Gilead's Kite says results ZUMA-2 trial support regulatory filings
Kite, a Gilead company, announced primary results from ZUMA-2, a global, multicenter, single-arm, open-label Phase 2 study of KTE-X19, an investigational CD19 chimeric antigen receptor T cell therapy, in adult patients with relapsed or refractory mantle cell lymphoma, or MCL. After a single infusion of KTE-X19, the best objective response via independent radiologic central review was 93%, with 67% of patients having achieved a complete response. These findings were presented today at the 61st American Society of Hematology Annual Meeting. With a median follow-up of 12.3 months at the time of data cutoff, 57% of patients remained in an ongoing response. Of the first 28 patients treated, 43% were alive and remained in continued remission without additional therapy. The 12-month estimates of progression-free survival and overall survival were 61% and 83%, respectively. Median duration of response, PFS and OS were not yet reached. Among the 68 patients evaluable for safety, cytokine release syndrome and neurologic events were observed in 91% and 63% of patients, respectively. Grade 3 or higher CRS and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Based on the results of the trial, Kite plans to submit a Biologics License Application for KTE-X19 to the U.S. Food and Drug Administration by the end of this year and a Marketing Authorization Application to the European Medicines Agency in the first quarter of 2020. KTE-X19 has been granted Breakthrough Therapy Designation by the FDA and Priority Medicines by the EMA for relapsed or refractory MCL based on interim data from ZUMA-2.