![]() 2 Department of Medical Oncology, Institut de Cancérologie de l'Ouest, Nantes, 44000, France.1 Department of Hematology & Medical Oncology, Weill Cornell Medicine, New York, NY 10021, USA.(ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®. The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. For full disclosures of the study authors, visit. Balar, of the Genitourinary Medical Oncology Program, Perlmutter Cancer Center at NYU Langone Health, is the corresponding author for The Lancet Oncology article.ĭisclosure: The study was funded by Merck Sharp & Dohme. The investigators concluded, “Pembrolizumab monotherapy was tolerable and showed promising antitumor activity in patients with BCG-unresponsive non–muscle invasive bladder cancer who declined or were ineligible for radical cystectomy and should be considered a clinically active nonsurgical treatment option in this difficult-to-treat population.”ĭr. No treatment-related deaths were reported. Immune-mediated adverse events occurred in 22 patients (22% grade 3 or 4 in 3), with common events including hypothyroidism (8%) hyperthyroidism (5%), and pneumonitis (3%). Treatment-related adverse events led to discontinuation of treatment in seven patients (7%), with causes consisting of pneumonitis in two patients and autoimmune nephritis, cholestatic hepatitis, hyponatremia, myalgia, and type 1 diabetes in one patient each. Serious treatment-related adverse events occurred in eight patients (8%). Median duration of complete response was 16.2 months, with 46% of responses lasting ≥ 12 months.Īmong the 101 patients include in the safety analysis, treatment-related adverse events of any grade occurred in 67 (66%) and were of grade 3 or 4 in 13 (13%) the most common grade 3 and 4 events were hyponatremia (3%) and arthralgia (2%).Pembrolizumab produced complete response at 3 months in 41% of patients.Median duration of complete response was 16.2 months (95% CI = 6.7–36.2 months), with 18 (46%) of 39 responders remaining in complete response for ≥ 12 months.Īt 12 months, the estimated progression-free survival to worsening of grade or stage or death was 83% (95% CI = 70.2%–90.4%) and estimated progression-free survival to muscle-invasive or metastatic disease or death was 97% (95% CI = 86.0%–99.2%). Complete response at 3 months was observed in 39 (41% 95% confidence interval = 30.7%–51.1%) of 96 evaluable patients. Median follow-up was 36.4 months (interquartile range = 32.0–40.7 months). The primary endpoint was rate of clinical complete response rate, defined as absence of high-risk non–muscle invasive bladder cancer or progressive disease, assessed by cystoscopy and urine cytology approximately 3 months after the first dose of pembrolizumab. Patients received pembrolizumab at 200 mg every 3 weeks for up to 24 months or until centrally confirmed disease persistence, recurrence, or progression, or unacceptable toxicity. In the multicohort trial, 101 patients (96 evaluable for efficacy) with BCG-unresponsive carcinoma in situ of the bladder, with or without papillary tumors, who were ineligible for or declined radical cystectomy (cohort A) were enrolled from sites in 14 countries between December 2015 and April 2018.
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