Relapsed B-ALL
A post hoc analysis of the Phase 1b/2 FELIX trial shows that obecabtagene autoleucel (obe-cel; Aucatzyl) can provide long-term survival for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), regardless of the type of remission achieved.
Patients who reached complete remission (CR) or complete remission with incomplete blood count recovery (CRi) both showed lasting benefits. At 24 months, overall survival was about 55.5% for patients in CR at three months, while those in CRi had a higher survival rate of 83.3%. Many patients initially in CRi later improved, with 63% converting to full CR by month three as their blood counts recovered.
Recovery of blood counts was generally quick, taking less than a month for most patients. Prior stem cell transplant did not slow recovery. While a few patients died from infections during remission, the treatment’s safety profile remained manageable with no unexpected long-term blood count issues.
Following results from the FELIX trial, the U.S. Food and Drug Administration approved obe-cel in November 2024 for this patient group.