Dr Ahmed on Real-World Findings With Brexu-Cel in MCL

Nausheen Ahmed, MD, assistant professor, Hematologic Malignancies and Cellular Therapeutics, The University of Kansas Medical Center, discusses findings from a real-world subgroup analysis of brexucabtagene autoleucel (brexu-cel; Tecartus) in patients with relapsed/refractory mantle cell lymphoma (MCL).

In 2020, brexu-cel received FDA approval in adult patients with relapsed/refractory MCL based on findings from the phase 2 ZUMA-2 trial (NCT02601313), in which the agent elicited an overall response rate (ORR) of 91% and a complete response (CR) rate of 68% in this population, which excluded patients with no prior BTK inhibitor exposure. A prospective, noninterventional cohort study used data from 380 patients with relapsed/refractory MCL from the Center for International Blood and Marrow Transplant Research registry to determine the efficacy and safety of brexu-cel in a real-world population.

In the entire real-world study population, the ORR was 90% with a 78% CR rate, response rates that are similar to those seen in ZUMA-2, Ahmed says. The ORR and CR rates were also similar across subgroups, Ahmed notes. In patients with prior BTK inhibitors, the ORR was 90% and the CR rate was 78% vs 92% and 83% in those with no prior BTK inhibitors. In patients with prior bendamustine, the ORR was 89% and the CR rate was 76% vs 92% and 81% in those with no prior bendamustine. In patients with prior autologous stem cell transplant (ASCT), the ORR was 91% and the CR rate was 82% vs 90% and 77% in those with no prior ASCT. In addition, the CR rates were better in patients who had received fewer prior lines of therapy than in those who had received 3 or more prior lines, Ahmed emphasizes. In patients with 1 to 2 prior lines of therapy, the ORR was 94% and the CR rate was 88% vs 89% and 76% in those with at least 3 prior lines of therapy.

The estimated 12-month CR and ORR rates were 69% and 64%, respectively. The median duration of response was 21.7 months, however, the median follow-up in this study was 12.0 months at the data cutoff date, and further follow-up is necessary for more mature data, Ahmed notes. The 12-month progression-free survival rate was 61% and the 12-month overall survival rate was 74%.

This study also investigated the cumulative incidence of relapse and the risk of non-relapse mortality in the real-world population and found that at 12 months, 31% of patients had relapsed, with a median time to relapse or progressive disease of 24.0 months.

A multivariate analysis showed that when the efficacy outcomes were adjusted by subgroup, the CR rates were higher in patients who had received 1 to 2 prior lines of therapy compared with those who had received 3 or more prior lines, with an odds ratio of 2.10, Ahmed concludes.