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ASH 2018: Update of ZUMA-1: Axicabtagene Ciloleucel in DLBCL

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Key Points

  • With a median follow-up of 27.1 months for 101 patients enrolled in phase II of the ZUMA-1 trial, the study found that 83% of patients had an objective response and 58% had a complete response.
  • The median duration of response was 11.1 months.
  • The median overall survival was not reached, and the median progression-free survival was 5.9 months.

A follow-up analysis of patients enrolled in the multicenter ZUMA-1 trial for diffuse large B-cell lymphoma (DLBCL) showed axicabtagene ciloleucel can induce durable responses, yield a median overall survival of more than 2 years, and has a manageable long-term safety profile. Axicabtagene ciloleucel was approved by the U.S. Food and Drug Administration (FDA) for treatment of DLBCL in October 2017 and by the European Commission in August 2018.

This update to ZUMA-1 was published by Locke et al in The Lancet Oncology and also presented by Neelapu et al at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 2967).

“This 2-year assessment demonstrates that [axicabtagene ciloleucel] can induce durable remissions in a substantial proportion of patients with an acceptable long-term safety profile,” said study coauthor Sattva S. Neelapu, MD, of The University of Texas MD Anderson Cancer Center, in a statement. “There also is evidence of gradual B-cell recovery in most patients with refractory large B-cell lymphoma who otherwise have limited treatment options.”

Updated Findings

With a median follow-up of 27.1 months for 101 patients enrolled in phase II of the trial, the study found that 83% of patients had an objective response and 58% had a complete response. The median duration of response was 11.1 months (4.2–not estimable). The median overall survival was not reached (12.8 months–not estimable), and the median progression-free survival was 5.9 months (95% confidence interval [CI] = 3.3–15.0 months).

Since the previous analysis at 1 year, additional serious adverse events were reported in 4 patients (grade 3 mental status changes, grade 4 myelodysplastic syndrome, grade 3 lung infection, and 2 episodes of grade 3 bacteraemia), none of which were judged to be treatment-related. No new treatment-related deaths occurred during the additional follow-up.

'Real-World' Outcomes

A subsequent “real-world” assessment of 274 patients who received axicabtagene ciloleucel after its FDA approval revealed similar results to the overall ZUMA-1 study. The real-world retrospective study included 17 centers that contributed data independent from the manufacturer-funded trial.

Findings from the study, led by Loretta Nastoupil, MD, were presented at the 2018 ASH Annual Meeting & Exposition (Abstract 91). By day 90, the real-world assessment reported 81% of patients had an objective response and 57% had a complete response. 

“Although limited by a relatively short follow-up, 90-day responses in the real-world setting are comparable to the best responses observed in the pivotal ZUMA-1 clinical trial,” said Dr. Nastoupil. “Safety appears comparable to the ZUMA-1 trial, despite nearly half of patients failing to meet ZUMA-1 eligibility criteria.”

The ZUMA-1 study was funded by Kite Pharma and, in part, by the Leukemia & Lymphoma Society Therapy Acceleration Program.

Disclosure: See the study authors’ full disclosures at ash.confex.com.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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