The assistant professor in the Division of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Medical Center discussed the real-world data she is presenting at EHA’s 2023 congress.
“When [brexu-cel] was approved in the US it was approved in the second-line setting, without any requirement for prior BTK inhibitor (BTKi) or any [other specific] prior therapy—as long as [patients] received 1 prior line of therapy... Hence, there's a need to understand the real-world outcomes in patients that may have been BTKi-naive and outcomes in patients who were not exposed to Bendamustine...”
Kite Pharma’s brexucabtagene autoleucel (brexu-cel, Tecartus), a marketed chimeric antigen receptor T-cell (CAR-T) therapy, was originally approved by the FDA as a second-line treatment for adult patients with relapsed/refractory (r/r) mantle cell lymphoma (MCL) in July 2020.1 The approval was based on results from the phase 2 ZUMA-2 clinical trial (NCT02601313). Because the indication does not require a specific first-line therapy to have been used, there has been interest in determining how prior treatment history affects the efficacy of brexu-cel in real-world practice.
Nausheen Ahmed, MD, an assistant professor in the Division of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Medical Center, is giving a talk entitled “Real-world outcomes of brexucabtagenea utoleucel (brexu-cel) for relapsed or refractory mantle cell lymphoma: a CIBMTR subgroup analysis by prior treatment” at the European Hematology Association (EHA) 2023 Congress, held June 8-11, both virtually and in Frankfurt, Germany.2 The presentation covers an analysis of real-world outcomes from a subgroup of 380 patients treated with brexu-cel who were registered in the Center for International Blood and Marrow Transplant Research (CIBMTR) observational database.
In an interview with CGTLive™’s sister publication OncLive™, Ahmed discussed the rationale behind the study and the efficacy results seen so far. She went over the demographics of the study population, noting that they were similar to those of the study population in ZUMA-2. Ahmed noted that the overall response rate (ORR) in the real-world study cohort was 90% and the complete response (CR) rate was 78%. She pointed out that across several subgroups within the cohort, based on the number and type of prior therapies received, ORRs and CR rates tended to be similar; although, patients who had received 1-2 prior lines of therapy had a significantly better CR rate than patients with 3 or more lines of prior therapy.