In the phase 3 KEYNOTE-671 trial evaluating Keytruda (pembrolizumab) as preoperative treatment (a regimen given before and after surgier) in patients with resectable stage 2, 3a or 3b non-small cell lung cancer has met one of its primary endpoints of event-free survival (time after treatment without cancer-related complications), according to a press release from Merck, the drug’s manufacturer.
At an interim analysis Keytruda plus chemotherapy followed by resection and then Keytruda again, demonstrated a statistically significant and clinically meaningful improvement in event-free survival, compared with a placebo.
There were also statically significant improvements in the secondary goals including pathological complete response (the lack of signs of cancer in tissue removed after surgery) and major pathological response (decreased cancer found in tissue).
Based on these results, the U.S. Food and Drug has accepted Merck’s new supplemental Biologics License Application for Keytruda for the treatment of this patient’s population in combination with chemotherapy in the preoperative setting. This application is used to request permission to introduce or deliver a biologic product intro interstate commerce.
The FDA has set a Prescription Drug User Free Act, or PDUFA, or target action date of Oct. 16, 2023.
Of note, there were no new safety signals with Keytruda observed.
This trial will continue to evaluate the other primary endpoint of overall survival (time from treatment until disease worsens) and further, detail results will be presented at an upcoming medical meeting.