Phase 2 study reveals high objective response rate for CAR T-cell therapy in patients with follicular lymphoma, marginal zone lymphoma
WEDNESDAY, Dec. 9, 2020 (HealthDay News) — Axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor T-cell therapy, is promising for the treatment of relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL), according to a study presented at the annual meeting of the American Society of Hematology, held virtually from Dec. 5 to 8.
Caron Jacobson, M.D., from the Dana Farber Cancer Institute in Boston, and colleagues presented the primary analysis of a phase 2 single-arm study of axi-cel in patients with R/R iNHL. A total of 146 patients with advanced-stage iNHL, including follicular lymphoma (FL; 124 patients) and marginal zone lymphoma (MZL; 22 patients) underwent leukapheresis followed by conditioning therapy and a single infusion of axi-cel. The primary end point was objective response rate (ORR).
The researchers found that the ORR was 92 percent among efficacy-evaluable patients with iNHL during a median follow-up of 17.5 months, with a 76 percent complete response rate. The ORR was 94 and 85 percent for patients with FL and MZL, respectively. Across key risk groups analyzed by FLIPI, POD24, GELF, refractory status, and prior lines of therapy, ORR was comparable. Overall, 62 percent of all treated patients had ongoing responses as of the data cutoff. Grade 3 or higher adverse events occurred in 86 percent of patients with iNHL, most commonly neutropenia, decreased neutrophil count, and anemia.
“We were very impressed with the magnitude of the responses, and also the durability. This treatment has meaningfully affected high-risk patients with these diseases,” Jacobson said in a statement. “I was also struck early on by how favorable the safety profile was compared to what we’ve been seeing in the fast-growing lymphomas such as large B cell lymphoma.”
Several authors disclosed financial ties to the pharmaceutical industry.
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