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Enliven Therapeutics Showcases Promising Results for ELVN-001 in CML

Overview of the Positive Phase 1b Data

Enliven Therapeutics, Inc. has recently announced positive initial results from its ongoing Phase 1b ENABLE clinical trial evaluating ELVN-001 in chronically ill patients suffering from chronic myeloid leukemia (CML). The findings suggest that ELVN-001, a novel small-molecule therapy, shows strong efficacy as a selective inhibitor of the BCRABL gene fusion, a key driver of CML.

As of the latest data cutoff on December 22, 2025, 60 patients had been enrolled in the initial cohorts of the trial. Among these patients, who were predominantly heavily pretreated, a cumulative major molecular response (MMR) rate of 69% was observed by 24 weeks. This impressive rate included a substantial 53% of patients achieving MMR by the same timeframe. These outcomes are particularly notable given that a significant number of participants had previously undergone treatment with four or more distinct tyrosine kinase inhibitors (TKIs).

ELVN-001's Efficacy and Safety Profile

The efficacy results are indicative of a robust performance by ELVN-001, despite the heavily pretreated nature of the patient population. Within specific dosing cohorts, namely the 80 mg and combined 60/120 mg cohorts, MMR rates were reported at 38% and 53% respectively, showcasing a clear potential for ELVN-001 to establish itself as a best-in-class active-site TKI.

In terms of safety, the results demonstrated a favorable profile across all evaluated doses, with no instances of a maximum tolerated dose identified and no new safety signals emerging. The favorable tolerability underlines the therapy's promise, suggesting that it will engage minimal adverse effects, a crucial criterion for long-term treatment regimens in CML patients.

Future Clinical Milestones

Enliven's Chief Medical Officer, Dr. Helen Collins, expressed enthusiasm regarding the data and the company’s advancements throughout 2025. Looking ahead, several significant milestones are expected throughout 2026. These include:

• - Mid-year presentation of additional Phase 1 data from the ENABLE trial
• - Regulatory engagement with the U.S. FDA to finalize dose selection and Phase 3 trial designs
• - Initiation of ENABLE-2, the Phase 3 clinical trial of ELVN-001, targeted for late 2026

The ENABLE trial, designed for patients with previously treated CML, aims to investigate safety, tolerability, and establish a recommended dose for further assessment of ELVN-001's efficacy against CML, incorporating both cases with and without T315I mutations.

Enliven Therapeutics: A Commitment to Innovation

Founded in Boulder, Colorado, Enliven Therapeutics focuses on the discovery and development of innovative therapeutic solutions that not only aim to extend life but also improve the quality of life for patients. Enliven’s precision oncology approach blends deep biological insights with advanced chemistry to devise potentially first-in-class or best-in-class treatments.

With ELVN-001 demonstrating promising early results, Enliven is among the forefronts in the battle against CML, seeking to meet significant needs in a patient population that has seen limited options for effective treatment. The anticipated advancements in their clinical pipeline signal an exciting future for both the company and the CML community.

Conclusion

As Enliven prepares for a pivotal year ahead, the encouraging data on ELVN-001 not only shines a light on potential pathway for treating chronic myeloid leukemia but also reflects the company's dedication to transformative therapeutic development. It will be intriguing to observe the evolving landscape as Enliven progresses towards significant trials and collaborations, potentially reshaping treatment standards in oncology.