Eli Lilly's Cyramza (ramucirumab) has failed to show a significant survival benefit in patients with liver cancer in a late-stage clinical trial.
The Phase III REACH study was comparing Cyramza plus best supportive care (BSC) with placebo/BSC in patients who had already received first-line treatment with Bayer's Nexavar (sorafenib).
The firm said its drug was linked with a survival benefit but that this was not statistically significant, and stressed that encouraging single-agent activity was observed, "with meaningful improvements in key secondary endpoints of progression-free survival, overall response rate and time to progression".
"Although the REACH study did not achieve statistical significance for survival, we are encouraged by the efficacy seen overall, especially in specific subpopulations," said Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology. "We plan to discuss these results with regulatory authorities," he added.
Liver cancer is a very difficult-to-treat tumour type and no Phase III study has been able to demonstrate improved survival in the second-line setting, the firm noted.
Cyramza has been granted Orphan Drug Designation for treatment of hepatocellular carcinoma in the US and EU.