• OS was significantly improved with the addition of ramucirumab (10.5 versus 9.1 months).
• The safety profile was manageable with appropriate dose reductions and supportive care.

Ramucirumab is a human IgG1 monoclonal antibody that specifically binds to VEGFR-2, preventing receptor activation. This agent is currently approved alone or combined with paclitaxel in the second-line treatment of advanced gastric cancer and was recently approved for use in combination with FOLFIRI or docetaxel as second-line therapy for patients with metastatic colorectal cancer or metastatic NSCLC, respectively.

The Phase III REVEL study evaluated the addition of ramucirumab to docetaxel as second-line treatment in 1,253 patients with disease progression on platinum doublet induction and demonstrated a modest improvement in survival in both squamous and nonsquamous disease along with a statistically significant improvement in response rates and PFS, which has led to the approval of this agent for these patients. It should be noted that despite the contraindication against the use of bevacizumab in squamous disease because of the risk of hemoptysis, this complication was not observed at a higher rate with ramucirumab in REVEL. Currently the clinical use of this agent and whether the modest improvement in outcome is justifiable in view of the financial cost is controversial, and, as with bevacizumab, the hope is that some type of predictive biomarker can select patients most likely to benefit. Dr Spigel’s view is that this agent is a reasonable option for second-line treatment but should not be considered a de facto standard. He noted that it may be of greater interest in patients with no prior bevacizumab treatment but can also be considered for those who have received bevacizumab in the first-line setting because those patients were allowed on REVEL.