Merck & Co. announced that the Phase III KEYNOTE-040 study of Keytruda (pembrolizumab) in previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) failed to meet its pre-specified primary endpoint of overall survival. A spokeswoman noted that the company has "already discussed these data with the FDA and do not anticipate any changes to the current indication at this time."
Keytruda gained FDA accelerated approval  last year for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Clearance of the anti-PD-1 therapy in this indication was based on tumour response rate and durability of response data from the KEYNOTE-012 study, with results showing an objective response rate of 16 percent, complete response rate of 5 percent, with responses of six months or longer observed in 82 percent of the responding patients.
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Merck said that despite the failure of the KEYNOTE-040 trial, the "current indication remains unchanged," adding that clinical trials continue, including KEYNOTE-048, a Phase III study of Keytruda in the first-line treatment of recurrent or metastatic HNSCC. According to ISI Evercore analyst Umer Raffat, head and neck cancer accounts for about 15 percent of Keytruda's sales.
In November last year, the FDA approved  Bristol-Myers Squibb's Opdivo (nivolumab) for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy. The clearance was based on data showing that the therapy improved survival versus chemotherapy, with median overall survival of 7.5 months for Bristol-Myers Squibb's drug compared to 5.1 months for investigator's choice of treatment.