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.
Trial targets a 10-percentage-point efficacy edge over existing TKIs
With the 450-patient cohort, Enliven's statistical design requires at least a 10-percentage-point improvement in MMR rate over the control arm to demonstrate superiority. The company characterizes this margin as a clinically meaningful advance relative to currently marketed second-generation TKIs used in relapsed or refractory CML.
USAN Council formalizes relcobatinib as nonproprietary drug name
The United States Adopted Names Council has adopted relcobatinib as the official nonproprietary name for ELVN-001, an investigational small molecule kinase inhibitor engineered to selectively target the BCR::ABL1 gene fusion that drives CML pathology.
"We are pleased to have reached alignment with the FDA on the design of the ENABLE-2 pivotal Phase 3 trial, providing a clear path to initiate the trial before year-end,