Table 2.
Phase 3 clinical trials in BRAF V600-mutant metastatic melanoma patients.
| Phase 3 Clinical Trial | % of BRAF V600-Mutant Patients | Experimental Arm | Standard Arm | Primary Endpoint in BRAF V600-Mutant Patients | Reference |
|---|---|---|---|---|---|
| COMBI-d | 100% | D + T | D | PFS: 9.3 months vs. 8.8 months (p = 0.03) | [59] |
| COMBI-v | 100% | D + T | V | 1-year OS: 72% vs. 65% (p = 0.005) | [60] |
| coBRIM | 100% | V + C | V | PFS: 9.9 months vs. 6.2 months (p < 0.001) | [63,64] |
| COLUMBUS | 100% | E + B | V | PFS: 14.9 months vs. 7.3 months (p < 0.0001) | [66,67] |
| KEYNOTE-006 | 36.2% | P | I | HR for PFS: 0.44–0.87 | [4,69] |
| CheckMate 067 | 31% | N + I | I | 5-year OS: 60% vs. 30% | [70,71] |
D: dabrafenib; T: trametinib; V: vemurafenib; C: cobimetinib; P: pembrolizumab; N: nivolumab; I: ipilimumab; PFS: progression-free survival; OS: overall survival; HR: hazard ratio.