Enliven Therapeutics Early Leukemia Drug Results Impress, Stock Soars

Core Viewpoint - Enliven Therapeutics Inc. has reported promising initial data from its Phase 1b ENABLE trial of ELVN-001 for chronic myeloid leukemia, leading to a significant increase in stock price. Group 1: Clinical Data - As of December 22, 2025, 60 heavily pre-treated patients were enrolled in the trial [2] - In the 80 mg QD cohort (n=19), major molecular response (MMR) achievement was 38% and deep molecular response (DMR) was 16%, which is favorable compared to previous Phase 1 trials of approved BCR::ABL1 TKIs [2] - In the randomized 60 mg and 120 mg cohorts (n=41), MMR achievement was 53% and DMR was 35% [3] - Across all Phase 1b cohorts, 100% of evaluable patients who achieved MMR at enrollment maintained or deepened their response [3] Group 2: Safety and Efficacy - Clinical activity was observed at doses from 60 mg to 120 mg QD, with no clear evidence of dose response in efficacy or safety [4] - ELVN-001 demonstrated a favorable safety and tolerability profile across all evaluated doses, consistent with previously reported data, with no maximum tolerated dose and no new safety signals identified [4] Group 3: Future Plans and Market Reaction - The company plans to initiate the ENABLE-2 Phase 3 trial of ELVN-001 in the second half of 2026 [5] - Enliven Therapeutics shares increased by 50.42% to $23.27 at the time of publication [5]