Table 1.
Phase 3 trials of checkpoint inhibitors alone or in combination for first line treatment of metastatic NSCLC.
| Trial | Histology | PD-L1 staining* | Therapy | ORR (95% CI) | Median PFS (95% CI) | Median OS (95% CI) |
|---|---|---|---|---|---|---|
| KEYNOTE-024 (5, 7) | Squamous and non-squamous | ≥50% | Pembrolizumab (n = 154) | 45.5% (37.4–53.7) | 10.3 mo (6.7-NR) | 30 mo (18.3-NR) |
| Platinum Doublet (n = 151) | 29.8% (22.6–37.8) | 6.0 mo (4.2–6.2) | 14.2 mo (9.8–19.0) | |||
| KEYNOTE-042 (8) | Squamous and non-squamous | ≥50% | Pembrolizumab (n = 299) | 39.5%a | 7.1 mo (5.9–9.0) | 20 mo (15.4–24.9) |
| Platinum doublet (n = 300) | 32.0%a | 6.4 mo (6.1–6.9) | 12.2 mo (10.4–14.2) | |||
| 1–49% | Pembrolizumab (n = 338) | 16.6% (12.8–21.0) | N/A | 13.4 (10.7–18.2) | ||
| Platinum Doublet (n = 337) | 21.7% (17.4–26.4) | N/A | 12.1 (11.0–14.0) | |||
| CheckMate-026 (10) | Squamous and non-squamous | ≥50% | Nivolumab (n = 88) | 34% (24.0–45.0) | 5.4a | 15.9a |
| Platinum doublet (n = 126) | 39% (30.0–48.0) | 5.8a | 13.9a | |||
| ≥5% | Nivolumab (n = 211) | 26% (20.0–33.0) | 4.2 mo (3.0–5.6) | 14.4 mo (11.7–17.4) | ||
| Platinum doublet (n = 212) | 33% (27.0–40.0) | 5.9 mo (5.4–6.9) | 13.2 mo (10.7–17.4) | |||
| CheckMate-227 (11) | Squamous and non-squamous | Any | Nivolumab + Ipilimumab (n = 583) | N/A | 4.9 mo (4.1–5.6) | N/A |
| Platinum doublet (n = 583) | N/A | 5.5 mo (4.6–5.6) | N/A | |||
| MYSTIC (12) | Squamous and non-squamous | ≥50% | Durvalumab (n = 118) | N/A | N/A | 18.3 mo (13.6–22.8) |
| Durvalumab + Tremelimumab (n = 108) | N/A | N/A | 15.2 mo (8.0–26.5) | |||
| Platinum doublet (n = 107) | N/A | N/A | 12.7 mo (10.3–15.1) | |||
| ≥25% | Durvalumab (n = 163) | 35.6%a | 4.7 mo (3.1–6.3) | 16.3 mo (12.2–20.8) | ||
| Durvalumab + Tremelimumab (n = 163) | 34.4%a | 3.9 mo (2.8–5.0) | 11.9 mo (9.0–17.7) | |||
| Platinum doublet (n = 162) | 37.7%a | 5.4 mo (4.6–5.8) | 12.9 mo (10.5–15.0) |
*
PD-L1 staining on tumor cells was defined by the 22C3 assay for pembrolizumab, the Dako 28-8 assay for nivolumab and the SP263 assay for durvalumab. Platinum includes either carboplatin or cisplatin.
a
Confidence interval not available.
PD-L1, programmed death ligand 1; ORR, objective response rate; PFS, progression free survival; OS, overall survival; CI, confidence interval; mo, months; NR, not reached; NE, not evaluable; N/A, not available.