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Positive Results Reported for Ramucirumab (Cyramza) in Phase III Second-Line Colorectal Cancer Study
The RAISE trial, a phase III study of ramucirumab (Cyramza, Eli Lilly) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), has met its primary efficacy endpoint of overall survival.
The global, randomized, double-blind study compared ramucirumab plus FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) with placebo plus FOLFIRI as a second-line treatment in patients with mCRC after treatment with bevacizumab, oxaliplatin, and a fluoropyrimidine in the first-line setting.
Initiated in 2010, the study enrolled more than 1,000 patients in 26 countries. In addition to the primary efficacy endpoint of overall survival, key secondary endpoints included progression-free survival, the overall response rate, and safety.
Results from the RAISE trial showed a statistically significant improvement in overall survival in patients treated with ramucirumab plus FOLFIRI compared with placebo plus FOLFIRI. The study also showed a statistically significant improvement in progression-free survival in the ramucirumab-plus-FOLFIRI arm compared with the placebo-plus-FOLFIRI arm. The most common grade-3 or greater adverse events occurring at a higher rate in the ramucirumab-plus-FOLFIRI arm compared with the control arm included neutropenia, fatigue, hypertension, and diarrhea.
Ramucirumab is a vascular endothelial growth factor receptor 2 (VEGFR-2) antagonist that specifically binds VEGFR-2 and blocks binding of the VEGF receptor ligands VEGF-A, C, and D. VEGFR-2 is an important mediator in the VEGF pathway. In an in vivo animal model, ramucirumab inhibited angiogenesis. Angiogenesis is a process by which new blood vessels form to supply blood to normal healthy tissues as well as to tumors, enabling the cancer to grow.
CRC is the fourth leading cause of cancer death worldwide, killing nearly 700,000 people in 2012. Only lung, liver, and stomach cancers caused more cancer-related deaths. In 2012, the global incidence of CRC was estimated to be more than 1.3 million. CRC is the second leading cause of cancer death in the U.S. The 5-year survival rate for patients with mCRC is 12%.
Source: Eli Lilly; September 12, 2014.