Dr Neelapu on 5-Year Data for Axi-Cel in R/R Follicular Lymphoma and MZL

“These results indicate that axi-cel continues to be a highly effective therapeutic approach for patients with relapsed/refractory indolent lymphoma with the long-term durability of these responses observed at 5 years, [along with] long-term survival.”

Sattva S. Neelapu, MD, professor, deputy department chair, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center; member, graduate faculty, Immunology Program, Graduate School of Biomedical Sciences, The University of Texas Health Science Center, discusses 5-year follow-up data from the phase 2 ZUMA-5 trial (NCT03105336) evaluating axicabtagene ciloleucel (axi-cel; Yescarta) in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma. Findings were presented at the 2024 ASH Annual Meeting.

The phase 2 study included 159 patients, of whom 127 had follicular lymphoma and 31 had MZL. At a median follow-up of 64.6 months (range, 32.3-81.4) for the overall population, the overall response rate (ORR) across all treated patients was 90%, including a complete response (CR) rate of 75%. Within the follicular lymphoma cohort, the ORR and CR rate were 94% and 79%, respectively; these respective rates were 77% and 65% in the MZL cohort.

The a median duration of response (DOR) was 60.4 months (95% CI, 39.7-not evaluable [NE]). Among patients with follicular lymphoma, a plateau in lymphoma-specific progression-free survival (PFS) was observed beyond 24 months, with only 4 relapses reported after this time point. The 5-year lymphoma-specific PFS rate for follicular lymphoma was 64.0% (95% CI, 54.4%-72.1%); the 5-year overall PFS rate for this group was 49.8% (95% CI, 39.8%-59.0%). For patients with MZL, 5-year PFS rate was 53.9% (95% CI, 32.9%-71.0%).

Safety outcomes remained consistent with prior analyses, and no new safety signals were observed since the 4-year analysis. Among the 46 deaths reported in the study, half were attributed to disease progression; the remainder were associated with competing risks, including second malignancies, cardiac events, and infections.

Neelapu highlights the sustained efficacy of axi-cel as a therapeutic option for patients with R/R indolent non-Hodgkin lymphoma, particularly in the follicular lymphoma cohort, where results suggest potential curative benefit.