The addition of necitumumab found to benefit patients with advanced squamous non-small-cell lung cancer.
Necitumumab added to gemcitabine and cisplatin chemotherapy was found to benefit patients with epidermal growth factor receptor (EGFR) with advanced squamous non-small-cell lung cancer, a recent study found.
The randomized phase 3 SQUIRE trial found that the addition of necitumumab to gemcitabine and cisplatin chemotherapy improved patient survival by 1.6 months, according to a study presented at the European Lung Cancer Conference 2016.
Included in the analysis were 982 patients with stage IV squamous non-small-cell lung cancer. Of these patients, 95% had EGFR expressing tumors and 5% had tumors with no EGFR protein.
Researchers found that the addition of necitumumab to gemcitabine and cisplatin chemotherapy improved the survival of patients with ECFR expressing tumors by 21%. Patients without the EGFR protein by 16% compared with chemotherapy in patients without the EFGR protein.
"Necitumumab is targeted at EGFR so it makes sense that the drug is active in patients with the receptor. Our analysis showed that the drug had no effect when the receptor was absent, presumably because there was no target to bind to,” said Luis Paz-Ares, MD, PhD, lead author of the study. “We cannot make robust conclusions because the subgroup of patients with negative EGFR was very small, but the hypothesis generated here is that those tumors do not respond well to necitumumab."
The European Medicines Agency approved necitumumad for patients with EGFR expressing tumors, but the FDA did not deem this study’s findings sufficient enough to do the same.
"Our results need to be interpreted with caution. A confirmatory study in patients with EGFR negative tumors is needed to assess whether they are good candidates for necitumumab or not,” Dr. Paz-Ares said.
More research is needed to determine the efficacy of necitumumab in a larger population, the researchers concluded.
"Information on outcome of patients with cut-off levels higher than in the current analysis would be of interest,” said Robert Pirker, MD, program director for lung cancer at Vienna General Hospital in Vienna, Austria, not involved in the study. “We also need to know the effect of necitumumab according to both percentages of positive cells and their staining intensity. This could be combined with fluorescence in situ hybridisation (FISH) analysis to detect gene amplification. This could give us a clearer picture of which patients benefit most from necitumumab."