Enliven Therapeutics has reached an agreement with the US Food and Drug Administration (FDA) regarding the final protocol for the ENABLE-2 pivotal Phase III clinical trial evaluating relcobatinib in adults with chronic myeloid leukaemia (CML).
The randomised 2L+ study will include around 450 adult participants who have undergone prior therapy with one or more tyrosine kinase inhibitors (TKIs).
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They will be randomised on a 1:1 basis to be given either 80mg of relcobatinib administered once daily or an investigator-chosen second-generation TKI, selected from bosutinib, dasatinib, or nilotinib.
The primary endpoint of the pivotal trial will evaluate major molecular response (MMR) rates at week 24, while MMR at week 96 will serve as the key secondary endpoint.
The trial has been powered so that an improvement of at least 10 percentage points in MMR over the active comparator arm is sufficient to show statistical superiority.
Enliven plans to commence enrolment in the study before the end of 2026.
Enliven chief medical officer Helen Collins said: “We are pleased to have reached alignment with the FDA on the design of the ENABLE-2 pivotal Phase III trial, providing a clear path to initiate the trial before year-end.
“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.
“We are encouraged by the enthusiasm from physicians and the broader CML community as we prepare to initiate the trial.”
Relcobatinib, previously designated as ELVN-001, received its nonproprietary name from the US Adopted Names Council.
It is an investigational small molecule kinase inhibitor developed to selectively target the breakpoint cluster region::abelson proto-oncogene 1 (BCR::ABL1) gene fusion, the primary oncogenic driver associated with CML.
In September 2024, Enliven reported the latest positive results from the Phase I clinical trial showing promise of ELVN-001 for treating patients with CML.
