Kite : Yescarta Quadruples Median Event-Free Survival Duration In Refractory Large B-Cell Lymphoma

Kite, a Gilead Company (GILD), said that yescarta CAR T-Cell Therapy Quadruples Median Event-Free Survival Duration Over Standard of Care in Second-Line Relapsed or Refractory Large B-Cell Lymphoma.

The primary analysis of ZUMA-7, a global Phase 3 study evaluating Yescarta (axicabtagene ciloleucel) as a one-time infusion, in a head-to-head study against standard of care (SOC) for adults with large B-cell lymphoma (LBCL) who relapsed or were refractory to first-line treatment. Yescarta was evaluated against the current SOC which is a multi-step process intended to culminate in a stem cell transplant.

ZUMA-7 was initiated in 2017 and is the first and largest Phase 3 randomized study of any CAR T-cell therapy in the second-line setting, enrolling 359 patients in 77 centers around the world. ZUMA-7 is considered a landmark trial for being the only study to reach the clinically meaningful two-year follow-up milestone.

The company said that, with a median follow-up of over two years, the study met the primary endpoint of event-free survival. Yescarta demonstrated a 2.5 fold increase in patients who were alive at two years and did not require the need for additional cancer treatment or experienced cancer progression and a four-fold greater median Event-Free Survival compared to Standard of Care. These statistically significant and clinically meaningful results were not confounded by any bridging chemotherapy.

Global regulatory filings to expand the indication for Yescarta to include second-line relapsed or refractory LBCL based on the ZUMA-7 data are currently underway.

The U.S. Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation to Yescarta for this patient population with a target action date under the Prescription Drug User Fee Act (PDUFA) of April 1, 2022.

Regulatory submissions have also been filed with other global health authorities, including the European Medicines Agency.

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