Real-World Data on Brexu-cel in Relapsed/Refractory B-Cell ALL

Evandro D. Bezerra, MD, the Ohio State Comprehensive Cancer Center – James Cancer Hospital & Solove Research Institute, discusses the main takeaways from a real-world analysis that looked at brexucabtagene autoleucel (Tecartus; brexu-cel) as a treatment for patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (ALL).

These real-world data come from the CIBMTR Registry and showed brexu-cel to be effective in this patient population. Findings were also consistent with those from ZUMA-3 (NCT02614066), a study which supported the FDA’s approval of the agent in 2021.

Notably, Bezerra explains that 91% of patients in the real-world evaluation were deemed ineligible for the ZUMA-3 trial. This was most commonly due to low disease burden, with nearly 40% of patients having less than 5% bone marrow blasts, a minimum requirement for ZUMA-3. However, the rates of complete response without hematological recovery with brexu-cel in this population were consistent with those observed in the clinical trial population.

Transcription:

0:09 | They are pretty consistent. We saw an 80% rate of [cytokine release syndrome (CRS)], 9% of CRS that was grade 3 or higher, 47% rates of [immune effector cell-associated neurotoxicity syndrome (ICANS)] and 23% of rates of grade 3 or higher ICANS. This is similar to the scene in the ZUMA-3 clinical trial, showing that brexu-cel has a safety profile consistent to that seen in the ZUMA-3 clinical trial and is manageable in the real-world setting.

0:38 | One of the main takeaways is that the ZUMA clinical trial patients had a minimal requirement of 5% blasts in the bone marrow to be eligible for the treatment. In the real-world setting, a lot of these patients are receiving brexu-cel with less than 5% bone marrow blasts. Despite this, brexu-cel still remain effective. Even the patients that are responding to salvage therapy or bridging therapy, they still respond to brexu-cel, and the patients should be considered to receive brexu-cel, despite having lower disease.

REFERENCE:

Bezerra E, Itani T, Wudhikarn K, et al. Real-world outcomes of brexucabtagene autoleucel (brexu-cel) for relapsed or refractory (R/R) adult B-cell acute lymphoblastic leukemia (B-cell ALL): evidence from the CIBMTR registry. Blood. 2023;142(suppl 1):1029. doi:10.1182/blood-2023-174543