Dr DeAngelo on the FDA Approval of Obe-Cel in R/R B-Cell Precursor ALL

"These were remarkable results. The durable remission for obe-cel in these [patients with] relapsed/refractory CD19-positive [B-cell precursor ALL] led to the FDA approval of this agent. Now we have 3 CAR T-cell therapies that are approved [in ALL], and this is a game changer for many of our patients."

Daniel DeAngelo, MD, PhD, professor, medicine, Harvard Medical School; chief, Division of Leukemia, institute physician, Dana-Farber Cancer Institute, discusses data supporting the FDA approval of obecabtagene autoleucel (obe-cel; Aucatzyl) for patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

On November 8, 2024, the FDA approved obe-cel for the treatment of adult patients with relapsed or refractory B-cell precursor ALL. This approval was based on findings from the phase 1/2 FELIX trial (NCT04404660), which enrolled patients aged at least 18 years with relapsed/refractory B-cell ALL and bone marrow blast levels of 5% or greater.

Findings, which were subsequently published in the New England Journal of Medicine, showed that patients with morphologic disease at baseline who were enrolled in the pivotal cohort 2A and received at least 1 infusion of obe-cel (n = 97) experienced an overall remission rate (ORR) of 77% (95% CI, 67%-85%), which consisted of a complete remission (CR) rate of 55% (95% CI, 45%-66%) and a CR with incomplete hematologic recovery (CRi) rate of 21% (95% CI, 14%-31%).

Regarding safety, cytokine release syndrome (CRS) occurred in 68.5% of patients who received at least 1 dose of the CAR T-cell therapy; the rate of with grade 3 or higher CRS was 2.4%. Immune effector cell–associated neurotoxicity syndrome (ICANS) occurred in 22.8% of patients at any grade and 7.1% of patients at grade 3 or higher.

The durable remission rates seen with obe-cel underscore its potential as a transformative option for patients with relapsed/refractory CD19-positive B-cell ALL, DeAngelo emphasizes. With its approval, obe-cel has become the third FDA-approved CAR T-cell therapy in B-cell precursor ALL, marking a significant development in the ALL treatment paradigm, he concludes.