Drugmaker Eli Lilly and Co. (LLY) Wednesday said Phase III trial of Cyramza or ramucirumab in patients with hepatocellular carcinoma, also known as liver cancer, did not meet its primary endpoint. Overall survival, however, favored the Cyramza arm but was not statistically significant.
The primary endpoint of the trial was overall survival and key secondary endpoints include progression-free survival, overall response rate, time to progression and safety.
"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," said Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology.
Eli Lilly had gained Cyramza by acquisition of ImClone Systems in 2008. It is being investigated in clinical trials as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumor types.
The company stated that 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.
The global, randomized, double-blind REACH trial compared Cyramza plus best supportive care to placebo plus best supportive care as a second-line treatment in patients with liver cancer. The patients were previously treated with sorafenib in the first-line setting.
Initiated in 2010, the study enrolled 565 patients across 27 countries. Liver cancer is the sixth most common cancer worldwide and the second-leading cause of cancer-related death. More than 80 percent of primary carcinomas of the liver are hepatocellular carcinomas or hepatomas.
According to Eli Lilly, the top-line safety data were consistent with what was seen in previous single-agent Cyramza studies.
The firm noted that no Phase III study has been able to demonstrate improved survival in the second-line setting in the difficult-to-treat tumor type liver cancer.
Cyramza has been granted Orphan Drug Designation for treatment of hepatocellular carcinoma in the U.S. and EU.
Cyramza as a single agent is approved in the U.S. for patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma who have progressed after prior fluoropyrimidine, or platinum-containing chemotherapy.
Lilly said it plans to present data from the REACH trial at a scientific meeting later this year.
Top-line results for RAISE, a Phase III trial of Cyramza as a potential treatment for metastatic colorectal cancer, are expected later this year, the company stated.
LLY is currently trading at $59.39, down 0.60 percent.
by RTT Staff Writer
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