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

Core Insights - Enliven Therapeutics announced positive data from the Phase 1 ENABLE clinical trial of ELVN-001 for chronic myeloid leukemia (CML), showing a cumulative major molecular response (MMR) rate of 44% by 24 weeks [1][5] - The trial included 74 patients with a median treatment duration of approximately 26 weeks, demonstrating a favorable safety and tolerability profile [1][5] - The updated data will be presented at the European Hematology Association (EHA) Congress in June 2025, with a webcast and conference call scheduled for the same day [1][7] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics, particularly for oncology [10] - The company aims to address unmet medical needs through a precision oncology approach, enhancing patient survival and well-being [10] Product Details - ELVN-001 is a selective small molecule kinase inhibitor targeting the BCR::ABL gene fusion, which is the oncogenic driver in CML [2][9] - The ongoing ENABLE trial is designed to evaluate the safety, tolerability, and recommended dose of ELVN-001 in patients who have failed or are intolerant to existing therapies [8] Clinical Trial Insights - As of January 21, 2025, 74 patients were enrolled in the ENABLE trial, with 66% having received three or more prior tyrosine kinase inhibitors [5] - Among evaluable patients, 44% achieved MMR by 24 weeks, with 100% of those maintaining MMR at the data cutoff [5] - The trial's results are favorable compared to previous Phase 1 trials of approved BCR::ABL1 TKIs, particularly given the heavily pretreated patient population [5] Upcoming Events - The oral presentation at the EHA Congress will be led by Dr. Andreas Hochhaus, focusing on the ENABLE trial results [6] - Following the presentation, additional data will be available on the company's website [6]