Eli Lilly and Company has announced that the RAISE trial, a Phase III study of ramucirumab (CYRAMZA™) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival.
Metastatic CRC (mCRC) occurs when the disease has spread throughout the body, away from its primary tumor site, to places like the liver, lungs or lining of the abdomen. It is estimated that one out of five colorectal cancer patients will be diagnosed with metastasis, and will have a poor five-year survival of 11.7%.
RAISE was a global, randomized, double-blind study comparing the efficacy of ramucirumab plus FOLFIRI (irinotecan, folinic acid and 5-fluorouracil) to 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.
CYRAMZA is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that binds to the VEGF Receptor 2, blocking the interaction with VEGF ligands and disrupting angiogenesis, an essential process involved in tumor growth and metastasis. In the U.S., CYRAMZA is already approved for use as a single agent in patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The RAISE trial began in 2010 and enrolled more than 1,000 patients across 26 countries. The primary endpoint was set to overall survival and key secondary endpoints included progression-free survival, overall response rate and safety.
The study showed a statistically significant improvement in overall survival and progression-free survival in patients treated with ramucirumab plus FOLFIRI compared to placebo plus FOLFIRI, and showed some minor side effects such as fatigue, hypertension or diarrhea.
“Patients with metastatic colorectal cancer — particularly those in the second-line setting — continue to need new treatment options that improve survival. We are pleased that the RAISE study demonstrated a survival benefit and are hopeful that ramucirumab will become a new anti-angiogenic treatment option after first-line bevacizumab-containing therapy for metastatic colorectal cancer patients,” Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology said in a company press release.
By 2015, Lilly is planning to present the full data from the RAISE trial at a scientific meeting, along with applications for regulatory licensing.
“We now have four Phase III ramucirumab trials that improved survival in three of the world’s most common and deadly cancers–gastric, lung, and colorectal–supporting global regulatory submissions in multiple indications. The RAISE data also build on Lilly’s growing presence in gastrointestinal cancer therapy,” added Dr. Gaynor in the press release.