Kite, a Gilead Company announced that the company’s Marketing Authorization Application (MAA) for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), has been fully validated and is now under evaluation by the European Medicines Agency (EMA).
The MAA is supported by data from the single arm, open-label, Phase 2 ZUMA-2 trial, which demonstrated an overall response rate of 93 percent, including 67 percent with complete response, as assessed by an Independent Radiologic Review Committee (IRRC) following a single infusion of KTE-X19 (median follow-up of 12.3 months). In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Detailed findings from this trial were recently presented during an oral session at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando.
“Relapse rates in mantle cell lymphoma remain overwhelmingly high and there is a significant need for new therapies that may improve patients’ prognosis,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “The EMA validation of our marketing application brings us closer to delivering on the promise of our industry-leading cell therapy development program, with the hope that we can bring KTE-X19 to appropriate patients in Europe as quickly as possible.”
Kite submitted a Biologics License Application (BLA) for KTE-X19 to the U.S. Food and Drug Administration (FDA) on December 11, 2019 for the treatment of adult patients with relapsed or refractory MCL. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) by the EMA.
KTE-X19 is investigational and not approved anywhere globally. Its efficacy and safety have not been established.
Source: Company Press Release