publication date: Aug. 4, 2015
Cyramza Liver Cancer Trial Fails OS Endpoint; Subgroup Data to Form Basis for New Study
A phase III trial of Cyramza (ramucirumab) as a second-line treatment for hepatocellular carcinoma failed to meet its primary endpoint of overall survival.
However, encouraging single-agent activity was observed, according to the drug’s sponsor, Eli Lilly & Co., with meaningful improvements in key secondary endpoints as well as within certain patient subgroups. Those findings will help form the basis for a new phase III trial.
While the trial’s primary endpoint of overall survival favored the Cyramza arm, it was not statistically significant. The trial results were published in The Lancet Oncology.
The global, randomized, double-blind trial, named REACH, compared Cyramza plus best supportive care to placebo plus best supportive care as a second-line treatment in patients with HCC after being treated with sorafenib in the first-line setting.
Median overall survival was 9.2 months on the ramucirumab arm compared to 7.6 months on the placebo arm (HR 0.866; 95% CI: 0.717-1.046; p=0.1391).
While the median OS was not statistically significant, a prespecified subgroup of patients with an elevated baseline of alpha-fetoprotein ≥ 400 ng/mL showed a greater survival improvement with ramucirumab treatment. Median OS in this subgroup of patients was 7.8 months in the ramucirumab arm compared to 4.2 months in the placebo arm (HR 0.674; 95% CI 0.508-0.895; p=0.0059).
The REACH study analyses presented at the Gastrointestinal Cancers Symposium earlier this year concluded that a greater reduction in the risk of … Continue reading CCL July – Cyramza Liver Cancer Trial Fails OS Endpoint; Subgroup Data to Form Basis for New Study
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