The FDA granted priority-review designation to the investigational chimeric antigen receptor (CAR) T-cell therapy KTE-X19 for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL).
The application is supported by data from the single-arm, open-label, phase II ZUMA-2 trial, which enrolled 74 patients with MCL whose disease was refractory to or has relapsed following up to 5 prior lines of therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy, and the Bruton tyrosine kinase inhibitors ibrutinib or acalabrutinib. According to results presented at the 2019 ASH Annual Meeting, 93% of patients responded to a single infusion of KTE-X19, including 67% of patients who achieved a complete response.
In the safety analysis, researchers reported that grade ≥3 cytokine release syndrome (CRS) and neurologic events occurred in 15% and 31% of participants, respectively. However, no grade 5 CRS or neurologic events were reported.
Phase II trials of KTE-X19 are ongoing and a final decision on the application is expected in August 2020. Previously, KTE-X19 was granted breakthrough-therapy designation.
Source: Gilead press release, February 10, 2020.