Enliven Therapeutics Inc. announced positive initial data from its ongoing Phase 1b ENABLE clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) who are relapsed, refractory, or intolerant to available tyrosine kinase inhibitors. As of December 22, 2025, 60 patients were enrolled across different dosing cohorts. The cumulative major molecular response (MMR) rate was 69% by 24 weeks, with 53% of patients achieving MMR within that period. ELVN-001 demonstrated a favorable safety and tolerability profile across all tested doses, with no new safety signals identified. Additional Phase 1 data are expected to be presented mid-2026, and the company plans to align with the FDA on dose selection and initiate a Phase 3 trial in the second half of 2026.

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