Enliven Secures FDA Alignment on Phase 3 CML Trial Design
Burlingame, Calif. – October 06, 2026 -- Enliven Therapeutics, Inc. (Nasdaq: ELVN) has reached alignment with the U.S. Food and Drug Administration on the final design of ENABLE-2, a pivotal Phase 3 trial testing relcobatinib against standard second-generation therapies in previously treated chronic myeloid leukemia (CML). The company remains on track to initiate the trial before year-end 2026.
FDA clears path for 450-patient head-to-head comparison
ENABLE-2 is designed to enroll approximately 450 adults with CML who have already received one or more tyrosine kinase inhibitors (TKIs). Participants will be randomized 1:1 to receive either relcobatinib at 80 mg once daily or an investigator-selected second-generation TKI -- dasatinib, nilotinib, or bosutinib. The primary endpoint is major molecular response (MMR) at Week 24, with MMR at Week 96 as a key secondary measure.