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EGFR Antibody

Necitumumab, IMC-11F8

Tags: cancer cell signaling, lung cancer, phase II

EGFR Antibody Derived from Yarden Y and Shilo BZ.1

Target

Epidermal growth factor receptor (EGFR) is a member of the ErbB (erythroblastic leukemia viral oncogene homolog) family of receptor tyrosine kinases. EGFR activation occurs in response to ligand stimulation and/or genetic alterations of the EGFR gene, such as somatic mutations, amplifications, or deletions. Activated EGFR induces downstream signaling through the MAPK (mitogen-activated protein kinases), PI3K/AKT (phosphoinositide 3-kinase/v-Akt murine thymoma viral oncogene) and PLCY (phospholipase CY) signal transduction pathways that mediate cell proliferation, cell survival, and cell migration, respectively, thereby contributing to neoplastic transformation and tumor growth.2,3

Molecule

Necitumumab (IMC-11F8) is a recombinant IgG1 human monoclonal antibody designed to bind and block the ligand binding site of EGFR.4-6

Clinical Development

Necitumumab is being investigated in clinical trials in patients with non-small cell lung cancer.

ImClone Systems
NCT01763788 Schema

An Open-Label, Multicenter, Phase 1b/2 Study to Evaluate Necitumumab in Combination With Gemcitabine and Cisplatin in the First-line Treatment of Patients With Advanced (Stage IV) Squamous Non-small Cell Lung Cancer (NSCLC)

Key Inclusion Criteria

  • Stage IV squamous NSCLC
  • Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • ECOG performance status of ≤1
  • No prior chemotherapy regimen, surgery, or chest radiotherapy

Key Exclusion Criteria

  • Has undergone major surgery within 28 days prior to enrollment or has major surgery planned, or has had subcutaneous venous access device placement within 7 days prior to enrollment
  • Has undergone any prior radiation therapy, except for Gamma Knife radiation and palliative radiation treatment, and at least 14 days have elapsed from last radiation treatment prior to enrollment
  • Has brain metastases that are symptomatic or require surgery, medication, or radiotherapy except Gamma Knife
  • Has diabetes requiring insulin
  • Has significant third-space fluid retention
  • Has history of interstitial pneumonitis
  • Has an ongoing or active infection

Please visit www.clinicaltrials.gov for more information on this clinical trial [NCT01763788].

Schema

A Single-Arm, Multicenter, Open-Label, Phase 2 Study of nab-Paclitaxel (Abraxane®) and Carboplatin Chemotherapy Plus Necitumumab (LY3012211) in the First-line Treatment of Patients With Stage IV Squamous Non-small Cell Lung Cancer (NSCLC)*

Key Inclusion Criteria

  • Stage IV squamous NSCLC at the time of study entry
  • Measurable disease at the time of study enrollment, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Tumor tissue available for analysis of EGFR protein expression by immunohistochemistry

Key Exclusion Criteria

  • Nonsquamous NSCLC
  • Has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
  • Has received previous chemotherapy for advanced NSCLC
  • Has had a major surgery or any investigational therapy in the 4 weeks prior to study entry
  • Has received systemic radiotherapy within 4 weeks prior to study entry or focal radiotherapy within 2 weeks prior to study entry
  • Has symptomatic central nervous system malignancy or metastasis

Please visit www.clinicaltrials.gov for more information on this clinical trial.

*Clinical trial conducted in partnership with Celgene. Abraxane® is a registered trademark of Celgene Corporation.

[NCT01769391]    Lung Cancer    A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-small Cell Lung Cancer

[NCT01788566]    Lung Cancer    A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-line Treatment of Participants With Lung Cancer