ASH 2023 | Real-world outcomes of brexu-cel for R/R B-ALL: evidence from the CIBMTR Registry
Evandro Bezerra, MD, The Ohio State University Comprehensive Cancer Center, Columbus, OH, discusses real-world outcomes with the use of brexucabtagene autoleucel (brexu-cel) in patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). In this study, brexu-cel demonstrated high efficacy, and outcomes were consistent with findings from the ZUMA-3 trial (NCT02614066), although 90% of patients would not have met the eligibility criteria for ZUMA-3. This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (edited for clarity)
So in our abstract we look at the real-world outcomes of brexu-cel for patients with relapsed/refractory B-cell ALL. As we all know, brexu-cel showed high efficacy for relapsed/refractory B-cell in the ZUMA III clinical trial, leading to the approval by the FDA and become standard-of-care for this population. But now we need the external validation of the clinical trial to show that that brexu-cel is effective and also safe in the real-world setting, when frequently the patients characteristics is not the same as the patients treated in a clinical trial...
So in our abstract we look at the real-world outcomes of brexu-cel for patients with relapsed/refractory B-cell ALL. As we all know, brexu-cel showed high efficacy for relapsed/refractory B-cell in the ZUMA III clinical trial, leading to the approval by the FDA and become standard-of-care for this population. But now we need the external validation of the clinical trial to show that that brexu-cel is effective and also safe in the real-world setting, when frequently the patients characteristics is not the same as the patients treated in a clinical trial.
So in our study, one interesting finding or highlight is that 90% of the patients would not be eligible to the clinical trial ZUMA III potentially. One of the reasons could be the low disease burden, like 40% of the patients had a less than 5% blast. But despite the significant difference in the patients population and the clinical trial and the patient population in the real-world setting, brexu-cel shows high effectiveness with CR rates, with or without hematology recovery, of 7.9%, and also overall survival at six months of 7.9%.
In regards to safety, again brexu-cel in the real-world setting shows a consistent safety profile to the clinical trial despite the patient population being different. CRS rates of grade three or higher was 9%, and ICANs rates of grade three or higher was 23%, showing that the safety profile of brexu-cel in the real-world setting was manageable despite the significant difference in the patients population.
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