Merck reports NRG-GY018 trial shows statistical significance, improvement in PFS

Merck announced results from the Phase 3 NRG-GY018 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy then continued as a single agent every six weeks for up to 14 cycles for the first-line treatment of patients with stage III-IV or recurrent endometrial carcinoma whose cancer was either mismatch repair proficient, or pMMR, or mismatch repair deficient, or dMMR. Results from the trial showed the Keytruda regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, or PFS, for patients, regardless of mismatch repair status. These late-breaking data are being presented for the first time during a scientific plenary at the 2023 Society of Gynecologic Oncology, or SGO, Annual Meeting on Women’s Cancer and are also being simultaneously published in the New England Journal of Medicine. The results are being discussed with regulatory authorities worldwide. In the pMMR cohort of 591 evaluable patients, after a median follow-up of 7.9 months, the Keytruda regimen significantly reduced the risk of disease progression or death by 46% compared to chemotherapy alone; median PFS was 13.1 months for the Keytruda regimen versus 8.7 months for chemotherapy alone. In the dMMR cohort of 225 evaluable patients, after a median follow-up of 12 months, the Keytruda regimen significantly reduced the risk of disease progression or death by 70% compared to chemotherapy alone; median PFS was not reached for the Keytruda regimen versus 7.6 months for chemotherapy alone. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Grade 3-5 adverse events, or AEs, occurred in 55.1% of patients receiving the Keytruda regimen and 45.3% of patients receiving chemotherapy alone in the pMMR cohort. In the dMMR cohort, Grade 3-5 AEs occurred in 63.3% of patients receiving the Keytruda regimen and 47.2% of patients receiving chemotherapy alone. There were no Keytruda -related AEs leading to death in either cohort.