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. 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. 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.2 This resulted in the FDA approving pembrolizumab for use in this patient population. The data presented were from cohort B of the phase 2 Keynote-057 trial (NCT02625961), which 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. Pembrolizumab (pembro) monotherapy for patients (pts) with high-risk non–muscle-invasive bladder cancer (HR NMIBC) unresponsive to bacillus Calmette–Guérin (BCG): Results from cohort B of the phase 2 KEYNOTE-057 trial.Treatment with pembrolizumab (Keytruda) was associated with antitumor activity in patients with BCG-unresponsive, papillary high-risk non–muscle-invasive bladder cancer (NMIBC) after approximately 45 months of follow-up, according to data presented at the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium. ![]() The authors concluded that patients with BCG unresponsive, non-carcinoma in situ papillary high risk NMIBC may benefit from pembrolizumab monotherapy. The 12-month PFS to either invasive or metastatic disease or death was 88.2% with a median PFS of 46.2 months and the estimated overall survival rate at 12 months was 96.2%. In addition, for any level of disease recurrence, the 12 month DFS was estimated as 41.7% with a median DFS of 6 months. The 12-month DFS rate was 43.5 % and the median DFS was 7.7 months (95% CI 6.5 – 13.6). Other outcomes explored included the 12-month DFS of any disease, progression-free survival (PFS) to worsening of grade, stage, or death as well as PFS to muscle invasion, metastasis, or death and finally, overall survival (OS).Ī total of 132 patients with a median age of 72 years were included and who had received a median of 10 prior BCG instillations. ![]() The primary endpoint as 12-month disease-free survival (DFS) as determined by central pathology and radiology review. These individuals received pembrolizumab at a dose of 200 mg every three weeks for less than 35 cycles. The data presented at the ASCO symposium relates to a second patient cohort from KEYNOTE-057 who had papillary tumours but without carcinoma in situ. In an earlier phase 2 study (KEYNOTE-057), patients with histologically confirmed BCG-unresponsive carcinoma in situ with or without papillary tumours, treated with pembrolizumab monotherapy showed that the drug was both tolerable and demonstrated promising anti-tumour activity. ![]() BCG has been used in the treatment of NMIBC for many years although in roughly half of high-risk patients, intra-vesical BCG treatment fails and NMIBC persists or recurs early. The vast majority (75 to 80%) of newly diagnosed bladder cancers are categorised as non-muscle invasive cancers (NMIBC). In results presented at the 2023 American Society for Clinical Oncology (ASCO) genitourinary cancer symposium, pembrolizumab monotherapy given to patients with Bacillus Calmette-Guerin (BGC) unresponsive, high-risk, non-muscle invasive bladder cancer, showed notable anti-tumour activity. Pembrolizumab monotherapy in high-risk, non-muscle-invasive bladder cancer patients unresponsive to BCG treatment shows anti-tumour activity
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