A Phase 3 study investigating the use of the cancer drugs Keytruda and Lenvima in patients with recurrent or metastatic head and neck squamous cell carcinoma has been concluded prematurely due to a lack of overall survival benefit for patients.
Merck & Co. and Eisai, the companies behind the study, announced on Friday that the combination of Keytruda plus placebo did not meet the threshold for overall survival compared to Keytruda plus Lenvima as a first-line treatment for patients with PD-L1 expressing tumors.
While an earlier interim analysis did show statistically significant improvements in progression-free survival and objective response rate, the ultimate primary endpoint of overall survival was not achieved.
Both Merck and Eisai emphasized that the safety profile of Keytruda plus Lenvima observed in the study was consistent with previously reported data on this drug combination.
In 2018, Merck and Eisai entered into a collaboration to jointly develop, manufacture, and commercialize Lenvima as both a monotherapy and in combination with Merck's renowned cancer drug Keytruda.
The combination of Keytruda and Lenvima has received approvals in the U.S., the EU, Japan, and other countries for the treatment of advanced renal cell carcinoma and certain types of advanced endometrial carcinoma. Moreover, ongoing research is exploring its potential in treating various other tumor types.