Dr Bezerra on the Real-World Efficacy of Brexu-Cel in B-ALL

Evandro D. Bezerra, MD, hematologic oncologist, the Ohio State University Comprehensive Cancer Center–James, discusses real-world outcomes associated with brexucabtagene autoleucel (Tecartus; brexu-cel) in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).

At the 2023 ASH Annual Meeting, investigators presented findings from a real-world investigation of the impact of the CD19-directed CAR T-cell therapy brexu-cel in patients with B-ALL from the Center for International Blood and Marrow Transplant Research Registry. In 2021, brexu-cel received FDA approval for use in adult patients with relapsed/refractory B-ALL, based on data from the phase 1/2 ZUMA-3 clinical trial (NCT02614066), Bezerra states. This study aimed to assess the outcomes of patients treated with brexu-cel in a real-world setting to determine whether the results aligned with those observed in ZUMA-3, Bezerra explains.

It is common for significant differences in patient characteristics to exist between real-world and clinical trial patient populations, he expands. An important initial finding of this real-world study was that 90% of patients might not have met the eligibility criteria for enrollment in the ZUMA-3 clinical trial, Bezerra elucidates. Despite this substantial difference in the patient population, brexu-cel was effective in the real-world setting, and generated high rates of complete remission (CR), he notes. At 6 months, the overall survival rate was 79% (95% CI, 71%-85%).

Initially, investigators hypothesized that the real-world study might reveal different response rates or toxicity profiles with brexu-cel vs those observed in ZUMA-3 due to potential variations in patient characteristics between the 2 populations, Bezerra continues. However, investigators found that the rates of CR without hematological recovery with brexu-cel in the real-world population were consistent with those observed in the clinical trial population, he says. Despite the significant differences between the clinical trial and real-world patient populations, the efficacy of brexu-cel in this real-world analysis remained consistent with the outcomes seen in the clinical trial, Bezerra concludes.