S11 Ep49: FDA Approval Insights: Zenocutuzumab for NRG1+ Pancreatic Adenocarcinoma and NSCLC: With Alison Schram, MD

In today’s episode, supported by Merus, we had the pleasure of speaking with Alison Schram, MD, about the FDA approval of zenocutuzumab-zbco (Bizengri) for patients with previously treated advanced pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) harboring NRG1 gene fusions. Dr Schram is an assistant attending physician at Memorial Sloan Kettering Cancer Center in New York, New York.  On December 4, 2024, the FDA granted accelerated approval to zenocutuzumab for the treatment of adult patients with advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring an NRG1 gene fusion who have disease progression on or after prior systemic therapy; and adult patients with advanced, unresectable, or metastatic NSCLC harboring an NRG1 gene fusion who have disease progression on or after prior systemic therapy. This regulatory decision was based on findings from the phase 2 eNRGy trial (NCT02912949), in which patients with pancreatic adenocarcinoma (n = 30) achieved an overall response rate (ORR) of 40% (95% CI, 23%-59%), and a duration of response (DOR) that ranged from 3.7 months to 16.6 months. In the NSCLC cohort (n = 64), the (ORR) of 33% (95% CI, 22%-46%), and the median DOR was 7.4 months (95% CI, 4.0-16.6).  In our exclusive interview, Dr Schram discussed the significance of this approval, key efficacy data from the pancreatic cancer and NSCLC cohorts of eNRGy, and the importance of using RNA-based testing to identify patients with NRG1 fusions. 

In this episode of Oncology Unplugged, a podcast series from MedNews Week, host Chandler Park, MD, a medical oncologist at the Norton Cancer Institute in Louisville, Kentucky, was joined by Guiseppe Curigliano, MD, PhD, a full professor of medical oncology at the University of Milan, as well as the director of the Early Drug Development Division and co-chair for the Experimental Therapeutics Program at the European Institute of Oncology in Italy.  In this exclusive interview, Drs Park and Curigliano discussed the potential future role of artificial intelligence across oncology disciplines; how advances in precision medicine will help improve patient care; the significance of seeing early research with fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) evolve into the present era, where the agent is FDA approved for the treatment of patients with HER2-positive solid tumors. They also discussed their insights on data from the phase 3 DESTINY-Breast06 trial (NCT04494425) investigating T-DXd in patients with HER2-low or -ultralow, hormone receptor–positive, metastatic breast cancer. 

In today’s episode, supported by BeiGene, Alexey Danilov, MD, PhD, hosted a discussion with Susan M. O'Brien, MD, about key data updates with BTK inhibitors in patients with chronic lymphocytic leukemia (CLL) that were presented at the 2024 ASH Annual Meeting. Dr Danilov is the Marianne and Gerhard Pinkus Professor of Early Clinical Therapeutics, the medical director of the Early Phase Therapeutics Program for the Systems Clinical Trials Office, co-director of the Toni Stephenson Lymphoma Center, and a professor in the Division of Lymphoma at the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope in Duarte, California. Dr O'Brien is the associate director for Clinical Science at the Chao Family Comprehensive Cancer Center, the medical director of the Sue & Ralph Stern Center for Clinical Trials & Research, and a professor of medicine in the Division of Hematology/Oncology in the University of California Irvine School of Medicine. In our exclusive interview, Drs Danilov and O'Brien discussed potentially practice-changing data with acalabrutinib (Calquence)–based regimens from the phase 3 AMPLIFY trial (NCT03836261) in CLL, key updates with zanubrutinib (Brukinsa) as monotherapy and in combination with sonrotoclax (BGB-11417) in patients with this disease, and practice-confirming findings with pirtobrutinib (Jaypirca) from the phase 3 BRUIN CLL-321 trial (NCT04666038) in patients with previously treated CLL.

In today’s episode, supported by Jazz Pharmaceuticals, we had the pleasure of speaking with James J. Harding, MD, director of Early Drug Development at Memorial Sloan Kettering Cancer Center, about the FDA approval of zanidatamab-hrii (Ziihera) for patients with HER2-positive metastatic biliary tract cancer. In our exclusive interview, Dr Harding discussed the significance of this approval, marking the first HER2-targeted therapy specifically for biliary tract cancer. He highlighted findings from the pivotal HORIZON BTC-01 trial (NCT04466891), explored how zanidatamab fits into the treatment paradigm, and addressed the role of HER2 profiling in guiding patient selection. Dr Harding also detailed ongoing research into zanidatamab in earlier treatment settings and emphasized its potential to transform care for patients with this challenging disease.

In our exclusive interview, Dr Cohen provided insights into the evolving role of circulating tumor DNA (ctDNA) in clinical decision-making for patients with colorectal cancer (CRC), particularly through findings from the CIRCULATE-Japan GALAXY trial (UMIN000039205). She highlighted how ctDNA has emerged as a strong prognostic factor for recurrence risk in CRC and explored its potential to guide therapy escalation or de-escalation. She also discussed the heterogeneity in the patient population included in the CIRCULATE-Japan GALAXY study and how ctDNA negativity correlates with improved disease-free and overall survival. Additionally, Dr Cohen outlined what data are still needed to integrate ctDNA testing into routine clinical practice and how sustained vs transient ctDNA clearance may influence treatment and surveillance strategies moving forward.

In our exclusive interview, Drs Chan and Hunter discussed the integration of asciminib (Scemblix) as a first-line therapy for patients with CML, optimal treatment sequencing in CML management, and how findings from the phase 2 OPTIC trial (NCT02467270) have influenced ponatinib (Iclusig) dosing strategies in patients with chronic-phase disease. They also addressed the role of mutational testing in guiding treatment selection, strategies to mitigate adverse effects, and the evolving role of stem cell transplantation in the treatment paradigm.

In our exclusive interview, Dr Moreau discussed key findings from an analysis of minimal residual disease negativity dynamics from IMROZ and the potential future implications of these findings for patients with newly diagnosed multiple myeloma who receive treatment with Isa-VRd.

In today’s episode, supported by BeiGene, we had the pleasure of speaking with Mazyar Shadman, MD, MPH, about updates in zanubrutinib (Brukinsa)–focused research in chronic lymphocytic leukemia (CLL) that were presented at the 2024 ASH Annual Meeting. Dr Shadman is an associate professor in the Clinical Research Division and the medical director of Cellular Immunotherapy at the Fred Hutchinson Cancer Center in Seattle, Washington. In our exclusive interview, Dr Shadman discussed key findings and implications from several clinical trials investigating zanubrutinib as monotherapy and in combination with agents such as obinutuzumab (Gazyva), sonrotoclax (BGB-11417), and venetoclax (Venclexta) in patients with CLL and other B-cell malignancies.

In today’s episode, we had the pleasure of speaking with Andre Goy, MD, about key updates from the 2024 ASH Annual Meeting. Dr Goy is physician in chief of Hackensack Meridian Health Oncology Care Transformation Services, as well as the chairman, chief physician officer, and chief of the Lymphoma Division at the John Theurer Cancer Center at Hackensack University Medical Center in New Jersey. In our exclusive interview, Dr Goy discussed top hematologic oncology research conducted by his colleagues at the John Theurer Cancer Center and his predictions for the future of the field in 2025 and beyond.