![]() In addition, 19 (14.4%) experienced a grade 3 or 4 TEAE, 17 (12.9%) experienced a serious TEAE, and 14 (10.6%) discontinued treatment due to TEAE. Regarding treatment-related adverse events (TEAEs), 97 patients (73.5%) experienced a TEAE. The 12-month PFS rate to muscle invasion, metastasis, or death was 88.2% (95% CI, 79.4%-93.3%), with a median of 46.2 months (95% CI, 36.8-not available). The 12-month PFS rate to worsening of grade, stage, or death was 88.2% (95% CI, 80.0%-93.2%), with a median of 44.5 months (95% CI, 34.6-not available). The 12-month rate of any-disease DFS (defined as low-grade Ta, high-risk NMIBC, and progressive disease) was 41.7% (95% CI, 33.1%-50.0%), and the median was 6.0 months (95% CI, 4.3-12.0). ![]() Patients had received a median of 10 prior instillations of BCG (range, 6-33) tumor stage at entry was T1 in 57 patients (43%) and high-grade Ta in 75 patients (57%) and baseline high-risk NMIBC status was persistent in 35 patients (26%), recurrent in 79 patients (60%), and progressive in 18 patients (14%). Median patient age was 72 years (range, 37-87). Secondary efficacy end points included 12-month DFS of any disease progression-free survival (PFS) to worsening of grade, stage, or death PFS to muscle invasion, metastasis, or death and overall survival (OS).Ī total of 132 patients received pembrolizumab, 104 (78.8%) of whom were male. Twelve-month disease-free survival (DFS) served as the primary end point. Participants received 200 mg pembrolizumab every 3 weeks for 35 or fewer cycles, or approximately 2 years. 3 Accordingly, cohort B of the Keynote-057 trial evaluated patients with papillary tumors only and no CIS.Ĭohort B included patients who were at least 18 years of age with BCG-unresponsive high-risk NMIBC with papillary tumors only at baseline, with an ECOG performance status of 0-2. In his presentation, Necchi noted that although prior research has been conducted in patients with BCG-unresponsive CIS3, limited data exist regarding the use of novel systemic therapies in non-CIS, high-grade papillary T1 or Ta disease. 2 This resulted in the FDA approving pembrolizumab for use in this patient population. Previously reported results from Cohort A of the trial, which evaluated the treatment in patients with carcinoma in situ (CIS) with or without papillary tumors, showed a clinical complete response rate of 40.6% at 3 months, along with a median duration of response of 16.2 months. Cohort B of the phase 2 Keynote-057 trial evaluated the safety and efficacy of pembrolizumab monotherapy in patients with BCG-unresponsive high-risk NMIBC who were either ineligible for or declined to undergo radical cystectomy, according to a presentation from Andrea Necchi, MD, associate professor at Vita-Salute San Raffaele University and head of Genitourinary Medical Oncology at the San Raffaele Hospital in Milan, Italy.
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