Merck announces findings from Phase III study of KEYTRUDA

The findings include updated survival data showing a 19 per cent reduction in the risk of death over standard treatment in the intent-to-treat population

Merck, known as MSD outside the US and Canada, announced results of the phase III KEYNOTE-040 trial investigating KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, compared to standard treatment (methotrexate, docetaxel or cetuximab) in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. As previously disclosed, the study did not meet its pre-specified primary endpoint of overall survival (OS).

The findings include updated survival data showing a 19 per cent reduction in the risk of death over standard treatment in the intent-to-treat population (HR, 0.81 [95% CI, 0.66-0.99]; one sided p = 0.0204), with pre-specified p-value required for statistical significance of 0.0175, and a median OS of 8.4 months with KEYTRUDA (95 per cent CI, 6.5-9.4) compared to 7.1 months with standard treatment (95 per cent CI, 5.9-8.1).

"These data, including progression-free survival and overall response rate, show the activity and efficacy of pembrolizumab in this disease, and are consistent with prior studies of pembrolizumab in recurrent head and neck squamous cell carcinoma," said Ezra Cohen, Associate Director for Translational Science, Moores Cancer Center and Co-Director, San Diego Center for Precision Immunotherapy, University of California, San Diego. "KEYNOTE-40 strengthens the rationale for further studies, and expansion into earlier lines of disease."

"Although the primary efficacy analysis did not show a statistically significant improvement in overall survival, these data add to the evolving science for KEYTRUDA in head and neck cancer," said Dr Jon Cheng, Associate Vice President, Merck Research Laboratories.