Disappointing Trial Results for Head and Neck Cancer Treatment
Merck & Co. Inc. and Eisai Co. Ltd. have released disappointing results from a Phase 3 trial evaluating their combined treatment for head and neck cancer. As a result, the companies have made the decision to discontinue the trial.
A Promising Combination
Merck's Keytruda, a breakthrough immunotherapy drug, was tested in combination with Eisai's oral medication, Lenvima. The goal was to determine the effectiveness of this combination as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.
Primary Endpoints and Interim Analysis
The trial had three primary endpoints: overall survival, progression-free survival, and objective response rate. In the first interim analysis, the Keytruda-Lenvima combination showed a statistically significant improvement in both progression-free survival and objective response rate when compared to Keytruda combined with a placebo.
A Disappointing Outcome
However, in the second interim analysis, the Keytruda-Lenvima combination did not demonstrate an improvement in overall survival when compared to Keytruda combined with a placebo. Upon evaluation, Merck and Eisai determined that the likelihood of reaching the protocol-specified threshold for statistical significance in overall survival was low.
Conclusion and Next Steps
Given these results, Merck & Co. Inc. and Eisai Co. Ltd. have decided to close the study. They are currently informing investigators involved in the trial about this decision.
Despite this setback, Merck & Co. Inc. and Eisai Co. Ltd. remain committed to discovering new treatments and continue to actively pursue research in the field of oncology.
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