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Inaticabtagene autoleucel for adult patients with R/R B-ALL: Phase II trial results
CAR T-cell therapies targeting CD19 have demonstrated promising efficacy for the treatment of patients with R/R B-ALL; a population with a significant unmet need for safe and effective treatments. Inaticabtagene autoleucel (inati-cel) is a novel autologous CD19-specific CAR T-cell therapy with a distinct scFv derived from the HI19α clone.1
A single-arm, open-label, multicenter phase II trial (NCT04684147) assessed the safety and efficacy of inati-cel in 48 adult patients with R/R B-ALL and ECOG PS of 0 to 1 across 10 centers in China.1 The primary endpoint was overall remission rate (ORR) at the end of Month 3. Results were published in Blood Advances by Wang et al.1
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Key learnings |
The primary endpoint was met, with a 3-month ORR of 70.8% vs a historical control rate of 25% (p < 0.0001). The bORR was 85.4%, with all responders achieving MRD negativity, and a median DOR of 20.7 months. |
With a median follow-up of 23.7 months, the median RFS was 12.4 months, with the median OS not reached. The estimated 24-month RFS and OS rates were 35.8% and 55.2%, respectively. |
With a median follow-up of 23.7 months, inati-cel exhibited a manageable long-term safety profile, with Grade ≥3 CRS and ICANS occurring in 12.5% and 6.2% of patients, respectively. |
Results from this trial led to the approval of inati-cel by the China National Medical Products Administration as the first CAR T-cell therapy for adult patients with R/R B-ALL in China, addressing a significant unmet medical need. |
Abbreviations: B-ALL, B-cell acute lymphoblastic leukemia; bORR, best overall remission rate; CAR, chimeric antigen receptor; CRS, cytokine release syndrome; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ICANS, Immune effector cell-associated neurotoxicity syndrome; inati-cel, inaticabtagene autoleucel; MRD, measurable residual disease; ORR, overall remission rate; OS, overall survival; R/R, relapsed/refractory; RFS, relapse-free survival; scFv, single-chain variable fragment.
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