Table 1.
Trial | Phase | No. of Patients | Treatment | FDA Approval | OS | PFS | ORR (%) | AEs (%) |
---|---|---|---|---|---|---|---|---|
CASPIAN | III | 537 | Durvalumab + chemotherapy vs. chemotherapy | Yes | 12.9 vs. 10.5 months (HR, 0.71; 95% CI: 0.60-0.86; P=0.0003) | 5.1 vs. 5.4 months (HR, 0.78; 95% CI: 0.65-0.94; p=0.0003) | 68 vs. 58 | Serious AEs 32.5 vs. 36.5 |
IMpower133 | III | 403 | Atezolizumab + chemotherapy vs. chemotherapy | Yes | 12.3 vs. 10.3 months (HR, 0.70; 95% CI: 0.54-0.91; P=0.007) | 5.2 vs. 4.3 months (HR, 0.77; 95% CI: 0.62-0.96; p=0.02) | 60.2 vs. 64.4 | Grade 3/4 AEs 56.6 vs. 56.1 |
IFCT-1603 | II | 73 | Atezolizumab vs. chemotherapy | Yes | 9.5 vs. 8.7 months (HR, 0.84; 95% CI: 0.45-1.58; P=0.60) | 1.4 (95% CI: 1.2-1.5) vs. 4.3 (95% CI: 1.5-5.9) | 2.3 (95% CI: 0.0-6.8) | Grade 3/4 AEs 4.2 vs. 75 |
OS: overall survival; PFS: progression-free survival; ORR: objective response rate; AEs: adverse events.