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Jeremy S. Abramson, MD, MMSc
Jeremy S. Abramson, MD, MMSc
Posted: Tuesday, January 21, 2025
Based on a primary analysis of the global phase II ZUMA-2 trial, autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy with brexucabtagene autoleucel appeared to be safe and active in patients with Bruton’s tyrosine kinase (BTK) inhibitor–naive relapsed or refractory mantle cell lymphoma (MCL). These findings from cohort 3, which were presented by Tom van Meerten, MD, PhD, of the University Medical Center Groningen, the Netherlands, and colleagues during the 2024 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 748), support the therapy’s continued use in the treatment-resistant disease setting.
“Brexucabtagene autoleucel is… approved for adults with relapsed or refractory MCL in the U.S. and European Union (after at least two prior lines of therapy, including a BTK inhibitor in European Union), based on results from cohort 1,” the investigators commented. “In cohort 3, brexucabtagene autoleucel demonstrated a high objective response rate and complete response rate in patients… who were naive to BTK inhibitor [therapy], consistent with cohort 1.”
This analysis focused on 86 patients who underwent leukapheresis, optional prespecified bridging therapy, lymphodepleting chemotherapy, and one infusion of brexucabtagene autoleucel. Follow-up data were provided for a median of 15.5 months.
The primary endpoint was met, with an objective response rate of 91%. A total of 73% of patients achieved a complete response; 17% had a partial response, 3% had stable disease, and 3% had progressive disease as their best response. The median duration of response was 26.2 months, with both the median durations of progression-free and overall survival at 27.1 months; the 12-month rates were 80%, 75%, and 90%, respectively.
No new safety signals were identified. The investigators reported a low rate of grade 3 or higher cytokine-release syndrome (6%) and an expected rate of grade 3 or higher neurologic events (eg, immune effector cell–associated neurotoxicity syndrome: 21%).
Disclosure: For full disclosures of the study authors, visit ash.confex.com.
2024 ASH Annual Meeting & Exposition
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