Efficacy and Safety: Brexu-cel's Impact on CNS Response in B-ALL


Ibrahim N. Muhsen, MD, discusses the findings and key takeaways from his presentation given at the 2024 Tandem Meeting.

Ibrahim N. Muhsen, MD, a hematology and medical oncology fellow at Baylor College of Medicine, discusses the findings and key takeaways from his presentation looking at central nervous system (CNS) responses to brexucabtagene autoleucel (brexu-cel; Tecartus) in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) entering chimeric antigen receptor (CAR) T-cell therapy with active CNS involvement.1

According to findings presented at the 2024 Tandem Meeting, brexu-cel led to notable efficacy in achieving high rates of CNS remission in patients with relapsed/refractory B-ALL.

Specifically looking at safety, cytokine release syndrome (CRS) of any grade was observed in 73.5% (n = 25) of patients. Grade 3/4 CRS was seen in 3% (n = 1) of patients. The median time to CRS onset was 5 days (range, 1-10), and these adverse events (AEs) lasted for a median of 4 days (range, 1-10). Notably, 26.5% (n = 9) of patients did not have a CRS event.

Any-grade immune effector cell-associate neurotoxicity syndrome (ICANS) was seen in 76.6% (n = 23) of patients. This included grade 3/4 ICANs in 35.3% (n = 12). The median time to ICANS onset was 7 days (range, 3-15), and the median duration of this toxicity was 3 days (range, 1-30).

Moreover, CRS that was grade 3 or 4 affected 3% (n = 1/34) of patients with CNS disease, 12% (n = 19/155) of patients without CNS disease whose data were included in the Real World Outcomes Collaborative for CAR T in ALL (ROCCA) consortium, and 24% (n = 13/55) of patients in the ZUMA-3 trial. Rates of grade 3/4 ICANS were 35.3% (n = 12/34), 30% (n = 47/155), and 24% (n = 13/55) in each respective group.

Overall, findings from the study showed that treating adult patients with CNS B-ALL with central nervous syste is feasible.


0:08 | When it comes to the safety of brexu-cel, our patient population that has a very low rate of high-grade CRS, we actually had only 1 patient that had grade 3 to 4 CRS. On the other hand, when it comes to ICANs, we had a higher number of patients who had grade 3 to 4 ICANs of 35%. However, when we compared the numbers to the number of patients who develop the grade 3 to 4 ICANs in the ROCCA consortium database without CNS involvement, the numbers were similar.

1:01 | Additionally, when it comes to the efficacy of the CAR T cells, we did see that our patients had a very high CNS response rate. We had 22 patients who showed response out of 25 who were evaluated, which is almost more than 85% of patients who achieved CNS1 status or no CNS disease after the CAR T-cell therapy. Our findings are very encouraging for the use of CAR T-cell therapy in patients who have CNS B-ALL. However, more studies are needed to confirm these results.

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