Nausheen Ahmed, MD, on the Impact of Prior Treatments on the Safety of Brexu-cel

“...This is the largest analysis to date looking at the effectiveness and the safety data for brexu-cel in the real-world population. We see that the outcomes were fairly similar to the ZUMA-2 outcomes...”

Kite Pharma’s brexucabtagene autoleucel (brexu-cel, Tecartus) was approved by the FDA as a second-line treatment for adult patients with relapsed/refractory (r/r) mantle cell lymphoma (MCL) in 2020 based on results from the phase 2 ZUMA-2 clinical trial (NCT02601313).¹ The FDA indication does not require a specific first-line therapy to have been used; as such, patients in real-world settings have varied treatment histories when receiving brexu-cel for r/r MCL.

Nausheen Ahmed, MD, an assistant professor in the Division of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Medical Center, presented a study entitled “Real-world outcomes of brexucabtagene autoleucel (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 study consisted of an analysis of efficacy and safety 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, with a focus on examining how prior treatment impacted these outcomes.

In an interview with CGTLive™’s sister publication OncLive™, Ahmed discussed the safety findings from the study. She emphasized that the safety outcomes in the real-world data were largely consistent with the safety outcomes in ZUMA-2, noting that 88% of patients experienced cases of cytokine release syndrome (CRS), 10% of patients experienced grade 3 or higher CRS cases, 60% of patients experienced cases of immune effector cell-associated neurotoxicity syndrome (ICANS), and 28% of patients experienced cases of grade 3 or higher ICANS. She also discussed findings from the multivariate regression analysis used to examine the impact of prior treatment history in the real-world data. Ahmed noted that patients who had been previously treated with bendamustine tended to have less high-grade ICANS but a greater risk of prolonged cytopenias. She also pointed out that patients who had received 1 to 2 prior lines of therapy tended to have higher grade CRS compared to patients who had received 3 or more prior lines of therapy. Ahmed additionally gave a summary of the main efficacy findings she presented and emphasized the importance of keeping in mind the short follow-up time for the data presented.

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REFERENCE
1. U.S. FDA Approves Kite’s Tecartus™, the first and only CAR T treatment for relapsed or refractory mantle cell lymphoma. News release. Kite, a Gilead Company. July 24, 2020. Accessed June 8, 2023. https://www.businesswire.com/news/home/20200724005428/en/
2. Ahmed N, Kambhampati S, Hamadani M, et al. Real-world outcomes of brexucabtagene autoleucel (brexu-cel) for relapsed or refractory mantle cell lymphoma: a CIBMTR subgroup analysis by prior treatment. Presented at: the European Hematology Association (EHA) 2023 Congress, June 8-11, held both virtually and in Frankfurt, Germany. Abstract #S220