On December 21, 2023, Kite Announced Axicabtagene Ciloleucel FDA Label Update, Incorporating the Pivotal Phase 3 ZUMA-7 Study’s Overall Survival (OS) Analysis
On December 21, 2023, Kite Announced Axicabtagene Ciloleucel FDA Label Update, Incorporating the Pivotal Phase 3 ZUMA-7 Study’s Overall Survival (OS) Analysis
On December 21, 2023, Kite, a Gilead company, announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axicabtagene ciloleucel), incorporating the pivotal Phase 3 ZUMA-7 study’s overall survival (OS) analysis.
The analysis demonstrated a statistically significant improvement in OS for Yescarta compared to standard of care (SOC) therapy, establishing Yescarta as a potential second-line treatment option for adult patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) within 12 months of first-line therapy.
ZUMA-7 is a randomized, open-label, global, multicenter, Phase 3 study evaluating the safety and efficacy of Yescarta versus SOC in adult patients with R/R LBCL within 12 months of initial first-line therapy. In this study, 359 patients from 77 global centers were randomized (1:1) to receive a single infusion of Yescarta or the previous SOC second-line treatment. The primary endpoint was event-free survival (EFS) as determined by blinded central review. Key secondary endpoints included objective response rate (ORR) and OS. Other secondary endpoints included patient-reported outcomes (PROs) and safety.
The ZUMA-7 study results demonstrated that Yescarta reduced the risk of death by 27.4% and improved OS by 38% relative to SOC. With an overall median follow-up time estimate of 46.7 months, the primary analysis for OS showed a statistically significant improvement for the Yescarta arm compared to the SOC arm, despite more than half (57%) of patients in the SOC arm subsequently receiving non-study cell therapy. The estimated 39-month OS rate was 55.9% for the Yescarta arm and 46% for the SOC arm.
Compared to SOC, Yescarta increased 2.5-fold the proportion of patients who were alive and free of disease progression or subsequent anti-cancer therapy at two years (40.5% vs. 16.3%), and quadrupled the median EFS (8.3 months vs. 2.0 months) (hazard ratio 0.398; 95% CI: 0.308-0.514, P<0.0001). ZUMA-7 is the largest and longest follow-up study of its kind, and importantly, participants in the Yescarta arm did not receive additional bridging chemotherapy, which could have influenced study outcomes.
“The U.S. label update for Yescarta is an important step in bolstering confidence for healthcare providers to use Yescarta immediately in eligible patients following progression or relapse of large B-cell lymphoma,” said Frank Neumann, MD, PhD, Senior Vice President and Global Head of Clinical Development at Kite. “Our ZUMA-7 overall survival analysis demonstrates that Yescarta as a second-line treatment is even more effective than standard of care at improving patient survival. Combined with our rapid, reliable manufacturing process, we hope to provide patients with a life-extending opportunity.”
Content Source:四川省医药保化品质量管理协会