Ono Pharmaceutical Co., Ltd....and Bristol-Myers Squibb...announced today that ONO received approval of Opdivo® (generic name: nivolumab) Intravenous Infusion (“Opdivo”), a human anti-human programmed cell death-1 (PD-1) monoclonal antibody in Japan for the following two additional indications, for a partial change in approved items of the manufacturing and marketing approval:...Microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed following chemotherapy...

...Have metastatic or locally advanced mismatch repair deficient/MSI-H disease...

We conducted a multicenter phase II, open-label, single-arm clinical trial to explore the effectiveness and safety of nivolumab monotherapy in patients with advanced rare cancers with dMMR/MSI-H...Objective response rate was 60% [95% confidence interval (CI), 26.2–87.8] by central assessment and 70% (95% CI, 34.8–93.3) by local investigators. Median progression-free survival was 10.1 months (95% CI, 0.9–11.1)....The trial met its primary endpoint with nivolumab, demonstrating clinical benefit in advanced dMMR/MSI-H rare solid cancers.

In this study, we evaluated the efficacy of the PD-1 inhibitor nivolumab across pre-treated solid MSI tumors….CB was observed in 62% (95% CI 46 – 54) (N = 80) with an OR in 45% (95% CI 53 – 70) (N = 58)….Nivolumab proved highly effective in pre-treated, advanced solid MSI tumors.