Axicabtagene ciloleucel exhibits improved overall survival versus SOC for initial treatment of adult patients with R/R LBCL

Primary overall survival (OS) analysis of the phase III ZUMA-7 trial shows a statistically significant improvement in OS for axicabtagene ciloleucel (axi-cel) versus standard of care (SOC) as initial treatment in adult patients with relapsed/refractory large B-cell lymphoma (LBCL) within 12 months of first-line therapy completion. Traditionally, SOC has been a multi-step process involving a salvage combination chemoimmunotherapy regimen, followed by high-dose therapy and stem cell transplant in those who respond to salvage chemotherapy.¹

ZUMA-7 (NCT03391466) is a randomized, open-label, global phase III trial evaluating the safety and efficacy of axi-cel versus SOC for the initial treatment of adult patients with relapsed/refractory LBCL. The primary endpoint is event-free survival, with key secondary endpoints including objective response rate and OS. Thus far, axi-cel has demonstrated favorable efficacy profiles along with acceptable safety. Data from this pivotal trial has already led to regulatory approvals from the U.S. Food and Drug Administration (FDA) and the European Commission.