December 18, 2019
- Gilead’s Kite subsidiary has announced that it has submitted a BLA for the investigational CAR-T KTE-X19 for the treatment of patients with relapsed or refractory mantle cell lymphoma (R/R MCL).
- The BLA is based on data from the Phase 2 ZUMA-2 trial which demonstrated an ORR of 93% (CR rate = 67%) in 60 evaluable patients. Enrolled patients had MCL that was refractory to or had relapsed following up to 5 prior lines of therapy.
- Grade 3 or higher cytokine release syndrome (CRS) and neurotoxicity were seen in 15% and 31% of patients, respectively. No Grade 5 CRS or neurological events were observed.
- Detailed findings from ZUMA-2 were presented Monday at ASH 2019.
- KTE-X19 has been granted FDA Breakthrough Therapy and EMA PRIME status for the MCL indication.
- Kite anticipates submitting a European Marketing Authorization Application in early 2020.