equip perioperative clinicians to identify and manage immune-related adverse events (irAEs) or side effects of immunotherapy. Rationale for Immunotherapy in Breast Cancer ReviewSelecting Triple Negative Breast Cancer Patients for Immunotherapy: https://pubmed.ncbi.nlm.nih.gov/37714640/Landmark Clinical Trials Discussed in this Episode KEYNOTE-355: https://pubmed.ncbi.nlm.nih.gov/33232653/ KEYNOTE-522: https://pubmed.ncbi.nlm.nih.gov/33232642/ IMpassion130: https://pubmed.ncbi.nlm.nih.gov/30345906/ IMpassion131: https://pubmed.ncbi.nlm.nih.gov/33930478/ Assessment of Surgical Outcomes in patients receiving chemoimmunotherapySurgical outcomes after neoadjuvant chemoimmunotherapy in triple-negative breast cancer: https://pubmed.ncbi.nlm.nih.gov/38332314/Immune Related Adverse Events and Management Schneider BJ, et al. Management of immune-related adverse events: https://pubmed.ncbi.nlm.nih.gov/34724392/ Brahmer JR, et al. SITC clinical practice guideline: https://pubmed.ncbi.nlm.nih.gov/34177534/ Please visit https://behindtheknife.org to access other high-yield surgical education podcasts, videos and more. If you liked this episode, check out our recent episodes here: https://behindtheknife.org/listenBehind the Knife Premium: https://behindtheknife.org/premiumOral Board Review: https://behindtheknife.org/oral-boardOral Board Simulator: https://behindtheknife.org/oral-board/simulatorGeneral Surgery Oral Board Review Course: https://behindtheknife.org/premium/general-surgery-oral-board-reviewTrauma Surgery Video Atlas: https://behindtheknife.org/premium/trauma-surgery-video-atlasDominate Surgery: A High-Yield Guide to Your Surgery Clerkship: https://behindtheknife.org/premium/dominate-surgery-a-high-yield-guide-to-your-surgery-clerkshipDominate Surgery for APPs: A High-Yield Guide to Your Surgery Rotation: https://behindtheknife.org/premium/dominate-surgery-for-apps-a-high-yield-guide-to-your-surgery-rotationVascular Surgery Oral Board Review Course: https://behindtheknife.org/premium/vascular-surgery-oral-board-reviewColorectal Surgery Oral Board Review Course: https://behindtheknife.org/premium/colorectal-surgery-oral-board-reviewSurgical Oncology Oral Board Review Course: https://behindtheknife.org/premium/surgical-oncology-oral-board-reviewCardiothoracic Oral Board Review Course: https://behindtheknife.org/premium/cardiothoracic-surgery-oral-board-reviewOBGYN Oral Board Review Coures: https://behindtheknife.org/course/obgyn-oral-board-reviewEPA Playbook: https://behindtheknife.org/course/epa-playbookSurgical Instrument Flashcards: https://behindtheknife.org/course/surgical-instrument-flashcardsABSITE Review: https://behindtheknife.org/course/absite-2026-exam-reviewDownload our App:Apple App Store: https://apps.apple.com/us/app/behind-the-knife/id1672420049Android/Google Play: https://play.google.com/store/apps/details?id=com.btk.app&hl=en_US
Too busy to read the Lens? Listen to our weekly summary here! In this week's episode, we discuss:Long-term, repeated intravitreal anti-VEGF injections were associated with a significantly increased risk of cataract surgery in the treated eye, with risk increasing in a dose-dependent manner.Prespecified OCT interpretation rules, particularly assessment of the TSNIT curve, accurately distinguished glaucomatous damage from myopic structural changes with high sensitivity and specificity.Delaying the initial retinopathy of prematurity screening examination until 34 weeks postmenstrual age in selected medium-risk infants safely reduced unnecessary examinations without missing treatment-requiring ROP.Subretinal AAV8-mediated PD-L1 gene therapy reduced retinal inflammation and preserved retinal structure and function in a rat model of autoimmune uveitis, suggesting a potential future immune-modulating treatment strategy.
Featuring an interview with Dr Mark Jeng and Dr Joshua K Sabari, including the following topics: · Case: A woman in her late 90s with recurrent HER2-mutant metastatic non-small cell lung cancer (NSCLC) receives third-line zongertinib (0:00) · Case: A woman in her early 60s with multiregimen-recurrent HER2-mutant metastatic NSCLC experiences a response to zongertinib (8:07) · Case: A man in his mid 80s experiences metastatic recurrence after resection of PD-L1-positive, HER2-mutant metastatic NSCLC (17:50) CME information and select publications
Featuring an interview with Dr Jamie E Chaft, including the following topics: Case: A man in his early 70s with a 40 to 50 pack-year history of smoking and cT2bN1 squamous cell carcinoma of the lung with PD-L1 60% treated with induction therapy and surgery (00:00) Available clinical data with immunotherapy in the neoadjuvant, perioperative and adjuvant settings (07:45) Factors in the selection of adjuvant immunotherapy, including circulating tumor DNA (11:39) Evolving approaches to management, including systemic therapy, surgery and radiation therapy techniques (19:28) Case: A woman in her early 60s with nonmetastatic non-small cell lung cancer (NSCLC) and an EGFR exon 19 deletion who is enrolled in the NeoADAURA study (24:03) Importance of clinical trials in the adjuvant setting (33:02) Data surrounding treatment in the neoadjuvant setting; key implications of the NeoADAURA study (35:41) Case: A man in his late 60s with a history of smoking and Stage III T4N3 NSCLC not otherwise specified with low PD-L1 expression, high tumor mutation burden, microsatellite stability and an STK11 mutation (41:34) Selecting patients for the NeoADAURA study treatment approach; deciding between chemoimmunotherapy and chemoradiation therapy (51:01) CME information and select publications
In this episode of the Oncology Brothers podcast, we dived deep into the recent FDA approvals for sacituzumab govitecan in frontline settings for metastatic triple-negative breast cancer. Joined by Dr. Sara Tolaney, a breast medical oncologist from the Dana-Farber Cancer Institute, we discussed the exciting developments in breast cancer treatment, with ASCENT-03 and ASCENT-04 trials. Key topics covered in this episode include: Overview of the recent FDA approvals for antibody-drug conjugates (ADCs) in breast cancer Detailed discussion on the ASCENT-04 trial focusing on PD-L1–positive metastatic triple-negative breast cancer Insights into the ASCENT-03 trial for PD-L1–negative disease Comparison of sacituzumab govitecan and datopotamab deruxtecan (Dato-DXd), including their efficacy and side effect profiles Management strategies for common side effects such as neutropenia and diarrhea Listen us on: Spotify: https://open.spotify.com/show/31BXhY9FM4gPWG10WgE11o Follow us on social media: X/Twitter: https://x.com/oncbrothers Instagram: https://www.instagram.com/oncbrothers Website: https://oncbrothers.com/ Join us as we explored the evolving landscape of breast cancer treatment and the importance of shared decision-making in patient care. Don't forget to like, subscribe, and hit the notification bell for more updates from the Oncology Brothers! #TripleNegativeBreastCancer, #Sacituzumab, #ASCENT03, #ASCENT04, #OncologyBrothers
The tumor microenvironment (TME), composed of immune cells, fibroblasts, and endothelial cells, has emerged as critical to pathogenesis, prognosis and treatment for cancer (schematic Figure below). There's no such thing as TMI (too much information) for TME! Yet there's still no way of assessing it in the clinic by a blood test, and even by invasive biopsy the sampling bias for TME without broader geographic context can lead to important mistakes. That isn't used for clinical decision making. The TME field is about to change.Recently, Professor Aaron Newman at Stanford and colleagues from many US leading centers published a landmark paper in Nature. It may ultimately be considered one of the most important leaps in cancer diagnostics in decades. Ground Truths is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.This was a massive undertaking involving 10 million single-cell RNAseq in 10 types of cancer to define 9 TME types by spatial omics which they called “spatial ecotypes”. It was AI-enabled by machine learning (Spatial Ecotyper from biopsy samples) and extrapolating that to knowledge to deep learning AI (Liquid Ecotyper from blood samples). The whole project took several years.Here's an infographic summary I made with the help of NotebookLM along with the Figures that follow.Some of the key points from our conversation:—TME is the soil in which the cancer cells live. It strongly influences whether the cancer cells will thrive or not, spread, respond to therapy, and determine the fate pf pre-cancerous lesion (as seen in recent important paper in pancreatic cancer evolution and colon cancer development).—Ecotypes, a term coined in 1922, to get at the local environment of tissue and cancer, was repurposed in this new project. Good metaphor: neighborhoods. And emphasis on location , location, location like real estate.—In the clinic today, the only window to TME is via a biopsy. But decisions for treatment are not based on TME, they are based on biomarkers like tumor mutation burden (TMB), PD-L1 levels , or volume of tumor DNA by liquid biopsy.—TME is dynamic and changes over time so a single snapshot won't cut it. —Spatial 3D maps of TME from 10 million cells, 10 cancer types led to 9 spatial ecotypes (with the Spatial Ecotyper machine learning). Validation across 3D grids (such as Visium) and multiple cohorts. The cell location base within TME is striking. —These 9 neighborhoods are conserved and very different. SE4-immune system is asleep, hypoxic; SE 7/8 are “war zones” rich with immune cells, hot tumor; SE 5 exhibits intense immunosuppression, hostile vs immune system, portends poor survival, SE9 deep in core, driving angiogenesis (new blood vessels)—Now rich information from these 9 SEs needs to be extrapolated to a holistic blood test of TME. It turns out an extension of tapping into methylation as used by some liquid biopsy cell-free DNA tests works very well, providing cell identity from the DNA fragments leaked into the blood. To get to TME spatial biology in a tube of blood. Akin to wastewater surveillance form municipals for detection of infectious disease pathogen sequence variants and circulating levels. A triumph of AI analytics made this possible!—The Liquid Ecotyper was validated in 78 patients with malignant melanoma pre-treatment from Yale University. SE 7/8 benefited from immune checkpoint therapy; SE4 resisted treatment, shorter survival. Matched with tissue biopsy work. —Work beyond publication ongoing in many types of lung cancer, bladder cancer, mesothelioma, and response to other therapies like CAR T and bispecific antibodies. This is critical since we have slew of different cancer immunotherapies (see my pyramid Ground Truths review) and we're not sure who, when, how to use them to drive optimal cancer outcomes in patients. May also help predict other types of therapy (not just immunotherapy) for cancer.—The blood test can performed serially which is a major advance compared with how we are currently “flying blind” and misled by imaging. —Started a company Liquid Cell Dx to make the TME blood test commercially available. May be available sooner in the academic centers in the current study.—The use of SEs may extend beyond cancer!A big thanks to Ground Truths subscribers from every US state and 212 countries. Your subscription to these free essays and podcasts makes my work in putting them together worthwhile. If you're not a subscriber, please join!If you found this interesting PLEASE share it!Paid subscriptions are voluntary and all proceeds from them go to support Scripps Research. They do allow for posting comments and questions, which I do my best to respond to. Please don't hesitate to post comments and give me feedback. Let me know topics that you would like to see covered.Many thanks to those who have contributed—they have greatly helped fund our summer internship programs for the past two years. It enabled us to accept and support a record number of 51 summer interns coming in 2026! These are high school, college and medical students selected from thousands of applicants. We couldn't do this expanded program without the funds coming in through Ground Truths.Thank you Dr Poonam Desai, Harshi Peiris, Ph.D., YOUR DOCTOR KLOVER, KL, Jessica Coffman, and >400 others for tuning into my live video with Aaron Newman! Join me for my next live video in the app. Get full access to Ground Truths at erictopol.substack.com/subscribe
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 transformative events reshaping the landscape of this dynamic industry. Replimune has made headlines with the resubmission of its oncolytic virus-based immunotherapy, RP1, to the U.S. Food and Drug Administration for treating advanced melanoma. The FDA's acceptance after two prior rejections is significant, suggesting a shifting regulatory landscape that could favor innovative cancer therapies like oncolytic viruses. These therapies represent a novel approach to engage the immune system in targeting tumors, and if RP1 gains approval, it may open doors for similar treatments, potentially offering new hope for melanoma patients. On the regulatory side, Amgen has encountered challenges with Tavneos after losing European Union endorsement due to data integrity issues. This serves as a stark reminder of the critical importance of maintaining stringent data management throughout drug development. With an FDA hearing on the horizon, the implications are far-reaching, emphasizing increased scrutiny from regulatory bodies worldwide. This scenario could lead to more rigorous guidelines governing data practices in the future. The European Commission's approval of Henlius' Hetronifly as a first-line treatment for squamous non-small cell lung cancer marks a milestone in cancer immunotherapy. This approval highlights the ongoing efforts to improve patient outcomes through innovative PD-1 inhibitor-based combination therapies, showcasing progress in the fight against one of the most challenging forms of cancer. Epicrispr Biotechnologies brings promising news from its phase 1/2 trial of EPI-321, a gene therapy for facioscapulohumeral muscular dystrophy. The trial's success in enhancing muscle function through epigenetic silencing underscores significant advancements in gene therapy applications for neurological disorders. Similarly, Abbisko Therapeutics' phase 2 trial reports a 90% objective response rate using FGFR2/3 and PD-L1 inhibitors for gastric cancer, demonstrating the potential of targeted small molecule therapies in oncology. In financial developments, Definium Therapeutics and Ligachem Biosciences have made substantial funding strides to bolster their drug development pipelines. Definium's $805 million raise aims to advance psychiatric and neurological treatments, while Ligachem's funding will enhance its antibody-drug conjugate platforms. These investments reflect strong investor confidence in next-generation therapeutic platforms and underscore innovative financing strategies crucial for sustaining research and development efforts. Bayer's recent legal victory at the Supreme Court overturning a $1.25 million verdict related to its Roundup product is another focal point. This ruling not only positively impacts Bayer's financial standing but also highlights the complexities surrounding product liability cases within pharmaceuticals and agrochemicals. Strategically, Moderna has unveiled an ambitious R&D roadmap aiming for break-even by 2028 with over seven new products on the horizon. By focusing on mRNA vaccines for oncology and rare diseases, Moderna continues to leverage its technology beyond COVID-19 applications, potentially transforming treatment paradigms across various therapeutic areas. Shifting focus to industry trends, Sanofi finds itself under investigation by the European Commission for antitrust violations linked to its flu vaccine marketing practices. This situation underscores growing scrutiny over competitive practices within the pharmaceutical sector and could influence regulatory compliance strategies across global markets. In technological advancements, Eli Lilly is employing artificial intelligence to raise awareness about Alzheimer's disease through creative engagements like a European radio show road trip. These initiatives reflect an industry-wide shift towards technology-driven marketing strategies aimed at personalizing patient interactions. Lastly, Merck KGaA's $11 billion acquisition of Bio-Techne exemplifies a strategic move to enhance capabilities in immune cell therapy production. This deal underscores the growing importance of manufacturing innovations in bringing advanced therapies to market and highlights strategic collaborations increasingly seen across the sector. The landscape is further defined by significant scientific breakthroughs such as Revolution Medicines' development of a second RAS blocker, showing improved chemotherapy responses in pancreatic cancer patients. These advancements underscore the need for continued investment in targeted therapeutics research as they promise better patient outcomes and highlight ongoing innovation within oncology. As these developments unfold, they reflect an industry poised for transformation amid evolving scientific, regulatory, and market dynamics aimed at improving patient care globally. With these insights into current trends and future directions, it's clear that the pharmaceutical and biotech sectors are navigating a period rich with potential for groundbreaking advancements that will shape healthcare outcomes worldwide.Support the show
The Tim Conway Jr. Show Hour 2 (6.25) This hour goes from hope to havoc. We kick off with a real breast cancer breakthrough — the FDA just greenlit Trodelvy as a first-line treatment for the hardest-to-treat triple-negative breast cancer, the first ADC approved across PD-L1 status, and it's already proving more durable than chemo. Then sports get ugly: the WNBA suspended Phoenix's Alyssa Thomas and slapped her with a flagrant 2 for driving her fist into Caitlin Clark's throat — a hit refs somehow missed live. Next, the House Whisperer himself, Dean Sharp, breaks down home electrical do's and don'ts (electricity isn't magic, it's water in a pipe) and the man-stuff guide to buying power tools. And we close on the stench story gripping LA: 85 million pounds of spoiled meat, seafood, and bread rotting inside a burned-out Boyle Heights warehouse, as crews race to haul it out before it becomes a full-blown biohazard. Breakthroughs, cheap shots, and a biohazard. Hit play. breakthrough, game-changer, greenlit, FDA-approved, cheap shot, flagrant, dropped the hammer, no-call, caught on camera, ugly, stench, biohazard, rotting, race against time, hauled out, do's and don'ts, man stuff, must-know, dangerous, exposed, accountability, fallout, sidelined, suspended, slammed, viral, jaw-dropping, hope vs. havoc, the truth about, what you need to know. See omnystudio.com/listener for privacy information.
Featuring perspectives from Dr Yelena Y Janjigian and Dr Samuel J Klempner, including the following topics: Introduction (0:00) Role of Anti-PD-1/PD-L1- and CLDN18.2-Directed Antibodies in the Management of Gastroesophageal Cancers — Dr Klempner (5:52) Management of HER2-Positive Gastroesophageal Cancers — Dr Janjigian (28:20) CME information and select publications
In this episode of Oncology Unplugged, host Chandler Park, MD, a medical oncologist at Norton Cancer Institute in Louisville, Kentucky, was joined by Neil M. Iyengar, MD, an associate professor and co-director of Breast Medical Oncology in the Department of Hematology and Medical Oncology at the Emory University School of Medicine, as well as the director of Survivorship Services at the Winship Cancer Institute of Emory University in Atlanta, Georgia.Their conversation focused on the rapidly evolving treatment paradigm for triple-negative breast cancer (TNBC), the integration of metabolic health strategies, the clinical emergence of antibody-drug conjugates (ADCs) in the frontline metastatic setting, and the management of treatment-related toxicities.Drs Park and Iyengar examined data from the phase 3 TROPION-Breast02 trial (NCT05374512), which evaluated first-line datopotamab deruxtecan-dlnk (Dato-DXd; Datroway) in patients with PD-L1-negative metastatic TNBC. The trial demonstrated improvements in both progression-free survival and overall survival (OS) with Dato-DXd compared with standard chemotherapy. Notably, the experts also highlighted a remarkable ORR with Dato-DXd, showing that the ADC may be a robust treatment option for symptomatic patients or those experiencing rapid progression.They also discussed individualizing treatment between Dato-DXd and sacituzumab govitecan-hziy (Trodelvy) based on biomarker status, dosing schedules, and distinct toxicity profiles. Furthermore, the experts emphasized the importance of proactive management of unique ADC-associated toxicities. For Dato-DXd, they recommended prophylactic dexamethasone mouthwash and lubricating eye drops to mitigate mucositis and corneal surface events. For sacituzumab govitecan, they noted the necessity of growth factor support for neutropenia and loperamide for diarrhea.Regarding early-stage disease, they reaffirmed the phase 3 KEYNOTE-522 trial (NCT03036488) regimen of pembrolizumab (Keytruda) plus chemotherapy as the standard of care, with adjuvant escalation using capecitabine or PARP inhibitors for patients with residual disease.Drs Park and Iyengar concluded by spotlighting metabolic health interventions for patients with breast cancer. Although GLP-1 receptor agonists show promise in breast cancer survivors, Dr Iyengar cautioned against their initiation during active neoadjuvant immunotherapy due to their potential effects on pathologic complete response rates. He advocated for lifestyle interventions, including resistance training and a plant-forward, high-protein diet, to maintain lean muscle mass and improve OS outcomes.
For more information regarding this CME/CE activity and to complete the CME/CE requirements and claim credit for this activity, visit:https://www.mycme.com/courses/the-evolving-role-of-antibody-drug-conjugates-in-metastatic-triple-negative-breast-cancer-10800SummaryThis CME/CE-certified podcast will provide multidisciplinary clinicians with an evidence-based update on the evolving role of TROP2-directed antibody-drug conjugates (ADCs) in the frontline treatment of metastatic triple-negative breast cancer. A medical and an ocular oncology specialist review the latest efficacy and safety data from pivotal clinical trials evaluating ADCs, their integration into contemporary treatment algorithms, and guideline recommendations based on PD-L1 status, BRCA mutation status, and immunotherapy eligibility. Learners will explore key factors influencing treatment selection, compare the benefits and limitations of more established therapeutic options, and examine practical strategies for preventing, recognizing, and managing ADC-associated toxicities. Special emphasis will be placed on multidisciplinary approaches to the management of ocular adverse events and other clinically significant toxicities to optimize patient outcomes and support safe implementation of these therapies in clinical practice.Learning ObjectivesEvaluate the current and emerging clinical evidence surrounding the use of trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugates (ADCs) in the first-line treatment of metastatic triple-negative breast cancer (TNBC)Integrate TROP2-directed ADCs into frontline treatment regimens for metastatic TNBC based on the latest clinical evidence, guidelines, and patient- and tumor-specific factorsApply multidisciplinary and patient-centric strategies for the prevention, recognition, and management of toxicities associated with the use of TROP2-directed ADCs in patients with metastatic TNBCThis activity is accredited for CME/CE CreditThe National Association for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.The National Association for Continuing Education designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.The National Association for Continuing Education is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 121222. This activity is approved for 0.50 contact hours (which includes 0.50 hours of pharmacology). For additional information about the accreditation of this program, please contact NACE at info@naceonline.com.Faculty and Moderator Aditya Bardia, MDProgram Director, Breast Medical Oncology, UCLAProfessor of Medicine, UCLALos Angeles, CADr. Bardia has disclosed the following financial relationships:Consultant: Alyssum, AstraZeneca/Daiichi, BMS, Eli Lilly, Genentech, Gilead, Menarini, Merck, Novartis, Pfizer, VyomeAdvisor/Advisory Board: Alyssum, AstraZeneca/Daiichi, Eli Lilly, Genentech, Gilead, Menarini, Merck, Novartis, Pfizer, VyomeContracted Research: AstraZeneca/Daiichi, Eli Lilly, Genentech, Gilead, Menarini, Merck, Novartis, PfizerStock options: Vyome (immuno-inflammatory and rare diseases)All of his consultant, advisor/advisory board, and contracted research disclosures are related to cancer.Maura Di Nicola, MDAssistant Professor of OphthalmologyBascom Palmer Eye InstituteMedical Director of Imaging and EchographyBascom Palmer Eye InstituteMiami, FLDr. Di Nicola has disclosed the following financial relationships:Consultant: AbbVie (ophthalmology), SpringWorks Therapeutics (oncology)Advisor/Advisory Board: AbbVie (ophthalmology)Research Grant: Castle Biosciences (ocular oncology)Please review additional planner disclosures here.Disclosure of Commercial SupportThis educational activity is supported by a medical education grant from AstraZeneca Pharmaceuticals and a medical education grant from Daiichi Sankyo, Inc.Please visit http://naceonline.com to engage in more live and on demand CME/CE content.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The landscape of these industries is one of constant evolution, characterized by scientific advancements, strategic mergers, and regulatory maneuvers that shape the future of healthcare. In a significant scientific breakthrough, Merck & Co. and Gilead Sciences have made strides in HIV treatment with the development of a weekly pill. This innovative regimen combines Merck's islatravir with Gilead's lenacapavir, showing promise in two phase 3 trials. If approved, this long-acting oral therapy could revolutionize HIV care by offering a more convenient dosing schedule, potentially improving patient adherence and outcomes substantially. This novel regimen signifies progress towards simplifying HIV treatments with once-weekly dosing. Meanwhile, in the oncology sector, Gilead's Trodelvy faced challenges when combined with Merck's Keytruda as a first-line treatment for PD-L1-high non-small cell lung cancer. The phase 3 EVOKE-03 trial was terminated, shifting attention to competitors like AstraZeneca and Daiichi Sankyo, who continue to advance their own therapies in this area. In a strategic move to bolster its position in lung cancer treatment, GlaxoSmithKline (GSK) is acquiring Nuvalent for $10.6 billion, aiming to secure near-approval cancer therapies capable of challenging market leaders like Roche and Pfizer. This acquisition underscores the focus on targeted cancer therapies that increase treatment efficacy by honing in on specific genetic markers. Nuvalent's innovative pipeline of small molecule inhibitors targets drug resistance and mutations in cancer treatment—a strategic addition to GSK's portfolio aimed at enhancing its position amidst rapid advancements and intense competition in oncology. In diabetes and obesity management, Eli Lilly is advancing with its new oral GLP-1 receptor agonist, Foundayo (orforglipron), which has shown competitive efficacy over oral semaglutide. Analysts see Lilly's progress as strengthening its leadership in the growing obesity drug market. Similarly, AstraZeneca is making progress with its own GLP-1 candidate, elecoglipron, as phase 2 data sets the stage for pivotal studies. Promising clinical trial data from Eli Lilly's retatrutide for obesity-related conditions and AstraZeneca's elecoglipron suggest a strengthening pipeline for GLP-1 receptor agonists known for their dual effects on weight management and glycemic control. On the diagnostics front, Roche reaffirms its €600 million investment in Germany amid industry retrenchments by companies like Eli Lilly and Boehringer Ingelheim. However, Roche remains cautious about future risks due to shifting economic conditions. The financial dynamics within biotech are also noteworthy. Parabilis Medicines is planning a potentially record-setting IPO following Kailera Therapeutics' successful public offering earlier this year. These trends indicate strong investor confidence and an influx of funding towards innovative cancer therapies. Meanwhile, CeQur's $100 million Series E funding round aims at accelerating insulin patch delivery systems' commercial growth—highlighting ongoing innovation in diabetes management solutions. Regulatory updates reveal AstraZeneca facing reprimands from the UK marketing watchdog due to repeated breaches related to LinkedIn activities—an ongoing challenge in pharmaceutical marketing compliance. The integration of digital health solutions continues apace as ixlayer partners with Vertex Pharmaceuticals to launch a digital acute pain management platform. This initiative aims at improving patient care by reducing reliance on opioid-based treatments. These developments paint a picture of an industry where scientific innovations, regulatory hurdles, and technological advancements intersect to shape future therapeutic landscapes. Precision oncology is another area witnessing substantial growth. The landscape also sees notable activity in rare disease therapeutics. Johnson & Johnson's Talvey has gained acceptance in Scotland for treating relapsed multiple myeloma using bispecific antibody technology—a trend toward leveraging immune system targeting technologies to enhance cancer treatment efficacy. Moreover, Zai Lab's Tivdak received approval from China's NMPA for cervical cancer treatment based on Phase 3 data, highlighting the rise of antibody-drug conjugates (ADCs) as potent oncology therapies due to their targeted delivery mechanisms. On the research collaboration front, AlzeCure Pharma's partnership with Eli Lilly focuses on Alzheimer's disease research through Alzstatin ACD680—a small molecule targeting neurodegenerative pathways—a testament to the collaborative efforts needed to tackle complex diseases like Alzheimer's. However, challenges persist as Bial discontinued its GCase activator program after failing Phase 2b trials for Parkinson's patients with GBA1 variants—a stark reminder of the high-risk nature inherent in drug development despite initial promise. These myriad developments underscore a vibrant period within pharmaceutical and biotech sectors where scientific advancements rapidly translate into actionable therapies promising substantial improvements in patient care by addressing unmet medical needs globally.Support the show
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we'll explore a landscape teeming with strategic partnerships, groundbreaking clinical trial results, regulatory shifts, and innovative therapeutic approaches that are redefining patient care and drug development. Pfizer's monumental $10 billion collaboration with Innovent Biologics stands out as a testament to the shifting dynamics of the oncology sector. This partnership aims to develop 12 antibody-drug conjugate (ADC) and multispecific antibody programs, spotlighting these therapies' growing significance in oncology. The precision of antibodies in delivering cytotoxic agents directly to cancer cells offers a new frontier in minimizing collateral damage to healthy tissues—a crucial advancement in cancer treatment. The deal not only highlights Pfizer's commitment to expanding its oncology pipeline but also underscores the strategic importance of leveraging China's accelerated drug development ecosystem. In regulatory news, AstraZeneca's Imfinzi has garnered FDA approval for BCG-naive high-risk non-muscle-invasive bladder cancer. This milestone for PD-L1 inhibitors reflects the evolving landscape of immunotherapy. By harnessing monoclonal antibodies in combination therapies, the potential for enhanced anticancer efficacy is significant. With few therapeutic alternatives available, this approval presents a lifeline for many bladder cancer patients. Clinical trial outcomes also continue to capture attention. Eli Lilly's Nectin-4 targeting ADC showed promising results in advanced urothelial cancer, positioning itself as a potential competitor to Padcev. This innovation in ADC technology demonstrates the industry's relentless pursuit of targeted therapies that can revolutionize treatment paradigms. Bristol Myers Squibb's mezigdomide offers another example by showing a 52% reduction in progression risk for relapsed or refractory multiple myeloma patients, emphasizing the focus on addressing specific molecular pathways. In the realm of bispecific antibodies, Phanes Therapeutics' CLDN18.2/CD47 targeting therapy reported encouraging Phase 2 results in metastatic pancreatic ductal adenocarcinoma. These antibodies' ability to simultaneously engage multiple targets enhances their therapeutic efficacy against stubborn cancers, broadening the horizon for treatment possibilities. Meanwhile, Replimune's resubmission of its RP1 melanoma Biologics License Application (BLA) highlights the intricate dance between drug development and regulatory processes amid organizational shifts at the FDA. Such efforts reflect the continual adaptation required within the industry to navigate complex regulatory landscapes. On the funding front, Psilera's successful $8.8 million seed round indicates growing interest in psychedelic therapies for neurological conditions. Similarly, Reprogram Biosciences raised $6 million for its AI-driven cell reprogramming oncology platform, illustrating how artificial intelligence is becoming integral to advancing drug discovery and development. However, not all updates were positive. Agios Pharmaceuticals faced setbacks as their pyruvate kinase activator failed a Phase 2b trial for lower-risk myelodysplastic syndromes, serving as a sobering reminder of the inherent risks involved in drug development. Dizal Pharma emerges as a beacon of hope in lung cancer treatment following Takeda's EGFR exon 20 drug setback. By challenging existing treatments with promising small molecule data, Dizal exemplifies precision medicine's role in redefining oncology protocols—offering personalized patient options that could set new standards in treatment efficacy. The issue of drug pricing remains contentious, particularly highlighted by an AARP analysis showing an 81% increase post-launch prices stateside compared to a 13% decrease abroad. This disparity raises critical questions about achieving equitable access across markets amid Medicare negotiations and global pricing strategies like "most favored nation" policies. Regulatory updates continue with Johnson & Johnson's Tremfya label expansion stateside and AbbVie's EU extension for Venclyxto—moves that reflect efforts to maximize therapeutic reach and commercial viability across diverse geographies. Finally, Gilead Sciences' decision to discontinue its lead rheumatoid arthritis drug from MiroBio underscores ongoing challenges within emerging fields like BTLA agonists—a reminder of both innovation's promise and its perilous nature when faced with unproven therapeutic avenues. As these varied developments unfold, they collectively signal an era characterized by rapid scientific innovation and strategic collaborations across geographies alongside evolving regulatory landscapes—all driving towards enhanced patient care through more effective treatments globally. This concludes today's insights from Pharma Daily—a world where dynamic change continues reshaping healthcare delivery standards towards unprecedented possibilities for patient outcomes worldwide. Thank you for joining us; stay tuned for more updates on tomorrow's horizon-shaping advancements.Support the show
In the first episode of a special daily series during the 2026 ASCO Annual Meeting, Dr. Monty Pal discusses 3 abstracts, including a follow-up on the EV-302 study in urothelial carcinoma, a potential new treatment option for patients with PD-L1-positive advanced non–small cell lung cancer, and a novel psychosocial digital application that improves fatigue and distress in patients with multiple myeloma. LINK TO FULL TRANSCRIPT
Welcome to IDEA Collider. In this episode, host Alex Gray is joined by IDEA Pharma colleagues David Radwaner and Tom Brockbank to dissect the history, strategy, and future of immuno-oncology (IO). The trio explores how PD-1 and PD-L1 therapies revolutionized cancer treatment, acting as a brake on the immune system to offer unprecedented durability and long-term survival for patients. They take a deep dive into the fascinating commercial and clinical race between Merck's Keytruda and BMS's Opdivo. Learn how Merck's strategic decisions—including smart statistical trial designs, targeted biomarker approaches in first-line non-small cell lung cancer, and tumor-agnostic labels like MSI-high—allowed Keytruda to secure market dominance. Finally, Alex, David, and Tom look ahead to the next ten years, discussing whether emerging players like AstraZeneca and China's Akeso / Summit will displace Keytruda, or if the future lies in combination therapies. Episode Timestamps: 00:00:00 - Introduction: Meet David Radwaner, Tom Brockbank, and host Alex Gray. 00:01:45 - The Origins of IO: The Nobel Prize-winning discovery of PD-1 and CTLA-4 checkpoints. 00:03:55 - Why PD-1 / PD-L1 Won: The unique breadth of utility and unparalleled durability of long-term survival. 00:06:21 - Keytruda vs. Opdivo: How Merck's strategic trial design and smart statistical work outpaced BMS's early lead. 00:11:48 - The NSCLC Inflection Point: Why narrowing the patient population (PD-L1 - 50%) cemented Keytruda's foundation in first-line lung cancer. 00:14:20 - Tumor-Agnostic Success: Merck's bold move into MSI-high and broad biomarker-led strategies. 00:16:09 - Science or Luck? Analyzing Merck's aggressive and risky clinical development strategy. 00:18:00 - The Next 10 Years: Will anyone displace Keytruda? Assessing the future strategies of Merck, BMS, AstraZeneca, and Akeso/Summit Don't forget to Like, Share, Subscribe, Rate, and Review! Keep up with Alex Gray; LinkedIn: https://www.linkedin.com/in/alexander-gray-934a653/ Keep up with David Radwaner; LinkedIn: https://www.linkedin.com/in/david-radwaner-1b496343/ Keep up with Tom Brockbank; LinkedIn: https://www.linkedin.com/in/tom-brockbank-159bb4116/ Follow IDEA Pharma On; Website: https://www.ideapharma.com/ Listen to more fantastic podcast episodes: https://ideacollider.simplecast.com/
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 noteworthy advancements and challenges that are shifting the landscape of drug development and patient care. Starting with AstraZeneca and Daiichi Sankyo, their Trop2-directed antibody-drug conjugate, Datroway, has secured FDA approval for first-line treatment in triple-negative breast cancer. This form of cancer is notoriously aggressive and offers limited treatment options, making this approval a significant milestone. It positions Datroway as a key player in the ADC market targeting TNBC, highlighting the increasing role of antibody-drug conjugates in oncology. This advancement not only expands therapeutic options for patients but also emphasizes the growing importance of ADCs in effectively targeting cancer cells while sparing healthy tissues. In another exciting development, Merck and Kelun Biotech have reported on their SAC-TMT ADC, which when paired with Keytruda, shows a profound impact on PD-L1-positive non-small cell lung cancer patients. Their combination therapy demonstrated a remarkable 65% reduction in disease progression or death compared to Keytruda alone. Presented at the ASCO annual meeting, these findings could potentially revolutionize first-line treatments for NSCLC, further underscoring the promising therapeutic potential of combining ADCs with immunotherapies. However, AstraZeneca faced a setback with a novel breast cancer drug as an FDA advisory committee recommended against its approval. Interestingly, the European Medicines Agency provided a favorable opinion, illustrating the divergent regulatory landscapes across continents. Such discrepancies highlight the complex regulatory environment pharmaceutical companies must navigate and could influence strategic decisions regarding market focus. On the legal front, Eli Lilly is embroiled in controversy over an alleged $200 million rebate fraud scheme involving its diabetes drug, Trulicity. This situation sheds light on ongoing issues within pharmaceutical distribution channels and raises questions about compliance and oversight mechanisms necessary to prevent such financial misconduct. Meanwhile, industry dynamics continue to evolve as AbbVie announced workforce reductions in its Allergan Aesthetics unit. This move reflects broader trends where companies streamline operations to prioritize core competencies and promising therapeutic areas. From a regulatory perspective, Maat Pharma's decision to seek re-examination for its graft-versus-host disease medication underscores the iterative nature of drug approval processes. Persistence in addressing regulatory feedback remains crucial as companies strive for successful market entry. In obesity management, Novo Nordisk's oral GLP-1 receptor agonist, Wegovy, gains traction as a convenient treatment option. The shift towards oral medications could significantly improve patient adherence and outcomes by offering an easier alternative to injections. Biogen's decision to terminate its collaboration with Denali Therapeutics after unsuccessful phase 2 trials for a Parkinson's disease candidate highlights the inherent risks in neurological drug development. Rigorous clinical evaluation remains essential to ensure efficacy before advancing therapies further. Despite these advancements, challenges persist as Biogen and Denali's BIIB122 failed in phase 2b trials for idiopathic Parkinson's disease. This underscores the complexity of neurological disorders and emphasizes the need for continued innovation targeting LRRK2 kinase inhibitors. In the realm of CAR-T therapies, Novartis' T-Charge platform faces competition from emerging in vivo technologies. This competitive landscape demonstrates rapid evolution within cell therapy domains, aiming to enhance efficacy and accessibility for patients. Meanwhile, strategic mergers and acquisitions continue as Liminatus Pharma acquires CAR-T biotech Innocsai for $320 million, underscoring sustained interest in oncology cell therapies. Switching gears to Eli Lilly's recent Phase 3 TRIUMPH-1 trial results for retatrutide, they reveal promising weight loss outcomes comparable to bariatric surgery. As a triple hormone receptor agonist targeting GLP-1, retatrutide holds significant potential in addressing obesity—a condition with profound public health implications. Medtronic's acquisition of SPR Therapeutics to enhance its chronic pain portfolio reflects a focus on minimally invasive treatments. Financially, Research Alliance III raised $75 million through a SPAC IPO targeting mergers with China-based biotech firms, signaling increased global collaboration within the sector. Dandelion Health's $14 million Series A funding aims to advance clinical intelligence platforms that could transform drug development through data analytics. Finally, Moderna's mRNA-based flu vaccine is set for review by the FDA's vaccine advisory committee after overcoming initial regulatory hurdles. This scrutiny highlights ongoing challenges faced by novel vaccine technologies within rigorous regulatory environments. In summary, these developments illustrate an industry at the forefront of scientific innovation while grappling with regulatory complexities and operational challenges. From antibody-drug conjugates and immunotherapy combinations to gene editing and advanced cell therapies, there's a clear commitment to improving patient outcomes through novel scientific approaches. As these trends evolve, they promise to redefine treatment landscapes across various therapeutic areas—offering new opportunities for scientific advancements and enhanced patient care worldwide.Support the show
What is PD-L1, and why does it matter so much in your lung cancer treatment plan? Patient host Colette Smith talks with Dr. Julie Brahmer of Johns Hopkins University Hospital to demystify PD-L1 testing, immunotherapy decisions, and personalized lung cancer care. You'll learn: What PD-L1 is and how cancer cells use it as a "cloaking device" How Tumor Proportion Scores (TPS) from 0 to 100 guide treatment choices When immunotherapy alone works—and when chemotherapy should be added Why repeat biopsies matter for long-term survivors The most common side effects of immunotherapy and how they're managed When immunotherapy may not be the right option Key questions to ask your oncologist at every stage of treatment Why every patient should ask about clinical trials Whether you're newly diagnosed or navigating a treatment change, this conversation offers clarity, hope, and actionable guidance. Get the full PD-L1 guide and download free patient resources: https://lcfamerica.org/about-lung-cancer/diagnosis/understand-pd-l1/ Heading to a doctor's appointment? Download LCFA's "Questions to Ask Your Care Team about PD-L1" PDF at lcfamerica.org. Learn more at lcfamerica.org. Guests: Dr. Julie Brahmer, Johns Hopkins University Hospital Colette Smith, Patient Host Show Notes - https://lcfamerica.org/wp-content/uploads/2026/05/LCFA-HWA-PD-L1-in-Lung-Cancer-Show-Notes.pdf Transcript - https://lcfamerica.org/wp-content/uploads/2026/05/LCFA-HWA-PDL1-Transcript.pdf YouTube - https://youtu.be/Ymff6MwaJTc Subscribe to Hope With Answers: Living With Lung Cancer podcast for future episodes on your favorite listening platform.
Featuring proceedings from a live event on January 9, 2026, held adjunct to the 2026 ASCO Gastrointestinal Cancers Symposium and moderated by Dr Samuel J Klempner, including the following topics: Treatment approach for metastatic HER2-negative, claudin 18.2-positive, microsatellite instability-high gastroesophageal (GE) cancer (0:00) Duration of chemotherapy for patients with advanced GE cancers receiving nivolumab/chemotherapy (3:06) Younger patient with metastatic PD-L1-positive gastric cancer (5:29) CME information and select publications
Cancer immunotherapy has transformed the treatment landscape for many advanced cancers over the past decade. Drugs targeting the PD-1 and PD-L1 pathways are now widely used across several tumor types, helping the immune system recognize and attack cancer cells more effectively. However, researchers are still working to understand how beneficial these therapies may be when used earlier in the disease course, particularly after surgery in patients with high-risk solid tumors. A research paper on this topic was published in Volume 17 of Oncotarget titled “Efficacy and safety of PD-1/ PD-L1 inhibitors as adjuvants in the treatment of patients with solid cancers: A systematic review and meta-analysis of randomized controlled trials.” Full blog - https://www.oncotarget.org/2026/05/20/immune-checkpoint-inhibitors-may-improve-outcomes-in-high-risk-solid-tumors/ Paper DOI - https://doi.org/10.18632/oncotarget.28855 Correspondence to - Dhai Almuteri - d.almuteri@qu.edu.sa Abstract video - https://www.youtube.com/watch?v=4Ce07bHfjB4 Sign up for free Altmetric alerts about this article - https://oncotarget.altmetric.com/details/email_updates?id=10.18632%2Foncotarget.28855 Subscribe for free publication alerts from Oncotarget - https://www.oncotarget.com/subscribe/ Keywords - cancer, PD-1, PD-L1, adjuvant immunotherapy, solid tumor To learn more about Oncotarget, please visit https://www.oncotarget.com and connect with us: Facebook - https://www.facebook.com/Oncotarget/ X - https://twitter.com/oncotarget Instagram - https://www.instagram.com/oncotargetjrnl/ YouTube - https://www.youtube.com/@OncotargetJournal LinkedIn - https://www.linkedin.com/company/oncotarget Pinterest - https://www.pinterest.com/oncotarget/ Reddit - https://www.reddit.com/user/Oncotarget/ Spotify - https://open.spotify.com/show/0gRwT6BqYWJzxzmjPJwtVh MEDIA@IMPACTJOURNALS.COM
Welcome to the Oncology Brothers podcast! In this episode, we dived deep into the world of BRAF V600E-driven non-small cell lung cancer (NSCLC) with our guest Dr. Gregory Riely, a thoracic medical oncologist from Memorial Sloan Kettering Cancer Center. Listen us on: Spotify: https://open.spotify.com/show/31BXhY9FM4gPWG10WgE11o Apple Podcast: https://podcasts.apple.com/us/podcast/oncology-brothers-practice-changing-cancer-discussions/id1653340966 Follow us on social media: X/Twitter: https://twitter.com/oncbrothers Instagram: https://www.instagram.com/oncbrothers Website: https://oncbrothers.com/ Join us as we explore: The prevalence of BRAF V600E mutations in NSCLC and how they compare to other oncogenic drivers. The latest treatment options, including BRAF-MEK inhibitors like Encorafenib-Binimetinib and Dabrafenib-Trametinib. Key clinical trial data that led to the approval of these therapies and their implications for patient care. The role of immunotherapy in treating BRAF V600E patients and how to effectively sequence treatments. Patient characteristics that influence treatment decisions, including smoking history and PD-L1 expression. Whether you're a practicing oncologist or simply interested in the latest advancements in cancer treatment, this episode is packed with valuable insights and expert opinions. Don't miss it! Subscribe to our channel for more discussions on oncology and stay updated on the latest in cancer care! #BRAFV600E, #NSCLC, #BRAFMEKinhibitor, #TargetedTherapy, #OncologyBrothers
Welcome to the Oncology Brothers podcast! In this episode, we dived deep into the treatment algorithm for metastatic non-small cell lung cancer (NSCLC) without actionable driver mutations in frontline settings. Listen us on: Spotify: https://open.spotify.com/show/31BXhY9FM4gPWG10WgE11o Apple Podcast: https://podcasts.apple.com/us/podcast/oncology-brothers-practice-changing-cancer-discussions/id1653340966 Follow us on social media: X/Twitter: https://twitter.com/oncbrothers Instagram: https://www.instagram.com/oncbrothers Website: https://oncbrothers.com/ We discussed the latest updates in lung cancer treatment, including the recent approval of Teliso-V for C-MET overexpressing disease and Zongertinib for HER2 positive cases. We explored the nuances of choosing between single-agent and dual checkpoint inhibitors, the role of PD-L1 scores, and the impact of molecular testing on treatment decisions. Special guest Dr. Christine Garcia, a thoracic medical oncologist and fellowship program director at Weill Cornell Medicine, shared her insights on the importance of biomarker testing, the implications of STK11 and KEAP1 mutations, and the evolving landscape of KRAS inhibitors. Key topics covered in this episode: The significance of NGS testing and PD-L1 scores in treatment decisions The role of chemotherapy in high PD-L1 patients Insights on dual checkpoint inhibitors based on recent clinical trials The latest options for KRAS G12C mutations and C-MET overexpression Practical considerations for managing treatment-related side effects Tune in for an informative discussion that bridges the gap between academic research and community practice in oncology. Don't forget to subscribe for more episodes on treatment algorithms and the latest in cancer care! #MetastaticNSCLC, #Immunotherapy, #KRASG12C, #BiomarkerTesting, #OncologyBrothers
Welcome to another episode of the Oncology Brothers podcast! In this episode, hosts Rahul and Rohit Gosain dive deep into the treatment algorithms for early-stage non-small cell lung cancer (NSCLC) with curative intent. Joined by leading thoracic medical oncologist Dr. Sanjay Popat from London, they discussed the critical role of next-generation sequencing (NGS) in treatment planning, the importance of proper staging, and the implications of actionable mutations. Listen us on: Spotify: https://open.spotify.com/show/31BXhY9FM4gPWG10WgE11o Apple Podcast: https://podcasts.apple.com/us/podcast/oncology-brothers-practice-changing-cancer-discussions/id1653340966 Follow us on social media: X/Twitter: https://twitter.com/oncbrothers Instagram: https://www.instagram.com/oncbrothers Website: https://oncbrothers.com/ Key topics covered included: The significance of NGS testing and its impact on treatment decisions. Insights from the CHECKMATE 816 trial, highlighting the benefits of neoadjuvant chemoimmunotherapy. The complexities of post-operative immunotherapy and patient-shared decision-making. The role of adjuvant chemotherapy in patients with actionable mutations like EGFR and ALK. The latest data on osimertinib and alectinib in the adjuvant setting. The standard of care for unresectable disease based on the PACIFIC trial and the implications of PD-L1 status. Join us for an informative discussion that unpacks the latest advancements in NSCLC treatment and emphasizes the importance of personalized care. Don't forget to subscribe for more episodes in our treatment algorithm series! #EarlyStageNSCLC, #CHECKMATE816, #NeoadjuvantTherapy, #PrecisionMedicine, #OncologyBrothers
Breast Cancer Briefing, hosted by Sara Nunnery, MD, MSCI, a breast medical oncologist and the director of Breast Cancer Research at Tennessee Oncology in Nashville, is a podcast series that breaks down the latest news in breast cancer research, one conversation at a time.In part 2 of this conversation, filmed live onsite at the 43rd Annual Miami Breast Cancer Conference, Dr Nunnery sat down with Irene Morae Kang, MD, an assistant professor in the Department of Medical Oncology & Therapeutics Research and the medical director of Women's Health Medical Oncology at City of Hope Orange County in Irvine, California.Their discussion focuses on the rapidly evolving treatment paradigm for first-line metastatic triple-negative breast cancer (TNBC), including the emergence of new data that is shifting standards of care. Dr Kang explained that TNBC is defined by the absence of estrogen, progesterone, and HER2 receptors, which historically restricted treatment options to non-targeted chemotherapy. A primary focus of the conversation was the role of PD-L1 expression and the use of immunotherapy. Dr Kang described PD-L1 as a checkpoint inhibitor protein on cancer cells that shuts off the immune system. By blocking this protein, oncologists can keep the body's T-cells vigilant to fight the cancer. However, she noted that immunotherapy is typically reserved for the approximately 40% of patients who express PD-L1 and may be contraindicated for those with active autoimmune diseases or a history of severe immune-related toxicities.The dialogue transitioned into the use of antibody-drug conjugates (ADCs). Dr Kang reviewed data from major trials using TROP2-targeting ADCs in the first-line setting. Dr Kang emphasized the importance of using these highly effective agents early, as many patients with TNBC do not survive to receive a second line of therapy.Finally, Dr Kang highlighted the distinct toxicity profiles and administration schedules that guide clinical decision-making. Although sacituzumab govitecan-hziy (Trodelvy) is frequently associated with neutropenia and alopecia, the primary toxicities associated with datopotamab deruxtecan-dlnk (Dato-DXd; Datroway) are stomatitis and ocular adverse effects like dry eye. Using Dato-DXd in practice requires a rigorous prophylactic regimen, including steroid mouthwash and lubricating eye drops. Ultimately, Dr Kang noted that because efficacy appears similar between the 2 ADCs, the choice often rests on the patient's lifestyle, their ability to adhere to preventative AE protocols, and infusion schedule preference.
Featuring perspectives from Dr Jaffer A Ajani, Dr Samuel J Klempner, Dr Rutika Mehta and Dr John Strickler, moderated by Dr Klempner, including the following topics: Role of PD-L1 status, tumor histology and pulmonary disease in selection of immune checkpoint inhibition as up-front therapy (0:00) Impact of metastatic site and autoimmune disease on clinical decision-making in the use of immune checkpoint inhibition (5:56) Biomarker assessment approach and treatment selection (10:50) CME information and select publications
In this clinically rich episode, host Dr. Ted Lain sits down with board-certified dermatologist and global skin cancer expert Dr. Todd Schlesinger — AAD Board of Directors member, Mohs surgeon, clinical assistant professor at George Washington University School of Medicine, and medical director of the Clinical Research Center of the Carolinas — for a deep dive into systemic and targeted therapies for non-melanoma skin cancer (NMSC). The doctors begin with a thorough breakdown of the hedgehog signaling pathway (PATCHED, Smoothened, GLI-1 transcription) and how mutations in this pathway drive basal cell carcinoma (BCC) growth. They compare the two FDA-approved hedgehog pathway inhibitors (HHIs) — vismodegib (Erivedge) and sonidegib (Odomzo) — covering their mechanisms of action, volume of distribution differences (16–18L vs. ~9,000L), indications for locally advanced and metastatic BCC, how to define "locally advanced," and complete vs. partial response rates. Dosing strategies are addressed in detail, including alternate-day dosing and treatment breaks backed by the MIKIE study and STEVIE safety study. For managing the most common adverse events — muscle cramps, dysgeusia, weight loss, and fatigue — Dr. Schlesinger shares his clinical protocol using L-carnitine supplementation (1,500–2,000mg liquid, started 2–4 weeks before therapy) along with calcium and CoQ10. The conversation then moves to PD-1 and PD-L1 checkpoint inhibitors for locally advanced and metastatic cutaneous squamous cell carcinoma (cSCC) and BCC, covering cemiplimab (Libtayo), pembrolizumab (Keytruda), and nivolumab (Opdivo). The hosts explain the immune checkpoint mechanism using a memorable analogy, discuss how UV exposure upregulates PD-1 on tumor cells, and explore the practical realities of dermatologists prescribing infusion-based immunotherapy — including multidisciplinary care team logistics, buy-and-bill considerations, and when to partner with oncology. The episode closes with an exciting look at the pipeline: intralesional therapies for nodular and superficial BCC from companies including Verica, iViva, PHIO, and Feldan, red light PDT for superficial BCC nearing FDA approval, and the broader question of where these drugs fit as neoadjuvant, adjuvant, or primary therapies — and what complete response benchmarks (80–95%) dermatologists should expect before adopting non-surgical primary options. To watch this and other episodes, be sure to check out our YouTube page DISCLAIMER: This podcast is not intended to provide diagnosis, treatment, or medical advice. Content provided in this podcast is for educational purposes only. Please consult with a physician regarding any health-related diagnosis or treatment.See omnystudio.com/listener for privacy information.
Featuring an interview with Dr Natalie Vokes, including the following topics: Perioperative minimal residual disease (MRD) detected by circulating tumor DNA (ctDNA) testing in patients with lung cancer (0:00) Ohara S et al. Clinical significance of perioperative MRD detected by ctDNA in patients with lung cancer with a long follow-up data: An exploratory study. JTO Clin Res Rep 2024;6(3):100762. Abstract Masuda K et al. MRDSEEKER (JCOG2111A): A prospective study to evaluate MRD and its association with prognosis in curative-intent NSCLC. World Conference on Lung Cancer 2025;Abstract P3.18.04. Zhou C et al. IMpower010: Biomarkers of disease-free survival in a phase 3 study of atezolizumab vs best supportive care after adjuvant chemotherapy in stage IB-IIIA NSCLC. ESMO IO 2021;Abstract 2O. MRD analysis of adjuvant therapy with osimertinib for resected EGFR-mutated Stage IB to IIIA non-small cell lung cancer (NSCLC) (8:28) Herbst RS et al. Molecular residual disease analysis of adjuvant osimertinib in resected EGFR-mutated stage IB-IIIA non-small-cell lung cancer. Nat Med 2025;31(6):1958-68. Abstract MRD analyses of perioperative chemoimmunotherapy for resected NSCLC (15:12) Forde PM et al. Overall survival with neoadjuvant nivolumab plus chemotherapy in lung cancer. N Engl J Med 2025;393(8):741-52. Abstract ctDNA dynamics in advanced NSCLC treated with immunotherapy (20:56) Vokes NI et al. Circulating tumor DNA (ctDNA) dynamics and survival outcomes in patients (pts) with advanced non-small cell lung cancer (aNSCLC) and high (>50%) programmed cell death ligand 1 (PD-L1) expression, randomized to cemiplimab (cemi) vs chemotherapy (chemo). ASCO 2023;Abstract 9022. Anagnostou V et al. ctDNA response after pembrolizumab in non-small cell lung cancer: Phase 2 adaptive trial results. Nat Med 2023;29(10):2559-69. Abstract Anagnostou V et al. A biomarker-directed, multi-center phase II/III study of ctDNA molecular response adaptive immuno-chemotherapy in patients with non-small cell lung cancer (BR.36). ASCO 2025;Abstract TPS8669. CME information and select publications
In this podcast, experts April K.S. Salama, MD; Omid Hamid, MD; James M.G. Larkin, MD, PhD; and Sapna Patel, MD; discuss the data for immune checkpoint inhibitors used to treat advanced cutaneous squamous cell carcinoma, including a review of PD-1 versus PD-L1 inhibition.
A fascinating step forward in Nature—where immunology meets cardiology.
Featuring perspectives from Dr Jaffer A Ajani, Dr Samuel J Klempner, Dr Rutika Mehta and Dr John Strickler, moderated by Dr Klempner, including the following topics: Older patient with metastatic claudin 18.2-positive gastroesophageal (GE) cancer (0:00) Management of nausea and vomiting with zolbetuximab for GE cancer (9:37) Younger patient with metastatic claudin 18.2-positive, PD-L1-positive GE cancer (15:34) CME information and select publications
In today's episode, we sat down with John Marshall, MD, and Christopher Lieu, MD, to discuss the clinical relevance of KRAS G12C and pan-RAS inhibitors in the management of pancreatic and colorectal cancers. Dr Marshall is chief of Hematology and Oncology, a professor of medicine and oncology, and director of the Otto J Ruesch Center for the Cure of Gastrointestinal Cancers at the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC. Dr Lieu is a professor of medicine, associate director for Clinical Research, and co-director of Gastrointestinal Medical Oncology at the University of Colorado Anschutz and the University of Colorado Cancer Center in Aurora. In our exclusive interview, the experts highlighted historical challenges in targeting RAS mutations, as well as recent breakthroughs. They also emphasized the importance of testing early for biomarkers like Claudin 18.2, PD-L1, HER2, and microsatellite instability in patients with gastroesophageal cancers. Furthermore, the experts discussed the need to use targeted therapies early in treatment to avoid treatment resistance, and noted the potential of novel RAS inhibitors and immunotherapies. Their conversation also touched on the importance of rebiopsy and the challenges of obtaining sufficient tissue for biomarker analysis.
Featuring perspectives from Dr Jaffer A Ajani, Dr Samuel J Klempner, Dr Rutika Mehta and Dr John Strickler, moderated by Dr Klempner, including the following topics: Younger patient with metastatic HER2-positive, PD-L1-positive gastric cancer (0:00) Older patient with metastatic HER2-positive gastroesophageal (GE) cancer (8:13) Clinical applications for zanidatamab in GE cancer (13:58) CME information and select publications
Welcome to the Oncology Brothers podcast! In this episode, we dived deep into the current treatment landscape for frontline HER2-positive gastroesophageal junction (GEJ) and gastric cancer. Listen us on: Spotify: https://open.spotify.com/show/31BXhY9FM4gPWG10WgE11o Apple Podcast: https://podcasts.apple.com/us/podcast/oncology-brothers-practice-changing-cancer-discussions/id1653340966 Follow us on social media: X/Twitter: https://twitter.com/oncbrothers Instagram: https://www.instagram.com/oncbrothers Website: https://oncbrothers.com/ Join us as we welcome Dr. Sunnie Kim from the University of Colorado and Dr. Samuel Cytryn from Memorial Sloan Kettering, who shared their insights on the latest advancements in HER2-targeted therapies. We discussed the pivotal TOGA and KEYNOTE-811, the promising data from the HERIZON-GEA01 study featuring Zanidatamab, and the implications of these findings for clinical practice. Key topics included: Current standard of care for HER2-positive GEJ and gastric cancer The role of PD-L1 status in treatment decisions Mechanisms and efficacy of Zanidatamab compared to traditional therapies Management of side effects, including diarrhea and infusion-related reactions Future directions in HER2-targeted therapies, including T-DXd based on the DESTINY Gastric-04 trial Don't forget to like, subscribe, and hit the notification bell for more updates on treatment algorithms, FDA approvals, and conference highlights! Accreditation/Credit Designation Physicians' Education Resource®, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Physicians' Education Resource®, LLC designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Acknowledgment of Commercial Support This activity is supported by an educational grant from Jazz Pharmaceuticals, Inc. Link to gain CME credits from this activity: https://www.gotoper.com/courses/new-precision-strategies-for-her2-gea-interpreting-new-data-to-inform-clinical-practice