The recently completed SQUIRE study, a randomized, multicenter, open-label phase III study of gemcitabine-cisplatin chemotherapy plus necitumumab (IMC-11F8; Eli Lilly & Co/ImClone) versus gemcitabine-cisplatin chemotherapy alone in the first-line treatment of patients with stage IV squamous non-small cell lung cancer (NSCLC) met its primary endpoint. The study result showed that patients with stage IV NSCLC experienced increased overall survival (OS) when administered necitumumab in combination with chemotherapy as a first-line treatment compared to chemotherapy alone.

The most common adverse events occurring more frequently in patients on the necitumumab arm were rash and hypomagnesemia. Serious, but less frequent, adverse events occurring more often on the necitumumab arm included thromboembolism.


Necitumumab could be the first biologic therapy indicated to treat patients with squamous lung cancer…


Study
The SQUIRE study enrolled 1,093 patients (age greater than or equal to 18 years, ECOG PS 0-2) with histologically- or cytologically-confirmed, stage IV squamous NSCLC, who had received no prior therapy for metastatic disease. All patients were randomized to receive first-line necitumumab plus chemotherapy consisting of gemcitabine and cisplatin in study Arm A, or gemcitabine-cisplatin chemotherapy alone in study Arm B. Patients also underwent radiographic assessment of disease status (computed tomography or magnetic resonance imaging) every six weeks (+/- 3 days), until radiographic documentation of progressive disease (PD). Chemotherapy continued for a maximum of six cycles in each arm (or until there was radiographic documentation of PD, toxicity requiring cessation, or withdrawal of consent); patients in Arm A continued to receive necitumumab (IMC-11F8) until there was radiographic documentation of PD, toxicity requiring cessation, or withdrawal of consent.

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First biologic
The trial drug, necitumumab, is a fully human IgG1 monoclonal antibody that is designed to block the ligand binding site of the human epidermal growth factor receptor (EGFR). Activation of EGFR has been correlated with malignant progression, induction of angiogenesis and inhibition of apoptosis or cell death.

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Commenting on the trial results, Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology, noted: “… this data represent a potential advance in treatment for patients with squamous non-small cell lung cancer, which is a difficult cancer to treat, if approved, necitumumab could be the first biologic therapy indicated to treat patients with squamous lung cancer.”

Lilly plans to present results from this study at a scientific meeting in 2014, and currently anticipates submitting to regulatory authorities before the end of 2014.

Lung Cancer
Lung cancer is the leading cause of cancer death in the US and most other countries. [1] Non-small cell lung cancer (NSCLC) is much more common than other types of lung cancer, and accounts for 85% of all lung cancer cases. [2] Patients with squamous cell carcinoma represent about 30% of all patients affected by NSCLC.[1]

For more information
[1]Yan W, Wistuba II, Emmert-Buck MR, Erickson HS. Squamous Cell Carcinoma – Similarities and Differences among Anatomical Sites. Am J Cancer Res. 2011 Jan 1;1(3):275-300.[Article][PubMed]
[2]U.S. National Institutes of Health. National Cancer Institute: SEER Cancer Statistics Review, 1973-2006 [Website]

Clinical trials
NCT00981058 – First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (SQUIRE)

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