ELVN-001 - (ENABLE-2)

October 6, 2026: Enliven Therapeutics (NASDAQ: ELVN) said it reached FDA alignment on the final design of ENABLE-2, a pivotal Phase 3 trial of relcobatinib (ELVN-001) in previously treated chronic myeloid leukemia. The company also said the USAN Council adopted relcobatinib as the nonproprietary name for ELVN-001.

ENABLE-2 is a planned randomized 2L+ Phase 3 study expected to enroll about 450 adults with CML previously treated with one or more tyrosine kinase inhibitors. Patients will be randomized 1:1 to relcobatinib 80 mg once daily or investigator-selected second-generation TKI therapy (dasatinib, nilotinib, or bosutinib). The primary endpoint is major molecular response at Week 24; the key secondary endpoint is MMR at Week 96.

The trial is designed so that at least a 10-percentage-point improvement in MMR versus control would be sufficient to demonstrate statistical superiority. Enliven said it remains on track to initiate ENABLE-2 before year-end 2026.