Asciminib monotherapy in patients with BCR::ABL1 T315I-mutated chronic-phase chronic myeloid leukemia: phase 1 trial final results.
LeukemiaJul 16, 2026 (epub)
Jorge E Cortes, Delphine Rea, Michael J Mauro et al.
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In 30 seconds
This phase 1 trial evaluated the long-term safety and efficacy of asciminib in 48 patients with BCR::ABL1 T315I-mutated chronic-phase chronic myeloid leukemia (CML-CP). After a median exposure of 3.5 years, 53.3% of evaluable patients achieved major molecular response (MMR), with 86% maintaining MMR for at least 144 weeks.
Key findings
- 53.3% of evaluable patients achieved major molecular response (MMR).
- 86% of patients maintained their first MMR for at least 144 weeks.
- The incidence of grade ≥3 adverse events was 60.4%, consistent over time.
- 4.4 cases of first all-grade adverse events occurred per 100 patient-years.
Why it matters
Asciminib offers a viable treatment option for patients with T315I-mutated CML-CP, a population with limited therapeutic alternatives. Understanding its long-term efficacy and safety is crucial for optimizing patient management.