S11 Ep38: FDA Approval Insights: Obe-Cel in B-Cell Precursor ALL

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.

Sagar D. Sardesai, MBBS, discusses the phase 3 ELAINE-3 trial evaluating lasofoxifene plus abemaciclib in ESR1-mutant, ER+/HER2- metastatic breast cancer.

In today’s episode, we had the pleasure of speaking with Alex F. Herrera, MD, about key safety and efficacy findings from the phase 3 SWOG S1826 trial (NCT03907488) evaluating nivolumab (Opdivo) plus doxorubicin, vinblastine, and dacarbazine (N+AVD) vs brentuximab vedotin (BV) plus AVD (BV+AVD) in adolescent and adult patients with stage III or IV advanced-stage classic Hodgkin lymphoma. Herrera is chief of the Division of Lymphoma in the Department of Hematology & Hematopoietic Cell Transplantation, as well as the associate medical director of the Briskin Center for Clinical Research and an associate professor in the Division of Lymphoma in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope in Duarte, California. After 2.1 years of follow-up (range, 0-4.2), N+AVD prolonged median progression-free survival (PFS) and had a more tolerable safety profile compared with BV+AVD. The 2-year PFS rate with N+AVD was 92% (95% CI, 89%-94%) vs 83% (95% CI, 79%-86%) with BV+AVD (HR, 0.45; 95% CI, 0.30-0.65). Notably, the benefit with N+AVD was consistent across diverse patient subgroups enrolled in the study. In our exclusive interview, Dr Herrera expanded on the rationale for conducting SWOG S1826, detailed key data showing sustained benefit and safety with N+AVD, and explained how these results support the use of N+AVD as a strong candidate for primary treatment in adolescent and adult patients with stage III or IV Hodgkin lymphoma.

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 rejoined by Stephen Liu, MD, a thoracic oncologist and the Head of Developmental Therapeutics at Georgetown University’s Lombardi Comprehensive Cancer Center in Washington, DC.  Their conversation encompassed findings from the phase 3 MARIPOSA trial (NCT04487080) investigating amivantamab-vmjw (Rybrevant) plus lazertinib (lacluze) in patients with EGFR-mutated advanced non–small cell lung cancer (NSCLC); toxicities associated with amivantamab and lazertinib to be aware of; the potential future implications of findings from the phase 3 PALOMA-3 trial (NCT05388669) of lazertinib plus subcutaneous amivantamab in patients with EGFR-mutated advanced or metastatic NSCLC; and how all these agents may fit into the NSCLC treatment armamentarium going forward.

In today’s episode, supported by Daiichi Sankyo, we had the pleasure of speaking with Misako Nagasaka, MD, PhD, about the use of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in patients with non–small cell lung cancer (NSCLC). Dr Nagasaka is an associate professor in the Division of Hematology and Oncology and the Division of Medicine at the University of California Irvine School of Medicine.  In our exclusive interview, Dr Nagasaka discussed key findings from the phase 2 DESTINY-PanTumor02 (NCT04482309) and DESTINY-Lung01 (NCT03505710) trials that led to the FDA approval of T-DXd for patients with unresectable or metastatic HER2-positive solid tumors, including those with NSCLC; where next-generation sequencing fits into her clinical practice; and the current role of T-DXd in lung cancer management.

In today’s episode, we had the pleasure of speaking with Binod Dhakal, MD, and Muhamed Baljevic, MD, about updates regarding patient identification for optimal multiple myeloma treatment. Dr Dhakal is an associate professor of medicine in the Division of Hematology at the Medical College of Wisconsin in Milwaukee. Dr Baljevic is an associate professor of medicine in the Division of Hematology Oncology, director of Plasma Cell Disorders Research, director of the Vanderbilt Amyloidosis Multidisciplinary Program, co-chair of the Protocol Review and Monitoring System, and disease team lead for plasma cell dyscrasias and lymphomas at the Vanderbilt-Ingram Cancer Center, part of the Vanderbilt University Medical Center in Nashville, Tennessee.  In our exclusive interview, Drs Dhakal and Baljevic discussed first- and subsequent-line treatment options for patients with multiple myeloma, treatment options beyond CAR T-cell therapy for unfit patients, and ongoing research that may expand the myeloma treatment paradigm in the future.

In today’s episode, supported by Revolution Medicines, we had the pleasure of speaking with John Strickler, MD, about key considerations for pancreatic cancer management in honor of Pancreatic Cancer Awareness Month, which is observed every November. Dr Strickler is a professor of medicine in the Division of Medical Oncology, associate director of Clinical Research – GI Oncology, and co-leader for the Precision Cancer Medicine and Investigational Therapeutics Program at the Duke Cancer Institute in Durham, North Carolina.  In our exclusive interview, Dr Strickler discussed the challenges of targeting RAS alterations in pancreatic cancer, the importance of biomarker testing in this disease, and efforts to improve pancreatic cancer screening methodologies and rates.

In today’s episode, we had the pleasure of speaking with Paul J. Shaughnessy, MD, about the FDA approval of obecabtagene autoleucel (obe-cel; Aucatzyl) for patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Dr Shaughnessy is the medical director of the Adult Blood and Marrow Stem Cell Transplant Program at Methodist Hospital in San Antonio, Texas. On November 8, 2024, the FDA approved obe-cel for the treatment of adult patients with relapsed or refractory B-cell precursor ALL. This regulatory decision was supported by findings from the phase 1/2 FELIX trial (NCT04404660), in which 42% (95% CI, 29%-54%) of efficacy-evaluable patients with relapsed or refractory CD19-positive B-cell ALL who received the CAR T-cell product achieved a complete response (CR) within 3 months. The median duration of CR achieved within 3 months was 14.1 months (95% CI, 6.1-not reached). In our exclusive interview, Dr Shaughnessy discussed the significance of this approval, key efficacy and safety findings from the pivotal FELIX trial, and where obe-cel currently fits into the ALL treatment paradigm.

Drs Park and Liu explore advancements in the management of EGFR-mutated NSCLC, highlighting clinical trial updates shaping current treatment strategies.