3303 Efficacy and safety in key patient subgroups of nivolumab (NIVO) alone or combined with ipilimumab (IPI) versus IPI alone in treatment-naïve patients with …

J Larkin, V Chiarion-Sileni… - … Journal of Cancer, 2015 - research.manchester.ac.uk
J Larkin, V Chiarion-Sileni, R Gonzalez, JJ Grob, CL Cowey, CD Lao, J Wagstaff, D Hogg
European Journal of Cancer, 2015research.manchester.ac.uk
Aims: Phase III study CheckMate 067 reported improved progression-free survival (PFS)
with NIVO+ IPI vs IPI alone. Here, we report results of subgroup analyses in this trial.
Methods: Treatment-naive MEL pts (N= 945) were randomized 1: 1: 1 to receive NIVO (3
mg/kg Q2W)+ placebo (PBO), or NIVO+ IPI (1 mg/kg+ 3 mg/kg Q3W X 4) followed by NIVO 3
mg/kg Q2W, or to IPI (3 mg/kg Q3W X 4)+ PBO until disease progression or unacceptable
toxicity. PFS, a co-primary endpoint, was evaluated in predefined subgroups. Results: In the …
Aims
Phase III study CheckMate 067 reported improved progression-free survival (PFS) with NIVO+ IPI vs IPI alone. Here, we report results of subgroup analyses in this trial.
Methods
Treatment-naive MEL pts (N= 945) were randomized 1: 1: 1 to receive NIVO (3 mg/kg Q2W)+ placebo (PBO), or NIVO+ IPI (1 mg/kg+ 3 mg/kg Q3W X 4) followed by NIVO 3 mg/kg Q2W, or to IPI (3 mg/kg Q3W X 4)+ PBO until disease progression or unacceptable toxicity. PFS, a co-primary endpoint, was evaluated in predefined subgroups.
Results
In the total population, median PFS was 11.5 months for NIVO+ IPI vs 2.9 months for IPI alone (hazard ratio [HR] vs IPI, 0.42; P< 0.00001), and was 6.9 months for NIVO alone (HR vs IPI, 0.57; P< 0.00001). Numerically longer PFS was observed with the combination vs NIVO or IPI alone in all predefined subgroups, including baseline lactate dehydrogenase> upper limit of normal (NIVO+ IPI: 4.2 months [95% CI: 2.8-9.3] vs NIVO: 2.8 months [95% CI: 2.6-4.0] vs IPI: 2.6 months [95% CI: 2.6-2.8]) and age
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