Eli Lilly & Co announced that the Phase III REACH trial of Cyramza (ramucirumab) in patients with hepatocellular carcinoma (liver cancer) failed to meet its primary endpoint of overall survival.
Cyramza is a VEGF receptor 2 antagonist approved in the U.S. as a single agent for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after prior fluoropyrimidine- or platinum-containing chemotherapy. The drug is designed to stop angiogenesis crucial to tumor growth by blocking activation of VEGF Receptor 2 and keeping VEGF-A, VEGF-C, and VEGF-D from binding. Cyramza has received Orphan Drug designation for the treatment of liver cancer in the U.S. and the EU.
The global, double-blind, randomized REACH trial investigated Cyramza in combination with best supportive care against the placebo and best supportive care as a second-line treatment in patients with hepatocellular carcinoma (HCC) after being treated with sorafenib in the first-line setting. Lilly reported that overall survival in the Cyramza arm of the trial was not statistically meaningful, though significant improvements in key secondary endpoints of progression-free survival, overall response rate, and time to progression were observed.
Richard Gaynor, SVP of product development and medical affairs for Lilly Oncology, said, “Although the REACH study did not achieve statistical significance for survival, we are encouraged by the efficacy seen overall, especially in specific subpopulations. We plan to discuss these results with regulatory authorities.”
Liver cancer remains an unconquered tumor type, with no Phase III study able to demonstrate improved survival in second line setting. The disease is the sixth most common cancer around the world and the second leading cause of death related to cancer. According to the World Health Organization, around 30,000 people live with liver cancer and approximately 24,000 will die from the disease in the United States every year.
The company said it intends to present data from the REACH trial at a future scientific meeting later this year.