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# Merck, Eisai Stop LEAP-010 Trial
- URL: https://www.fdaweb.com/merck-eisai-stop-leap-010-trial/
- Published: 2023-08-25T12:00:00.000Z
- Updated: 2026-09-14T18:52:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155180

Merck and Eisai have terminated the Phase 3 LEAP-010 trial evaluating Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy, plus Eisai’s Lenvima (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI), as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma whose tumors express PD-L1\. The decision to stop the trial was based on an interim analysis that found the data did not demonstrate the combination’s improvement in overall survival compared to Keytruda plus placebo, according to the companies. An earlier interim analysis showed a statistically significant improvement in progression-free survival and objective response rate compared to Keytruda plus placebo.

The companies note that the safety profile of Keytruda plus Lenvima was consistent with previously reported data on the combination. “A full evaluation of the data from this study, including pre-planned subgroup analyses, is ongoing,” they say. “The companies will work with investigators to share the results with the scientific community.”