Eli Lilly and Company has announced that the global Phase III REACH trial of CYRAMZA™ (ramucirumab) in patients with hepatocellular carcinoma (liver cancer) did not meet its primary endpoint.
Encouraging single-agent CYRAMZA activity was observed, with meaningful improvements in key secondary endpoints of progression-free survival, overall response rate and time to progression. Overall survival favoured the CYRAMZA arm but was not statistically significant.
The global, randomised, double-blind REACH trial compared CYRAMZA plus best supportive care to placebo plus best supportive care as a second-line treatment in patients with hepatocellular carcinoma (HCC) after being treated with sorafenib in the first-line setting. The top-line safety data were consistent with what was seen in previous single-agent CYRAMZA studies.
The most common ( > 5 per cent incidence) grade > /=3 adverse events occurring at a higher rate on the CYRAMZA arm, compared to the control arm, were hypertension and fatigue.
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. There are no approved therapies.
Dr Richard Gaynor, M.D., senior vice president, 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.”