S12 Ep19: FDA Approval Insights: T-DXd in HER2-Low/-Ultralow Metastatic Breast Cancer: With Aditya Bardia, MD, MPH, FASCO

Dr Tap discusses the significance of the FDA approval of vimseltinib for symptomatic TGCT, in which surgical resection may worsen functional limitation or cause severe morbidity. He also discussed key efficacy and safety data from the pivotal phase 3 MOTION trial and the increasingly important role that multidisciplinary collaboration will play as this targeted therapy is further integrated into clinical practice. 

This featured podcast brings together 2 experts to discuss the care of patients with epithelioid sarcoma.

Dr Fakih discusses the significance of this approval, key findings from the pivotal CodeBreaK 300 trial (NCT05198934), and how this combination fits into the current KRAS G12C–mutated mCRC treatment paradigm.

In today’s episode, we had the pleasure of speaking with Aditya Bardia, MD, MPH, FASCO, about the FDA approval of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for the treatment of adult patients with unresectable or metastatic, hormone receptor–positive, HER2-low or -ultralow breast cancer, as determined by an FDA-approved test, that has progressed on at least 1 endocrine therapy in the metastatic setting. Dr Bardia serves as a professor in the Department of Medicine in the Division of Hematology/Oncology and is the director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center. In our exclusive interview, Dr Bardia discussed the significance of this approval, findings from the pivotal DESTINY-Breast06 trial (NCT04494425), and what this new indication for T-DXd means for the future of HER2 testing in breast cancer.

In this episode of Oncology Unplugged, a podcast series from OncLive and MedNews Week, podcast host Chandler Park, MD, a medical oncologist at Norton Cancer Institute in Louisville, Kentucky, was joined by Petros Grivas, MD, PhD; and Ruben Raychaudhuri, MD, to talk about a pilot trial investigating neoadjuvant accelerated methotrexate, vinblastine,doxorubicin, and cisplatin (aMVAC) plus pembrolizumab (Keytruda) in patients with non-urothelial muscle-invasive bladder cancer, findings from which were presented at the 2025 Genitourinary Cancers Symposium. Dr Grivas is clinical director of the Genitourinary Cancers Program and a professor in the Clinical Research Division at Fred Hutchinson Cancer Center, as well as a professor in the Division of Hematology and Oncology at the University of Washington School of Medicine in Seattle. Dr Raychaudhuri is an assistant professor in the Clinical Research Division at Fred Hutchinson Cancer Center, as well as an assistant professor in the Division of Hematology and Oncology at the University of Washington School of Medicine. In their exclusive conversation, Drs Park, Grivas, and Raychaudhuri discussed key efficacy and safety findings from this study; the need for conducting dedicated research in bladder cancer patient populations with variant histologies; and the potential of biomarkers, such as HER2 expression, to improve the bladder cancer treatment paradigm in the future.

In today’s episode, we had the pleasure of speaking with Rachna Shroff, MD, MS, FASCO, about the phase 3 SWOG S1815 trial (NCT03768414) evaluating the addition of nab-paclitaxel (Abraxane) to gemcitabine and cisplatin in patients with newly diagnosed, advanced biliary tract cancer. Dr Shroff of the interim clinical affairs director, the associate director of Clinical Investigations, and co-lead of the Gastrointestinal Clinical Research Team, at The University of Arizona Cancer Center. She is also a professor in the Department of Medicine, chief of the Division of Hematology/Oncology, medical director for the Oncology Service Line, and associate dean for Clinical and Translational Research at The University of Arizona College of Medicine in Tucson. In our exclusive interview, Dr Shroff discussed the rationale for this research, key efficacy and safety data from the trial, and the potentially wide-reaching future implications of these findings.

Dr Moertel discussed the significance of this approval, key efficacy and safety data from the phase 2 ReNeu trial (NCT03962543), and considerations for integrating mirdametinib into clinical practice for patients with NF1-associated PN.

In today’s episode, supported by Genentech, we had the pleasure of speaking with Komal Jhaveri, MD, FACP, about the clinical use of inavolisib (Itovebi) for patients with hormone receptor (HR)–positive, PIK3CA-mutated, locally advanced or metastatic breast cancer. Dr Jhaveri is section head of the Endocrine Therapy Research Program, clinical director of the Early Drug Development Service, and the Patricia and James Cayne Chair for Junior Faculty at Memorial Sloan Kettering Cancer Center in New York, New York. In our exclusive interview, Dr Jhaveri discussed the importance of having a PI3K inhibitor available for the treatment of patients with HR-positive metastatic breast cancer, advice for managing inavolisib-related adverse effects, and best practices for early biomarker testing in patients with breast cancer.

In our exclusive interview, Dr Bardia discussed the significance of this approval, pivotal findings from the phase 3 TROPION-Breast01 trial (NCT05104866), the clinical relevance of being able to improve progression-free survival and quality of life with Dato-DXd compared with standard chemotherapy, and key considerations for sequencing antibody-drug conjugates.

In today’s episode, supported by Takeda, we had the pleasure of speaking with Mark B. Geyer, MD, and Elias Jabbour, MD, about updates in the management of Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL). Dr Geyer is the Adolescent and Young Adult Program leader and the Adult Lymphoblastic Leukemia Program leader in the Leukemia Service, as well as the chair of Quality Assessment in the Cellular Therapy Service at Memorial Sloan Kettering Cancer Center in New York, New York. Dr Jabbour is a professor in the Department of Leukemia in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston. In our exclusive interview, Drs Geyer and Jabbour discussed the use of ponatinib (Iclusig) in patients with Ph-positive ALL as evidenced by key findings from research such as the pivotal phase 3 PhALLCON trial (NCT03589326). They also highlighted the potential efficacy of this agent in combination with blinatumomab (Blincyto) and shared insights on how the safety profile of this agent affects its clinical use.