Merck & Co. Inc. MRK, -1.66% and Eisai Co. Ltd. 4523, -1.23% ESAIY, -1.95% said Friday a late-stage trial of a treatment for head and neck cancer failed to meet its main goals and the companies have decided to shut it down. The Phase 3 trial sought to evaluate Merck’s Keytruda plus Lenvima, an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma. The primary endpoints were overall survival, porgression-free survival and objective response rate. Two planned interim analyses conducted by an independent data monitoring committee found in the first analysis that Keytruda and Lenvima achieved a statistically significant improvement in PFS and ORR compared with Keytruda and placebo. But the second analysis, the two did not demonstrate an improvement in OS compared to KEYTRUDA plus placebo, “and the likelihood of reaching the protocol-specified threshold for statistical significance for OS was evaluated by Merck and Eisai and deemed to be low,” said the companies. The partners have decided to close the study and are informing investigators of that decision.
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