Table 1.
Posted results of monotherapy with pembrolizumab, atezolizumab, nivolumab, durvalumab and avelumab in advanced NSCLC
Identifier | Trials | Agent | phase | Indication | Population | Arms | Biomarkers | ORR | mPFS | mOS | mDOR | Adverse effects (grade ≥ 3) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT01295827 | Keynote 001 | Pembrolizumab | I | Second line | Advanced NSCLC | Pembrolizumab | Regardless PD-L1 | 19.40% | 3.7 m | 12.0 m | NR | 9.50% |
PD-L1 ≥ 50% | 45.20% | 6.3 m | NR | 12.5 m | NA | |||||||
NCT01905657 | Keynote 010 | Pembrolizumab | II/III | Second line | Previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells | Pembrolizumab = 2 mg/kg | PD-L1 ≥ 50% | 30.00% | 5.0 m | 14.9 m | NR | 13.00% |
Pembrolizumab = 10 mg/kg | PD-L1 ≥ 50% | 29.00% | 5.2 m | 17.3 m | NR | 16.00% | ||||||
Docetaxel | PD-L1 ≥ 50% | 8.00% | 4.1 m | 8.9 m | 8 m | 35.00% | ||||||
NCT02142738 | Keynote 024 | Pembrolizumab | III | First line | Previously untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells and no mutation of EGFR or ALK | Pembrolizumab 200 mg/3 weeks | PD-L1 ≥ 50% | 44.80% | 10.3 m | NR | NR | 26.60% |
Platinum-based chemotherapy | 27.80% | 6.0 m | 14.5 m | 6.3 m | 53.30% | |||||||
NCT02220894 | Keynote 042 | Pembrolizumab | III | First line | Previously untreated advanced non-small-cell lung cancer without a sensitising EGFR mutation or ALK translocation and with ECOG 0 or 1, and a PD-L1 TPS of 1% or greater | Pembrolizumab | PD-L1 ≥ 50% | 39.50% | 7.1 m | 20.0 m | 20.2 m | 17.80% |
PD-L1 ≥ 20% | 33.40% | 6.2 m | 17.7 m | |||||||||
PD-L1 ≥ 1% | 27.30% | 5.4 m | 16.7 m | |||||||||
Platinum-based chemotherapy | PD-L1 ≥ 50% | 32.00% | 6.4 m | 12.1 m | 10.8 m | 41.90% | ||||||
PD-L1 ≥ 20% | 28.90% | 6.6 m | 13.0 m | 8.3 m | ||||||||
PD-L1 ≥ 1% | 26.50% | 6.5 m | 12.1 m | 8.3 m | ||||||||
NCT02008227 | OAK | Atezolizumab | III | Second line | Previously treated NSCLC | Atezolizumab | ITT population | 14.00% | 2.8 m | 13.8 m | 16.3 m | 15.00% |
Docetaxel | 13.00% | 4.0 m | 9.6 m | 6.2 m | 43.00% | |||||||
NCT01642004/NCT01673867 | Checkmate 017/057 | Nivolumab | III | Second line | Previously treated patients with advanced squamous or nonsquamous non–small-cell lung cancer | Nivolumab | NA | NA | 2.56 m | 11.1 m | Squamous: 25.2 m | 10.00% |
Non-squamous: 17.2 m | ||||||||||||
Docetaxel | NA | 3.52 m | 8.1 m | Squamous: 8.4 m | 55.00% | |||||||
Non-squamous: 5.6 m | ||||||||||||
NCT01693562 | Study 1108 | Durvalumab | I/II | Second line | Pretreated NSCLC EGFR/ALK wild type | Durvalumab from 0.1 to 10 mg/kg q2w or 15 mg/kg q3w | PD-L1 ≥ 25% | 25.30% | 2.8 m | 15.4 m | NR | 10.00% |
PD-L1<25% | 6.10% | 1.5 m | 7.6 m | |||||||||
First line | Treatmentnaïve advanced NSCLC EGFR/ALK wild type |
Durvalumab 10 mg/kg q2w |
PD-L1 ≥ 25% | 28.60% | 4.0 m | 21 m | NR | 9.00% | ||||
PD-L1<25% | 11.00% | NA | NA | |||||||||
NCT02220894 | ATLANTIC | Durvalumab | II | Third line | Heavily pretreated advanced NSCLC EGFR/ALK positive | Durvalumab | PD-L1 ≥ 25% | 14.10% | 1.9 m | 13.3 m | 7.4 m | 5.40% |
PD-L1<25% | 3.60% | 1.9 m | 9.9 m | NR | ||||||||
Heavily pretreated advanced NSCLC EGFR/ALK wild type or unknown | Durvalumab | PD-L1 ≥ 90% | 30.90% | 2.4 m | NR | NR | 17.60% | |||||
PD-L1 ≥ 25% | 7.50% | 3.3 m | 10.9 m | 8.20% | ||||||||
PD-L1<25% | 3.30% | 1.9 m | 9.3 m | |||||||||
NCT02766335 | Lung-Map | Durvalumab | II | Second line | Pretreated NSCLC EGFR/ALK wild type | Durvalumab | PD-L1 ≥ 25% | 14.30% | NA | 10.7 m | NR | 34.00% |
PD-L1<25% | 6.90% | NA | 11.6 m | |||||||||
Docetaxel | NA | 6.70% | NA | 7.7 m | NR | NA | ||||||
NCT02125461 | PACIFIC | Durvalumab | III | Second line | Unresectable stage III NSCLC after chemoradiation Regardless of PD-L1 status | Durvalumab | NA | 28.40% | 16.8 m | 23.2 m | NR | 29.90% |
Placebo | 16.00% | 5.6 m | 14.6 m | 26.10% | ||||||||
NCT02395172 | JAVELIN Lung 200 | Avelumab | III | Second line | Platinum-treated patients with advanced NSCLC | Avelumab | PD-L1 ≥ 1% | 19.00% | 3.4 m | 11.4 m | NR | 10.00% |
Patients can obtain survival and life quality benefits from monotherapy with tolerable adverse reactions
ORR objective response rate, mPFS median Progression Free Survival, mOS median Overall survival, mDOR median Duration of Response, NR not reached, NA nona, ITT intend to treat