Phase III KEYNOTE-412 trial of Keytruda fails to meet primary endpoint in head and neck cancer.
Merck Inc announced that the Phase III 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. Results will be presented at an upcoming medical meeting.
KEYNOTE-412 is a randomized, double-blind Phase III trial (ClinicalTrials.gov, NCT03040999) evaluating Keytruda with concurrent CRT, followed by Keytruda as maintenance therapy for the treatment of patients with unresected locally advanced HNSCC. The primary endpoint was EFS, and the secondary endpoints included overall survival and safety. The trial enrolled an estimated 780 newly diagnosed adults with oropharyngeal or larynx/hypopharynx/oral cavity squamous cell carcinoma who were randomized to receive Keytruda (200 mg every three weeks) in combination with CRT (cisplatin plus radiation), followed by Keytruda as maintenance therapy for approximately one year, or placebo plus cisplatin and CRT, followed by placebo.
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