Table 3.
Trial | Phase | No. of Patients | Treatment | FDA Approval | OS | PFS | ORR (%) | AEs (%) |
---|---|---|---|---|---|---|---|---|
CheckMate 451 | III | 834 | Nivolumab plus Ipilimumab vs. Nivolumab vs. placebo | No | 9.2 months vs. 9.6 months (HR, 0.92; 95% CI: 0.75-1.12; P=0.37) | 1.7 months (1.5-2.6) vs. 1.9 months (1.6-2.6) vs. 1.4 months (1.4-1.5) | 9.1 vs. 11.5 vs. 4.2 | Grade 3/4 AEs 52.2 vs. 11.5 vs. 8.4 |
CASPIAN trial | III | 537 | Durvalumab + Tremelimumab + chemotherapy vs. chemotherapy | Yes | 10.4 months vs. 10.5 months (HR, 0.81; 95% CI, 0.67-0.97; P=0.02) | 16.9% (95% CI: 12.6-21.7) vs. 5.3% (95% CI: 2.9-8.8) | 58 vs. 58 | Serious AEs 47.4 vs. 36.5 |
CA184-156 | III | 1132 | Ipilimumab + chemotherapy vs. chemotherapy | No | 11 months vs. 10.9 months (HR 0.94; 95% CI: 0.81-1.09; P=0.3775) | 4.6 months vs. 4.4 months (HR 0.85; 95% CI: 0.75-0.97; P=0.0161) | 62 vs. 62 | Grade 3/4 AEs 48 vs. 45 |
CheckMate-032 | I/II | 243 | Nivolumab vs. Nivolumab + Ipilimumab | No | 5.7 months (3.8-7.6) vs. 4.7 months (3.1-8.3) | 1.4 months (1.3-1.4) vs. 1.5 months (1.4-2.2) | 11.6 vs. 21.9 | Grade 3/4 AEs 12.9 vs. 37.5 |
OS: overall survival; PFS: progression-free survival; ORR: objective responserate; AEs: adverse events.