Opdivo-Yervoy Combination Approved for Kidney Cancer
April 16, 2018 – The U.S. FDA has approved a combination of Opdivo (nivolumab) 3mg/kg and low-dose Yervoy (ipilimumab) 1mg/kg as a first-line treatment for intermediate- and poor-risk advanced renal cell carcinoma (RCC). It is the first immuno-oncology pairing to receive this indication. Both Opdivo and Yervoy are manufactured by Bristol-Myers Squibb.
Approval was based on clinical trials in which the Opdivo-Yervoy combination was found to be superior to the current standard of care, Pfizer’s Sutent® (sunitinib). The Opdivo-Yervoy combination significantly increased overall survival rates regardless of PD-L1 expression level and achieved a higher objective response rate. Patients who received the combination also experienced fewer severe or life-threatening adverse events compared to those taking Sutent. Risk of death was reduced by 37% with Opdivo-Yervoy versus Sutent, and the objective response rate was 41.6% compared to just 26.5% with Sutent.
Recommended dosing is one infusion every three weeks of Opdivo 3mg/kg and Yervoy 1mg/kg, for a total of four doses. Monotherapy then follows with Opdivo 240mg every two weeks or 480mg every four weeks.
An estimated 75% to 80% of patients diagnosed with advanced RCC are considered intermediate- and poor-risk patients. The population has a survival rate of just 36% after one year, and 8% after five years.
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