KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.
Of patients with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years.Ībout KEYTRUDA ® (pembrolizumab) injection, 100 mg Approximately 10-20% of patients with advanced prostate cancer will develop CRPC within five years, and at least 84% of these patients will have metastases at the time of CRPC diagnosis. In patients with mCRPC, their prostate cancer grows and spreads to other parts of the body, despite the use of androgen-deprivation therapy to block the action of male sex hormones. Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone. Prostate cancer is the second most common cancer in men globally and is associated with a significant mortality rate. Secondary endpoints include time to initiation of the first subsequent anti-cancer therapy, prostate-specific antigen response rate, objective response rate and duration of response.Ībout metastatic castration-resistant prostate cancer The dual primary endpoints are OS and rPFS.
#Keynote 189 trial#
The trial enrolled 1,030 patients who were randomized to receive either KEYTRUDA (200 mg every three weeks for up to approximately two years) plus chemotherapy and prednisone or placebo plus chemotherapy and prednisone. KEYNOTE-921 is a randomized, double-blind Phase 3 trial (, NCT03834506) evaluating KEYTRUDA in combination with chemotherapy (docetaxel) and prednisone compared with placebo in combination with chemotherapy and prednisone for the treatment of patients with mCRPC who have not received chemotherapy for mCRPC but whose disease has progressed on or is intolerant to a next-generation hormonal agent. 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.
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. Merck has a strong commitment to the development of new treatment options for people with prostate cancer.
“We are grateful to the patients and investigators for their participation in this study.” Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. We will continue to advance our clinical development program to evaluate KEYTRUDA-based combinations and novel candidates for patients with this disease,” said Dr. “Results from this study serve as an important reminder that metastatic prostate cancer remains very difficult to treat, and more research is needed. Results will be presented at an upcoming medical meeting. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. 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. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today 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).
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