Enliven Aligns With FDA on Phase 3 Leukemia Trial, Targets Late 2026 Start

Key Points

• Enliven Therapeutics reached FDA alignment on the final design of ENABLE-2, its pivotal Phase 3 trial of relcobatinib in previously treated chronic myeloid leukemia.
• The company remains on track to initiate the trial before year-end 2026.
• Approximately 450 adults will receive either relcobatinib or an investigator-selected second-generation tyrosine kinase inhibitor.
• The primary endpoint is major molecular response at Week 24, with a key secondary assessment at Week 96.
• Relcobatinib, previously known as ELVN-001, remains investigational. FDA alignment on trial design is not product approval.

Enliven Therapeutics (NASDAQ: ELVN) has agreed with the FDA on the final design of ENABLE-2, moving its planned Phase 3 chronic myeloid leukemia study closer to initiation. The trial will directly compare relcobatinib with three established second-generation treatment options in patients who have received at least one prior tyrosine kinase inhibitor.

ENABLE-2 Will Compare Relcobatinib With Existing Treatments

The randomized trial is expected to enroll approximately 450 adults with previously treated chronic myeloid leukemia, or CML. Participants will be assigned equally to relcobatinib 80 mg once daily or an investigator-selected treatment: dasatinib, nilotinib or bosutinib.

This head-to-head design will test whether relcobatinib can deliver better results than those second-generation tyrosine kinase inhibitors, rather than evaluating the drug without an active comparison group.

Molecular Response Is the Main Efficacy Measure

ENABLE-2’s primary endpoint is major molecular response, or MMR, at Week 24. Its key secondary endpoint is MMR at Week 96, providing a later assessment of treatment response.

Enliven said the trial is designed so that an MMR rate at least 10 percentage points higher than the control group would be sufficient to demonstrate statistical superiority. The company believes that difference would be clinically meaningful. It is a trial-design target—not a reported treatment result.

Relcobatinib Targets the Genetic Driver of CML

The United States Adopted Names Council has adopted relcobatinib as the nonproprietary name for ELVN-001.

The investigational small-molecule kinase inhibitor is designed to target BCR::ABL1, the gene fusion that drives CML. Enliven describes the candidate as potentially best in class, but ENABLE-2 must still establish how it performs against the selected comparison treatments.

Investor Takeaway: A Clearer Trial Plan

For ELVN investors, FDA alignment clarifies the pivotal study’s design and supports the company’s goal of starting ENABLE-2 before the end of 2026. The direct comparison with existing treatments will be central to evaluating relcobatinib’s potential differentiation.

The next milestone is trial initiation, followed by enrollment and eventual results. The announcement does not provide a data-readout date, regulatory filing timeline or revenue forecast, and agreement on the study design does not guarantee a successful trial or FDA approval.