THURSDAY, Dec. 20, 2018 (HealthDay News) -- For patients with recurrent or metastatic head and neck squamous cell carcinoma, pembrolizumab has a favorable safety profile and is associated with prolongation of overall survival, according to a study published online Nov. 30 in The Lancet.
Ezra E.W. Cohen, M.D., from the University of California in San Diego, and colleagues conducted a randomized open-label phase 3 study at 97 medical centers in 20 countries. Patients with head and neck squamous cell carcinoma that progressed during or after platinum-containing treatment for recurrent or metastatic disease or whose disease recurred or progressed within three to six months of previous multimodal therapy containing platinum were randomly assigned to receive either pembrolizumab (247 patients) or the investigator's choice of standard doses of methotrexate, docetaxel, or cetuximab (248 patients) between Dec. 24, 2014, and May 13, 2016.
The researchers found that 73 and 83 percent of patients in the pembrolizumab and standard-of-care groups had died as of May 15, 2017. In the intention-to-treat population, the median overall survival was 8.4 and 6.9 months with pembrolizumab and standard of care, respectively (hazard ratio, 0.8). Fewer pembrolizumab-treated patients than standard-of-care patients had grade 3 or worse treatment-related adverse events (13 versus 36 percent).
"The clinically meaningful prolongation of overall survival and favorable safety profile of pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma support the further evaluation of pembrolizumab as a monotherapy and as part of combination therapy in earlier stages of disease," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Merck, which manufactures pembrolizumab and funded the study.