A pembrolizumab-based regimen failed to significantly extend EFS among patients with unresected locally advanced head and neck squamous cell carcinoma, according to the agent’s manufacturer.
The randomized phase 3 KEYNOTE-412 trial included 780 adults with newly diagnosed oropharyngeal or larynx/hypopharynx/oral cavity squamous cell carcinoma.
Researchers randomly assigned patients to receive 200 mg pembrolizumab (Keytruda, Merck) every 3 weeks with concurrent chemoradiation, followed by pembrolizumab maintenance therapy for approximately 1 year, or placebo plus chemoradiation followed by placebo.
EFS served as the primary endpoint. Secondary endpoints included OS and safety.
Final analysis showed a numeric improvement in EFS for patients assigned the pembrolizumab regimen; however, the difference did not reach statistical significance.
The safety profile of pembrolizumab appeared consistent with that observed in prior studies of the agent for treatment of HNSCC.
Complete results of KEYNOTE-412 will be submitted for presentation at a medical meeting.
Pembrolizumab — an anti-PD-1 therapy — is approved in the United States as monotherapy or as part of combination therapy for certain patients with metastatic or unresectable, recurrent HNSCC.
“There have been limited advances for patients with locally advanced HNSCC and, unfortunately, these results suggest that this disease remains very challenging to treat,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer for Merck Research Laboratories, said in a press release. “We are proud of the significant role Keytruda plays in the treatment of certain later stages of HNSCC, and we are committed to investigating Keytruda-based regimens for this debilitating type of cancer in earlier stages of disease.”