Eli Lilly Announces Phase III Results For Cyramza In Hepatocellular Carcinoma
By Cyndi Root
Eli Lilly and Company announced in a press release that a Phase III trial for Cyramza (ramucirumab) in hepatocellular carcinoma did not meet its primary endpoint. The REACH trial with Cyramza plus best supportive care (BSC) showed favorable overall survival, but it was not statistically significant. Cyramza patients did show improvements in progression-free survival, overall response rate, and time to progression.
The Food and Drug Administration (FDA) has granted Cyramza Orphan Drug Designation for the treatment of hepatocellular carcinoma.
Richard Gaynor, M.D., SVP of 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.”
Cyramza Phase III Study
In the REACH trial evaluating Cyramza in hepatocellular carcinoma, the safety data was consistent with data from other Cyramza trials. Common adverse events were fatigue and hypertension. The study began in 2010, was conducted in 27 countries, and enrolled 565 patients. The study compared Cyramza plus best supportive care vs. a placebo and best supportive care. All patients had been previously treated with sorafenib in the first-line setting. The REACH trial’s primary endpoint of overall survival was not met, but investigators did see encouraging signs in other measures.
Cyramza
Lilly acquired Cyramza when it acquired ImClone Systems in 2008. Cyramza (ramucirumab) is FDA-approved for advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after prior fluoropyrimidine — or platinum — containing chemotherapy. In the study leading to Cyramza’s approval in that indication, patients had a median overall survival of 5.2 months compared to 3.8 months for patients taking a placebo. Cyramza patients’ tumors did not grow as quickly as placebo patients did.
Lilly is investigating Cyramza as a single agent and as an agent combined with other anti-cancer therapies. Three Phase III trials of Cyramza — two in gastric cancer and one in non-small cell lung cancer — showed improved overall survival and progression free survival. A Phase III study in breast cancer did not meet its endpoint of improved progression-free survival. Later in the year, Lilly expects results from the Phase III trial of Cyramza in metastatic colorectal cancer.