Phase III LEAP-003 trial of Keytruda + Lenvima is discontinued after no improvement in survival in melanoma

Merck Inc and Eisai provided an update on the Phase III LEAP-003 trial investigating Keytruda (pembrolizumab) anti-PD-1 therapy, plus Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. Based on results from LEAP-003, Merck Inc and Eisai are discontinuing the Phase III LEAP-003 trial evaluating Keytruda plus Lenvima for the first-line treatment of adults with unresectable or metastatic melanoma.

This decision is based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis and determined Keytruda plus Lenvima did not demonstrate an improvement in overall survival (OS), one of the study’s dual primary endpoints, versus Keytruda alone. Merck and Eisai are informing study investigators of the decision and advising them to reach out to patients in the study regarding treatment. At an earlier interim analysis, the trial’s other dual primary endpoint, progression-free survival (PFS), showed a statistically significant improvement in the Keytruda plus Lenvima arm versus the Keytruda plus placebo arm.

The safety profile of the therapy was consistent with previously reported data on the combination. A full evaluation of the data from these studies, including pre-planned key subgroup analyses, is ongoing. The companies will work with investigators to share the results with the scientific community.