Keytruda Fails in Phase 3 Trial for Head and Neck Cancer


The KEYNOTE-412 study did not meet its primary endpoint of event-free survival.

Merck’s Keytruda (pembrolizumab) failed to meet the primary endpoint of event-free survival (EFS) for the treatment of patients with unresected locally advanced head and neck squamous cell carcinoma (HNSCC). The phase 3 KEYNOTE-412 trial was evaluating Keytruda with concurrent chemoradiation therapy (CRT) followed by Keytruda as maintenance therapy.

At the final analysis of the study, there was an improvement in EFS for patients who received the Keytruda regimen compared with placebo plus CRT. But these results did not meet statistical significance.

The KEYNOTE-412 trial enrolled about 780 newly diagnosed adults with oropharyngeal or larynx/hypopharynx/oral cavity squamous cell carcinoma. The primary endpoint was EFS, and the secondary endpoints included overall survival and safety. The safety profile in this trial was consistent with previously reported studies in HNSCC. Results will be presented at an upcoming medical meeting.

Eliav Barr, M.D.

Eliav Barr, M.D.

“There have been limited advances for patients with locally advanced HNSCC, and unfortunately, these results suggest that this disease remains very challenging to treat,” Dr. Eliav Barr, M.D., senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in a press release.

Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. Most head and neck cancers are squamous cell carcinomas that begin in the flat, squamous cells. In the United States, it is estimated there will be more than 66,000 new cases of head and neck cancer diagnosed and more than 15,000 deaths from the disease in 2022.

Keytruda is currently approved as monotherapy and in combination regimens for patients with metastatic or with unresectable, recurrent HNSCC in the United States, Europe, China, Japan and other countries around the world. Merck is continuing research of Keytruda as monotherapy and in combination with other medicines, including KEYNOTE-689 for the neoadjuvant and adjuvant treatment of resectable locally advanced HNSCC.

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