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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%