Table 6 Landmark clinical trials in the development of BRAF inhibitors
From: Clinical development of targeted and immune based anti-cancer therapies
Drug Name | Clinical Trial ID | Trial Name | Population | Comparator | Year | Sponsor | Phase | N | Median OS (months) | Median PFS (months) |
|---|---|---|---|---|---|---|---|---|---|---|
BRAF inhibitors | ||||||||||
 Sorafenib (Nexavar®) | ||||||||||
  Sorafenib (400 mg BD) | NCT00105443 | SHARP | HCC | Placebo | 2005–2008 | Bayer | III | 602 | 10.8 vs 8.0 | 5.5 vs 2.8 |
  Sorafenib (800 mg) | NCT00984282 |  | Thyroid | Placebo | 2009–2017) | Bayer | III | 417 | 52.7 vs 54.8% | 10.8 vs 5.8 |
  Sorafenib (400 mg BD) | NCT00119249 |  | Melanoma |  | 2005–2007 | NCI | II | 74 | NR | NR |
 Vemurafenib (Zelboraf®) | ||||||||||
  Vemurafenib (960 mg BD) | NCT01910181 | BRIM | Metastatic melanoma | None | 2013–2018 | Hoffmann-La Roche | I | 46 | 13.5 | 8.6 |
  Vemurafenib (960 mg BD) | NCT00949702 | BRIM2 | Melanoma | None | 2009–2014 | Hoffmann-La Roche | II | 132 | NA | 6.1 |
  Vemurafenib (960 mg BD) | NCT01006980 | BRIM3 | Metastatic melanoma | Dacarbazine | 2010–2015 | Hoffmann-La Roche | III | 675 | 13.6 vs 9.7 | NR |
 Dabrafenib (Tafinlar®) | ||||||||||
  Dabrafenib (150 mg BD) | NCT01153763 | BREAK-2 | Melanoma | None | 2010–2016 | GSK | II | 92 | 3.0 | 1.4 |
  Dabrafenib (150 mg BD) | NCT01227889 | BREAK-3 | Melanoma | Dacarbazine | 2010–2014 | GSK | III | 251 | 20.0 vs 15.6 | 6.7 vs 2.9 |
  Dabrafenib (150 mg BD) + trametinib | NCT01336634 |  | NSCLC | Dabrafenib | 2011–2015 | Norvatis | II | 174 | 18.2 vs 12.7 | 10.2 vs 5.5 |
  Dabrafenib (150 mg BD) | NCT01723202 |  | Thyroid | Trametinib | 2012–2018 | National Comprehensive Cancer Network | II | 53 | NR | NR |
 Regorafenib (Stivarga®) | ||||||||||
  Regorafenib (160 mg/d) | NCT01103323 | CORRECT | Colorectal cancer | Placebo + BSC | 2010–2014 | Bayer | III | 760 | 6.4 vs 5.0 | 1.9 vs 1.7 |
  Regorafenib (160 mg/d) | NCT01271712 | GRID | GIST | Placebo | 2011–2012 | Bayer | III | 199 | 2.7 vs 2.6 | 4.8 vs 0.9 |
  Regorafenib (160 mg/d) | NCT01774344 | RESORCE | HCC | Placebo | 2013–2017 | Bayer | III | 573 | 10.6 vs 7.8 | 3.6 vs 1.5 |
Cobimetinib (Cotellic®) | ||||||||||
  Cobimetinib (60 mg/d) + vemurafenib | NCT01689519 | coBRIM | Melanoma | Vemurafenib + Placebo | 2012–2015 | Hoffmann-La Roche | III | 495 | 22.3 vs 17.4 | 9.9 vs 6.2 |
 Trametinib (Mekinist®) | ||||||||||
  Trametinib (2 mg/d) + dabrafenib | NCT01682083 | COMBI-AD | Melanoma | Placebo | 2013–2017 | Norvatis | III | 870 | NR | NR |
  Trametinib (2 mg/d) + dabrafenib | NCT02034110 |  | Thyroid |  | 2014–2020 | Norvatis | II | 100 | 80% | 79% |