Dr Ahmed on the Rationale for Investigating Real-World Outcomes of Brexu-Cel in R/R MCL

Nausheen Ahmed, MD, assistant professor of Hematologic Malignancies and Cellular Therapeutics, the University of Kansas Medical Center, discusses the rationale for investigating real-world outcomes of patients with relapsed/refractory mantle cell lymphoma (MCL) treated with brexucabtagene autoleucel (brexu-cel; Tecartus).

In July 2020, the FDA approved brexu-cel for adult patients with relapsed/refractory MCL, based on findings from the phase 2 ZUMA-2 trial (NCT02601313). Accordingly, investigators launched a real-word study of patients registered in the Center for International Blood and Marrow Transplant Research database to assess real-world outcomes in patients with MCL treated with the CAR T-cell therapy. These findings were presented at the 2023 ASCO Annual Meeting and the 2023 EHA Congress.

ZUMA-2 enrolled patients who had received treatment with prior exposure to bendamustine, an anthracycline, or a BTK inhibitor. When brexu-cel received FDA approval, it was indicated for second-line use, regardless of prior therapy, Ahmed says. However, in Europe, the indication for brexu-cel is after 2 prior lines of therapy, including a prior BTK inhibitor.

Based on these different indications and varying treatment histories for patients administered brexu-cel, investigators sought to better understand the real-world outcomes for patients treated with the CAR T-cell therapy based on the number of and types of prior treatments, she says.

Specifically, questions remain regarding if prior treatment with bendamustine could reduce the efficacy of CAR T-cell therapy, Ahmed continues. The real-world study also assessed whether the number of prior lines of therapy affects outcomes for this patient population, Ahmed concludes.