Data from Pharmawand - Curated by EPG Health - Date added 19 November 2018
Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending approval of the Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination to include first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). This recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
The CHMP recommendation is based on positive data from the Phase III CheckMate -214 clinical trial, which was stopped early following a planned interim analysis that showed the combination of Opdivo 3 mg/kg plus Yervoy 1 mg/kg demonstrated a significant increase in overall survival (OS) with a 37% decreased risk of death in intermediate- and poor-risk patients, regardless of PD-L1 expression level, compared to a current standard of care, sunitinib (Hazard Ratio [HR] 0.63; 99.8% Confidence Interval [CI]: 0.44 to 0.89; p<0.0001). Median OS in patients treated with Opdivo plus low-dose Yervoy was not yet reached (95% CI: 28.2 to not estimable [NE]), compared to 25.9 months for patients treated with sunitinib. Opdivo plus low-dose Yervoy also delivered durable responses with a higher objective response rate of 41.6% (95% CI: 36.9 to 46.5; p<0.0001; n=177/425) versus 26.5% for sunitinib (95% CI: 22.4 to 31.0; n=112/422). Median duration of response (durability) for Opdivo plus low-dose Yervoy was not yet reached (95% CI: 21.8 to NE) among responded patients, compared to 18.2 months for sunitinib (95% CI: 14.8 to NE). The overall safety profile was consistent with prior studies of Opdivo in combination with low-dose Yervoy.0>