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Phase II ZUMA-12 Trial Evaluates First-Line Use of Axicabtagene Ciloleucel in High-Risk LBCL

By: Vanessa A. Carter, BS
Posted: Thursday, May 19, 2022

Sattva S. Neelapu, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues conducted the phase II ZUMA-12 trial to evaluate the safety and efficacy of axicabtagene ciloleucel as a first-line therapy for high-risk large B-cell lymphoma (LBCL). The results of this primary analysis, which were published in Nature Medicine, ultimately determined that this chimeric antigen receptor (CAR) T-cell therapy is not only effective in this patient population, but also demonstrates a manageable safety profile.

“Further investigation is warranted in these patient populations to determine the benefit of axicabtagene ciloleucel as first-line therapy compared with standard chemoimmunotherapy,” concluded the investigators.

This multicenter, single-arm study enrolled 40 patients with high-risk LBCL who did not complete a first-line treatment regimen of two chemoimmunotherapy cycles. Participants first underwent leukapheresis and then received chemotherapy followed by a single intravenous infusion of axicabtagene ciloleucel.

The median patient age was 61 years, and the complete response rate was 78% among 37 evaluable patients; the median time to complete response was 30 days. The objective response rate was 89%, and 73% of participants remained in objective response at the median follow-up of 15.9 months. Median duration of response, event-free survival, and progression-free survival were not reached. Of note, robust CAR T-cell expansion occurred in all patients in a median time to peak of 8 days, the investigators reported.

All 40 participants experienced at least one adverse event, and grade 3 or higher events were reported in 34 individuals. The most common treatment-emergent adverse event was pyrexia (100%), followed by headache (70%) and decreased neutrophil count (55%). Of particular interest, grade 3 or higher neurologic events and cytokine-release syndrome affected nine and three patients, respectively.

Disclosure: For full disclosures of the study authors, visit nature.com.


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