FDA Approves Nivolumab for Adjuvant Treatment of High-Risk Urothelial Carcinoma


Median disease-free survival was nearly twice as long among patients with urothelial carcinoma who received nivolumab compared with placebo.

Officials with the FDA have approved nivolumab (Opdivo; Bristol Myers Squibb) for the treatment of patients with urothelial carcinoma who are at high risk of recurrence following radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement, or programmed death-ligand 1 (PD-L1) status.

The approval is for nivolumab 240 mg administered every 2 weeks or 480 mg administered every 4 weeks. The approval, under the FDA’s Real-Time Oncology Review pilot program, is based on the phase 3 CheckMate-274 trial, which compared nivolumab with a placebo.

CheckMate-274 is a randomized, double-blind, placebo-controlled, multi-center trial investigating nivolumab as an adjuvant treatment in patients who had undergone radical resection of urothelial carcinoma originating in the bladder or upper urinary tract and who had a high risk of recurrence. Researchers randomized 353 patients to the nivolumab arm and the major efficacy outcome measures were investigator-assessed disease-free survival in all randomized patients and in those with tumors expressing PD-L1 of 1% or greater.

Among patients who received nivolumab in the trial, researchers found that median disease-free survival was nearly twice as long as those who received placebo (20.8 months and 10.8 months, respectively). Nivolumab also reduced the risk of disease recurrence or death by 30% compared to placebo.

Among patients whose tumors expressed PD-L1 of 1% or greater, median disease-free survival was not reached for those in the nivolumab arm compared to 8.4 months in the placebo arm. Furthermore, nivolumab reduced the risk of disease recurrence or death by 45%, according to the study.

“This approval is a major milestone for patients who have undergone major surgery to remove the bladder or parts of the urinary tract and are in need of additional treatment approaches that can help reduce the risk of their [urothelial carcinoma] returning,” said Matthew D. Galsky, MD, a primary investigator in CheckMate-274, in a press release. “Nivolumab provides a new FDA-approved treatment shown to reduce the risk of disease recurrence or death based on the safety and efficacy findings from CheckMate-274 and has the potential to become a new standard of care option in this setting.”

Adverse events (AEs) leading to discontinuation of nivolumab occurred in 18% of patients in the CheckMate-274 trial and treatment was delayed for AEs in 33% of patients. Serious AEs occurred in 30% of patients and included urinary tract infection (UTI). Fatal AEs occurred in 1% of patients and included pneumonitis. The most common AEs included rash (36%), fatigue (36%), diarrhea (30%), pruritus (30%), musculoskeletal pain (28%), and UTI (22%).

“[Urothelial carcinoma] is the third type of cancer where Opdivo has been the first approved [programmed cell death protein 1] inhibitor in the adjuvant setting,” said Adam Lenkowsky, senior vice president and general manager of US Cardiovascular, Immunology, and Oncology at Bristol Myers Squibb, in the press release. “Now with this advancement, we can offer new hope to the conversations between health care providers and their [urothelial carcinoma] patients where historically no approved treatment options have existed to help prevent disease recurrence post-surgery.”


US Food and Drug Administration Approves Opdivo (nivolumab) for the Adjuvant Treatment of Patients with High-Risk Urothelial Carcinoma. News release. Bristol Myers Squibb; August 20, 2021. Accessed August 20, 2021. https://news.bms.com/news/details/2021/U.S.-Food-and-Drug-Administration-Approves-Opdivo-nivolumab-for-the-Adjuvant-Treatment-of-Patients-with-High-Risk-Urothelial-Carcinoma/default.aspx

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