Asciminib monotherapy in patients with chronic myeloid leukemia in chronic phase without BCR::ABL1^T315I treated with at least 2 prior TKIs: Phase 1 final results.

ABSTRACT: Asciminib is the first approved BCR::ABL1 inhibitor that Specifically Targets the ABL Myristoyl Pocket (STAMP). The present final analysis of the phase 1, open-label, nonrandomized trial (NCT02081378) assessed the long-term safety, tolerability, and antileukemic activity of asciminib in 115 patients with chronic myeloid leukemia in chronic phase without the BCR::ABL1^T315I mutation who received asciminib 10-200 mg twice daily (BID) or 80-200 mg once daily (cutoff: March 14, 2023). Median exposure duration was 5.9 (range, 0-8.4) years; 60.9% of patients continued receiving asciminib through post-trial access. Grade ≥3 adverse events (AEs) occurred in 88 patients (76.5%). AEs led to treatment discontinuation, dose adjustment/interruption, or additional therapy in 15 (13.0%), 74 (64

SUBMITTER: Hochhaus A 

PROVIDER: S-EPMC12055594 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature