Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.A phase 3 study evaluating the use of Merck’s Keytruda (pembrolizumab) immunotherapy in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival (OS).
Subscribe to our email newsletter
The phase 3 Keynote-045 trial demonstrated that Keytruda was superior compared to investigator choice chemotherapy.
The drug’s safety profile was consistent with that observed in earlier reported trials involving patients with advanced urothelial cancer.
Depending on a pre-specified interim analysis, an independent Data Monitoring Committee has recommended that the t be stopped early.
Merck plans to present the trials’ results at an upcoming medical meeting.
Merck Research Laboratories president Roger Perlmutter said: “The results of Keynote-045 represent a major breakthrough and will be welcome news for patients dealing with previously treated advanced urothelial cancer.
“We look forward to sharing the findings from this study with the medical community and with regulatory authorities around the world.”
Keytruda increases the ability of the body’s immune system to help identify and fight tumor cells.
It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which could affect both tumor cells and healthy cells.
Last month, the US Food and Drug Administration granted breakthrough therapy designation and priority review to Keytruda for the first-line treatment of patients with advanced non–small cell lung cancer whose tumors express PD-L1.
The European Commission approved Keytruda to treat patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer (NSCLC) following at least 1 chemotherapy regimen.
Image: Keytruda (pembrolizumab) Injection 100 mg. Photo: courtesy of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.