Merck Keytruda fails head and neck cancer trial
Merck, known as MSD outside the United States and Canada, has announced that the Phase 3 KEYNOTE-412 trial evaluating KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, with concurrent chemoradiation therapy (CRT) followed by KEYTRUDA as maintenance therapy (the KEYTRUDA regimen), did not meet its primary endpoint of event-free survival (EFS) for the treatment of patients with unresected locally advanced head and neck squamous cell carcinoma (HNSCC).
At the final analysis of the study, there was an improvement in EFS for patients who received the KEYTRUDA regimen compared to placebo plus CRT; however, these results did not meet statistical significance per the pre-specified statistical plan. The safety profile of KEYTRUDA in this trial was consistent with previously reported studies in HNSCC.
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