Merck phase 3 KEYNOTE 921 trial of Keytruda plus chemotherapy in patients with mCRPC fails to meet dual primary endpoints

Merck, known as MSD outside the United States and Canada, announced that the phase 3 KEYNOTE-921 trial evaluating Keytruda in combination with chemotherapy (docetaxel) compared to chemotherapy alone did not meet its dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). In the study, there were modest trends toward an improvement in both OS and rPFS for patients who received Keytruda plus chemotherapy compared with chemotherapy alone; however, these results did not meet statistical significance per the pre-specified statistical plan. The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting.

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