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Cyramza Failed in Phase III Trial for Liver Cancer
- Updated: June 11, 2014
Cyramza is a cancer drug developed by Eli Lilly and Co., it has already been approved for stomach cancer. The developers were hoping that this drug will be effective for liver cancer patients as well. But the drug failed to meet the primary endpoint in a Phase III REACH trial. The drug couldn’t increase the survival rate in patients with hepatocellular carcinoma significantly. In an earlier study, cyramza had failed to increase survival rates in breast cancer patients. Cyramza was given special approval by the US and European administrative bodies in 2011 and 2012 to treat liver cancer, because it showed promise in earlier study results. Such “orphan drug” approvals are given only to drugs that are capable of treating rare diseases.
The trial was randomized, double blind and compared cyramza plus best supportive care to placebo plus best supportive care for patients who have been unresponsive to standard chemotherapy treatment for liver cancer. There were 565 patients involved.
“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.
Cyramza was used as a second line treatment in the study. No Phase III study has yet showed improved survival for patients with liver cancer, in the second line setting, there are no approved therapies in this area and there is high demand for drugs that could meet the need.
Cyrmza has been found to be affective against the most common form of lung cancer, in a late stage trial and is being tested against colorectal cancer.