Necitumumab is a recombinant human IgG1 monoclonal antibody that binds with high affinity and specificity to EGFR-1. It blocks the ligand binding site, preventing activation of the receptor by all known ligands.
A multicentre phase III study evaluated the efficacy of necitumumab in 1093 patients with stage IV squamous NSCLC.
Patients were randomised to receive necitumumab in combination with gemcitabine and cisplatin (n=545) or gemcitabine and cisplatin chemotherapy alone (n=548).
Overall survival rate
Necitumumab plus gemcitabine and cisplatin produced a significantly longer median overall survival rate (primary efficacy endpoint) of approximately 11.5 months (95% CI 10.4–12.6) compared with 9.9 months (95% CI 8.9–11.1) for patients receiving gemcitabine and cisplatin (p=0.01)
The most common adverse events were skin reactions, venous thromboembolic events and laboratory abnormalities. The safety profile of the triple combination therapy was found to be acceptable and in line with expectations.