Enliven, FDA agree on phase 3 trial design for relcobatinib for chronic myeloid leukemia
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- Enliven Therapeutics (ELVN) and the US FDA have agreed on a design for the phase 3 trial of relcobatinib for chronic myeloid leukemia (CML) in those who have failed on prior treatments.
- The ENABLE-2 trial plans to enroll 450 adults with CML who were previously on one or more tyrosine kinase inhibitors. Participants will be randomized to receive either relcobatinib 80 mg once daily or an investigator-selected second-generation TKI. The primary endpoint is major molecular response at week 24.
- Relcobatinib, also known as ELVN-001, is a kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, which promotes the development of CML.
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