Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has granted an additional indication for its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab). The drug is now approved for use in combination with chemotherapy for adults with primary advanced or recurrent endometrial carcinoma, irrespective of mismatch repair status. This marks the third FDA approval for Keytruda as a treatment for endometrial carcinoma and the 40th indication approval in the U.S. market, according to the company’s press release.
The FDA’s decision was supported by data from the Phase III NRG-GY-18 study (KEYNOTE-868; NCT03914612), a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 810 patients with advanced or recurrent endometrial carcinoma. The study compared the treatment regimen of Keytruda plus chemotherapy followed by Keytruda alone with chemotherapy plus placebo followed by placebo. The results showed that Keytruda reduced the risk of disease progression or death by 40% in patients with mismatch repair proficient (pMMR) tumors (HR=0.60 [95% CI, 0.46-0.78]; p<0.0001) and by 70% in patients with mismatch repair deficient (dMMR) tumors (HR=0.30 [95% CI, 0.19-0.48]; p<0.0001).- Flcube.com
