Enliven Therapeutics Secures FDA Approval for Phase 3 Trial Design

The clinical-stage biopharmaceutical company, based in Burlingame, California, plans to enroll approximately 450 adult patients who have already undergone treatment with at least one tyrosine kinase inhibitor. Participants will be randomized to receive either 80 mg of relcobatinib daily or an investigator-selected second-generation therapy, such as dasatinib, nilotinib, or bosutinib. The primary objective is to measure major molecular response at week 24, with a secondary look at week 96.

Dr. Helen Collins, Enliven’s Chief Medical Officer, stated that the trial aims to establish relcobatinib as a best-in-class option for the CML community. The study is powered to demonstrate statistical superiority if the drug achieves at least a 10 percentage point improvement in major molecular response rates compared to the control arm. Relcobatinib is designed to selectively target the BCR::ABL1 gene fusion, which serves as the primary oncogenic driver of the disease.