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ARTICLE | Clinical News

BMS reports Phase Ib data for Yervoy, nivolumab combo

May 16, 2013 12:56 AM UTC

Bristol-Myers Squibb Co. (NYSE:BMY) reported interim data late Wednesday from 52 evaluable patients showing that concurrent dosing with the pharma's Yervoy ipilimumab plus nivolumab led to an objective response rate (ORR) of 40% in a Phase Ib trial to treat unresectable stage III or stage IV metastatic melanoma. In 17 patients, a concurrent dosing regimen of 3 mg/kg Yervoy plus 1 mg/kg nivolumab led to an ORR of 53%. Next month, Bristol-Myers plans to start a Phase III trial to evaluate this concurrent dosing regimen as first-line treatment of advanced melanoma. Bristol-Myers said prior studies showed that Yervoy as a single agent produced an ORR of 11%, while 3 mg/kg nivolumab as a single agent produced an ORR of 41%.

Patients in the concurrent dosing arms received Yervoy plus nivolumab every three weeks for 12 weeks followed by nivolumab every three weeks for 12 weeks. At week 24, patients then received one concurrent combination treatment every three months. The trial, which also consists of two sequential dosing arms, is enrolling about 136 patients who had received up to three prior therapies. Data will be presented at the American Society of Clinical Oncology meeting in June. ...