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GU Symposium 2021: Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Cancer

By: Sarah Campen, PharmD
Posted: Thursday, February 11, 2021

Treatment with nivolumab following radical surgery, with or without cisplatin-based chemotherapy, appears to significantly improve outcomes in patients with muscle-invasive urothelial carcinoma, according to the initial results of the phase III CheckMate 274 trial. “Nivolumab is the first immune therapy to be used in the adjuvant setting that provides a statistically significant and clinically meaningful improvement in disease-free survival for patients with high-risk muscle-invasive urothelial carcinoma after radical surgery with curative intent, irrespective of PD-L1 status,” stated Dean F. Bajorin, MD, FACP, FASCO, of Memorial Sloan Kettering Cancer Center, New York, in an American Society of Clinical Oncology press release. The findings were presented during the 2021 Genitourinary Cancers Symposium (Abstract 391), from February 11 to 13.

In this double-blind trial, patients with high-risk muscle-invasive urothelial carcinoma of the bladder, ureter, or renal pelvis were randomly assigned either nivolumab at 240 mg every 2 weeks (n = 353) or placebo (n = 356) after radical surgery for up to 1 year of adjuvant treatment. The study population included 140 patients in the nivolumab arm and 142 patients in the placebo arm with positive PD-L1 tumors (PD-L1 ≥ 1%).

Among all study patients, the median disease-free survival was improved for those treated with nivolumab after surgery compared with those who received placebo (21 months vs. 10.9 months). Disease-free survival for the subset of patients with tumors positive for PD-L1 was also improved with nivolumab; however, the median was not yet reached by the time of analysis. As for safety, grade 3 and 4 treatment-related adverse events occurred in 17.9% and 7.2% of patients in the nivolumab and placebo arms, respectively.

Disclosure: For full disclosures of study authors, visit

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