March 21, 2023
1 min read
Axicabtagene ciloleucel significantly extended survival compared with historic standard of care in a curative setting for adults with previously untreated relapsed or refractory large B-cell lymphoma, according to the agent’s manufacturer.
Results of the randomized phase 3 ZUMA-7 study showed the improvement in OS, a prespecified key secondary endpoint, among patients who were refractory to first-line chemoimmunotherapy or experienced disease relapse within 12 months of initial treatment.
Axicabtagene ciloleucel (Yescarta, Kite Pharma/Gilead Sciences) — also known as axi-cel — is an autologous, gene-edited, CD19-directed chimeric antigen receptor T-cell therapy. FDA approved axi-cel last year as initial treatment of relapsed/refractory large B-cell lymphoma based on data from the ZUMA-7 trial.
ZUMA-7 examined the safety and efficacy of axi-cel vs. standard of care among 359 adults with relapsed or refractory large B-cell lymphoma at 77 centers worldwide. Standard of care consists of a platinum-based salvage combination chemoimmunotherapy regimen followed by high-dose therapy and autologous hematopoietic stem cell transplantation for responders to the chemoimmunotherapy.
EFS served as the primary endpoint.
Results showed a 2.5-fold increase compared with standard of care in the percentage of patients alive at 2 years who did not experience disease progression or require additional cancer treatment (40.5% vs. 16.3%). Researchers reported a fourfold increase in median EFS (8.3 months vs. 2 months; HR = 0.39; 95% CI, 0.3-0.51) with axi-cel vs. standard of care, as well as higher rates of overall response (83% vs. 50%; OR = 5.31; 95% CI, 3.1-8.9) and complete response (65% vs. 32%).
An interim OS analysis occurred at the time of the primary EFS analysis, with the prespecified primary OS analysis to be conducted after 210 deaths or no later than 5 years after random assignment of the first patient in the trial, according to a Kite press release.
Axi-cel had a safety profile consistent with that of prior studies. Grade 3 or higher cytokine release syndrome occurred among 7% and neurologic events among 25% of the 168 safety-evaluable patients who received axi-cel. Most patients in the standard-of-care group (83%) experienced high-grade events, mostly cytopenias.
Complete results will be presented at a medical meeting later this year, according to the press release.
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