Merck announced that the Phase 3 NRG-GY018 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel) met its primary endpoint of progression-free survival (PFS) for the treatment of patients with stage III-IV or recurrent endometrial carcinoma regardless of mismatch repair status. At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with chemotherapy then continued as single agent every six weeks for up to 14 cycles demonstrated a statistically significant and clinically meaningful improvement in PFS compared with chemotherapy alone in these patients whose endometrial carcinoma was either mismatch
repair proficient (pMMR) or mismatch repair deficient (dMMR). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and discussed with regulatory authorities. This trial was sponsored by the U.S. National Cancer Institute (NCI), part of the National Institutes of Health. NRG Oncology designed and led the trial with funding from the NCI and participation from all the National Clinical Trials Network (NCTN) Groups. Merck provided funding and support through a Cooperative Research and Development Agreement
(CRADA) between Merck and NCI. Merck has a comprehensive clinical development program in endometrial cancer. In the U.S., KEYTRUDA has two approved indications in endometrial cancer: in combination with LENVIMA(R) (lenvatinib), for the treatment of patients with advanced endometrial carcinoma that is pMMR, as determined by an FDA-approved test, or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation; and as a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.