Enliven Therapeutics Announces Updated Positive Data from Phase 1 Clinical Trial of ELVN-001 in CML at EHA 2025 Congress

Core Insights - Enliven Therapeutics announced positive data from the Phase 1 ENABLE clinical trial for ELVN-001, a treatment for chronic myeloid leukemia (CML), showing a cumulative major molecular response (MMR) rate of 47% and an achieved MMR rate of 32% by 24 weeks [1][11] - The trial demonstrated a favorable safety and tolerability profile, with only 3.4% of patients experiencing dose reductions due to treatment-emergent adverse events (TEAEs) and 4.6% discontinuing treatment due to TEAEs [11] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics aimed at improving the quality of life and survival for patients [13] - The company is based in Boulder, Colorado, and aims to address unmet needs in precision oncology [13] Clinical Trial Details - The ENABLE trial is a Phase 1 study evaluating ELVN-001 in previously treated CML patients, with a focus on safety, tolerability, and determining the recommended dose for further evaluation [9] - As of April 28, 2025, 90 patients were enrolled, with a median treatment duration of approximately 29 weeks [5] Efficacy Data - Among 53 evaluable patients, 25 (47%) achieved MMR by 24 weeks, with 13 of 41 (32%) achieving and 12 of 12 (100%) maintaining MMR [5][11] - The trial included heavily pretreated patients, with 67% having received three or more prior TKIs [5] Safety Profile - ELVN-001 was well tolerated across all evaluated doses, with low levels of dose reductions and discontinuations [11] - The maximum tolerated dose was not reached, and the pharmacokinetic profile supports once-daily dosing [11][12] Future Outlook - Enliven plans to initiate a head-to-head Phase 3 pivotal trial for ELVN-001 in 2026, leveraging insights from historical Phase 1 data to guide regulatory pathways [7][9]