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Merck: Phase 3 KEYNOTE-412 Trial With KEYTRUDA Fails To Meet Primary Endpoint

Merck (MRK) said the phase 3 KEYNOTE-412 trial evaluating KEYTRUDA with concurrent chemoradiation therapy followed by KEYTRUDA as maintenance therapy did not meet its primary endpoint of event-free survival for the treatment of patients with unresected locally advanced head and neck squamous cell carcinoma. The company noted that the results did not meet statistical significance per the pre-specified statistical plan.

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

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