Dr Ahmed on a Study of Real-World Outcomes With Brexu-Cel in Relapsed/Refractory MCL

Nausheen Ahmed, MD, assistant professor, hematologic malignancies and cellular therapeutics, The University of Kansas Medical Center, discusses the rationale and design of a subgroup analysis of real-world outcomes with brexucabtagene autoleucel (brexu-cel; Tecartus) in patients with relapsed/refractory mantle cell lymphoma (MCL).

In 2020, the FDA approved brexu-cel for patients with relapsed/refractory MCL. This approval was supported by findings from the single-arm phase 2 ZUMA-2 trial (NCT02601313), in which, at a minimum follow-up of 6 months, the overall response rate (ORR) was 87% (95% CI, 75%-94%), including a complete response (CR) rate of 62% (95% CI, 48%-74%). At the 3-year follow-up analysis of ZUMA-2, the ORR was 91% (95% CI, 81.8%-96.7%), including a CR rate of 68% (95% CI, 55.2%-78.5%).

This noninterventional, prospective subgroup analysis included real-world patient data from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry, Ahmed says. This study evaluated long-term safety and efficacy outcomes with brexu-cel in a more diverse population of patients with relapsed/refractory MCL than what was included in the ZUMA-2 trial, Ahmed explains. Patients were stratified by the type of therapy they had received prior to brexu-cel, including BTK inhibitors, bendamustine, and autologous stem cell transplant (ASCT), as well as the number of prior lines of therapy they had received.

This study enrolled 500 patients from the CIBMTR database across 84 centers who received brexu-cel in the United States between July 2020 and December 2022, of whom 380 were eligible for inclusion in the real-world safety and efficacy analysis. At the time of the presentation of the findings from this study at the 2023 EHA Congress, some patients were still in follow-up, Ahmed notes.

The ORR with brexu-cel in this real-world study was 90%, including a 78% CR rate. In patients who had and had not previously received BTK inhibitors, the ORRs were 90% and 92%, respectively. In patients who had and had not received prior bendamustine, the ORRs were 89% and 92%, respectively. In patients who had and had not previously received ASCT, the respective ORRs were 91% and 90%.