Enliven Therapeutics Inc. (ELVN) has announced promising updates from their Phase 1 clinical trial of ELVN-001, targeting chronic myeloid leukemia (CML) patients who have either not succeeded with existing treatments, cannot tolerate them, or are unsuitable candidates for these therapies. ELVN-001 continues to demonstrate clinical benefits for these heavily pretreated CML patients.
The recent data encompasses 39 patients across different dose levels, with 18 of them being evaluable for molecular response at the 24-week mark. Mirroring the 12-week results presented in April 2024, a cumulative major molecular response (MMR) rate of 44.4% (8 out of 18) was observed at 24 weeks in patients who could be evaluated for a response. Additionally, ELVN-001 has maintained a favorable tolerance profile, requiring no dose reductions and showing a median treatment duration of 20 weeks.
With increased patient enrollment and extended follow-up periods, Enliven Therapeutics continues to observe significant anti-CML activity, even among patients previously treated with asciminib. Furthermore, the safety profile of ELVN-001 remains consistent with expectations, demonstrating high selectivity across longer treatment durations and higher dose levels.
These findings underscore the potential clinical utility of ELVN-001 for patients across the entire CML treatment spectrum.
