Eli Lilly and Company has reported positive results from its RAISE trial, a Phase III trial of ramucirumab (CYRAMZA) in combination with chemotherapy, to treat patients with metastatic colorectal cancer (mCRC).
Ramucirumab is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that binds VEGF Receptor 2 and blocks binding of VEGF receptor ligands VEGF-A, VEGF-C and VEGF-D.
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In the trial, ramucirumab plus FOLFIRI was compared 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.
The global, randomised, double-blind Phase III trial met its primary endpoint of overall survival by showing statistically significant improvement in these patients.
The trial also showed a statistically significant improvement in progression-free survival in the ramucirumab-plus-FOLFIRI arm compared with the placebo-plus-FOLFIRI arm.
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Neutropenia, fatigue, hypertension and diarrhoea were the most common adverse events occurring at a higher rate on the ramucirumab-plus-FOLFIRI arm compared to the control arm.
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By GlobalDataLilly Oncology senior vice-president, product development and medical affairs Richard Gaynor said: "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."
The drug works by blocking the protein, VEGF, which is created from tumours and is responsible for providing nourishment to blood vessels.
The company is planning to present data from the RAISE trial at a scientific meeting in 2015 and expects to start regulatory submissions in the first half of next year.
Gaynor said: "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."
The RAISE trial was started in 2010, and more than 1,000 patients were enrolled across 26 countries.
In the US, ramucirumab is approved for use as a single agent for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after prior fluoropyrimidine- or platinum-containing chemotherapy.
