A phase 3 trial of frontline pembrolizumab monotherapy met its co-primary endpoint of OS among patients with recurrent or metastatic head and neck squamous cell carcinoma whose tumors expressed PD-L1, according to the manufacturer.
Pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — is indicated for the treatment of certain patients with melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, Hodgkin lymphoma, urothelial carcinoma and gastric cancer.
The open-label KEYNOTE-048 trial included patients with previously untreated HNSCC with tumors that expressed PD-L1 (combined proportion score 20). Researchers randomly assigned patients to pembrolizumab or cetuximab in combination with platinum chemotherapy (cisplatin or carboplatin) plus 5-FU.
Results from an interim analysis showed improved OS among those treated with pembrolizumab compared with standard of care.
At the time of the analysis, the co-primary endpoint of PFS had not been reached.
The safety profile appeared consistent with the known safety of the agent among patients with HNSCC.
“This interim analysis of KEYNOTE-048 trial has shown that Keytruda monotherapy has the potential to help patients with head and neck cancer whose tumors express high levels of PD-L1,” Roy Baynes, MD, PhD, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said in a press release. “We look forward to presenting these initial results from the KEYNOTE-048 trial at an upcoming medical meeting and are grateful to the investigators and patients for their continued involvement in this important study.”