Enliven Therapeutics Announces Positive Data Update from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia

Core Insights - Enliven Therapeutics presented updated Phase 1 data for ELVN-001, showing a cumulative major molecular response (MMR) rate of 44.4% (8/18) by 24 weeks in patients with chronic myeloid leukemia (CML) who have failed or are intolerant to existing therapies [1][3][6] - The drug ELVN-001 is a highly selective small molecule kinase inhibitor targeting the BCR-ABL gene fusion, which is the oncogenic driver in CML [2][11] - The trial demonstrated that ELVN-001 is well-tolerated, with no dose reductions and a median treatment duration of 20 weeks, indicating a favorable safety profile [1][8][9] Patient Demographics - As of June 25, 2024, 39 patients were enrolled in the Phase 1 trial across five dose levels, with a median treatment duration of 20 weeks [5] - A significant portion of the patient population was heavily pretreated, with 69.2% having received three or more prior tyrosine kinase inhibitors (TKIs) and 25.6% having received five or more [5] Efficacy Data - Among the 18 evaluable patients, a cumulative MMR rate of 44.4% was observed by 24 weeks, with stable or deepening responses noted between weeks 12 and 24 [6][7] - In TKI-resistant patients, the cumulative MMR rate was 41.7% (5/12), and in post-asciminib patients, it was 40.0% (4/10) [7] Safety Profile - ELVN-001 has shown a favorable safety profile, with no dose reductions or discontinuations due to treatment-emergent adverse events (TEAEs) at doses of 40 mg or higher [8] - There were no Grade 3 or higher non-hematologic treatment-related adverse events reported, indicating a well-tolerated treatment [8] Clinical Implications - The ongoing trial suggests that ELVN-001 may address the limitations of current active-site TKIs, particularly for patients who have failed treatment with allosteric inhibitors [4][9] - The data presented reinforces the potential clinical utility of ELVN-001 across the CML treatment paradigm, especially given the chronic nature of the disease [4][9]