Necitumumab is an IgG1 antibody with efficacy as a first-line treatment in individuals with advanced squamous cell non-small cell lung cancer (NSCLC), says Anne S. Tsao, MD. In the phase III SQUIRE trial 1093 patients were randomized to receive a platinum-based chemotherapy and gemcitabine with or without necitumumab. Although response rates and progression-free survival were not notable, a statistically significant improvement in overall survival (OS) was seen with the addition of necitumumab to chemotherapy. Median OS was approximately 11.5 months in those who were given necitumumab and 9.9 months in the chemotherapy-only cohort (P = .012).

With few options in the squamous cell setting, Tsao notes, the results are compelling. If approved it would likely be considered for frontline use. The FDA has scheduled an ODAC advisory hearing to discuss the biologics license application (BLA) for necitumumab in combination with gemcitabine and cisplatin as a first-line treatment for patients with locally advanced or metastatic squamous NSCLC. The meeting is scheduled for July 9, 2015.

The Southwest Oncology Group (SWOG) 0819 trial is currently assessing a subset of patients with at least 4 copies of the EGFR gene who received treatment with cetuximab, states Roy S. Herbst, MD. These individuals were identified by fluorescence in situ hybridization (FISH) assay and are thought to have a greater benefit from anti-EGFR therapy. While results that either support or refute this theory will not be available for a few years, it may be practical to search for similar biomarker assays in necitumumab studies, comments Herbst.