Enliven Reports Positive Initial Phase 1b Data for ELVN-001 in CML and Outlines 2026 Clinical Milestones
Encouraging Results from the ENABLE Trial
Enliven Therapeutics, Inc. (Nasdaq: ELVN) has announced promising initial results from its Phase 1b ENABLE clinical trial for ELVN-001, a targeted therapy for patients battling chronic myeloid leukemia (CML) that is relapsed, refractory, or intolerant to existing treatments. As of December 22, 2025, the trial demonstrated a cumulative major molecular response (MMR) rate of 69% by 24 weeks, with 53% of participants achieving MMR during this period.
Key Data Highlights from the Phase 1b Trial
In the trial, a total of 60 patients were enrolled, where they received varying dosages of the medication. The data indicates that:
- 47% MMR achieved in the 80 mg cohort (n=19).
- 69% MMR achieved in the randomized 60 mg and 120 mg cohorts (n=41).
- 38% of patients in the 80 mg cohort achieved MMR.
- 53% of patients in the higher dose cohorts achieved MMR.
- 100% maintenance of MMR was observed in evaluable patients.
- Deep Molecular Response (DMR) rates were 16% and 35% for the respective cohorts.
Despite the heavily pretreated patient population, which included patients with significant prior TKI treatments, the efficacy of ELVN-001 sets a favorable comparison to other existing therapies.
Favorable Safety and Tolerability Profile
The data reinforces ELVN-001's potential as a best-in-class active-site tyrosine kinase inhibitor. The safety profile across all evaluated dose levels has remained consistent with previously reported findings, indicating no maximum tolerated dose or new safety signals. This can significantly impact the treatment options available for CML patients.
Looking Ahead: Milestones for 2026
With significant progress made, Enliven plans to present additional Phase 1 data during mid-2026 and align with the FDA on dose selection and design for the upcoming Phase 3 trial, expected to commence in the latter half of 2026.
- Mid-year presentation of additional Phase 1 data.
- Regulatory alignment with the FDA on the trial design.
- Initiation of ENABLE-2, the Phase 3 clinical trial of ELVN-001.
About Enliven Therapeutics
Enliven Therapeutics is committed to advancing the discovery and development of small molecule therapeutics aimed at improving patient health. The company is headquartered in Boulder, Colorado, and focuses on addressing unmet medical needs through precision oncology.
Forward-Looking Statements
This article contains forward-looking statements about Enliven and its product, ELVN-001, including anticipated clinical milestones and regulatory discussions, which are subject to various risks and uncertainties.