Lilly Posts Positive Trial Results For Cyramza In Gastric Cancer
Eli Lilly & Co. announced positive results from the global Phase 3 trial of Cyramza (ramucirumab) in combination with paclitaxel in patients with advanced gastric (stomach) cancer or gastroesophageal junction (GEJ) adenocarcinoma.
Cyramza is a vascular endothelial growth factor receptor 2 antagonist designed to specifically bind and block activation of VEGF receptor 2 to inhibit it from binding to its VEGF receptor ligands. The drug is approved by the U.S. Food and Drug Administration (FDA) as a single agent treatment for patients with advanced gastric or GEJ adenocarcinoma whose disease has progressed after undergoing chemotherapy. Earlier this month, Lilly announced that the drug hit its primary endpoint in the company’s Phase 3 metastatic colorectal cancer (mCRC) trial.
The global double-blinded, randomized, Phase 3 RAINBOW study investigated the combination treatment of ramucirumab and paclitaxel against placebo and paclitaxel as treatment in patients with advanced gastric cancer or GEJ adenocarcinoma, which was refractory to or progressive after chemotherapy. Results show that the ramucirumab and paclitaxel arm improved median overall survival (37 percent) in patients. The combination treatment also met secondary endpoints in progression free survival (52 percent increase) and objective response rate. The company published the study results online in the journal The Lancet Oncology.
Richard Gaynor, SVP of product development and medical affairs for Lilly Oncology, said, “We are encouraged by the RAINBOW study results and are pleased that we now have a second Phase 3 trial of ramucirumab which has demonstrated improved survival in advanced gastric cancer patients.”
“I am very pleased that this trial demonstrated a significant and clinically meaningful benefit for patients with advanced stomach cancer. Currently, there is a significant need for effective therapies to help combat this deadly disease and ramucirumab in this combination could provide a valuable second-line treatment option,” said Hansjochen Wilke, principal investigator of the RAINBOW trial.
Lilly said that it plans to use the RAINBOW data to support applications for approval in the U.S. and EU. The company also plans to go ahead on its scheduled regulatory submission for ramucirumab in Japan in the second half of 2014.