Clinical TrialJun 11, 2026, 08:11 AM
Enliven Therapeutics Reports Positive Phase 1 Data for ELVN-001; FDA Aligns on Phase 3 Dose
AI Summary
Enliven Therapeutics, Inc. (ELVN) announced updated positive data from its Phase 1 ENABLE clinical trial evaluating ELVN-001 for chronic myeloid leukemia (CML). The data showed encouraging efficacy, with a 61% Major Molecular Response (MMR) rate by 24 weeks in the 80 mg QD Phase 1b cohort. The drug demonstrated a favorable safety profile and alignment with the FDA on the 80 mg QD dose for the upcoming Phase 3 ENABLE-2 trial. This trial is expected to enroll patients previously treated with one or more TKIs.
Key Highlights
- Enliven Therapeutics announced updated positive data from the Phase 1 ENABLE trial for ELVN-001 in CML patients.
- 161 patients enrolled; 76% remain on study with a median treatment duration of 35 weeks.
- 69 patients in Phase 1b were evaluable for MMR by 24 weeks, with an overall MMR rate of 54%.
- In the 80 mg QD Phase 1b cohort, 28 patients were evaluable for MMR by 24 weeks, achieving a 61% MMR rate.
- Deep Molecular Response (DMR) achieved by 22% in overall Phase 1b and 30% in the 80 mg QD cohort by 24 weeks.
- ELVN-001 was generally well-tolerated; Grade >=3 TEAEs reported in 34% of patients overall.
- 80 mg QD selected as the recommended dose for the Phase 3 ENABLE-2 trial.
- ENABLE-2 will enroll patients previously treated with one or more TKIs.
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