FDA Approves Second Indication For Merck's Keytruda In Endometrial Cancer

The FDA approved Merck & Co Inc's MRK Keytruda as a single agent for advanced endometrial carcinoma that is microsatellitestability-high (MSI-H) or mismatch repair deficient (dMMR).

• The approval covers endometrial carcinoma patients who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. 
• The approval is based on new data from Cohorts D and K of the KEYNOTE-158 trial. 
• The objective response rate (ORR) was 46% for patients who received KEYTRUDA, including a complete response rate of 12% and a partial response rate of 33%. 
• Related: Merck Lays Out Keytruda Data In Post Surgery Early-Stage Lung Cancer Setting.
• Of the responding patients (n=41), 68% had responses lasting 12 months or longer, and 44% had responses lasting 24 months or longer. 
• The median duration of response (DOR) was not reached.
• This is the second indication for Keytruda in endometrial cancer. It is also indicated with Eisai Co Ltd ESALY Lenvima (lenvatinib) for advanced endometrial carcinoma that is not MSI-H or dMMR. 
• Price Action: MRK shares are up 0.22% at $79.23 during the premarket session on the last check Tuesday.