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Adding an antibody against the VEGF receptor to second-line chemotherapy added about six weeks of life: enough for a licence, not enough for NICE.
Ramucirumab is a human IgG1 antibody against the extracellular domain of VEGFR-2. REVEL screened 1,825 patients between December 2010 and January 2013 and randomised 1,253 with stage IV squamous or non-squamous disease progressing on or after first-line platinum chemotherapy to docetaxel 75 mg/m2 with ramucirumab 10 mg/kg (628) or with placebo (625), stratified by sex, region, performance status and previous maintenance therapy.
Median overall survival was 10.5 months against 9.1 months (hazard ratio 0.86, 95 percent confidence interval 0.75 to 0.98, p=0.023) and median progression-free survival 4.5 against 3.0 months (0.76, 0.68 to 0.86). Squamous histology was included, which was unusual for an anti-angiogenic drug after the pulmonary haemorrhage seen with bevacizumab in squamous disease.
The FDA approved the combination in 2014. NICE TA403 (24 August 2016) does not recommend ramucirumab with docetaxel, so it is not funded in England, and the six-week median gain is why. Ramucirumab reappeared in lung cancer in the Lung-MAP substudy S1800A, where it was combined with pembrolizumab after progression on immunotherapy.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,253 enrolled.
Shares Ramucirumab, Eli Lilly (incl. Loxo), VEGF / VEGFR, Anti-angiogenic therapy.
Shares Ramucirumab, Docetaxel, Anti-angiogenic therapy, Monoclonal antibodies.
Shares Ramucirumab, Docetaxel, Anti-angiogenic therapy, Monoclonal antibodies.
Shares Squamous cell carcinoma of the lung, Eli Lilly (incl. Loxo), Monoclonal antibodies, Lung cancer (all types).
Shares LUME-Lung 1, Adenocarcinoma of the lung, VEGF / VEGFR, Anti-angiogenic therapy.
Shares Ramucirumab, Eli Lilly (incl. Loxo), Anti-angiogenic therapy, Monoclonal antibodies.
Shares Ramucirumab, Eli Lilly (incl. Loxo), VEGF / VEGFR, Anti-angiogenic therapy.
Shares Ramucirumab, Docetaxel, Anti-angiogenic therapy, Monoclonal antibodies.