An EGFR antibody added to chemotherapy for squamous lung cancer: it worked, by about six weeks, and almost nobody uses it.
Necitumumab is a second-generation recombinant human IgG1 antibody against EGFR. SQUIRE ran at 184 sites in 26 countries and randomised 1,093 patients with untreated stage IV squamous non-small-cell lung cancer 1:1 to gemcitabine 1,250 mg/m2 on days 1 and 8 with cisplatin 75 mg/m2 on day 1, with or without necitumumab 800 mg on days 1 and 8. Chemotherapy ran for up to six 3-week cycles; necitumumab continued until progression. The trial was open-label because the acne-like rash characteristic of EGFR antibodies would have unmasked it anyway.
Overall survival was significantly longer with necitumumab, by about six weeks at the median, at the cost of hypomagnesaemia, rash and venous thromboembolism. The FDA approved the combination in 2015 and the EMA in 2016 for EGFR-expressing squamous disease.
SQUIRE is a study in what a statistically significant result is worth. The magnitude was small, the regimen was displaced within two years by pembrolizumab with carboplatin and paclitaxel (KEYNOTE-407), and necitumumab is now almost never given. It has no NICE appraisal.
Shares Eli Lilly (incl. Loxo), Gemcitabine, Monoclonal antibodies, Cisplatin.
Shares Squamous cell carcinoma of the lung, Eli Lilly (incl. Loxo), Monoclonal antibodies, Lung cancer (all types).
Shares KEYNOTE-407, Squamous cell carcinoma of the lung, Non-small-cell lung cancer.
Shares Squamous cell carcinoma of the lung, Gemcitabine, Cisplatin, Lung cancer (all types).
Shares Squamous cell carcinoma of the lung, Cisplatin, Platinum agents, Lung cancer (all types).
Shares Eli Lilly (incl. Loxo), Cisplatin, Cytotoxic chemotherapy, Non-small-cell lung cancer.
Shares Squamous cell carcinoma of the lung, Platinum agents, Cytotoxic chemotherapy.
Shares Squamous cell carcinoma of the lung, Platinum agents, Cytotoxic chemotherapy.