Enliven Therapeutics Inc (Nasdaq:ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, announced on Tuesday that it has reached alignment with the US Food and Drug Administration (FDA) on the final design of the ENABLE-2 pivotal trial, a Phase 3 trial of relcobatinib (ELVN-001) in patients with previously treated chronic myeloid leukaemia (CML).

United States Adopted Names (USAN) Council has adopted relcobatinib as the non-proprietary name for ELVN-001. Relcobatinib is an investigational, potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver of CML.

ENABLE-2 is a planned randomised 2L+ phase 3 trial expected to enrol approximately 450 adults with CML previously treated with one or more tyrosine kinase inhibitors (TKIs). Participants will be randomised 1:1 to receive either relcobatinib 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 the key secondary endpoint of MMR at Week 96.

With approximately 450 participants, the trial is designed such that an improvement in MMR rate of at least 10 percentage points over the control arm would be sufficient to demonstrate statistical superiority. Enliven believes this difference would represent a clinically meaningful improvement over currently available second-generation TKIs.

The trial is expected to start before the end of 2026.