Table 1.
Phase II/III Trials of First-Line Immunotherapy
| Study (Phase) | Treatment (No. of Patients) | mPFS (Months) | mOS (Months) | ORR (%) | G3–4 Treatment-Related AEs |
|---|---|---|---|---|---|
| 1st line-setting | |||||
| IMvigor210 (phase II) | Atezolizumab (119) | 2.7 | 15.9 | 23 | 16 |
| ICS 2/3 | 12.3 | 19 | |||
| ICS 0/1 | 19.1 | 20 | |||
| KEYNOTE-052 (phase II) | Pembrolizumab (370) | 11.3 | 27 | ||
| CPS <10 | 18.5 | 47 | |||
| CPS ≥10 | 9.7 | 20 | |||
| IMvigor130 (phase III) | Atezolizumab + CDDP/CBDCA + gemcitabine (451) | 8.2 | 16 | 47 | 85 |
| Atezolizumab (362) | 6.3 | 15.7 | 23 | 42 | |
| CPS ≥10 | 16.1 | ||||
| CDDP/CBDCA + gemcitabine + placebo (400) | 6.2 | 13.4 | 44 | 86 | |
| CPS ≥10 | 15.2 | ||||
| KEYNOTE-361 (phase III) | Atezolizumab + CDDP/CBDCA + gemcitabine (351) | 8.3 | 17.0 | 54.7 | 30 |
| Pembrolizumab (307) | 15.6 | 30.3 | 1 | ||
| CDDP/CBDCA + gemcitabine + placebo (352) | 7.1 | 14.3 | 44.8 | 33 | |
| DANUBE (phase III) | Durvalumab + tremelimumab (342) | 3.7 | 15.1 | 36.2 | 27 |
| Durvalumab (346) | 2.3 | 44.9 | 14 | ||
| PD-L1 positive | 14.4 | ||||
| CDDP/CBDCA + gemcitabine (344) | 6.7 | 12.1 | 49.1 | 60 | |
| PD-L1 positive | 12.1 | ||||
Abbreviations: mPFS, median progression-free survival; mOS, median overall survival; ORR, objective response rate; AE, adverse event; CDDP/CBDCA, cisplatin/carboplatin; ICS, immune cell score; CPS, combined positive score; PD-L1, programmed death ligand-1.