Lung Cancer Drug Necitumumab Increases Survival in Phase III Trial
Regulatory submission expected in 2014 (August 13)
A recently completed phase III study of first-line treatment with necitumumab (IMC-11F8) in combination with gemcitabine and cisplatin met its primary endpoint, finding that patients with stage IV metastatic squamous non–small-cell lung cancer (NSCLC) experienced increased overall survival compared with patients treated with chemotherapy alone.
The most common adverse events (AEs) occurring more frequently in patients in the necitumumab arm were rash and hypomagnesemia. Serious, but less frequent, AEs occurring more often in the necitumumab arm included thromboembolism.
Necitumumab is a fully human immunoglobulin G1 (IgG1) monoclonal antibody that is designed to block the ligand binding site of the human epidermal growth factor receptor (EGFR). Activation of the EGFR has been correlated with malignant progression, induction of angiogenesis, and inhibition of apoptosis.
The SQUIRE trial enrolled 1,093 patients aged 18 years or older with histologically or cytologically confirmed stage IV squamous NSCLC, who had received no prior therapy for metastatic disease. The patients were randomly assigned to receive first-line necitumumab plus chemotherapy consisting of gemcitabine and cisplatin, or gemcitabine-cisplatin chemotherapy alone. Patients underwent radiographic assessment of disease status (computed tomography or magnetic resonance imaging) every 6 weeks until radiographic documentation of progressive disease.
Eli Lilly, the developer of necitumumab, expects to submit a New Drug Application to the FDA before the end of 2014.
Source: Eli Lilly; August 13, 2013.