Table 1.
Trial | Phase | Treatment Arms | Line of Treatment | Number of Patients Mutated Versus Wild Type |
Results Mutated Versus Wild Type (95% C.I. Range) | Reference |
---|---|---|---|---|---|---|
CheckMate 057 | III | Docetaxel vs. Nivolumab | ≥2 | 82 versus 340 |
HR OS 1.18 (0.69–2.00) HR PFS 1.45 (0.90–2.37) versus HR OS 0.66 (0.51–0.86) HR PFS 0.83 (0.65–1.06) |
[15] |
KEYNOTE-010 | II-III | Docetaxel vs. Pembrolizumab | ≥2 | 86 versus 875 |
HR OS 0.88 (0.45–1.70) HR PFS 1.79 (0.94–3.42) versus HR OS 0.66 (0.55–0.80) HR PFS 0.83 (0.73–0.98) |
[16] |
POPLAR | II | Docetaxel vs. Atezolizumab | ≥2 | 19 versus 147 |
HR OS 0.99 (0.29–3.40) HR PFS N/A versus HR OS 0.73 (0.53–0.99) HR PFS N/A |
[17] |
OAK | III | Docetaxel vs. Atezolizumab | ≥2 | 85 versus 628 |
HR OS 1.24 (0.71–2.18) HR PFS N/A versus HR OS 0.69 (0.57–0.83) HR PFS N/A |
[18] |
ATLANTIC trial (cohort 1) | II | Durvalumab | ≥3 | 97 | 12% ORR (PD-L1 ≥25%) 4% (PD-L1 <25%) ** |
[48] |
NCT02879994 | II | Pembrolizumab | 1 | 11 * | No Responses ** | [24] |
* The study was ceased because of lack of efficacy. HR, Hazard Ratio; OS, overall survival; PFS, progression free survival; N/A not available; ORR Objective Response Rate; PD-L1, programmed cell death ligand-1; ICI, immune checkpoint inhibitors. ** In this cohort, only mutated patients were enrolled.