Benzinga | Sep 30, 2021 04:54PM EDT

Gilead Says Kite Submits Supplemental Biologics License Application To FDA For Earlier Use Of Yescarta In Large B-cell Lymphoma

Kite, a Gilead Company (NASDAQ:GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Yescarta(r) (axicabtagene ciloleucel) to expand its current indication to include the treatment of adults with relapsed or refractory large B-cell lymphoma (LBCL) in the second-line setting.

The sBLA filing is based on data from the ZUMA-7 study with the longest follow-up -- over two years -- of any Phase 3 CAR T-cell therapy trial. Top-line results from the primary analysis of ZUMA-7 were recently reported and showed superiority of Yescarta compared to standard of care (SOC) in second-line relapsed or refractory LBCL. With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). This represents a clinically meaningful 60% reduction in risk of EFS events versus standard of care. The study also met the key secondary endpoint of objective response rate (ORR). The interim analysis of overall survival (OS) showed a trend favoring Yescarta; however, the data are immature at this time, and further analyses are planned for the future.

Detailed results from ZUMA-7 have been submitted for presentation at an upcoming medical congress. Kite is in discussions with global health authorities regarding submissions to expand the currently approved indications for Yescarta.

"Yescarta demonstrated an impressive clinical benefit over the current standard of care in the ZUMA-7 study, and these findings highlight the potential of this transformative therapy to help even more patients," said Frank Neumann, MD, PhD, Kite's Global Head of Clinical Development. "Approximately 40% of adult patients diagnosed with LBCL require second-line treatment, and we are committed to working with the FDA to provide a new treatment option for these patients."

About ZUMA-7 Study Design

ZUMA-7 is a randomized, open-label, global, multicenter, Phase 3 study evaluating the safety and efficacy of Yescarta versus current standard of care for second-line therapy (platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy) in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy. In the study, 359 patients in 77 centers around the world were randomized (1:1) to receive a single infusion of Yescarta or current standard-of-care second-line therapy. The primary endpoint is event free survival (EFS) as determined by blinded central review, and defined as the time from randomization to the earliest date of disease progression per Lugano Classification, commencement of new lymphoma therapy, or death from any cause. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). Additional secondary endpoints include progression-free survival (PFS), patient reported outcomes (PROs) and safety.

ZUMA-7 was conducted under a Special Protocol Agreement (SPA) with the U.S. Food and Drug Administration whereby the trial design, clinical endpoints and statistical analysis were agreed in advance with the Agency.