Table 1.
Summary of Key Clinical Data from Studies of Regimens Approved and Recommended in Key Guidelines for the Treatment of Advanced Squamous Cell Lung Cancer
| Study | Number of NSCLC Patients in Trial/Number with Lung SCC | Patient Population | Median PFS | Median OS | Survival HR vs Chemotherapy in Lung SCC Patients (95% CI) |
|---|---|---|---|---|---|
| First-line treatment | |||||
| Pembrolizumab vs platinum-based chemotherapy (KEYNOTE-024)92,93 | 305/56 | PD-L1 TPS ≥50% | 10.3 vs 6.0 months; P<0.001 | 30.0 vs 14.2 months; P=NR | PFS 0.35 (0.17–0.71) |
| Pembrolizumab vs platinum-based chemotherapy (KEYNOTE-042)11 | 1274/492 | PD-L1 TPS ≥1% | TPS ≥1%: 5.4 vs 6.5 months; P=NR TPS 1–49%: NR |
TPS ≥1%: 16.7 vs 12.1 months; HR=0.81; P=0.0018 TPS 1–49%: 13.4 vs 12.1 months; HR=0.92 |
NR (SCC patients were not analyzed separately) |
| Pembrolizumab + platinum-based chemotherapy vs platinum-based chemotherapy (KEYNOTE-407)94 | 559/559 | Unselected (PD-L1 TPS <1% and ≥1%) | 6.4 vs 4.8 months; P<0.001 | 15.9 vs 11.3 months; HR=0.64; P<0.001 | PFS 0.56 (0.45–0.70) |
| Nivolumab + ipilimumab vs platinum-based chemotherapy (CheckMate 227)13,15 | PD-L1 ≥1%: 1189/350 | Unselected (PD-L1 <1% and ≥1%) | PD-L1 ≥1%: 5.1 vs 5.6 months; HR 0.82 | PD-L1 ≥1%: 17.1 vs 14.9 months; P=0.007 | PD-L1 ≥1%: OS 0.69 (0.52–0.92) |
| Atezolizumab vs platinum-based chemotherapy (IMpower110)16 | 554/167 | PD-L1 ≥1% on TC or IC | TC3 or IC3 WT: 8.1 vs 5.0 months; P=0.0070 | TC3 or IC3 WT: 20.2 vs 13.1 months; HR=0.59; P=0.0106 | OS 0.56 (0.23–1.37) (for TC3 or IC3 WT) |
| Second-line treatment | |||||
| Nivolumab vs docetaxel (CHECKMATE 017)23 | 272/272 | Unselected patients with progressive disease after first-line platinum-based chemotherapy | 3.5 vs 2.8 months; P<0.001 | 9.2 vs 6.0 months; P<0.001 | PFS 0.62 (0.47–0.81) |
| Ramucirumab + docetaxel vs docetaxel (REVEL)22 | 1253/328 | Unselected patients with progressive disease after first-line platinum-based chemotherapy | Overall population: 4.5 vs 3.0 months; P<0.0001 | Patients with SCC: 9.5 vs 8.2 months; HR=0.88 | NR (SCC patients not analyzed separately) |
| Atezolizumab vs docetaxel (OAK)24 | 850/222 | Unselected patients with progressive disease after ≤2 previous chemotherapy regimens | Overall population: 2.8 vs 4.0 months; P=NS | Overall population: 13.8 vs 9.6 months; HR=0.73; P=0.0003 | OS 0.73 (0.54–0.98) |
| Pembrolizumab 2 mg/kg vs pembrolizumab 10 mg/kg vs docetaxel (KEYNOTE-010)84 | 1033/222 | Patients with PD-L1 TPS ≥1% and progressive disease after platinum-based chemotherapy | Overall population: 3.9 vs 4.0 vs 4.0 months; P=NS | Overall population: 10.4 vs 12.7 vs 8.5 months; P<0.001 for both pembrolizumab groups vs docetaxel | OS 0.74 (0.50–1.09); P=NS |
Abbreviations: CI, confidence intervals; HR, hazard ratio; IC, tumor-infiltrating immune cells; NR, not reported; NS, not significant; NSCLC, non-small-cell lung carcinoma; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; SCC, squamous cell carcinoma; TC, tumor cells; TPS, tumor proportion score; WT, wild-type.