Merck, known as MSD outside the United States and Canada, today announced the first presentation of results from an interim analysis of KEYNOTE-057, a Phase 2 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, for previously treated patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) or CIS plus papillary disease (Cohort A). An interim analysis of the study's primary endpoint showed a complete response (CR) rate of 38.8 percent (95% CI, 29.4-48.9) (n=103) at three months with KEYTRUDA in patients whose disease was unresponsive to Bacillus Calmette-Guérin (BCG) therapy, the current standard of care for this disease, and who were ineligible for or who refused to undergo radical cystectomy. These results, as well as other study findings, are being presented today in an oral session at the ESMO 2018 Congress (Abstract #864O).
"Treatment options for high-risk non-muscle invasive bladder cancer have historically been limited, with many patients relying on surgery as their only option following disease recurrence. Additionally, about 40 percent of patients with high-risk non-muscle invasive bladder cancer progress to muscle invasive disease," said professor Ronald de Wit, M.D., Ph.D., group leader experimental systemic therapy of urogenital cancers, Erasmus MC Cancer Institute. "These data from KEYNOTE-057 are encouraging for patients with this hard-to-treat form of bladder cancer who are ineligible for surgery."
"The nearly 40 percent complete response rate with KEYTRUDA in patients with high-risk non-muscle invasive bladder cancer is encouraging and adds to the growing body of data showing the anti-tumor activity of KEYTRUDA as monotherapy across different types of cancer," said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. "There are few options for the treatment of recurrent non-muscle invasive bladder cancer, and we look forward to continuing to study KEYTRUDA for the treatment of these patients whose disease has reoccurred and who have limited therapeutic options."