KTE-X19 receives conditional approval in Europe for the treatment of relapsed/refractory MCL

On December 16, 2020, the autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, KTE-X19, was granted conditional marketing authorization by the European Commission for the treatment of adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who have received ≥ 2 prior lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor.

This decision was based on positive results from the pivotal phase II ZUMA-2 trial (NCT02601313), evaluating the use of autologous anti-CD19-transduced CD3⁺ cells for the treatment of patients with R/R MCL who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy, and a Bruton’s tyrosine kinase inhibitor. The ZUMA-2 trial has met its primary endpoint, with 93% of patients responding to a single infusion of the anti-CD19-transduced CD3⁺ cells, and 67% of patients achieving a complete response. KTE-X19 formerly received a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in October 2020, and accelerated U.S. Food and Drug Administration (FDA) approval for the treatment of R/R MCL in July 2020.

Patients with MCL who relapse after or are refractory to initial therapies have a poor prognosis and treatment options are limited. KTE-X19 is the first CAR T-cell therapy for patients with R/R MCL, and its conditional approval represents a positive step forward by providing a new option for the treatment of these patients in Europe.