Axi-Cel Produces Durable Response in Follicular Lymphoma, MZL

In results reported from the ZUMA-5 study, axicabtagene ciloleucel (axi-cel) produced sustained long-term responses in patients with follicular lymphoma (FL) and marginal zone lymphoma (MZL). These findings were published in Blood.

Axi-cel is an autologous, anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. ZUMA-5 is a phase II, multicenter, single arm study of axi-cel for use in relapsed or refractory indolent non-Hodgkin lymphoma (iNHL).

“After [three] years of follow-up in ZUMA-5, axi-cel demonstrated continued durable responses, with very few relapses beyond [two] years, and manageable safety in patients with [relapsed or refractory] iNHL,” the investigators wrote regarding the long-term outcome findings.

In a previously conducted primary analysis of 104 patients in the study over a median follow-up of 17.5 months, the treatment produced an overall response rate (ORR) of 92% and complete response rate of 74%.

The patients in the long-term outcomes analysis cohort had iNHL that was relapsed or refractory after at least two lines of therapy. They underwent leukapheresis and lymphodepleting chemotherapy, and then received axi-cel infusions.

The long-term ORR findings found in this cohort were comparable to in the primary analysis. For the 127 patients with FL in the cohort, ORR was 94% after a median follow-up of 41.7 months. For the cohort’s 31 patients with MZL, ORR was 77% after a median follow-up of 31.8 months.

The median progression-free survival was 40.2 months for patients with FL but was not reached by patients with MZL. Neither set of patients reached medians of overall survival.

The investigators found that any grade 3 or higher adverse events mainly occurred in recently treated patients. However, they did observe certain clinical factors correlating with less favorable remission outcomes in patients.

“Elevated baseline total metabolic tumor volume and recent prior bendamustine use may affect durable remissions of patients with FL,” the investigators wrote.

Reference

Neelapu SS, Chavez JC, Sehgal AR, et al. Three-year follow-up analysis of axicabtagene ciloleucel in relapsed/refractory indolent non-Hodgkin lymphoma (ZUMA-5). Blood. 2024;143(6):496-506. doi:10.1182/blood.2023021243