Kite files for US approval of second CAR-T cell therapy

Gilead Sciences (Nasdaq: GILD) subsidiary Kite has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

If approved, KTE-X19 would be the first CAR-T cell therapy for mantle cell lymphoma, noted the company, whose Yescarta (axicabtagene ciloleucel) became the first chimeric CAR-T cell therapy to be approved by the US Food and Drug Administration for the treatment of adult patients with relapsed or refractory large B-cell lymphoma in October 2017.

The BLA submission is based on data from the Phase II ZUMA-2 trial, which demonstrated an overall response rate of 93%, including 67% with complete response, as assessed by an Independent Radiologic Review Committee (IRRC) following a single infusion of KTE-X19. In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15% and 31% of patients, respectively. No Grade 5 CRS or neurologic events occurred. Detailed findings from this trial were recently presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando.