
OncLive® On Air
524 episodes — Page 4 of 11

S14 Ep 25S14 Ep25: Sequencing, Efficacy, and Safety Data May Further Evolve the Role of Fruquintinib in CRC: With Kanwal P. S. Raghav, MBBS, MD
In today’s episode, we had the pleasure of speaking with Kanwal P. S. Raghav, MBBS, MD, about the role of fruquintinib (Fruzaqla) in the treatment of adult patients with pretreated, metastatic colorectal cancer (CRC). Dr Raghav is a professor in the Department of Gastrointestinal Medical Oncology in the Division of Cancer Medicine, associate vice president of the Department of Ambulatory Medical Operations, and executive medical director of the Department of Ambulatory Treatment Centers at The University of Texas MD Anderson Cancer Center in Houston.In our exclusive interview, Dr Raghav discussed the mechanism of action of fruquintinib, key efficacy data from the phase 3 FRESCO (NCT02314819) and FRESCO-2 (NCT04322539) trials, the treatment settings where this agent is most frequently administered, and adverse effects to be aware of. He also noted how the role of fruquintinib in earlier lines of therapy has yet to be defined due to a lack of optimal predictive biomarkers. Dr Raghav concluded by emphasizing the importance of clinical trials for improving outcomes for patient with CRC.

S14 Ep 24S14 Ep24: FDA Approval Insights: Maintenance Lurbinectedin Plus Atezolizumab for ES-SCLC: With Anne Chiang, MD, PhD; and Stephen Liu, MD
In today’s episode, we had the pleasure of speaking with Anne Chiang, MD, PhD, and Stephen Liu, MD, about the FDA approval of lurbinectedin (Zepzelca) plus atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as maintenance treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after frontline induction therapy with atezolizumab or atezolizumab and hyaluronidase, carboplatin, and etoposide. Chiang is an associate professor of medicine in the Section of Medical Oncology and the associate cancer center director of Clinical Initiatives at the Yale School of Medicine in New Haven, Connecticut. Dr Liu is an associate professor of medicine at Georgetown University, as well as the director of Thoracic Oncology and head of Developmental Therapeutics at the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC. In our exclusive interview, Drs Chiang and Liu discussed the significance of this approval, key efficacy and safety data from the pivotal phase 3 IMforte trial (NCT05091567), and how the addition of this regimen in the ES-SCLC treatment paradigm may affect clinical practice.

S14 Ep 23S14 Ep23: Early Biomarker Testing Optimizes Tepotinib Use in NSCLC With MET Exon 14 Skipping Mutations: With Stephen Liu, MD
In today’s episode, we had the pleasure of speaking with Stephen Liu, MD, about the use of tepotinib (Tepmetko) in patients with metastatic non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations. Dr Liu is an associate professor of medicine at Georgetown University, as well as the director of Thoracic Oncology and head of Developmental Therapeutics at the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC.In our exclusive interview, Dr Liu discussed key efficacy and safety findings from the phase 2 VISION trial (NCT02864992) that led to the FDA approval of tepotinib for this indication; the comparable response rates seen between tissue and liquid biopsy results, as well as across NSCLC treatment lines; and the importance of early biomarker testing, including RNA sequencing, to identify actionable mutations and optimize treatment.

S14 Ep 22S14 Ep22: Expanding JAK Inhibitor Use Offers Increased Treatment Options for Cytopenic Myelofibrosis: With Andrew Kuykendall, MD
In today’s episode, we had the pleasure of speaking with Andrew Kuykendall, MD, who gave an overview of the myelofibrosis treatment paradigm. Dr Kuykendall is an assistant member in the Department of Malignant Hematology at Moffitt Cancer Center in Tampa, Florida. In our exclusive interview, Dr Kuykendall discussed the prevalence of patients with myelofibrosis who have mutations in JAK2, CALR, or MPL; the crucial roles of the JAK1, JAK2, and IRAK1 pathways in disease progression; the importance of considering JAK inhibition in eligible patients; and the challenges associated with managing cytopenic myelofibrosis.

S14 Ep 21S14 Ep21: Early CAR T-Cell Therapy Data Highlight Therapeutic Potential and Emerging Challenges in GI Cancers: With Kohei Shitara, MD
In our exclusive interview, Dr Shitara discussed preliminary efficacy data with CAR T-cell therapy in gastrointestinal cancers; highlighted challenges related to durability of response, patient selection, and manufacturing logistics with these therapies; and outlined ongoing biomarker analyses exploring tumor microenvironment factors influencing resistance.

S14 Ep 20S14 Ep20: The Evolving Role of Noncovalent BTK Inhibition Informs CLL Treatment Selection: With Asad Dean, MD
In today’s episode, we had the pleasure of speaking with Asad Dean, MD, about treatment selection for patients with chronic lymphocytic leukemia (CLL) in the second-line setting. Dr Dean is a physician at the Texas Oncology-Fort Worth Cancer Center. In our exclusive interview, Dr Dean discussed the roles of covalent BTK inhibitors and BCL-2 inhibitors in the management of CLL. He highlighted the importance of molecular profiling for treatment rechallenge decisions and the potential for resistance mutations in this disease. He also noted the role of pirtobrutinib (Jaypirca) in overcoming treatment resistance, along with clinical signs indicating that patients may need a therapy change. Dr Dean also mentioned the high response rates seen with CAR T-cell therapy in patients with CLL and explained the possibility for combination regimens in CLL. Additionally, he expressed optimism about BTK degraders and bispecific antibodies.

S14 Ep 19S14 Ep19: Zidesamtinib Is Associated With CNS Activity and Low Rates of Neurologic AEs in Pretreated ROS1+ NSCLC: With Alexander Drilon, MD
In today’s episode, we had the pleasure of speaking with Alexander Drilon, MD, about the phase 1/2 ARROS-1 trial (NCT05118789) investigating zidesamtinib (NVL-520) in TKI-pretreated patients with advanced ROS1-positive non–small cell lung cancer (NSCLC). Dr Drilon is chief of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center in New York, New York.In our exclusive interview, Dr Drilon discussed the efficacy data and implications of the ARROS-1 trial, highlighted the unique mechanism of action of zidesamtinib, noted the high central nervous system (CNS) response rates and favorable safety profile associated with the agent, and emphasized the potential for zidesamtinib to become a standard first-line therapy in the NSCLC treatment paradigm, especially for patients with prior TKI resistance or CNS disease.

S14 Ep 18S14 Ep18: Patient Characteristics and Disease Factors Guide the Use of Dostarlimab in Recurrent Endometrial Cancer: With Dana M. Chase, MD
In our exclusive interview, Dr Chase discussed the management of recurrent endometrial cancer, emphasizing the importance of biomarker profiles and previous therapies. For first recurrences, she explained that carboplatin and paclitaxel with pembrolizumab (Keytruda) or dostarlimab-gxly (Jemperli) is recommended for patients with mismatch repair–deficient (dMMR) disease, whereas those with MMR-proficient (pMMR) disease may benefit from carboplatin, paclitaxel, and pembrolizumab (Keytruda) or lenvatinib (Lenvima). She also highlighted findings from the phase 3 RUBY trial (NCT03981796) that supported the FDA approval of dostarlimab, showing significant improvements in progression-free and overall survival in both dMMR and pMMR patients. Chase also noted the rising incidence of endometrial cancer, its deadly nature, and the importance of clinical trials for advancing treatment options.

S14 Ep 17S14 Ep17: Expert Guidance on Frequently Asked Questions Regarding the Use of ADCs in TNBC
In this podcast, experts Aditya Bardia, MD, MPH, FASCO, Erika P. Hamilton, MD, and Virginia Kaklamani, MD, DSc, discuss frequently asked questions regarding the use of antibody-drug conjugates (ADCs) in triple-negative breast cancer (TNBC).

S14 Ep 16S14 Ep16: Establishing the Rationale for ADC and ICI Combinations in TNBC
In this podcast, experts Virginia Kaklamani, MD, DSc, and Tiffany A. Traina, MD, FASCO, discuss the rationale for and data to support combining TROP2-targeting antibody-drug conjugates (ADCs) with immune checkpoint inhibitors (ICIs) to treat triple-negative breast cancer (TNBC).

S14 Ep 15S14 Ep15: Cohort Analysis Shows Importance of Early-Onset CRC Awareness and Investigation: With Evelyn Y. Wong, MD
In today’s episode, we had the pleasure of speaking with Evelyn Y. Wong, MD, about the growing challenge of early-onset colorectal cancer (CRC) and the insights from a recent cohort analysis conducted in Singapore. Dr Wong is a consultant medical oncologist specializing in gastrointestinal cancers at the National Cancer Centre Singapore.In our exclusive interview, Wong discussed the rationale for investigating early-onset CRC, emphasizing the rising incidence worldwide and the need to better understand whether unique molecular or survival patterns distinguish these patients from those with late-onset disease. She reviewed data from approximately 2500 patients in a consented Singaporean cohort, highlighting that molecular characteristics were largely consistent across age groups, but survival outcomes appeared more favorable in younger patients, potentially due to their ability to tolerate more intensive therapies.Additionally, Wong underscored the importance of multicenter and international collaborations to strengthen these findings and advance prospective studies that can more precisely connect molecular features with environmental exposures and epidemiologic drivers. She also emphasized the role of increasing awareness among clinicians, researchers, pharmaceutical partners, and patient advocates to ensure that the unique needs of younger patients with CRC are addressed within the broader oncology community.

S14 Ep 14S14 Ep14: Expert Roundtable and Panel Discussions: Current and Future Landscape of TNBC
In this podcast, experts Aditya Bardia, MD, MPH, FASCO; Erika P. Hamilton, MD; and Tiffany A. Traina, MD, FASCO; discuss navigating between currently available therapies for patients with triple-negative breast cancer (TNBC). They also discuss the potential ramifications of ongoing clinical trials on future treatment paradigms.

S14 Ep 13S14 Ep13: Dissecting Clinical Trial and Real-World Data for ADCs in TNBC
In this podcast, experts Filipa Lynce, MD, and Rita Nanda, MD, discuss recent clinical trial and real-world data for antibody-drug conjugates (ADCs) used to treat triple-negative breast cancer (TNBC).

S14 Ep 12S14 Ep12: Evaluating the Latest Data and Ongoing Trials for Novel ADC Approaches in TNBC
In this podcast, experts Aditya Bardia, MD, MPH, FASCO; and Erika P. Hamilton, MD, discuss recent efficacy and safety data of TROP2-targeted antibody-drug conjugate (ADC) plus immune checkpoint inhibitor combinations for advanced triple-negative breast cancer (TNBC).

S14 Ep 11S14 Ep11: Breaking Down the Rationale for Targeting TROP2 in TNBC
In this podcast, experts Filipa Lynce, MD, and Rita Nanda, MD, discuss unmet needs in triple-negative breast cancer (TNBC) and the rationale for using TROP2-targeting antibody-drug conjugates (ADCs) in this disease.

S14 Ep 10S14 Ep10: Patient Characteristics and Care Team Collaboration Influence Treatment Decision-Making in CLL: With John N. Allan, MD; and Melissa Rubianes
In today’s episode, we had the pleasure of speaking with John N. Allan, MD, and Melissa Rubianes about factors that influence treatment decision-making in chronic lymphocytic leukemia (CLL). Allan is an associate professor of clinical medicine and a member of the lymphoma faculty in the Division of Hematology and Medical Oncology, as well as a member of the CLL Research Center at Weill Cornell Medicine in New York, New York. Rubianes is a hematology/oncology physician assistant (PA) at Weill Cornell. In our exclusive interview, Allan and Rubianes discussed best practices for oncologists and PAs when it comes to collaborating with each other to make treatment decisions for patients with CLL, disease factors and patient characteristics that affect their treatment sequencing decisions, ongoing studies and emerging therapies for CLL that they're excited to see, and more.

S14 Ep 9S14 Ep9: Tepotinib Efficacy and Safety Profiles Underscore the Importance of Biomarker-Directed Decision-Making in NSCLC: With Balazs Halmos, MD, MS
In today’s episode, we had the pleasure of speaking with Balazs Halmos, MD, MS, about the phase 2 VISION trial (NCT02864992) evaluating tepotinib (Tepmetko) in patients with MET exon 14 skipping mutation–positive non–small cell lung cancer (NSCLC). Dr Halmos is a professor in the Department of Oncology (Medical Oncology) and the Department of Medicine (Oncology and Hematology), director of Thoracic Oncology, and associate director of Clinical Science at Montefiore Einstein Comprehensive Cancer Center in Bronx, New York. In our exclusive interview, Halmos discussed the rationale and design of the VISION trial, the significance of MET exon 14 skipping mutations as a distinct oncogenic driver, and the clinical utility of tepotinib, which is a selective MET TKI. He reviewed the trial’s efficacy results, which demonstrated consistent response rates across lines of therapy and diagnostic methods, as well as tolerability findings that highlighted the importance of monitoring and managing MET-related adverse effects. Dr Halmos also reflected on subgroup analyses from the trial, noting the agent’s activity across treatment settings, particularly in older patients and those with central nervous system involvement. Additionally, Halmos underscored the critical role of comprehensive biomarker testing in NSCLC, highlighting how parallel tissue- and circulating tumor DNA–based testing can optimize timely identification of actionable alterations and ensure patients receive the most effective frontline therapy. He also discussed practical considerations for dose selection and modifications with tepotinib, offering insights into strategies for maximizing treatment benefit and maintaining patient quality of life.

S14 Ep 8S14 Ep8: Recent FDA Approvals and Ongoing Research Expand Treatment Options for Soft Tissue Sarcoma: With Samantha A. Armstrong, MD; and Karine Tawagi, MD
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 feature a conversation about soft tissue sarcoma management. Drs Armstrong and Tawagi discussed that soft tissue sarcomas represent a rare and heterogeneous group of malignancies that arise from mesenchymal cells rather than epithelial cells and encompass several distinct histologic subtypes. They explained that although uncommon, these sarcomas are frequently emphasized in board examinations, partly because their management has historically been stable, though recent FDA approvals and ongoing research have expanded therapeutic options.They noted that risk factors may include prior radiation exposure, environmental agents, and viral infections. Additionally, they shared that chronic lymphedema is associated with angiosarcoma, whereas rare hereditary syndromes may predispose individuals to specific sarcoma subtypes. Clinically, they explained that sarcomas may arise anywhere in the body, though many occur in the thigh, buttocks, or groin, typically presenting as painless, enlarging masses often mistaken for benign lesions. They emphasized that diagnosis requires core needle biopsy to preserve tissue architecture and that staging relies on MRI of the primary site and CT of the chest, given the strong predilection for pulmonary metastases. They also summarized the five subtypes of soft tissue sarcoma—synovial, clear cell, angiosarcoma, rhabdomyosarcoma, and epithelioid.They reported that the cornerstone of localized disease management is surgical resection, preferably limb-sparing when feasible, combined with radiation for larger or high-risk tumors. They also highlighted novel strategies like immunotherapy. For metastatic disease, they stated that surgical resection of pulmonary metastases can achieve durable remissions in select patients.

S14 Ep 7S14 Ep7: Clinical Trial and Real-World Data With NALIRIFOX Shape the Future of Pancreatic Cancer Care: With Tara E. Seery, MD; Paul E. Oberstein, MD; and Priyadarshini Pathak, MBBS
In today’s episode, we passed the mic to Tara E. Seery, MD, who moderated an OncLive Insights discussion on the future of the pancreatic cancer treatment paradigm. Rounding out the discussion with additional expert perspectives were Paul E. Oberstein, MD, and Priyadarshini Pathak, MBBS. Seery is a medical oncologist at the Hoag Family Cancer Institute in Newport Beach, California. Oberstein is an associate professor in the Department of Medicine at the New York University (NYU) Grossman School of Medicine; as well as the director of the Gastrointestinal Medical Oncology Program, the assistant director of the Pancreatic Cancer Center, and the service chief of the Gastrointestinal Medical Oncology Program at NYU Langone's Perlmutter Cancer Center. Pathak is an assistant in medicine at Massachusetts General Hospital and an instructor in medicine at Harvard Medical School in Boston. In this exclusive conversation, Drs Seery, Oberstein, and Pathak highlighted key data from the phase 3 NAPOLI 3 trial (NCT04083235) of NALIRIFOX (liposomal irinotecan, 5-fluorouracil [5-FU], leucovorin, and oxaliplatin) vs nab-paclitaxel (Abraxane) and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma; the toxicity profiles of NALIRIFOX and FOLFIRINOX (leucovorin, 5-FU, irinotecan, and oxaliplatin); real-world data with these regimens, and more.

S14 Ep 6S14 Ep6: Advances in ctDNA Testing Guide Clinical Decision-Making in GI Cancer Management: With Scott Kopetz, MD, PhD, FACP
In today’s episode, we spoke with Scott Kopetz, MD, PhD, FACP, about the use of circulating tumor DNA (ctDNA) in patients with colorectal cancer (CRC). Dr Kopetz is the deputy chair for Translational Research and a professor in the Department of Gastrointestinal (GI) Medical Oncology in the Division of Cancer Medicine, as well as the leader of the Department of Cancer Center Support Grant in the GI Program, the TRACTION medical director in the Division of Therapeutics Discovery, and the associate vice president for Translational Integration at The University of Texas MD Anderson Cancer Center in Houston, Texas.In our conversation, Dr Kopetz discussed the high positive predictive value of ctDNA assays, which indicate disease presence when positive. He emphasized clinical trials that have shown strong prognostic implications with this type of assay, as well as study findings that demonstrated that ctDNA results could reduce chemotherapy use without compromising efficacy. Additionally, he noted the potential significance of ongoing trials that are exploring the use of ctDNA to guide therapy. Overall, he explained that ctDNA testing is becoming a standard in clinical practice for colorectal cancer.

S14 Ep 5S14 Ep5: Safety and Quality-of-Life Considerations Shape ADT Use in Prostate Cancer: With Tanya B. Dorff, MD
In today’s episode, supported by Sumitomo, we spoke with Tanya B. Dorff, MD, about the use of androgen deprivation therapy (ADT) in patients with prostate cancer. Dr Dorff is section chief of the Genitourinary Disease Program, as well as a professor in the Department of Medical Oncology & Therapeutics Research at City of Hope in Duarte, California. In our conversation, Dr Dorff discussed the role of ADT in prostate cancer management, highlighting where this class of agents fits into National Comprehensive Cancer Network guidelines and how this class has evolved with the development of LHRH antagonists and agonists. She explained how the observational OPTYX study (NCT05467176), a registry of relugolix (Orgovyx) use, aims to address safety and efficacy in combination with androgen receptor pathway inhibitors in patients with advanced prostate cancer. She also noted how early data from OPTYX presented at the 2025 ASCO Annual Meeting showed relugolix's use in localized and metastatic settings. Dorff also talked through relugolix's safety profile, particularly regarding cardiovascular risk, as well as the quality-of-life effects associated with ADT. She also addressed strategies to mitigate financial toxicity, along with the potential for future ADT-sparing treatments.

S14 Ep 4S14 Ep4: FDA Approval Insights: Dordaviprone in H3K27M-Mutated Diffuse Midline Glioma: With Patrick Y. Wen, MD
In today’s episode, supported by Chimerix, we spoke with Patrick Y. Wen, MD, about the FDA approval of dordaviprone (Modeyso) for the treatment of adult and pediatric patients at least 1 year of age with H3K27M-mutated diffuse midline glioma who have progressive disease following prior therapy. Dr Wen is the director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute; as well as a professor of neurology at Harvard Medical School in Boston, Massachusetts.In our conversation, Dr Wen discussed the significance of this accelerated approval across patient age groups, key efficacy and safety data that supported this approval, and the importance of biomarker testing in patients with glioma. He also highlighted potential next steps for expanding the investigation of dordaviprone in patients with glioma and emphasized the ways that multidisciplinary collaboration can provide patients with personalized, optimized care.

S14 Ep 3S14 Ep3: FDA Approval Insights: Taletrectinib in ROS1+ Advanced/Metastatic NSCLC: With Joel Neal, MD, PhD; and Christian Rolfo, MD, PhD
In today’s episode, supported by Nuvation Bio, we spoke with Joel Neal, MD, PhD, and Christian Rolfo, MD, PhD, about the FDA approval of taletrectinib (Ibtrozi) for the treatment of patients with locally advanced or metastatic, ROS1-positive non–small cell lung cancer (NSCLC). Dr Neal is a professor of medicine in the Division of Oncology at the Stanford Cancer Institute at Stanford University in Palo Alto, California. Dr Rolfo is the director of the Division of Medical Oncology at The Ohio State University Comprehensive Cancer Center—James and a professor in the College of Medicine at The Ohio State University in Columbus.In our conversation, Drs Neal and Rolfo discussed the significance of this approval, key data from the pivotal phase 2 TRUST-I (NCT04395677) and TRUST-II (NCT04919811) trials, and taletrectinib's current role in the NSCLC treatment paradigm.

S14 Ep 2S14 Ep2: FDA Approval Insights: Zongertinib in HER2-Mutated NSCLC: With Ticiana Leal, MD, and Misako Nagasaka, MD, PhD
In today’s episode, supported by Boehringer Ingelheim, we spoke with Ticiana Leal, MD, and Misako Nagasaka, MD, PhD, about the FDA approval of zongertinib (Hernexeos) for previously treated patients with HER2 TKD–mutant advanced non–small cell lung cancer (NSCLC). Dr Leal is an associate professor and director of the Thoracic Medical Oncology Program in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia; as well as medical director of the Clinical Trials Office and leader of the Lung Cancer Disease Team at the Winship Cancer Institute of Emory University. Dr Nagasaka is an associate professor of medicine in the Division of Hematology and Oncology at the University of California, Irvine (UCI) School of Medicine; as well as a medical oncologist at UCI Health.In our conversation, Drs Leal and Nagasaka discussed the significance of this approval, key efficacy and safety findings from the pivotal phase 1 Beamion LUNG-1 trial (NCT04886804), and where zongertinib currently fits into the NSCLC treatment paradigm.

S14 Ep 1S14 Ep1: Obe-Cel Data Are Poised to Refine and Expand the ALL Treatment Paradigm: With Aaron Logan, MD, PhD; and Bijal Shah, MD, MS
In today’s episode, supported by Autolus, we spoke with Aaron Logan, MD, PhD, and Bijal Shah, MD, MS, about the evolving use of obecabtagene autoleucel (obe-cel; Aucatzyl) in the relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) treatment paradigm. Dr Logan is an associate professor of clinical medicine in the Division of Hematology/Oncology at the University of California, San Francisco (UCSF) School of Medicine, as well as a member of the UCSF Helen Diller Family Comprehensive Cancer Center. Dr Shah is an associate member in the Department of Malignant Hematology at Moffitt Cancer Center in Tampa, Florida. In our conversation, Drs Logan and Shah discussed where obe-cel currently fits into the B-ALL treatment paradigm, how the use of this agent might expand going forward, and what the future looks like for the broader CAR T-cell therapy development field in ALL.

S13 Ep 50S13 Ep50: SUPRAME Trial Propels the Development of TCR-Based Therapy in Cutaneous Melanoma: With Jason Luke, MD
In today’s episode, supported by Immatics, we spoke with Jason Luke, MD, about the development of the PRAME-directed T-cell receptor (TCR) T-cell therapy IMA203 in the ongoing phase 3 SUPRAME trial (NCT06743126) in patients with previously treated, unresectable or metastatic cutaneous melanoma.In our conversation, Dr Luke discussed the rationale for evaluating IMA203 in patients with cutaneous melanoma, the mechanism of action of this novel drug, the design of this study, earlier data that support the continued investigation of this agent in this population, and what these findings may mean for the future of TCR therapy in melanoma.

S13 Ep 49S13 Ep49: Distinguishing Pathway to Precision for c-Met and MET Alterations in NSCLC
In this podcast, experts Erminia Massarelli, MD, PhD, MS; Jorge J. Nieva, MD; Sandip Patel, MD; and Ignacio I. Wistuba, MD, discuss new therapies for patients with c-Met–overexpressing non–small cell lung cancer.

S13 Ep 48S13 Ep48: Refining First-Line Immunotherapy Strategies in Hepatocellular Carcinoma: With Masatoshi Kudo, MD, PhD
In today’s episode, we spoke with Masatoshi Kudo, MD, about the evolving treatment landscape in hepatocellular carcinoma (HCC) and how recent comparative analyses are helping refine the use of first-line immunotherapy-based regimens. Dr Kudo is a professor and chairman in the Department of Gastroenterology and Hepatology at Kindai University Faculty of Medicine in Osaka, Japan.

S13 Ep 47S13 Ep47: Multidisciplinary Collaboration Gives Forward Momentum to HER2 IHC Testing in NSCLC: With Ronan J. Kelly, MD, MBA, FASCO; and Michelle Shiller, DO, AP/CP, MGP
In today’s episode, supported by Daiichi-Sankyo, we spoke with Ronan J. Kelly, MD, MBA, FASCO; and Michelle Shiller, DO, AP/CP, MGP, about HER2 immunohistochemistry (IHC) testing in non–small cell lung cancer (NSCLC). Kelly is director of the Charles A. Sammons Cancer Center and chief science officer at Baylor University Medical Center in Dallas, Texas; the W.W. Caruth Jr. Endowed Chair of Immunology at Baylor University Medical Center; chief of Oncology at Baylor Scott & White Health System; founder and medical director of the Texas Cancer Interception Institute; a clinical professor at the Texas A&M University College of Medicine; an adjunct associate professor of oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland; and a professor in the Clinical Sciences Division at the Translational Genomics Research Institute in Phoenix, Arizona. Shiller is a molecular genetic pathologist at Baylor University Medical Center. In our conversation, Drs Kelly and Shiller discussed the importance of performing IHC testing for HER2 in NSCLC, how IHC results may influence treatment decision-making beyond the scope of next-generation sequencing results, and recommendations for more efficient and collaborative IHC testing implementation in clinical practice.

S13 Ep 46S13 Ep46: FDA Approval Insights: Linvoseltamab in Relapsed/Refractory Multiple Myeloma: With Nisha Joseph, MD; and Hans Lee, MD
In today’s episode, we spoke with Nisha Joseph, MD, and Hans Lee, MD, about the FDA's accelerated approval of linvoseltamab-gcpt (Lynozyfic) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Joseph is an associate professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia. Lee is the director of Myeloma Research at the Sarah Cannon Research Institute in Nashville, Tennessee. In our conversation, Drs Lee and Joseph discussed the significance of this approval, key data from the pivotal phase 1/2 LINKER-MM1 trial (NCT03761108), and where linvoseltamab fits into the relapsed/refractory myeloma treatment paradigm alongside other approved agents.

S13 Ep 45S13 Ep45: Exploring NCCN Guideline Updates and Advancing Immunotherapy Strategies in Nasopharyngeal Carcinoma: With Neal S. Akhave, MD
In our conversation, Dr Akhave discussed the addition of toripalimab (Loqtorzi), a PD-1 inhibitor, to the NCCN Guidelines following its launch in the United States. Supported by data from the phase 3 JUPITER-02 trial (NCT03581786), toripalimab is now incorporated into frontline therapy for patients with recurrent metastatic or de novo metastatic Epstein–Barr virus (EBV)–positive NPC, in combination with gemcitabine and cisplatin. He explained how this regimen has produced substantial improvements in progression-free survival (PFS), nearly tripling median PFS compared with chemotherapy alone, while maintaining a manageable safety profile.

S13 Ep 44S13 Ep44: Frank’s Path to Advancing Hematology Through Innovation and Discovery: With Girindra Raval, MD; and David A. Frank, MD, PhD, FACP
In this episode, Raval welcomed David A. Frank, MD, PhD, FACP, who is director of the Division of Hematology and a professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine. He also serves as director of the Winship Innovation Initiative and as an advisor to the Morningside Center for Innovative and Affordable Medicine within the Woodruff Health Sciences Center.

S13 Ep 43S13 Ep43: Real-World Perspectives on mCRC and GI Neuroendocrine Neoplasms; With Rocío García-Carbonero, MD, PhD
In our conversation, Dr García-Carbonero discussed a subgroup analysis from the phase 3 FRESCO-2 trial (NCT04322539), which evaluated fruquintinib (Fruzaqla) in previously treated metastatic CRC (mCRC). She reviewed efficacy outcomes by metastatic site, including liver-only, lung-only, bone, and peritoneal disease. Fruquintinib demonstrated improvements in overall survival and progression-free survival across all subgroups, underscoring its feasibility in later-line settings for patients with mCRC. She also addressed prognostic differences between metastatic sites, noting that all patient groups derived benefit from treatment. Dr García-Carbonero also shared findings from PROMETCO, the first international, prospective, real-world study in mCRC, which is examining real-world outcomes for this patient population.

S13 Ep 42S13 Ep42: Endometrial (Uterine) Cancer 2025 UPDATE
In this episode, OncLive On Air® partnered with Two Onc Docs, Tawagi and Armstrong reviewed key principles in the diagnosis and management of uterine and endometrial cancers, incorporating updates in surgical approaches, adjuvant therapy selection, molecular testing, and the management of rare uterine sarcomas. The discussion outlined the epidemiology, risk factors, clinical presentation, diagnostic evaluation, staging, histologic classification, and treatment algorithms relevant to board preparation and clinical practice.

S13 Ep 41S13 Ep41: The European Approval of Mirdametinib Expands the Treatment Paradigm for NF1-Associated Plexiform Neurofibromas: With Ignacio Blanco, MD, PhD
In our exclusive interview, Dr Blanco discussed the significance of this regulatory milestone for a population that has historically lacked effective medical options. He reviewed the pivotal phase 2b ReNeu clinial trial (NCT03962543)that supported this decision, which enrolled both adult and pediatric patients with nonresectable PNs and evaluated clinical and radiologic response rates. Dr Blanco detailed the study’s findings, including overall response rates of 41% and 52% in the adult and pediatric populations, respectively; meaningful reductions in tumor volume; improvements in patient-reported pain and quality of life; and the favorable safety profile characterized primarily by dermatologic and gastrointestinal adverse effects.

S13 Ep 40S13 Ep40: The Role of Combination Checkpoint Blockade Is Evolving in MSI-H mCRC: With Elena Élez, MD, PhD
In our exclusive interview, Dr Élez discussed recent data comparing nivolumab (Opdivo) monotherapy with nivolumab plus ipilimumab (Yervoy) across multiple lines of therapy in patients with MSI-H mCRC. She detailed efficacy and quality‑of‑life outcomes, noting that the combination appeared to offer enhanced clinical benefit without a negative effect on tolerability. Dr Élez also highlighted the importance of tailoring immunotherapy strategies based on patient characteristics and treatment goals and reflected on the nuances of sequencing single‑agent vs combination checkpoint blockade.

S13 Ep 39S13 Ep39: Efficacy of Immune Checkpoint Inhibition in Oncology May Translate to Neurologic Disorders: With Shailee S. Shah, MD
In today’s OncClub episode, we had the pleasure of speaking with Shailee S. Shah, MD, about a retrospective study she and colleagues conducted to understand the effect of immune checkpoint inhibitors on patients with cancer and pre-existing neurologic autoimmune diseases, including multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome, and Parkinson's disease. Dr Shah is a clinical assistant professor of neurology (MS/neuroimmunology) at the Northwestern University Feinberg School of Medicine in Chicago, Illinois. In our exclusive interview, Dr Shah discussed the design of this study, key findings, and how these results emphasize the need for multidisciplinary care and risk stratification for more effective and comprehensive patient care. Check out the full OncClub subseries to see additional findings and insights from this research!

S13 Ep 38S13 Ep38: Guideline Updates and Trial Data Solidify the Role of HER2/MET IHC Testing in NSCLC: With Martin F. Dietrich, MD, PhD
In today’s episode, we had the pleasure of speaking with Martin F. Dietrich, MD, PhD, about updates and best practices for HER2 and MET immunohistochemistry (IHC) testing for patients with non–small cell lung cancer (NSCLC). Dr Dietrich is a medical oncologist at Cancer Care Centers of Brevard in Rockledge, Florida; as well as an assistant professor of internal medicine at the University of Central Florida in Orlando. In our exclusive interview, Dr Dietrich discussed the rationale for testing for these mutations in patients with NSCLC, standard practices for implementing these tests in the clinic, and when testing may be appropriate at disease progression.

S13 Ep 37S13 Ep37: Retrospective Data Highlight Improved Efficacy With Maintenance Therapy vs Treatment Breaks in mCRC: With Connie Lai, MD
In today’s episode, we had the pleasure of speaking with Connie Lai, MD, a medical oncology resident at Queen Elizabeth Hospital in Hong Kong, about a retrospective, dual-center study examining post-induction treatment strategies in metastatic colorectal cancer (mCRC).

S13 Ep 36S13 Ep36: CRISPR-Edited CISH Knockout TIL Therapy Paves Novel Treatment Paths in CRC: With Branden Moriarity, PhD; and Beau Webber, PhD
In today’s OncClub episode, we had the pleasure of speaking with Branden Moriarity, PhD; and Beau Webber, PhD, about a study evaluating neoantigen-reactive CISH knockout tumor-infiltrating lymphocyte (TIL) therapy in patients with metastatic gastrointestinal cancers. Dr Moriarity is an associate professor in the Division of Pediatric Hematology/Oncology, co-director of the Center for Genome Engineering and the Genome Engineering Shared Resource (GESR), and a member of the Center for Genome Engineering at the University of Minnesota in Minneapolis, where he is also a faculty member in the Department of Pediatrics; the Microbiology, Immunology and Cancer Biology (MICaB) PhD Graduate Program; the PhD Program in Molecular, Cellular, Developmental Biology and Genetics; the Cellular and Molecular Biology (CMB) Graduate Program, and the Masters Program in Stem Cell Biology. He is also a member of the Stem Cell Institute at the Masonic Cancer Center. Dr Webber is an associate professor in the Division of Pediatric Hematology/Oncology, co-director of the GESR, and a member of the Stem Cell Institute at the University of Minnesota Medical School, where he is also a faculty member in the Department of Pediatrics, the Molecular Pharmacology & Therapeutics Graduate Program, and the Masters Program in Stem Cell Biology. He is also a member of the Masonic Cancer Center. In our exclusive interview, Drs Moriarity and Webber discussed how targeting the CISH gene using CRISPR enhances T-cell function, key safety and efficacy findings from this study in 12 patients, and future research efforts that may focus on reducing manufacturing time and cost, as well as enhancing T-cell resilience. Check out the full OncClub subseries to see additional findings and insights from this research!

S13 Ep 35S13 Ep35: Telisotuzumab Vedotin Represents a New Treatment Development for c-Met–Overexpressing NSCLC: With Joshua K. Sabari, MD
In today’s episode, we spoke with Joshua K. Sabari, MD, about the use of telisotuzumab vedotin-tllv (Emrelis) in patients with c-MET–overexpressing, nonsquamous, EGFR wild-type advanced non–small cell lung cancer (NSCLC). Dr Sabari is an assistant professor in the Department of Medicine at the New York University Grossman School of Medicine; as well as the director of High Reliability Organization Initiatives at the Perlmutter Cancer Center in New York. In our exclusive interview, Dr Sabari highlighted key data from the phase 2 LUMINOSITY study (NCT03539536) investigating telisotuzumab vedotin in this patient population, the significance of targeting c-Met overexpression, and how findings from the ongoing phase 2 TeliMET NSCLC-04 trial (NCT06568939) of telisotuzumab vedotin in patients with c-Met–overexpressing, locally advanced or metastatic nonsquamous NSCLC may further influence the NSCLC treatment paradigm.

S13 Ep 34S13 Ep34: Cortes’ Journey Helps Reshape Hematologic Cancer Care: With Girindra Raval, MD; and Jorge Cortes, MD
Cancer, Character, and Calling: The Oncologist's Journey, hosted by Girindra Raval, MD, is a podcast highlighting how top oncologists have navigated the field over the course of their careers, the passion that drove them to enter the oncology space, and the ongoing work that will continue to transform cancer care. Each episode, Raval will welcome a top oncologist to dive into their background, highlight their career achievements, discuss key issues still being addressed in their fields, and explore their interests outside of the clinic and lab. In this episode, Raval welcomed Jorge Cortes, MD, who is director of the Georgia Cancer Center and a professor in the Department of Medicine at Augusta University. Raval is an associate professor in the Department of Medicine: Hematology and Oncology at the Medical College of Georgia of Augusta University. In their conversation, Raval and Cortes dived into Cortes’ upbringing in Mexico, his family life, and his experience earning his medical degree from the Universidad Nacional Autonoma de Mexico in Mexico City. They also spoke about Cortes’ work during his 27-year tenure at The University of Texas MD Anderson Cancer Center in Houston, where he served as a professor of medicine, deputy department chair, chair of the acute myeloid leukemia and chronic myeloid leukemia sections, and deputy division chair, among other roles. Cortes detailed how that experience facilitated long-lasting collaborations and friendships. He then touched on his goals as director of the Georgia Cancer Center since taking over the role in 2019 and explained how it felt to leave MD Anderson after nearly 3 decades. Raval and Cortes also discussed how the hematologic oncology field has evolved during Cortes’ career and how he expects the management of these malignancies as ongoing research continues. Cortes also highlighted his goals as director of the Georgia Cancer Center.

S13 Ep 33S13 Ep33: Isatuximab-Based Triplet Delivered via On-Body System Shows Promise in RRMM: With Xavier Leleu, MD, PhD; and Beth Faiman, PhD, MSN, APN-BC
In our exclusive interview, Drs Leleu and Faiman discussed the unique methods and design of IRAKLIA, key efficacy and safety findings from this trial, and the benefits of using on-body delivery systems to deliver effective therapies to patients in more convenient and patient-centered ways.

S13 Ep 32S13 Ep32: European Approval of Zanidatamab Expands Treatment Options for HER2+ Biliary Tract Cancer: With Arndt Vogel, MD
In today’s episode, we had the opportunity to speak with Arndt Vogel, MD, about the European Commission’s (EC's) July 2025 marketing authorization of zanidatamab-hrii (Ziihera) for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic HER2-positive biliary tract cancer. Dr Vogel is a faculty member at the University of Toronto Institute of Medical Science, a scientist at the Toronto General Hospital Research Institute, and a medical oncologist at the UHN–Princess Margaret Cancer Centre in Canada. In our exclusive interview, Dr Vogel highlighted the clinical importance of this decision, emphasizing that it represents a significant advancement for a molecularly defined subgroup of patients with limited treatment options and historically poor outcomes. He explained that biliary tract cancers, including cholangiocarcinoma, are associated with high recurrence rates and poor survival, even in patients who undergo curative-intent surgery. For patients in the advanced setting, second-line chemotherapy offers modest clinical benefit, with objective response rates of approximately 6%, a median progression-free survival of approximately 3 months, and a median overall survival of approximately 12 months. Vogel discussed the data supporting the EC’s approval, which was based on findings from the phase 2b HERIZON-BTC-01 trial (NCT04466891)—the largest study conducted to date evaluating HER2-directed therapy in this patient population. In the trial, at a median follow-up of 21.9 months, patients with centrally confirmed HER2-positive tumors (n = 80) who received zanidatamab achieved a confirmed objective response rate (cORR) of 41.3% (95% CI, 30.4-52.8). The median duration of response was 14.9 months (95% CI, 7.4-not reached), and the median overall survival reached 15.5 months (95% CI, 10.4-18.5).

S13 Ep 31S13 Ep31: IHC Testing Leads to Early Detection of TP53-Mutant AML and MDS: With Jonathan M. Gerber, MD; and Shyam A. Patel, MD, PhD
In today’s episode, we had the pleasure of speaking with Jonathan M. Gerber, MD; and Shyam A. Patel, MD, PhD, about a study they conducted investigating the use of immunohistochemistry (IHC) as a biomarker for early TP53 mutation identification in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Dr Gerber is a member of the faculty in the Department of Medicine at New York University (NYU) Grossman School of Medicine; as well as the chief clinical officer of the NYU Perlmutter Cancer Center. Dr Patel is an associate professor at the University of Massachusetts Chan Medical School; as well as a hematologist and oncologist at the UMass Memorial Medical Center in Worcester. In our exclusive interview, Drs Gerber and Patel discussed the evaluation of p53 IHC as a surrogate biomarker for TP53-mutant MDS and AML. They shared how the presence of TP53 mutations in these diseases significantly worsens prognosis, necessitating urgent treatment. They also highlighted how IHC results are available within 48 to 72 hours. Gerber and Patel explained this study's design and patient population, as well as how IHC's inverse correlation with overall survival highlights its potential as an early biomarker, though it has lower sensitivity for certain mutations.

S13 Ep 30S13 Ep30: Biopsy-Guided Approach Enables Surgery Omission After pCR in HER2+ and Triple-Negative Breast Cancer: With Henry M. Kuerer, MD, PhD, FACS, CMQ
In today’s episode, we had the opportunity to speak with Henry M. Kuerer, MD, PhD, FACS, CMQ, about the potential to safely omit surgery in a subset of patients with early-stage HER2-positive or triple-negative breast cancer who achieve a pathologic complete response (pCR) following neoadjuvant systemic therapy. Dr Kuerer is a professor of breast surgical oncology at The University of Texas MD Anderson Cancer Center in Houston, Texas.In our conversation, Dr Kuerer reviewed the rationale behind a prospective phase 2 clinical trial (NCT02945579) testing image-guided vacuum-assisted core biopsy to identify patients with no residual disease after neoadjuvant therapy. He outlined the strict technical and eligibility criteria that enabled accurate detection of pCR—including tumors downsizing to less than 2 cm and biopsy of at least 12 cores from the tumor bed—and discussed why this biopsy-based approach may be more reliable than standard surgery in detecting residual disease. He also highlighted the broader clinical implications of the findings, noting that patients with biopsy-confirmed pCR may proceed directly to radiotherapy and avoid breast surgery altogether.

S13 Ep 29S13 Ep29: FDA Approval Insights: Oncomine DX Express Test Companion Diagnostic for Sunvozertinib in Non–Small Cell Lung Cancer: With Apar Kishor Ganti, MD; and Allison Cushman-Vokoun, MD, PhD, FCAP
In today’s episode, supported by Thermo Fisher Scientific, we had the pleasure of speaking with Apar Kishor Ganti, MD; and Allison Cushman-Vokoun, MD, PhD, FCAP, about the FDA approval of the Oncomine DX Express Test for use as a companion diagnostic for sunvozertinib (Zegfrovy) in EGFR exon 20 insertion mutation–positive non–small cell lung cancer and for use in tumor profiling. Dr Ganti is a professor in the University of Nebraska Medical Center (UNMC) Division of Oncology & Hematology, the Dr. and Mrs. D. Leon UMNC Research Fund Chair in Internal Medicine, and the associate director for Clinical Research at the Fred & Pamela Buffett Cancer Center in Omaha. Dr Cushman is the Henry F. Krous Professor of Pathology, a professor in the UNMC Department of Pathology, Microbiology and Immunology, director of the Division of Diagnostic Molecular Pathology and Human Genetics, medical director of the Molecular Diagnostics and Personalized Medicine Laboratory at Nebraska Medicine, director of the Molecular Genetic Pathology Fellowship Program, and associate director of the UMNC MD-PhD Scholars Program. In our exclusive interview, Drs Ganti and Cushman discussed the significance of the launch of the Oncomine DX Express Test, the benefits and limitations of rapid next-generation sequencing, and features that set Oncomine DX apart from other available tests.

S13 Ep 28S13 Ep28: Toripalimab Plus De-Intensified Chemo Represents the Potential Future of Nasopharyngeal Cancer Management: With Justine Bruce, MD
In today’s episode, supported by Coherus BioSciences, we had the pleasure of speaking with Justine Bruce, MD, about the ongoing evolution of nasopharyngeal carcinoma management. Dr Bruce is a faculty member in the Division of Hematology, Medical Oncology and Palliative Care within the Department of Medicine at the University of Wisconsin, as well as the director of the VA Medical Oncology Clinical Research Program and chair of the Protocol Review and Monitoring Committee at the University of Wisconsin Carbone Cancer Center in Madison.In our exclusive interview, Dr Bruce discussed evolving treatment strategies for nasopharyngeal cancer, emphasizing the shift from chemoradiation followed by adjuvant chemotherapy to induction chemotherapy with gemcitabine and cisplatin. She also noted how toripalimab-tpzi (Loqtorzi) combined with gemcitabine and cisplatin showed improved overall survival (OS) in the first-line setting in the phase 3 JUPITER-02 trial (NCT03581786). Bruce also expressed her preference for OS as the gold standard for determining the efficacy of nasopharyngeal cancer treatments and noted the need for more US-based trials to reflect the local patient population.

S13 Ep 26S13 Ep26: ASCO 2025 Plenary — MATTERHORN
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 bring a discussion of key data from the phase 3 MATTERHORN trial (NCT04592913), which were presented at the 2025 ASCO Annual Meeting. MATTERHORN was a randomized, double-blind, multinational study evaluating the addition of durvalumab (Imfinzi) to FLOT (5-fluorouracil, leucovorin, oxaliplatin, and docetaxel) in patients with previously untreated, resectable gastric or gastroesophageal junction adenocarcinoma. In the MATTERHORN trial, 948 patients were randomly assigned 1:1 to receive either durvalumab or placebo in combination with perioperative FLOT, followed by 10 cycles of durvalumab or placebo as adjuvant therapy. The primary end point was event-free survival (EFS); secondary end points included overall survival (OS) and pathological complete response (pCR). The trial met its primary end point. Durvalumab plus FLOT (n = 474) significantly improved EFS vs placebo plus FLOT (n = 474; HR, 0.71; 95% CI, 0.58-0.86; P < .001), representing a 29% reduction in risk of progression, recurrence, or death. The interim OS analysis showed a nonsignificant trend favoring durvalumab (HR, 0.78; 95% CI, 0.62-0.97; P = .025). The pCR rate was 19% (95% CI, 15.75%-23.04%) with durvalumab vs 7.2% (95% CI, 5.02%-9.88%) with placebo. Toxicity profiles were comparable between the 2 groups, though immune-related adverse effects were more frequent with durvalumab. Importantly, the addition of durvalumab did not delay surgery or initiation of adjuvant therapy. Although the MATTERHORN regimen is not yet FDA approved or included in the National Comprehensive Cancer Network guidelines, this trial demonstrates a promising EFS benefit and potential practice-changing implications, pending mature OS data and further molecular subgroup analyses, according to Armstrong and Tawagi.

S13 Ep 25S13 Ep25: FDA Approval Insights: Darolutamide for Metastatic Castration-Sensitive Prostate Cancer: With Alicia Morgans, MD, MPH; and Neal Shore, MD, FACS
In today’s episode, supported by Bayer, we had the pleasure of speaking with Alicia Morgans, MD, MPH, and Neal Shore, MD, FACS, about the FDA approval of darolutamide (Nubeqa) plus androgen deprivation therapy for patients with metastatic castration-sensitive prostate cancer (mCSPC). Morgans is the medical director of the survivorship program at Dana-Farber Cancer Institute; as well as an associate professor of medicine at Harvard Medical School, both in Boston, Massachusetts. Shore is the medical director of the Carolina Urologic Research Center.In our exclusive interview, Drs Morgans and Shore discussed the significance of this approval; key efficacy, safety, and quality of life data from the pivotal phase 3 ARANOTE trial (NCT04736199); and how this regulatory decision both opens doors for the treatment of more patients and raises questions about the optimal role of darolutamide in the management of mCSPC.