Patients with relapsed or refractory mantle cell lymphoma (MCL) treated with brexucabtagene autoleucel (brexu-cel) exhibited a promising overall response rate (ORR) and sustained benefits, especially in those who achieved a complete response (CR), according to data from the phase II ZUMA trials.
After a median of four years of follow-up, participants in the pivotal ZUMA-2 study had a median overall survival (OS) of nearly five years, stated lead author Andre Goy, MD, from the John Theurer Cancer Center at Hackensack Meridian Health in New Jersey, while presenting at the 65th American Society of Hematology Annual Meeting & Exposition in San Diego, California.
Dr. Goy also discussed primary findings from ZUMA-18, an expanded access study. “Consistent with ZUMA-2 findings, brexu-cel demonstrated a high level of efficacy in patients with [relapsed or refractory] MCL in ZUMA-18, with an ORR of 87% and median OS not yet reached at 33.5 months of follow-up,” Dr. Goy stated.
The ZUMA-2 cohort included 68 patients with a median follow-up of 47.5 months (range, 37.9-68.3), at which point the median OS was 45.4 months (range, 1.2-63.0) with 30 patients (44%) still alive. The median OS was 58.7 months (range, 4.8-61.9) in the 46 patients with CR, 16.3 months (range, 1.2-63.0) in the 16 with partial response (PR), and 8.5 months (range, 2.3-22.9) in the six with no response.
The 23 patients who received brexu-cel in ZUMA-18 had a median age of 69.0 years (range, 43-79), and were 78% male with a median of four (range, 1-10) prior lines of therapy. After a median follow-up of 33.35 months (range, 24.5-35.3), the investigator-assessed ORR was 87% (95% CI, 66.4-97.2), including 13 patients with a CR (57%; 95% CI, 34.5-76.8), seven with a PR (30%; 95% CI, 13.2-52.9), and two with progressive disease (9%; 95% CI, 1.1-28.0). Researchers reported the median OS was not reached (95% CI, 10.4-Not Estimable) and the 24-month OS rate was 58%.
Noting that no new safety signals were identified in ZUMA-18, Dr. Goy and colleagues ultimately concluded that, “together, these results support the continued use of brexu-cel in the [relapsed or refractory] MCL setting.”
Reference
Goy A, Jacobson CA, Flinn IW, et al. Outcomes of patients with relapsed/refractory mantle cell lymphoma (R/R MCL) treated with brexucabtagene autoleucel (brexu-cel) in ZUMA-2 and ZUMA-18, an expanded access study. Abstract #106. Presented at the 65th ASH Annual Meeting and Exposition; December 9-12, 2023; San Diego, California.