KENILWORTH (NJ) (dpa-AFX) - Wednesday, Merck & Co., Inc. (MRK) announced that the Phase 3 KEYNOTE-C93 trial evaluating KEYTRUDA has met its primary endpoint of progression-free survival or PFS for the treatment of patients with mismatch repair deficient advanced or recurrent endometrial cancer.
The randomized, open-label trial evaluated KEYTRUDA monotherapy versus carboplatin plus paclitaxel in patients. Its dual primary endpoints are PFS, as assessed by blinded independent central review according to Response Evaluation Criteria in Solid Tumors version 1.1, and Overall Survival or OS. A key secondary endpoint of the study is Overall Response Rate or ORR.
A pre-specified interim analysis, conducted by an independent Data Monitoring Committee, showed improvement in OS during the trial. However, these OS data were not mature at the time of this analysis. This analysis also showed a clinically meaningful ORR, as well as complete response rate and duration of response for KEYTRUDA.
'This is the first Phase 3 trial of a PD-1 inhibitor to show improved PFS compared to platinum doublet chemotherapy when given as monotherapy in the frontline setting for these patients, potentially providing a chemo-free option,' said Dr. Brian Slomovitz, director of Gynecologic Oncology and deputy director of the Braman Comprehensive Cancer Center at Mount Sinai Medical Center in Miami Beach, Florida, and the study's overall principal investigator.
In the pre-market hours, MRK is trading at $123.26, up 2.04 percent on the New York Stock Exchange.
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