Lilly's Cyramza Hits Primary Endpoint In mCRC Phase 3 Trial
Eli Lilly & Co. announced that the Phase 3 trial of Cyramza (ramucirumab) plus chemotherapy in patients with metastatic colorectal cancer (mCRC) achieved its primary endpoint of overall survival.
Cyramza is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that inhibits angiogenesis, or the formation of new blood cells that, in cancer, help provide a tumor with its own growth-enabling blood supply. In April, the company reported that the U.S. Food and Drug Administration (FDA) approved Cyramza as a monotherapy for patients with advanced gastric cancer after prior chemotherapy.
The global, double-blind, and randomized RAISE study assessed ramucirumab in combination with the chemotherapy drug Folfiri against placebo and Folfiri as a second-line treatment in patients with mCRC following first-line treatment with bevacizumab, oxaliplatin and a fluoropyrimidine. Results show that patients treated with ramucirumab and Folfiri achieved a statistically significant improvement in overall survival as well as in progression-free survival.
Dr. Richard Gaynor, SVP of product development and medical affairs for Lilly Oncology, said, “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."
He added that Lilly currently has four Phase 3 trials for the drug on the record showing that Cyramza was effective in enhancing survival in gastric, lung, and colorectal cancer. Dr. Gaynor said these results support regulatory applications in several indications. The drug however failed in a late-stage trial in June where it was investigated as treatment for patients with advanced liver cancer. It was also unsuccessful in improving treatment outcomes for patients with breast cancer in another study.
Lilly said it will present findings from the RAISE trial at an upcoming scientific meeting next year. The company also said it anticipates filing regulatory submissions for ramucirumab in the first half of 2015.