Eli Lilly and Co. announced that the Phase 3 REACH trial of Cyramza (ramucirumab) in patients with hepatocellular carcinoma, also known as liver cancer, did not meet its primary endpoint; overall survival favored the Cyramza arm, but was not statistically significant. 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 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 grade >/=3 adverse events occurring at a higher rate on the Cyramza arm compared to the control arm were hypertension and asthenia (fatigue).
“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.
Liver cancer is a very difficult-to-treat tumor type and no Phase III study has been able to demonstrate improved survival in the second-line setting. This is an area of very high unmet need for which there are no approved therapies.
Lilly plans to present data from the REACH trial at a scientific meeting later this year.
Cyramza has been granted Orphan Drug Designation for treatment of hepatocellular carcinoma in the U.S. and EU. Orphan drug status is given- in the U.S. by the FDA’s Office of Orphan Products Development (OOPD) and in the EU by the European Commission- to medicines that have demonstrated promise for the treatment of rare diseases.
Date: June 11, 2014
Source: Eli Lilly and Co.