Ipilimumab: Phase II data

The double-blind, Phase II Study 041 trial in 203 previously untreated stage IIIb/IV NSCLC patients showed that both regimens of 10 mg/kg ipilimumab every 3 weeks in combination with chemotherapy met the primary endpoint of significantly improving irPFS vs. chemotherapy alone. Ipilimumab given concurrent with the first 4 cycles of chemotherapy improved irPFS by 5.52 months vs. 4.3 months for chemotherapy alone (p=0.094), and ipilimumab phased in during cycles 3-6 of chemotherapy improved irPFS by 5.68 months (p=0.026). The study protocol specified a p-value of <0.1 to meet the primary endpoint. ...