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Lung Cancer Drug Necitumumab Improves Survival in Phase III Trial

Largest phase III study ever conducted in first-line squamous NSCLC

Lung cancer patients with metastatic squamous-cell carcinoma have seen few treatment advancements over the last two decades, leaving these patients with a poor prognosis. This is in contrast to the progress seen in non-squamous non–small-cell lung cancer (NSCLC). Results from the largest phase III trial ever conducted in first-line squamous NSCLC have provided the first detailed look at a potential new treatment option for these patients.

Necitumumab (IMC-11F8, Eli Lilly) is a recombinant human immunoglobulin G1 (IgG1) monoclonal antibody designed to block the ligand binding site of the human epidermal growth factor receptor-1(EGFR-1). Activation of EGFR has been correlated with malignant progression, induction of angiogenesis, and inhibition of apoptosis.

In the phase III SQUIRE trial, patients with stage IV metastatic squamous NSCLC showed a significant improvement in overall survival (hazard ratio, 0.84; P = 0.012), with a median survival period of 11.5 months, when treated with necitumumab in combination with gemcitabine and cisplatin as first-line therapy, compared with 9.9 months for those treated with chemotherapy alone. Grade 3 or higher adverse events occurring more frequently in patients in the necitumumab arm were hypomagnesemia and rash.

The SQUIRE study results were released in advance of the American Society of Clinical Oncology (ASCO) annual meeting, to be held May 30–June 3 in Chicago, Illinois. Additional safety and efficacy information will be presented at that meeting.

The SQUIRE trial enrolled 1,093 patients (18 years of age or older; ECOG performance status: 0–2) with histologically or cytologically confirmed stage IV squamous NSCLC who had not received prior therapy for metastatic disease. The study’s primary endpoint was overall survival.

The patients were randomly assigned to receive first-line necitumumab plus chemotherapy consisting of gemcitabine and cisplatin, or gemcitabine/cisplatin chemotherapy alone. The patients underwent radiographic assessments of disease status (computed tomography or magnetic resonance imaging) every 6 weeks until radiographic documentation of progressive disease (PD) was obtained. Combination chemotherapy continued for a maximum of six cycles in each treatment arm or until radiographic documentation of PD, toxicity requiring cessation, or withdrawal of consent occurred. Patients treated with first-line necitumumab plus gemcitabine/ cisplatin with no progression continued to receive single-agent necitumumab until radiographic documentation of PD, toxicity requiring cessation, or withdrawal of consent occurred.

Lung cancer is the leading cause of cancer death in the U.S. and most other countries, killing nearly 1.6 million people worldwide each year. In the U.S., lung cancer is responsible for nearly 30% of all cancer deaths — more than those from breast, colon, and prostate cancers combined. NSCLC accounts for 85% of all lung cancer cases. Patients with squamous-cell carcinoma represent about 30% of all patients with NSCLC, and non-squamous patients represent the remaining 70%.

Source: Eli Lilly; May 14, 2014.

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