The Keytruda regimen study by Merck fails to reach its primary goal

The Phase III KEYNOTE-B21 (ENGOT-en11/GOG-3053) research study, which aimed to treat patients with newly diagnosed high-risk endometrial cancer after surgery to cure it, has not reached its primary endpoint, according to Merck & Co (MSD). The GOG Foundation and the European Network for Gynecologic Oncology Trial (ENGOT) organizations work together to conduct the trial, which MSD sponsors.

1,095 patients participated in the randomized, double-blind trial to compare adjuvant Keytruda with chemotherapy, regardless of radiation status, against adjuvant placebo plus chemotherapy, with or without radiotherapy. Disease-free survival (DFS) and overall survival (OS) are the major objectives, whereas safety is one of the secondary outcomes. An independent data monitoring committee’s interim review revealed that the Keytruda regimen did not increase DFS compared to a placebo. Keytruda’s safety profile matched that of earlier research, and no new safety signals were found. The trial’s extensive data analysis is still in progress.
In the US, Keytruda is now approved for treating specific forms of advanced endometrial cancer. For patients with mismatch repair proficient (pMMR) advanced endometrial cancer who have progressed in their illness despite systemic treatment, it is authorized in conjunction with Lenvima. For patients with advanced post-systemic treatment who have MSI-H or mismatch repair deficient advanced endometrial cancer and are not qualified for radiation or curative surgery, it is also authorized as a monotherapy.

The most prevalent kind of cancer that damages the uterus starts in the endometrium, which is the inner lining of the organ. Merck’s Keytruda is a member of the PD-1 inhibitor drug family, which enhances the body’s immune system’s capacity to identify and combat tumor cells.
MSD released the results of the final analysis earlier this month from the Phase III KEYNOTE-811 trial, which treated locally advanced, metastatic, unresectable, or HER2-positive gastric or gastroesophageal junction adenocarcinomas using Keytruda plus trastuzumab and chemotherapy.
Based on official data, endometrial cancer causes approximately 13,000 fatalities annually in the United States.