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[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Necitumumab IgG1 MAb  ADCC 1 3 PTEN AKT STAT PI3-K pY pY pY GRB2 SOS RAS RAF MEK MAPK Gene activation Cell-cycle progression Survival (↓ apoptosis) Angiogenesis Proliferation Metastasis Chemo- therapy Radiation EGFR pool ↑  DNA  repair activity 2 Necitumumab (IMC-11F8), a fully human IgG1 monoclonal antibody, targets the Epidermal Growth Factor Receptor (EGFR) Kuenen B, Witteveen PO, Ruijter R, Giaccone G, Dontabhaktuni A, Fox F, Katz T, Youssoufian H, Zhu J, Rowinsky EK, Voest EE. A phase I pharmacologic study of necitumumab (IMC-11F8), a fully human IgG1 monoclonal antibody directed against EGFR in patients with advanced solid malignancies. Clin Cancer Res. 2010 Mar 15;16(6):1915-23. Epub 2010 Mar 2.
[object Object],[object Object],Rationale for necitumumab ( IMC-11F8 ) in NSCLC ,[object Object],Marie Prewett, Rajiv Bassi, Hagop Youssoufian, Eric K. Rowinsky, James R. Tonra. The fully human EGFR antibody IMC-11F8 significantly increases the antitumor effects of cisplatin+gemcitabine in human non-small cell lung cancer models. AACR 2009, Abstract #2774 Imclone Systems, Data on File Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31.
Studies of necitumumab (IMC-11F8) in NSCLC Ongoing trials www.clinicaltrials.gov ; accessed on August 28th, 2010 Study ID Ph Eligibility/Line Arm(s) N (projected) NCT00982111 (INSPIRE) III Stage IV, non-squamous, first line ,[object Object],[object Object],947 NCT00981058 (SQUIRE) III Stage IV, squamous , first line ,[object Object],[object Object],947
INSPIRE:  phase III, 1st-line NSCLC, non-squamous www.clinicaltrials.gov ; NCT00982111; accessed on August 28 th , 2010 Primary endpoint: Overall Survival
SQUIRE: phase III, 1st-line NSCLC , squamous www.clinicaltrials.gov ; NCT00981058; accessed on August 28 th , 2010 Primary endpoint: Overall Survival
 

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Necitumumab imc 11 f8 ott 2010

  • 1.
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  • 4. INSPIRE: phase III, 1st-line NSCLC, non-squamous www.clinicaltrials.gov ; NCT00982111; accessed on August 28 th , 2010 Primary endpoint: Overall Survival
  • 5. SQUIRE: phase III, 1st-line NSCLC , squamous www.clinicaltrials.gov ; NCT00981058; accessed on August 28 th , 2010 Primary endpoint: Overall Survival
  • 6.  

Editor's Notes

  1. Karen: Do we have a more appropriate published reference?