Regulatory Decision Summary for Opdivo

Authorization was based on the safety and efficacy results of a Phase 3 multi-centre, randomized, double-blind, controlled clinical trial CheckMate 274.

Patients with recently resected urothelial carcinoma received either Opdivo (240 mg intravenously every 2 weeks) (n = 353) or placebo (n = 356).

The primary efficacy endpoints were disease-free survival (DFS) in the all-randomized population and in the tumor PD-L1 ≥1% population. At the first interim analysis, the nivolumab arm demonstrated statistically and clinically significant DFS results in both the all-randomized and tumor PD-L1 ≥1% populations. Overall survival (OS) is a key secondary endpoint that was not mature at this interim analysis, thus an improvement in OS has not yet been established. The DFS represents promising evidence of efficacy. As confirmatory evidence, the sponsor has committed to submitting the OS results for Checkmate-274 study.

There are more risks associated with nivolumab treatment than with placebo. However, the risks are generally manageable through close monitoring and various treatment modifications as described in the product monograph.

• The recommended dose for this indication is 240 mg nivolumab administered intravenously over 30 minutes every 2 weeks until regression or toxicity is observed up to 1 year.
• In addition, a 480 mg every four weeks (Q4W) dosing regimen has also been authorized which has the potential to facilitate treatment during the COVID-19 pandemic.