Introduction - Obecabtagene autoleucel, a novel chimeric antigen receptor (CAR) T-cell therapy aimed at CD19, is a revolutionary medication for individuals with newly diagnosed high-risk B-cell acute lymphoblastic leukemia (ALL). The evaluation of the safety and efficacy of the drug is done in adult patients who either present with high-risk genetic characteristics at diagnosis or still show detectable disease following the initial phase of chemoimmunotherapy. The primary objective is to ascertain the number of patients who remain free of events for 18 months post-treatment.1

Methods- An international Phase Ib/II study assessing the CD19-targeted CAR T-cell treatment

obecabtagene autoleucel in adults (≥18 years) suffering from relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) was reviewed. Participants were divided into two groups: Cohort 2A comprised individuals with morphological disease (≥5% bone marrow blasts), while Cohort 2B consisted of patients with observable residual disease.. The primary goal in Cohort 2A was the overall remission rate (ORR), defined as the percentage of patients who attained complete remission (CR) or CR with incomplete hematologic recovery (CRi). Additional objectives included event-free survival (EFS), overall survival (OS), and safety. The study is designed to assess the efficacy and safety of obe-cel in a high-risk adult patient group.1,2

Results- In a study with 153 participants, 127 (83.0%) received at least one dose of obe-cel and were part of the evaluable group. In Cohort 2A, which comprised 94 individuals and had a median followup duration of 20.3 months, the overall remission rate stood at 77% (95% CI: 67–85). This included 55% of patients achieving complete remission (CR) and 21% attaining CR along with incomplete hematologic recovery (CRi). These findings surpassed the null hypotheses of ≤40% for overall response rate (ORR) and ≤20% for CR (P < 0.001). Among all who received treatment, the median event-free survival (EFS) was 11.9 months (95% CI: 8.0–22.1), with estimated EFS rates of 65.4% at 6 months and 49.5% at 12 months. The median overall survival (OS) was recorded at 15.6 months (95% CI: 12.9 to not evaluable), with estimated OS rates of

80.3% at 6 months and 61.1% at 12 months. The treatment was mostly well tolerated, with grade 3 or higher cytokine release syndrome occurring in 2.4% of patients and grade 3 or higher neurotoxicity (ICANS) affecting 7.1%.2

Conclusion -The progress in CAR T-cell therapies has transformed healthcare; however, challenges such as severe cytokine release syndrome (CRS) and related neurotoxicity have hindered their broader application. Obecabtagene autoleucel is an innovative drug.

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2025
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