Health-related quality of life (HRQoL) and updated follow-up from KEYNOTE-057: Phase II study of pembrolizumab (pembro) for patients (pts) with high-risk (HR) non-muscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guérin (BCG)

KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC

“…In KEYNOTE-057, the safety profile of pembrolizumab monotherapy was consistent with the previously established safety profile of pembrolizumab in advanced urothelial and other cancers [44]. Most AEs reported in this study were grade 1 or 2 and were effectively managed [49]. The possible role of immune checkpoint signaling in BCG resistance and the efficacy of pembrolizumab in patients with BCG-unresponsive high-risk NMIBC suggest that combining immune checkpoint blockade and BCG therapy may increase the antitumor activity of BCG-based therapy.…”

“…KEYNOTE-057 ( NCT02625961) is an openlabel Phase II study of pembrolizumab monotherapy (200 mg every 3 weeks for up to 2 years) in patients with BCG-unresponsive, high-risk NMIBC, divided into two cohorts: patients with CIS with or without papillary disease (cohort A) and patients with papillary disease without CIS (cohort B). In an interim analysis of 102 patients enrolled in cohort A of the KEYNOTE-057 study, pembrolizumab demonstrated encouraging antitumor activity and durable response [49]. No patient with recurrent disease had experienced progression to muscle-invasive or metastatic disease while on study therapy, based on protocol-specified disease assessments [49].…”

“…In an interim analysis of 102 patients enrolled in cohort A of the KEYNOTE-057 study, pembrolizumab demonstrated encouraging antitumor activity and durable response [49]. No patient with recurrent disease had experienced progression to muscle-invasive or metastatic disease while on study therapy, based on protocol-specified disease assessments [49]. Recently, pembrolizumab monotherapy was approved by the US FDA for patients with BCG-unresponsive CIS who were ineligible for or declined to undergo cystectomy [44].…”