Sumary of CAR T-cell therapy shows ‘high and durable response rates’ in adults with B-cell ALL:
- Brexucabtagene autoleucel induced an overall remission rate of greater than 70% among adults with relapsed or refractory B-cell acute lymphoblastic leukemia who received a single infusion of the therapy, according to phase 2 study results..
- Data from ZUMA-3 trial — presented during the virtual ASCO Annual Meeting — also showed that approximately a quarter of patients treated with the chimeric antigen receptor T-cell therapy experienced grade 3 or greater cytokine release syndrome or neurotoxicity..
- Kite Pharma/Gilead) — formerly known as KTE-X19 — among adults with relapsed or refractory B-cell ALL, according to Bijal D..
- “The 1-year overall survival rate for patients with relapsed or refractory B-cell ALL is 26% after first salvage therapy and decreases with subsequent lines of therapy.”.
- Novel targeted agents have led to improved initial complete response rates, but OS remains less than 8 months or longer depending on whether patients undergo subsequent allogeneic hematopoietic stem cell transplant, Shah said..
- Brexucabtagene autoleucel, an autologous, gene-edited CAR T-cell therapy, targets the CD19 protein on the surface of cancer cells..
- The therapy previously received FDA approval for the treatment of adults with relapsed or refractory mantle cell lymphoma..
- The manufacturer has submitted a supplemental biologics license application to the FDA for the B-cell ALL indication based on results of the phase 1 portion of the ZUMA-3 trial….