Table 2 Landmark clinical trials in the development of monoclonal antibodies targeting EGFR
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) |
|---|---|---|---|---|---|---|---|---|---|---|
Monoclonal antibodies to EGFR | ||||||||||
 Cetuximab (Erbitux®) | ||||||||||
  Cetuximab (400 mg/m2 initial + 250 mg/m2/week) + cisplatin + vinorelbine | NCT00148798 | FLEX | NSCLC | Cisplatin + vinorelbine | 2005–2014 | Merck KGaA | III | 1861 | 11.3 vs 10.1 | 4.8 vs 4.8 |
  Cetuximab (400 mg/m2 initial + 250 mg/m2/week) | NCT01001377 | ASPECCT | Metastatic CRC | Panitumumab | 2010–2017 | Amgen | III | 1010 | 10.0 vs 10.4 | 4.4 vs 4.1 |
  Cetuximab [400/250 mg/m2 (initial/weekly)] + Chemotherapy | NCT00122460 | EXTREME | H&N Cancer | Chemotherapy | 2004–2011 | Merck KGaA | III | 442 | 10.1 vs 7.4 | 5.6 vs 3.3 |
  Cetuximab [400/200 mg/m2 (initial/weekly)] + FOLFIRI | NCT00154102 | CRYSTAL | Metastatic CRC (KRAS WT) | FOLFIRI | 2004–2011 | Merck KGaA | III | 1221 | 23.5 vs 20.0 | 9.9 vs 8.4 |
  Cetuximab + 5-FU/FA + oxaliplatin (FOLFOX-4) | NCT00125034 | OPUS | Metastatic CRC (KRAS WT) | 5-FU/FA + oxaliplatin | 2005–2010 | Merck KGaA | II | 344 | 22.8 vs 18.5 | 8.3 vs 7.2 |
 Panitumumab (Vectibix®) | ||||||||||
  Panitumumab (6 mg/kg/2w) + FOLFOX | NCT00364013 | PRIME | Metastatic CRC (WT KRAS) | FOLFOX | 2006–2013 | Amgen | III | 1183 | 23.9 vs 19.7 | 9.6 vs 8.0 |
  Panitumumab (6 mg/kg/2w) + FOLFOX | NCT00364013 | PRIME | Metastatic CRC (Mutant KRAS) | FOLFOX | 2006–2013 | Amgen | III | 1183 | 15.5 vs 19.3 | 7.3 vs 8.8 |
  Panitumumab (6 mg/kg/2w) + BSC | NCT01412957 | ‘0007 | Metastatic CRC (WT RAS) | BSC | 2011–2017 | Amgen | III | 377 | 10.0 vs 6.9 | 5.2 vs 1.7 |
 Necitumumab (Portrazza®) | ||||||||||
  Necitumumab (800 mg/ m2/3w) + gemcitabine + cisplatin | NCT00981058 | SQUIRE | NSCLC | Gemcitabine + cisplatin | 2010–2018 | Eli Lilly and Company | III | 1093 | 11.5 vs 9.9 | 5.7 vs 5.5 |
  Necitumumab (500 mg/m2/3w) + Chemotherapy | NCT00982111 | INSPIRE | NSCLC | Chemotherapy | 2009–2018 | Eli Lilly and Company | III | 633 | 11.3 vs 11.5 | 5.6 vs 5.6 |