Key clinical point: KTE-X19, an anti-CD19 chimeric antigen receptor T-cell therapy, demonstrated unprecedented efficacy in the ZUMA-2 trial, according to an investigator involved in the study.
Major finding: KTE-X19 produced a 93% overall response rate in patients with relapsed/refractory mantle cell lymphoma.
Study details: A phase 2 trial of 68 patients who received KTE-X19.
Disclosures: The trial was sponsored by Kite, a Gilead company. Dr. Wang reported financial relationships with Kite and other companies.
Wang M et al. ASH 2019..
Arguably the most urgently needed therapies for mantle cell lymphoma are treatments with activity following failure of BTK inhibitors; these patients have an average survival of just 3 months. In the ZUMA-2 trial, patients previously treated with a BTK inhibitor received KTE-X19 CART cells (identical to axicabtagene ciloleucel with an additional purification step during the manufacturing process). These preliminary data demonstrate significant activity and hint at a complete response rate that may be even higher than DLBCL. They also hint at a rate of neurotoxicity that may be higher than expected. The results should be interpreted with the caveat that they are preliminary, have limited follow up, and that the population of patients enrolled in CART cell studies may not fully represent the entirety of patients that experience BTK-inhibitor failure. So far, however, those caveats have not dampened the enthusiasm for access to a new class of therapies for mantle cell lymphoma.—Peter Martin, MD