Table 1.

Efficacy and toxicity from randomized trials of ipilimumab combined with nivolumab

Checkmate 069a (19)Checkmate 067 (11)
Ipilimumab (N = 47)Ipi/Nivo (N = 95)Ipilimumab (N = 315)Nivolumab (N = 316)Ipi/Nivo (N = 314)
Efficacy
 Response rate (%)1161194458
P value vs. Ipi<0.001<0.001<0.001
 Complete response (%)0222912
 Median PFS (months)4.4NR2.96.911.5
 HR vs. ipilimumab0.40 (95% CI, 0.23–0.68)0.57 (95% CI, 0.43–0.760.42 (95% CI, 0.31–0.57)
Toxicity (%)
 Drug-related AEs9391868296
 Grade 3–42454271655
Selected AEs of interest (all grades, %)
 Colitis132312112
 Hypophysitis612418
 Hypothyroidism15164915
 Hepatic4287630
 Pneumonitis411216
 Skin toxicity %5971544259
AE leading to discontinuation174715836
  • Abbreviations: AE, adverse event; NR, not reached.

  • aFor Checkmate 069 efficacy data limited to BRAF wild-type patients (N = 72 Ipi/Nivo, and N = 37 I), toxicity data from the entire population (N = 95 Ipi/Nivo, and N = 47 I).