Merck & Co. announced Tuesday that an FDA advisory committee voted 9 to 4 in favour of recommending its anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of certain patients with high-risk, non-muscle-invasive bladder cancer (NMIBC). The agency is expected to render its decision based on a priority review in January 2020.
The company's filing is supported by data from the single-arm Phase II KEYNOTE-057 trial of 102 patients with high-risk NMIBC, with carcinoma in-situ with or without papillary tumours. An interim analysis of the study's primary endpoint showed a complete response rate of 38.8% at three months in patients whose disease was unresponsive to Bacillus Calmette-Guérin (BCG) therapy and who were ineligible for or who refused to undergo radical cystectomy.
Roy Baynes, head of global clinical development and chief medical officer at Merck Research Laboratories, noted that the high-risk NMIBC patient population "currently [has] limited non-surgical treatment options approved by the FDA." The agency cleared Keytruda in 2017 for certain patients with locally advanced or metastatic urothelial carcinoma in both the first- and second-line settings.
Earlier this month, a new joint venture between Ferring Pharmaceuticals and Blackstone Life Sciences reported that the experimental gene therapy nadofaragene firadenovec had met the primary endpoint of a Phase III study, with over half of patients with high-grade, BCG-unresponsive NMIBC achieving a complete response at three months.
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