Patients with epidermal growth factor receptor ( EGFR ) expressing advanced squamous non-small-cell lung cancer benefit most from Necitumumab ( Portrazza ) added to Gemcitabine and Cisplatin chemotherapy, according to a subgroup analysis from the SQUIRE trial.
The randomised phase III SQUIRE trial demonstrated that the addition of Necitumumab to Gemcitabine and Cisplatin chemotherapy improved overall survival in patients with stage IV squamous non-small-cell lung cancer by 1.6 months compared to chemotherapy alone.
The current study analysed outcomes in the subgroup of patients with EGFR expressing tumours compared to those with no EGFRs.
Out of 982 patients in the SQUIRE trial, 95% had EGFR expressing tumours and 5% had tumours with no EGFR protein.
The addition of Necitumumab to Gemcitabine and Cisplatin chemotherapy improved overall survival and progression free survival by 21% and 16%, respectively, as compared to chemotherapy alone in patients whose tumours expressed the EGFR protein.
There was no benefit in patients with no EGFR in their tumours.
Based on this analysis, the European Medicines Agency ( EMA ) has decided that Necitumumab is approved only for patients with EGFR expressing tumours.
On the other hand the US Food and Drug Administration ( FDA ) has taken the more conservative approach which recognises that SQUIRE was designed for all-comers without prior selection, and this subgroup analysis is insufficient evidence to conclude that patients with EGFR negative tumours are not candidates.
According to investigators, the results need to be interpreted with caution. A confirmatory study in patients with EGFR negative tumours is needed to assess whether they are good candidates for Necitumumab or not. ( Xagena )
Source: European Lung Cancer Conference ( ELCC ), 2016