Enliven Therapeutics Announces FDA Alignment on ENABLE-2 Phase 3 Trial Design for Relcobatinib (ELVN-001) in Previously Treated Chronic Myeloid Leukemia
Enliven Therapeutics reached alignment with the FDA on the final design of the ENABLE-2 pivotal Phase 3 trial of relcobatinib (ELVN-001) in previously treated chronic myeloid leukemia. The randomized trial will enroll approximately 450 adults with CML previously treated with TKIs, comparing relcobatinib 80 mg once daily head-to-head against investigator-selected second-generation TKIs (dasatinib, nilotinib, or bosutinib). The primary endpoint is major molecular response at Week 24, and a 10-percentage-point MMR improvement over control would demonstrate statistical superiority.
Key figures
- Drug Name
- relcobatinib (ELVN-001)
- Phase Of Trial
- Phase 3
- Randomization
- 1:1 relcobatinib 80 mg once daily vs investigator-selected second-generation TKI
- Primary endpoint
- MMR at Week 24
- Expected enrollment
- 450
- Superiority threshold
- at least 10 percentage point improvement in MMR rate over control
- Key secondary endpoint
- MMR at Week 96
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