Favorable Long-Term Data Reported for Axi-cel

Axicabtagene ciloleucel (axi-cel) induced sustained durable response with a manageable safety profile after three years of follow-up in patients with relapsed or refractory indolent non-Hodgkin lymphomas (NHL), including follicular lymphoma (FL) and marginal zone lymphoma (MZL), according to long-term data from the phase II ZUMA-5 study.

“A substantial proportion of patients with [relapsed or refractory] iNHL remained alive without progression,” noted the study’s lead author, Sattva Neelapu, MD, from the University of Texas MD Anderson Cancer Center in Houston; however, he added that “elevated baseline total metabolic tumor volume and recent prior bendamustine use [within six months] may impact durable remissions in patients with FL.”

Long-Term Non-Hodgkin Lymphoma Treatment with Axi-Cel

ZUMA-5 included patients with relapsed or refractory indolent NHL after two or more prior lines of therapy who underwent leukapheresis and lymphodepleting chemotherapy with axi-cel infusions at a dose of 2×10⁶ chimeric antigen receptor (CAR) T-cells/kg. In the initial primary analysis after a median follow-up of 17.5 months, the overall response rate (ORR) was 92%, including a complete response (CR) rate of 74%.

Subsequently, the rate of ORR was 94% after a median follow-up of 41.7 months in 127 patients with FL, and 77% after a median follow-up of 31.8 months in 31 patients with MZL. The median progression-free survival was 40.2 months in the FL group, and was not reached in the MZL group. Median overall survival was not reached in either group.

Grade ≥3 adverse events of interest reported after the primary analysis were predominantly in recently treated patients, the authors noted. They also reported that very few relapses occurred after the two-year timepoint.

“Further analyses of survival are warranted to assess the curative potential of CAR T-cell therapy in this disease,” Dr. Neelapu and colleagues suggested.

Reference

Neelapu S, Chavez J, Sehgal A. Three-year follow-up analysis of axicabtagene ciloleucel in relapsed/refractory indolent non-Hodgkin lymphoma (ZUMA-5). Blood 2023; blood.2023021243. doi: doi.org/10.1182/blood.2023021243