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August 13, 2013

Eli Lilly reports positive data from Phase III study of necitumumab

Eli Lilly and Company has reported positive data from the phase three study of necitumumab (IMC-11F8), a fully human IgG1 monoclonal antibody, in patients with stage IV metastatic squamous non-small cell lung cancer (NSCLC).

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Eli Lilly and Company has reported positive data from the phase three study of necitumumab (IMC-11F8), a fully human IgG1 monoclonal antibody, in patients with stage IV metastatic squamous non-small cell lung cancer (NSCLC).

Known as SQUIRE, the study demonstrated increased overall survival (OS) in a patient group administered with necitumumab in combination with gemcitabine and cisplatin as a first-line treatment, as compared to chemotherapy alone, thus meeting the primary endpoint.

Lilly Oncology product development and medical affairs vice-president Dr Richard Gaynor said the data represents a potential advance in treatment for patients with squamous non-small cell lung cancer, a difficult cancer.

"If approved, necitumumab could be the first biologic therapy indicated to treat patients with squamous lung cancer," Gaynor said.

A total of 1,093 patients with histologically or cytologically-confirmed, stage IV squamous NSCLC and new to the treatment, were enrolled and were randomised with first-line necitumumab plus chemotherapy, consisting of gemcitabine and cisplatin in study arm A, or gemcitabine-cisplatin chemotherapy alone in study arm B.

"The data represents a potential advance in treatment for patients with squamous non-small cell lung cancer."

For every six weeks, patients underwent radiographic assessment of disease status until the radiographic documentation of progressive disease (PD).

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As per the study design, 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.

The most common adverse effects on the necitumumab arm were rash and hypomagnesemia, while serious, but less frequent, adverse events occured included thromboembolism.

Lilly plans to submit the data to regulatory authorities before the end of 2014.


Image: Eli Lilly and Company SQUIRE study found improved overall survival in patients with stage IV squamous NSCLC. Photo: courtesy of Guanaco152003.

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