Enliven Therapeutics Announces FDA Alignment on ENABLE-2 Phase 3 Trial Design for Relcobatinib (ELVN-001) in Previously Treated Chronic Myeloid Leukemia
PR Newswire•06/10/2026•16:05 ET
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Key Highlights
- ➤FDA aligned on ENABLE-2 Phase 3 design for relcobatinib in previously treated CML
- ➤ENABLE-2 plans approximately 450 adults previously treated with one or more TKIs
- ➤Patients randomized 1:1 to relcobatinib 80 mg daily or second-generation TKI
- ➤Primary endpoint is major molecular response at Week 24
- ➤Enliven remains on track to initiate ENABLE-2 before year-end 2026
Expert Statements
Helen Collins, M.D., Chief Medical Officer of Enliven Therapeutics
“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,”
Helen Collins, M.D., Chief Medical Officer of Enliven Therapeutics
“ENABLE-2 is designed to directly compare relcobatinib to the second-generation TKIs and evaluate its potential to be the best-in-class ATP-competitive inhibitor for patients with CML.”
Helen Collins, M.D., Chief Medical Officer of Enliven Therapeutics
“We are encouraged by the enthusiasm from physicians and the broader CML community as we prepare to initiate the trial.”
Enliven Therapeutics Announces FDA Alignment on ENABLE-2 Phase 3 Trial Design for Relcobatinib (ELVN-001) in Previously Treated Chronic Myeloid Leukemia PR Newswire
Enliven remains on track to initiate ENABLE-2 before year-end 2026
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