Enliven Reports Positive Initial Phase 1b Data for ELVN-001 in CML and Outlines 2026 Clinical Milestones

Core Insights - Enliven Therapeutics announced positive initial data from the Phase 1b ENABLE clinical trial for ELVN-001, showing a cumulative major molecular response (MMR) rate of 69% by 24 weeks, with 53% of patients achieving MMR [1][2] - ELVN-001 is positioned as a potentially best-in-class active-site TKI for chronic myeloid leukemia (CML), demonstrating a favorable safety and tolerability profile across all evaluated doses [1][3][11] - The company anticipates multiple key data, regulatory, and operational catalysts in 2026, including the initiation of a Phase 3 trial [1][2][11] Clinical Data Summary - In the Phase 1b trial, 60 patients were enrolled, with 53% having received four or more prior TKIs, indicating a heavily pretreated population [5][6] - The 80 mg QD cohort (n=19) showed an MMR achievement rate of 38% and a deep molecular response (DMR) rate of 16% [5][6] - The randomized 60 mg and 120 mg cohorts (n=41) demonstrated higher rates of MMR achievement at 53% and DMR at 35% [5][6] ELVN-001 Program Updates - ELVN-001 is designed to specifically target the BCR::ABL gene fusion, the oncogenic driver in CML, and has shown activity against the T315I mutation, which is resistant to most approved TKIs [3][8] - The ENABLE trial is a dose escalation and expansion study aimed at evaluating the safety, tolerability, and recommended dose for further clinical evaluation [7] Future Milestones - The company plans to present additional Phase 1 data mid-year 2026 and is preparing for regulatory interactions with the FDA regarding dose selection and Phase 3 trial design [11] - The initiation of ENABLE-2, the Phase 3 clinical trial of ELVN-001, is expected in the second half of 2026 [11]