In a study reported in the Journal of Clinical Oncology, Caron A. Jacobson, MD, and colleagues found that commercial use of the chimeric antigen receptor T-cell therapy axicabtagene ciloleucel in patients with relapsed or refractory B-cell non-Hodgkin lymphoma was associated with an overall response rate similar to that reported in the pivotal ZUMA-1 trial. However, complete response rates, duration of response, and other efficacy outcomes were better among patients who would have met ZUMA-1 eligibility requirements.
Caron A. Jacobson, MD
As stated by the investigators, “Axicabtagene ciloleucel was approved by the U.S. Food and Drug Administration for relapsed aggressive B-cell non-Hodgkin lymphoma in part on the basis of durable remission rates of approximately 40% in a clinical trial population. Whether this efficacy, and the rates of toxicity, would be consistent in a postcommercial setting, with relaxed eligibility criteria and bridging therapy, is unknown.”
They also noted that the ZUMA-1 trial has been criticized for including highly selected patients.
Study Details
The study included 122 patients from 7 medical centers who received axicabtagene ciloleucel between December 2017 and October 2018 in a modified intent-to-treat population (excluding patients who had T cells collected but did not receive the therapy). Of these, 76 (62%) would not have been eligible for the ZUMA-1 trial on the basis of patient or disease characteristics or the use of bridging therapy (42 ineligible due to bridging therapy alone); 46 would have met trial eligibility requirements.
Key Findings
Median follow-up was 10.4 months.
Among all 122 patients, response was observed in 85 (70%), with complete response in 61 (50%). Median duration of response was 11.0 months. Median progression-free survival was 4.5 months. Median overall survival was not reached, with a 1-year rate of 67%.
“Axicabtagene ciloleucel yields similar rates of overall response and toxicity in commercial and trial settings, although complete response rates and duration of response were more favorable in patients eligible for ZUMA-1.”— Caron A. Jacobson, MD, and colleagues
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Overall response rates were similar among ZUMA-1–eligible and ZUMA-1–ineligible groups (70% vs 68%, P = .250), with the complete response rate being significantly higher in the ZUMA-1–eligible group (63% vs 42%, P = .016). Median duration of response (not reached vs 5.0 months, P = .014), median progression-free survival (not reached vs 3.3 months, P = .020), and 1-year overall survival (89% vs 54%, P <.001) were significantly better in the ZUMA-1–eligible group.
There were no significant differences between the ZUMA-1–eligible and ZUMA-1–ineligible groups in rates of grade ≥ 3 cytokine release syndrome (15% vs 16%, P = .830) or grade ≥ 3 neurotoxicity (35% vs 36%, P = .810).
The investigators concluded, “Axicabtagene ciloleucel yields similar rates of overall response and toxicity in commercial and trial settings, although complete response rates and duration of response were more favorable in patients eligible for ZUMA-1.”
Dr. Jacobson, of Dana-Farber Cancer Institute, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported in part by an award from the National Cancer Institute. For full disclosures of the study authors, visit ascopubs.org.
