Brexu-Cel Benefits B-ALL Patients – Even Without CNS Involvement

Summary of brexu-cel (Tecartus) in B-ALL with CNS Involvement:

This article details findings‍ from a Real-World Outcomes collaborative for CAR T in ALL (ROCCA) consortium study evaluating the efficacy and safety of brexu-cel (Tecartus) in patients with B-cell acute lymphoblastic leukemia (B-ALL), specifically focusing on ⁣those with central nervous system (CNS) involvement.

Key Findings:

Efficacy: Brexu-cel demonstrated efficacy in patients with CNS involvement,‍ achieving high rates of‍ CNS disease remission and comparable progression-free and overall survival to patients without CNS involvement.
Safety: The toxicity profile of brexu-cel was comparable between patients with and without CNS involvement. Rates of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated‍ Neurotoxicity syndrome (ICANS) were similar in both groups. CRS & ICANS Rates:
CNS Group ⁢(n=31): 74.2% CRS (1 case grade 3/4),⁣ 64.5% ICANS (11 patients grade 3/4)
Non-CNS Group⁢ (n=158): 84.8% CRS ⁢(12.0% grade 3/4), 54.4% ICANS (30% ‍grade 3/4)
Study Details:
‍ 189 patients total were infused with brexu-cel.
CNS involvement was categorized as CNS-2 (blasts in CSF with ⁢low WBC count) or CNS-3 (blasts with⁣ high WBC count and/or clinical symptoms).
Median follow-up was 13.8 months.
⁣
Relapse occurred in 12 patients in the CNS group, with a median time to ‍relapse of 100 days; 5 of these relapses were in the‍ CNS.
Patient Characteristics:
CNS Group: Median age 46.5 years, 58.1% male,45.2% Ph-positive disease.
* Non-CNS Group: Median age 46 ⁢years, 56.3% male, 54.4% Ph-negative disease.

Context & Comparison to Previous Studies:

The findings are consistent with ⁢previous studies like ZUMA-3 (NCT02614066),which reported high rates of CRS and ⁢ICANS (89% CRS,60% neurotoxicity,~25% grade 3/4). ZUMA-3 demonstrated a 71% complete remission rate⁢ in patients with relapsed/refractory B-ALL.In⁤ essence, ⁣the study provides real-world evidence⁤ supporting the use of brexu-cel as an effective and reasonably safe treatment option for patients with B-ALL, even those with challenging CNS involvement.