FDA approves Opdivo for resected esophageal or GEJ cancer

The US Food and Drug Administration has approved another important indication for Opdivo (nivolumab, injection for intravenous use), this one for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).

The approval, granted to US pharma major Bristol Myers Squibb (NYSE: BMY), is based on results from the Phase III CheckMate -577 trial that evaluated Opdivo (n=532) compared to placebo (n=262) in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection. According to BMS, whose shares closed up 2.2% at $67.00 on the news yesterday, Opdivo is the first and only immunotherapy approved in this patient population.

In the trial, among patients who received Opdivo, median disease-free survival (DFS) was twice as long as in those who received placebo (22.4 months [95% Confidence Interval [CI]: 16.6 to 34.0] compared to 11.0 months [95% CI: 8.3 to 14.3]). Opdivo reduced the risk of disease recurrence or death by 31% compared to placebo (Hazard Ratio [HR] 0.69; 95% CI: 0.56 to 0.85; P=0.0003).