Drug and Device News August 2018 | P&T Community

Opdivo, Yervoy Combination For Colorectal Cancer Cases

The combination of nivolumab (Opdivo) and ipilimumab (Yervoy), both made by Bristol-Myers Squibb, has received FDA accelerated approval for the treatment of adult and pediatric patients 12 years of age and older with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

The approval was based on data from this population in CheckMate-142, an ongoing phase 2, multicenter, nonrandomized, multiple-parallel cohort, open-label study. Among the 82 patients, 46% responded to treatment with nivolumab plus ipilimumab (3.7% complete responses and 43% partial responses). Among these 38 responders, the median duration of response was not reached.

The recommended dosing schedule is nivolumab 3 mg/kg, followed by ipilimumab 1 mg/kg on the same day, every three weeks for four doses, followed by nivolumab maintenance therapy (240 mg every two weeks) after completion of four doses of

... read more at: https://www.ptcommunity.com/journal/article/full/2018/8/453/drug-and-device-news-august-2018