Expert Insights into the Efficacy and Safety of Brexucabtagene Autoleucel CART19 Cell Therapy in Adults with Advanced Acute Lymphoblastic Leukemia

Panelist introductions by Gregory Roloff, MD from the University of Chicago Comprehensive Cancer Center, Chicago, Illinois; Jae Park, MD, Memorial Sloan Kettering Cancer Center, New York, New York; and Bijal Shah, MD, from the Moffitt Cancer Center, Tampa, Florida.

Faculty review the objectives of the 2023 ASH Insights Program on the Efficacy and Safety of Brexucabtagene Autoleucel CART19 Cell Therapy in Adults with Advanced Acute Lymphoblastic Leukemia.

Drs. Roloff, Park, and Shah provide a brief overview of the current, CAR-T cell therapeutic landscape for relapsed or refractory acute lymphoblastic leukemia in adults with a particular focus on those who have completed two or more lines of prior therapy.

Dr. Bijal and colleagues discuss the objectives, clinical outcomes, and safety profile of the Phase 2 ZUMA 3 clinical trial, which evaluated treatment of adult patients with relapsed or refractory, B-precursor, acute lymphoblastic leukemia with the anti-CD-19/anti-CD20 bispecific CAR-T cell therapy, KTE-X19 (brexucabtagene autoleucel).

Panelists evaluate PFS, OS, and the prognostic significance of negative MRD.

Dr. Roloff and colleagues offer expert opinion on optimizing treatment sequences for patients with relapsed or refractory ALL who have received two or more prior lines of therapy and the disease and patient factors that inform their treatment plans.

Dr. Roloff and faculty assess outcomes from the retrospective, multicenter ROCCA analysis (Real-world Outcomes Collaborative of CAR-T in Adult ALL) and propose some social determinants of health SDoH variables that bear further investigation.

Dr. Park and co-panelists review the patient and disease characteristics, including patient age, high pre-apheresis disease burden, and bridging response to inotuzumab or blinatumomab among other variables that might best support consideration of post-CART19 maintenance therapy.

Dr. Shah and colleagues dissect the social determinants of health, including limited personal resources, frailty, distance to treatment facilities, therapeutic compliance, and other considerations that impact effective treatment sequencing for patients with relapsed or refractory ALL, including access to care and CAR-T cell availability.

Dr. Shah and faculty provide updates on emerging therapies, which exhibit promise for the treatment of relapsed or refractory acute lymphoblastic leukemia such as tisagenlecleucel and Obe-cel; obecabtagene autoleucel, preliminary outcomes of which were presented in the FELIX study at the 65th ASH Annual Meeting.