Positive results from pivotal ZUMA-2 trial in relapsed or refractory mantle cell lymphoma. - Kite/Gilead

Kite, a Gilead Company announced primary results from ZUMA-2 , a global, multicenter, single-arm, open-label Phase II study of KTE X19, an investigational CD19 chimeric antigen receptor (CAR) T cell therapy, in adult patients with relapsed or refractory mantle cell lymphoma (MCL).

After a single infusion of KTE X19, the best objective response via independent radiologic central review (n=60 evaluable for efficacy analysis) was 93 percent, with 67 percent of patients having achieved a complete response. These findings were presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, in Orlando from December 7�10, 2019.

With a median follow-up of 12.3 months (range: 7.0 to 32.3 months) at the time of data cutoff, 57 percent of patients remained in an ongoing response. Of the first 28 patients treated (minimum follow-up of 24 months), 43 percent were alive and remained in continued remission without additional therapy. The 12-month estimates of progression-free survival (PFS) and overall survival (OS) were 61 percent and 83 percent, respectively. Median duration of response, PFS and OS were not yet reached. Among the 68 patients evaluable for safety, cytokine release syndrome (CRS) and neurologic events were observed in 91 percent and 63 percent 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.

Comment: Based on the results of the trial, Kite plans to submit a Biologics License Application (BLA) for KTE X19 to the FDA by the end of this year and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first quarter of 2020. KTE X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) by the EMA for relapsed or refractory MCL based on interim data from ZUMA-2.