Enliven Therapeutics disclosed that its next‑generation BCR‑ABL inhibitor, ELVN‑001, achieved a cumulative major molecular response (MMR) rate of 69% by 24 weeks in the ongoing Phase 1b ENABLE trial. In the randomized 60 mg and 120 mg cohorts, 53% of patients reached MMR, and 35% achieved deep molecular response (DMR). The 80 mg cohort produced 38% MMR and 16% DMR, while 100% of evaluable patients who were in MMR at enrollment maintained or deepened their response through the study period.
The results position ELVN‑001 as a potential best‑in‑class active‑site tyrosine‑kinase inhibitor for chronic myeloid leukemia (CML), particularly for patients who are relapsed, refractory, or intolerant to existing therapies. The drug’s activity against the T315I resistance mutation and its favorable safety profile—no new safety signals and no maximum tolerated dose identified—provide a strong clinical advantage over current options such as asciminib and other emerging TKIs.
Enliven’s strategic focus on ELVN‑001 follows the discontinuation of its HER2 program, allowing the company to concentrate resources on a single, high‑potential CML candidate. The appointment of Scott Garland to the board further signals a commitment to advancing the program through late‑stage development and eventual commercialization.
Investor sentiment reflected the strength of the data, with the company’s shares surging more than 50% following the announcement. The market reaction was driven by the high MMR and DMR rates, the absence of safety concerns, and the clear path to a pivotal Phase 3 trial slated for the second half of 2026.
Chief Medical Officer Helen Collins said, “We are excited about these initial Phase 1b data, the progress we made throughout 2025, and the year ahead. ELVN‑001 has the potential to be the best‑in‑class active‑site TKI for the treatment of CML and an important treatment option across all lines of therapy.” She added that the company is preparing for regulatory interactions with the FDA to align on dose selection and support the Phase 3 launch.
The strong Phase 1b data de‑risk the ELVN‑001 program and enhance Enliven’s competitive position in a crowded CML market. By demonstrating superior efficacy and safety, the company is poised to capture a meaningful share of the CML treatment landscape, provided the upcoming Phase 3 trial confirms these early signals and secures regulatory approval.
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