Merck’s Phase 3 KEYNOTE-B21 trial has shown that its anti-PD-1 therapy, KEYTRUDA, in combination with chemotherapy, did not improve disease-free survival (DFS) in high-risk endometrial cancer patients after surgery. An interim analysis revealed that KEYTRUDA plus chemotherapy, with or without radiotherapy, did not meet the study’s criteria for DFS compared to placebo plus chemotherapy. Therefore, the study’s other primary endpoint, overall survival (OS), was not formally tested.
The safety profile of KEYTRUDA remained consistent with previous studies, without any new safety concerns. Merck is thoroughly reviewing the data and will share the results with the scientific community. Despite this setback, Merck remains committed to exploring the potential of KEYTRUDA in endometrial cancer.
Merck has several ongoing clinical trials evaluating KEYTRUDA-based combinations and investigational candidates in endometrial and gynecologic malignancies. Two approved indications for KEYTRUDA in endometrial cancer in the U.S. include its use in combination with LENVIMA for advanced MSI-H or dMMR endometrial carcinoma, and as a single agent for advanced endometrial carcinoma that is pMMR or non-MSI-H.
Merck’s clinical development program in endometrial carcinoma continues to progress, with ongoing trials evaluating KEYTRUDA in various treatment regimens. The FDA has granted priority review for a supplemental Biologics License Application based on the NRG-GY018/KEYNOTE-868 trial results, with a target action date of June 21, 2024.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
