Merck Provides Update on Phase 3 KEYNOTE-921 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Chemotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Reno, Nevada (UroToday.com) -- Merck (NYSE: MRK), 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.


“Results from this study serve as an important reminder that metastatic prostate cancer remains very difficult to treat, and more research is needed. We will continue to advance our clinical development program to evaluate KEYTRUDA-based combinations and novel candidates for patients with this disease,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We are grateful to the patients and investigators for their participation in this study.”
Merck has a strong commitment to the development of new treatment options for people with prostate cancer. Merck has an extensive clinical development program evaluating KEYTRUDA, Merck’s anti-PD1 therapy, as monotherapy and in combination with other anti-cancer therapies in prostate cancer, including the Phase 2 trials KEYNOTE-199 and KEYNOTE-365 and the Phase 3 registrational trials KEYNOTE-641 and KEYNOTE-991. Additionally, last month, Merck entered into a global development and commercialization agreement with Orion Corporation for Orion’s investigational candidate ODM-208, which is currently being evaluated in a Phase 2 clinical trial for the treatment of patients with mCRPC.

Source: "Merck Provides Update On Phase 3 KEYNOTE-921 Trial Evaluating KEYTRUDA® (Pembrolizumab) Plus Chemotherapy In Patients With Metastatic Castration-Resistant Prostate Cancer - Merck.Com". 2022. Merck.Com.
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