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. These data were presented at the 31 st Annual Meeting and Associated Programs of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Md., during the Oral Late-breaking Abstract Session II today from 11:30 - 11:45 a.m. EST. "Metastatic urothelial carcinoma is an area of significant unmet medical need, especially for patients in the advanced stages of the disease who have progressed on standard chemotherapy," said Padmanee Sharma, M.D., Ph.D., study investigator and professor at The University of Texas MD Anderson Cancer Center. "Earlier this year, we presented encouraging results from this trial for Opdivo monotherapy, and now we are seeing the promise of a combination regimen with Opdivo and Yervoy for previously treated patients with this common type of advanced bladder cancer. These findings support the need for further study of combination therapy to assess outcomes and potential survival in patients with metastatic urothelial carcinoma." Urothelial carcinoma is the most common type of bladder cancer, accounting for approximately 90% of bladder cancer cases. Bladder cancer is the ninth most commonly diagnosed cancer in the world, with an estimated 430,000 new cases diagnosed per year and more than 165,000 deaths annually. The majority of bladder cancers are diagnosed at an early stage, but rates of recurrence and disease progression are high, and approximately 78% of patients will experience a recurrence within five years. Survival rates vary depending on the stage and type of the cancer and when it is diagnosed. For Stage IV bladder cancer, the five-year survival rate is 15%.