Dr. Leslie on the FDA Approval of Axicabtagene Ciloleucel for Second-Line Relapsed/Refractory LBCL

Lori A. Leslie, MD, assistant professor, Hackensack Meridian School of Medicine, director, Indolent Lymphoma and Chronic Lymphocytic Leukemia Research Programs, John Theurer Cancer Center, discusses the FDA approval of axicabtagene ciloleucel (axi-cel; Yescarta) for second-line relapsed/refractory large B-cell lymphoma (LBCL).

On April 1, 2022, the FDA approved axi-cel for adult patients with LBCL that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. The approval is based on findings from the phase 3 ZUMA-7 study (NCT03391466). At a median follow-up of 2 years, findings from the trial showed the study met its primary end point of event-free survival (EFS) vs standard of care (SOC) in this patient population (HR, 0.40; 95% CI, 0.31-0.51; P < .0001), resulting in a 60% reduction in the risk of EFS events vs SOC.

The study also met its secondary end point of objective response rate. Although the data remain immature at this time, findings from the interim analysis of overall survival (OS) suggested there was a trend favoring axi-cel vs SOC. The approval is exciting and immediately practice changing for patients, particularly for high-risk patients who have poor responses with salvage chemotherapy and autologous transplant, Leslie says.