High Response With Brexu-Cel in R/R MCL: Data Driving FDA Approval

In an interview with Targeted Oncology, Michael Wang, MD, The University of Texas MD Anderson Cancer Center, highlights the pivotal efficacy and safety findings from cohort 3 of the ZUMA-2 study (NCT04880434) that supported the supporting full FDA approval of brexucabtagene autoleucel (brexu-cel; Tecartus) in relapsed/refractory mantle cell lymphoma (R/R MCL) in early April.

Watch part 1 and part 2 of Dr Wang’s interview.

Cohort 3 enrolled 86 patients without prior exposure to Bruton tyrosine kinase inhibitors and demonstrated strong efficacy at a median follow-up of 23 months. The overall response rate reached 91%, with a complete remission rate of 79%, reinforcing the deep and durable responses seen with brexu-cel. These outcomes further validated the activity of chimeric antigen receptor (CAR) T-cell therapy in a broader patient population.

Safety findings were consistent with the known profile of CAR T therapies and were considered manageable. Cytokine release syndrome (CRS) occurred in 93% of patients, but only 12% experienced grade 3 or higher events. Similarly, immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in 80% of patients, with 33% experiencing grade 3 or higher severity. Infections occurred in 63% of patients, with one-third classified as grade 3 or higher.

As Dr Wang explains, the combination of robust efficacy, manageable toxicity, and longer follow-up—along with pooled data from all 3 cohorts—ultimately led to full FDA approval. This milestone expands access to a potentially life-saving therapy and marks a significant advancement for patients with R/R MCL.

Read the full interview here.