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Ramucirumab (IMC-1121B) targets VEGFR-2. Ramucirumab is being investigated in many malignancies including gastric cancer. The Phase III trial in patients with advanced breast cancer failed to improve the primary end point The REGARD trial, a Phase III study, in patients with advanced gastric cancer in the second line setting, had a marginal improvement in overall survival but did not achieve the expected hazard ratio target (of 0.69) and the median duration of therapy with ramucirumab was meager 8 weeks (only 2 weeks longer than the placebo’s). Other notable agents in the second line setting are docetaxel and irinotecan. Preliminary results of the RAINBOW trial suggest that ramucirumab may be providing more than marginal advantage. In this review, we briefly summarize the process of angiogenesis and address the emerging cost-benefit issues that surround all newly developed agents including ramucirumab.
Financial & competing interests disclosure
Supported in part by the grant CA127672 (JAA) by the National Cancer Institute, USA, and donations received from the Caporella, Dallas, Sultan, Park, Smith, Frazier, Oaks, Sultan and Cantu Families, the Schecter Private Foundation, Rivercreek Foundation, Kevin Fund, Myer Fund, Dio Fund, Milrod Fund, and the Multidisciplinary Research Grants provided by the University of Texas M. D. Anderson Cancer Center, Houston, USA. JA Ajani has received grants and honoraria from Lilly/ImClone.
The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Key issues
Drug: ramucirumab, IMC-1121B.
Mechanism of action: antiangiogenic agent, fully human monoclonal antibody, causes selective blockade of VEGF receptor 2.
Pharmacokinetics: high-binding affinity to VEGF receptor 2 (∼50 pM), nonlinear receptor-mediated clearance.
Common side effects: hypertension, abdominal pain, nausea, fatigue, thromboembolism and proteinuria.
Important Phase III trials in gastric cancer: REGARD, RAINBOW.
Current US FDA status: priority review.
Future perspective: the overall tolerable safety profile and higher efficacy along with improved survival rates in Phase III trials might yield ramucirumab a potential therapeutic niche.