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Lilly Announces Phase III Necitumumab Study Meets Primary Endpoint Of Overall Survival

INDIANAPOLIS, Aug. 13, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that SQUIRE, a recently completed Phase III study, met its primary endpoint, finding that patients with stage IV metastatic squamous non-small cell lung cancer (NSCLC) experienced increased overall survival (OS) when administered necitumumab (IMC-11F8) in combination with gemcitabine and cisplatin as a first-line treatment, as 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.

"We are pleased with these data which represent a potential advance in treatment for patients with squamous non-small cell lung cancer, which is a difficult cancer to treat," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology. "If approved, necitumumab could be the first biologic therapy indicated to treat patients with squamous 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 percent of all lung cancer cases. [2] Patients with squamous cell carcinoma represent about 30% of all patients affected by NSCLC. 1

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.

About the Study

SQUIRE enrolled 1093 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. 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 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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