During the 2025 ICML meeting, Prof Olalekan Oluwole, Hematologist at the Vanderbilt-Ingram Cancer Center in Nashville shared the results of a systematic literature review and meta-analysis evaluating real-world outcomes for patients with relapsed/refractory mantle cell lymphoma (R/R MCL) treated with brexucabtagene-autoleucel (brexu-cel).
The analysis at hand included 19 unique cohorts, including 6 cohorts from the EU and 12 from the US. In terms of efficacy, real-world data were similar or even better than what was reported in clinical trials, with a complete response (CR) rate of 73% across the European cohorts and 81% in the US (76% ovrall). The median overall survival (OS) in this meta-analysis was 40.6 months, with 1- and 2-year OS rates of 73.1% and 59.5%, respectively. The real-world median PFS was 18.4 months, with 1- and 2-year rates of 58.9% and 45.1%, respectively.
Interestingly, the toxicity of brexu-cel in the real-world setting proved to be better than what was seen in the pivotal ZUMA-2 trial, likely reflecting the increased experience of physicians to deal with brexu-cel related toxicities. In this real-world analysis, the incidence of grade ≥3 cytokine release syndrome (CRS) was 12%, with a grade ≥3 ICANS incidence of 20%.
References:
Nissen F, et al. et al. ICML 2025; Abstract 606 (Pub only).