Bristol-Myers Squibb (BMY) Release: Opdivo (Nivolumab) And Yervoy (Ipilimumab) Regimen Shows Promising Efficacy And Safety In Previously Treated Patients With Advanced Form Of Bladder Cancer
11/14/2016 12:50:37 PM
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today additional results from the Phase 1/2 open-label CheckMate-032 trial investigating two combination schedules of Opdivo (nivolumab) plus Yervoy (ipilimumab) in patients with locally advanced or metastatic urothelial carcinoma (mUC) previously treated with platinum-based therapy. In these preliminary data, the primary endpoint of investigator-assessed confirmed objective response rate (ORR) was 38.5% (95% CI: 20.2 – 59.4) in patients who received Opdivo 1 mg/kg plus Yervoy 3 mg/kg (n=26) compared to 26.0% (95% CI: 17.9 – 35.5) in patients treated with Opdivo 3 mg/kg plus Yervoy 1 mg/kg (n=104). No new safety signals have been identified. The incidence of Grade 3-4 treatment-related adverse events (AEs) was 30.8% in the Opdivo 1 mg/kg plus Yervoy 3 mg/kg group and 31.7% in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg group. Treatment-related AEs led to discontinuation of therapy in 7.7% of patients in the Opdivo 1 mg/kg plus Yervoy 3 mg/kg group and 13.5% in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg group.
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