Opdivo nivolumab: Additional Phase III data

Additional data from the open-label, international Phase III CheckMate -025 trial in 821 patients with advanced or metastatic clear cell RCC who received 1 or 2 prior anti-angiogenic therapies showed that 3 mg/kg IV Opdivo every 2 weeks led to a median OS, the primary endpoint, of 25 months vs. 19.6 months for once-daily 10 mg oral Afinitor everolimus (HR=0.73, 98.5% CI: 0.57, 0.93, p=0.002). BMS said the pre-specified criterion for superiority was p<=0.0148. Opdivo led to an ORR of 25% vs. 5% for Afinitor (p<0.001) and a median PFS of 4.6 months vs. 4.4 months for Afinitor (p=0.11). An ad hoc sensitivity analysis showed that Opdivo led to a median PFS of 15.6 months in patients who had not had disease progression or died at 6 months vs. 11.7 months for Afinitor (HR=0.64, 95% CI: 0.47, 0.88). Data were published in The New England Journal of Medicine and presented at the European Cancer Congress in Vienna. ...