Pembrolizumab for high-risk (HR) non–muscle invasive bladder cancer (NMIBC) unresponsive to bacillus Calmette-Guérin (BCG): Phase II KEYNOTE-057 trial

Abstract

Methods: Eligible pts had histologically confirmed high-grade BCG-unresponsive NMIBC, including CIS alone or combination of CIS and papillary disease (cohort A), had been treated with adequate BCG therapy (at least 5/6 induction instillations and 2/3 maintenance therapy instillations), and were unable or unwilling to undergo radical cystectomy. Pts received pembro 200 mg Q3W for 24 mo or until recurrence, progression, or unacceptable toxicity. The primary end point for cohort A was complete response (CR); key secondary end points were safety and duration of response. Pts found to have HR NMIBC or progressive disease during treatment were required to discontinue.