Dr Gruenbaum on Important Developments and Unmet Needs in MCL

“[MCL] is a heterogeneous disease, and we are seeing a range of exciting new treatment options, [such as] approvals of targeted agents that have moved into the first-relapsed [setting] and are now moving into frontline therapy and combinations.”

Lore Gruenbaum, PhD, chief scientific officer and senior vice president of Research at Blood Cancer United, discussed the mantle cell lymphoma (MCL) field as a whole, touching on both where the field sits currently and the direction it needs to move towards in the future.

Gruenbaum began by outlining the specific characteristics of MCL as a disease, emphasizing its heterogeneity, which adds to the diversity of the MCL field, which has a range of exciting new treatment options, she added. Gruenbaum specifically highlighted the April 2026 FDA approval of brexucabtagene autoleucel (Tecartus; brexu-cel) for the treatment of adult patients with relapsed or refractory MCL.

The approval was supported by data from the phase 2 ZUMA-2 trial (cohorts 1 and 2, NCT02601313; cohort 3, NCT04880434) that showed the promising efficacy of the CAR T-cell therapy. Efficacy-evaluable patients in cohort 3 who received brexu-cel (n = 86) achieved an overall response rate (ORR) of 91% (95% CI, 82.5%-95.9%), whereas efficacy-evaluable patients in cohort 1 (n = 60) achieved an ORR of 87% (95% CI, 75%-94%). The complete response rates in cohorts 3 and 1 were 79% (95% CI, 69.0%-87.1%) and 62% (95% CI, 48%-74%), respectively. Cohort 3 of the trial had a median follow-up of 23 months compared with 8.6 months for cohort 1.

Gruenbaum pointed out how brexu-cel is now the second CAR T-cell therapy approved for MCL alongside lisocabtagene maraleucel (liso-cel; Breyanzi). Although the increasing number of approved treatments is promising, there are still pressing unmet needs that the field must address, she said. Gruenbaum underscored the importance of figuring out the optimal treatment options for patients with high-risk disease, like those with TP53 mutations, as well as the need to clearly define functional cure.