Enliven Therapeutics declares updated positive data from phase 1 trial of ELVN-001 in CML

Enliven Therapeutics, a clinical-stage biopharmaceutical company, announced updated positive results from the phase 1 trial of ELVN-001 in chronic myeloid leukemia (CML) patients who are intolerant or unresponsive to available therapies. The data was presented at the ESH-iCMLf 26th John Goldman Conference.

ELVN-001, a highly selective kinase inhibitor, targets the BCR-ABL gene fusion, the primary driver of CML. The trial, involving 39 patients across five dose levels, showed a cumulative major molecular response (MMR) rate of 44.4% at 24 weeks in 18 evaluable patients. Notably, 41.7% of TKI-resistant patients and 40% of post-asciminib patients achieved MMR.

ELVN-001 has been well-tolerated with no dose reductions and no Grade 3 non-hematologic treatment-related adverse events. The phase 1 study aims to evaluate safety, pharmacokinetics, and MMR in CML patients, including those with T315I mutations. ELVN-001 may offer a promising treatment option for heavily pretreated CML patients resistant to current therapies.