KEYNOTE-057: Phase 2 study of pembrolizumab for patients (pts) with Bacillus Calmette Guerin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (NMIBC).

Abstract

TPS4576Background: The majority of pts presenting with bladder cancer ( > 70,000 cases/y in the United States) have NMIBC. Despite standard of care therapy with transurethral resection of bladder tumor [TURBT] and BCG administration, a large percentage of pts will have disease recurrence/progression. PD-L1 is widely expressed in urothelial tumors. Pembrolizumab, an anti–PD-1 antibody, blocks the interaction of PD-1 and its ligands, PD-L1 and PD-L2. KEYNOTE-057 (NCT02625961) is a single-arm, open-label, phase 2 study to evaluate pembrolizumab in pts with high-risk NMIBC unresponsive to BCG. Methods: Key inclusion criteria include age ≥ 18 y; BCG-unresponsive NMIBC (high-grade Ta, T1, and/or carcinoma in situ [CIS] despite adequate BCG treatment); ineligible for/or declines radical cystectomy; ECOG PS 0-2. Pts must have undergone ≥ 2 cystoscopic procedures with the most recent ≤ 8 wk of study start, including complete TURBT (tissue sample must be available). Pts will receive pembrolizumab 200 mg Q3W for 24 ...