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Ramucirumab is a fully human monoclonal antibody directed against VEGFR-2 that works on the receptor of endothelial cells as well as tumor cells, explains Roy S. Herbst, MD, PhD. Ramucirumab was approved by the FDA in December 2014 for the treatment of patients with metastatic non-small cell lung cancer (NSCLC), based on the phase III REVEL trial.
In the international study, 1253 patients with nonsquamous and squamous cell NSCLC received either ramucirumab plus docetaxel or placebo plus docetaxel. Patients in the study had experienced disease progression after treatment with platinum-based chemotherapy for locally advanced or metastatic disease.
Median overall survival with ramucirumab was superior compared with placebo (10.5 vs 9.1 months; hazard ratio [HR], 0.857; P = .0235), as was median progression-free survival (4.5 vs 3.0 months; HR, 0.762; P < .0001). The overall response rate was also significantly better with ramucirumab (23% vs 14%; P < .0001). Although there were concerns about toxicity profile, particularly in patients with squamous cell disease, ramucirumab did not produce a significantly higher rate of severe adverse events.