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Leo I. Gordon, MD, FACP


Axicabtagene Ciloleucel in High-Risk Large B-Cell Lymphoma: Primary Analysis of ZUMA-12

By: Joseph Fanelli
Posted: Tuesday, March 1, 2022

According to findings of the phase II ZUMA-12 trial, presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 739), axicabtagene ciloleucel, the autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, may promote high rates of rapid and complete responses in patients with high-risk large B-cell lymphoma (LBCL). Julio C. Chavez, MD, of the Moffitt Cancer Center, Tampa, Florida, and colleagues concluded that axicabtagene ciloleucel resulted in durable response, event-free survival, and progression-free survival for this population of patients.

“Overall, axicabtagene ciloleucel may benefit patients exposed to fewer prior therapies, and further trials in first-line high-risk LBCL are warranted to assess axicabtagene ciloleucel in this setting,” the authors said.

In this trial, the authors enrolled 40 patients with high-risk LBCL. Each patient underwent leukapheresis and received conditioning chemotherapy followed by a single axicabtagene ciloleucel infusion.

After 15.9 months of median follow-up, 37 patients had centrally confirmed double- or triple-hit histology or an International Prognostic Index score of at least 3 or higher and were eligible for evaluation. Among these patients, the complete response rate was 78%, and 89% of patients had an objective response, with a median time to initial response of 1 month. For all 40 patients treated, 90% demonstrated an objective response, with 73% of patients having ongoing responses at the time of data cutoff. The median duration of response, event-free survival, and progression-free survival at 12-month estimates were 81%, 73%, and 75%, respectively.

All patients had adverse events of any grade, with 85% of the group experiencing grade 3 adverse events or higher. The most common adverse event was cytopenia.

Disclosure: For full disclosures of the study authors, visit

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