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# Keytruda/Chemo Approved for Endometrial Cancer
- URL: https://www.fdaweb.com/keytruda-chemo-approved-for-endometrial-cancer/
- Published: 2024-06-17T12:00:00.000Z
- Updated: 2026-09-14T14:33:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157190

FDA has approved Merck’s Keytruda (pembrolizumab) for use with carboplatin and paclitaxel, followed by single-agent pembrolizumab in adult patients with primary advanced or recurrent endometrial carcinoma.

Approval was based on data from the KEYNOTE-868/NRG-GY018 (NCT03914612) trial that enrolled 810 patients with advanced or recurrent endometrial carcinoma, according to an [agency release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-primary-advanced-or-recurrent-endometrial-carcinoma?utm%5Fmedium=email&utm%5Fsource=govdelivery). It included two separate cohorts based on mismatch repair (MMR) status — 222 patients in the mismatch repair deficient (dMMR) cohort, and 588 patients in the mismatch repair (pMMR) proficient cohort.

The trial’s primary efficacy outcome was progression-free survival (PFS), assessed by the investigator according to RECIST 1.1\. “In the dMMR cohort, median PFS was not reached (NR) (95% CI: 30.7, NR) in the pembrolizumab and chemotherapy arm and 6.5 months (95% CI: 6.4, 8.7) in the placebo and chemotherapy arm (Hazard ratio \[HR\] 0.30 \[95% CI: 0.19, 0.48\]; p-value <0.0001),” the release says. “In the pMMR cohort, median PFS was 11.1 months (95% CI: 8.7, 13.5) in the pembrolizumab and chemotherapy arm and 8.5 months (95% CI: 7.2, 8.8) for those receiving placebo and chemotherapy arm (HR 0.60 \[95% CI: 0.46, 0.78; p-value <0.0001).”

FDA says that adverse reactions associated with pembrolizumab and chemotherapy were similar to previously reported events with the exception of higher rash incidents.