Obe-cel Leads to High Response Rates in Adults With B-Cell ALL

December 06, 2024

Obecabtagene autoleucel (obe-cel), a second-generation anti-CD19 CAR T-cell therapy, demonstrated high response rates and reduced immune toxicity in adults with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), according to new research.

Findings from the FELIX trial, published in the New England Journal of Medicine, support the Food and Drug Administration’s recent approval of obe-cel (marketed as Aucatzyl by Autolus Inc.) for this aggressive blood cancer. 

The global trial reported a 77% overall remission rate (55% complete remission and 21% complete remission with incomplete hematologic recovery). The median event-free survival (EFS) was 11.9 months, and the estimated EFS rates at six and 12 months were 65.4% and 49.5%, respectively.

Importantly, obe-cel showed a significantly reduced incidence of severe cytokine release syndrome (2.4%) and neurotoxicity (7.1%) compared to earlier ALL therapies. While prior treatments often require subsequent stem cell transplants (SCT), most patients treated with obe-cel achieved durable remissions without SCT. Among 99 patients who responded to obe-cel, only 18 went on to receive a SCT. 

According to Claire Roddie, MD, PhD, lead investigator at the UCL Cancer Institute, the results “demonstrate that obe-cel can induce durable remissions with substantially fewer toxicity issues, which is great news for patients with what has historically been a very difficult cancer to treat.”