Inaticabtagene Autoleucel Demonstrates Efficacy and Tolerability for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

Inaticabtagene autoleucel (Inati-cel) demonstrated high response rates and durable remissions among adult patients with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL), according to findings from a phase 2, single-arm, multicenter study published in Blood Advances.

Previous research on inaticabtagene autoleucel, a novel CD19 chimeric antigen receptor (CAR) T-cell therapy, for R/R B-ALL has shown promising efficacy, researchers conducted a phase 2, single-arm, multicenter trial to evaluate the efficacy and safety of inaticabtagene autoleucel in adult patients with CD19+ R/R B-ALL.

The primary end point of the trial was overall response rate [ORR] at 3 months, complete remission (CR) or CR with incomplete hematologic recovery (Cri). A total of 48 patients received an infusion of inaticabtagene autoleucel infusion. The median age was 31 years (range, 18 to 58). The median marrow blast percentage was 62.5% (range, 5 to 96.5).

At month 3, the ORR was 70.8% (95% CI, 55.9 to 83.1). The best ORR was 85.4%, with all patients who achieved minimal residual disease negativity. The median follow-up was 23.7 months, and the median duration of remission was 20.7 months (95% CI, 6.4 to not reached). Additionally, the median overall survival was not reached (95% CI, 13.0 months to not reached).

In terms of safety, grade ≥ 3 cytokine release syndrome was reported by 12.5% of patients and neurologic events were reported by 6.2% of patients.

“The findings of this study have significant implications for clinical practice, offering a promising therapeutic option for adult patients with R/R B-ALL who have exhausted standard treatments,” the researchers concluded, “Inati-cel's high remission rates and manageable safety profile suggest its potential to become a cornerstone in B-ALL management, particularly when conventional therapies have failed.”

Source:

Wang Y, Lv L, Song Y, et al. Inaticabtagene autoleucel in adult relapsed or refractory B-cell acute lymphoblastic leukemia. Blood Advances. Published online February 14, 2025. doi: 10.1182/bloodadvances.2024014182