Phase III KEYNOTE-407 trial of Keytruda meets primary endpoint in first line metastatic squamous non-small cell lung cancer.- Merck Inc.

Merck announced that the pivotal Phase III KEYNOTE-407 trial investigating Keytruda (pembrolizumab) in combination with carboplatin-paclitaxel or nab-paclitaxel, as first-line treatment for metastatic squamous non-small cell lung cancer (sNSCLC), met the dual primary endpoints of overall survival (OS) and progression-free survival (PFS). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), treatment with Keytruda in combination with chemotherapy resulted in significantly longer OS and PFS than chemotherapy alone.

The safety profile of Keytruda in this combination was consistent with that previously observed in lung cancer. As previously announced, Merck has submitted a supplemental Biologics License Application (sBLA) to the FDA and these new data will be shared with the agency. These data from KEYNOTE-407 will be presented at the 2018 ASCO Annual Meeting.

Comment: Keytruda can be used to treat advanced lung cancer in people who have specific protein and genetic markers, potentially giving 1,400 extra patients access to the immunotherapy. Last year the drug was recommended by NICE for routine by the NHS as a second line option for some patients with lung cancer. Merck Inc has agreed to make the drug available under special arrangements with NHS England, which will allow for the further collection of data while the drugs are funded at a discounted price.