As reported in the Journal of Clinical Oncology by Neelapu et al, the 5-year follow-up of the phase II ZUMA-5 trial has shown sustained responses with axicabtagene ciloleucel (axi-cel) in patients with relapsed or refractory indolent non-Hodgkin lymphoma.
Study Details
In the single-arm, multicenter trial, 159 patients, including 127 with follicular lymphoma and 31 with marginal zone lymphoma, received lymphodepleting chemotherapy and axi-cel (2 × 106 CAR T cells/kg).
Key Findings
Median follow-up was 64.6 months (range = 32.3–81.4 months). The objective response rate was 90%, including complete response in 75%. Median duration of response was 60.4 months.
Median progression-free survival among all patients was 62.2 months (95% confidence interval [CI] = 34.9 months to not evaluable), with a 5-year rate of 50.4%. Median progression-free survival was 57.3 months (95% CI = 30.9 months to not evaluable) among patients with follicular lymphoma, with a 5-year rate of 49.8%, and not reached (95% CI = 12.4 months to not evaluable) among patients with marginal zone lymphoma, with a 5-year rate of 53.9%.
Median time to next treatment remained not reached, with an estimated 5-year rate of 53.3%. Median overall survival was not reached, with an estimated 5-year rate of 69.0%. At data cutoff, 55% of patients were alive without requiring subsequent anticancer therapy. Among patients with follicular lymphoma, the 5-year lymphoma-specific death rate was 15.6%.
Durable responses and prolonged survival in patients with follicular lymphoma were associated with robust early CAR T-cell expansion and naive product phenotype.
Since the 3-year analysis of the trial, a total of 13 patients experienced new adverse events, including one serious event considered related to axi-cel (grade 3 myelodysplastic syndrome).
The investigators concluded: “These findings confirm sustained responses and manageable safety with axi-cel in the long term among patients with [relapsed or refractory indolent non-Hodgkin lymphoma] and its potential as a curative therapy in [follicular lymphoma].”
Sattva S. Neelapu, MD, of The University of Texas MD Anderson Cancer Center, Houston, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Kite, a Gilead Company. For full disclosures of all study authors, visit ascopubs.org.
