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CAR-T Therapy Induces Response in Majority of Patients With MCL
Results from a follow-up of the phase 2 ZUMA-2 trial revealed that the majority of patients with relapsed or refractory mantle cell lymphoma (MCL) benefited from treatment with KTE-X19, an anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy (N Engl J Med. 2020;382:1331-1342).
“Patients with relapsed or refractory [MCL] who have disease progression during or after the receipt of Bruton’s tyrosine kinase (BTK) inhibitor therapy have a poor prognosis,” explained Michael Wang, MD, The University of Texas MD Anderson Cancer Center, Houston, and colleagues.
The multi-center ZUMA-2 trial evaluated KTE-X19 in patients with relapsed or refractory MCL after 5 prior lines of therapy including a BTK inhibitor.
A total of 74 patients were enrolled on the trial. KTE-X19 was manufactured for 71 patients and, ultimately, 68 patients received the therapy. Patients underwent leukapheresis and optional bridging therapy, followed by conditioning chemotherapy and a single infusion of KTE-X19 at a dose of 2×106 CAR T-cells per kg of body weight.
The primary end point of the trial was the percentage of patients with an objective response. This was assessed by an independent radiologic review committee according to the Lugano classification. The primary efficacy analysis was to be conducted after 60 patients received treatment and were followed up with for 7 months, per study protocol.
Overall, 93% of the 60 patients in the primary efficacy analysis had an objective response; 67% had a complete response. An intention-to-treat analysis including all 74 patients showed that 85% of patients had an objective response, with 59% having complete responses.
After a median follow-up of 12.3 months, 57% of the 60 patients in the primary efficacy analysis were in remission. The estimated progressions-free survival was 61% and overall survival was 83% at 12 months.
The most common adverse events of grade ≥3 were cytopenias, which occurred in 94% of patients, and infections, which occurred in 32% of patients. Grade ≥3 cytokine release syndrome occurred in 15% of patients and neurologic events occurred in 31% of patients. No events were fatal, and grade 5 infections were reported in 2 patients.
“KTE-X19 induced durable remissions in a majority of patients with relapsed or refractory [MCL]. The therapy led to serious and life-threatening toxic effects that were consistent with those reported with other CAR T-cell therapies,” Dr Wang and colleagues concluded.—Janelle Bradley
