Update on Phase 3 KEYNOTE-361 Trial Evaluating Pembrolizumab as Monotherapy and in Combination with Chemotherapy in Patients with Advanced or Metastatic Urothelial Carcinoma

San Francisco, CA (UroToday.com) -- Merck, known as MSD outside the United States and Canada, announced that the Phase 3 KEYNOTE-361 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with advanced or metastatic urothelial carcinoma (bladder cancer) did not meet its pre-specified dual primary endpoints of overall survival (OS) or progression-free survival (PFS), compared with standard of care chemotherapy. In the final analysis of the study, there was an improvement in OS and PFS for patients treated with KEYTRUDA in combination with chemotherapy (cisplatin or carboplatin plus gemcitabine) compared to chemotherapy alone; however, these results did not meet statistical significance per the pre-specified statistical plan. The monotherapy arm of the study was not formally tested since superiority was not reached for OS or PFS in the KEYTRUDA combination arm. The safety profile of KEYTRUDA in this trial was consistent with previously reported studies, and no new safety signals were identified. Results will be presented at an upcoming medical meeting and will be discussed with regulatory authorities.

“In this study, KEYTRUDA in combination with chemotherapy in previously untreated patients with advanced or metastatic bladder cancer was rigorously tested against an active control of the current standard of care chemotherapy combination regimen,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

“While we are disappointed in these study results, KEYTRUDA has been established as an important option in the treatment of metastatic bladder cancer, and we are committed to continuing our research to help more patients with this disease. We are grateful to the patients and investigators for their participation in this study.”

KEYTRUDA has three FDA-approved bladder cancer indications across multiple types and stages of bladder cancer. Additionally, Merck has an extensive clinical development program in bladder cancer and is continuing to evaluate KEYTRUDA as monotherapy and in combination with other anti-cancer therapies across several disease settings (i.e., metastatic, muscle invasive bladder cancer, and non-muscle invasive bladder cancer).

Source: WIRE, BUSINESS. 2020. "Merck Provides Update On Phase 3 KEYNOTE-361 Trial Evaluating KEYTRUDA® (Pembrolizumab) As Monotherapy And In Combination With Chemotherapy In Patients With Advanced Or Metastatic Urothelial Carcinoma". Businesswire.Com.

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