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Eli Lilly's Cyramza meets primary endpoint in phase 3 liver cancer trial

PBR Staff Writer Published 05 April 2018

Eli Lilly’ liver cancer treatment Cyramza (ramucirumab) has met its primary endpoint of overall survival (OS) and the secondary endpoint of progression-free survival (PFS) in the phase 3 Reach-2 study.

The company has revealed the top-line results from the phase 3 study of Cyramza as a single agent in the second-line treatment of people with hepatocellular carcinoma (HCC).

Cyramz, which is an antiangiogenic therapy, is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by restricting the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D.

Cyramza has showed a survival benefit in four aggressive and difficult-to-treat tumor types in phase 3 studies, including as a single agent in both gastric cancer and HCC.

Lilly is planning to start regulatory submissions for Cyramza in the middle of this year.

Reach-2 is a global, randomized, double-blind and placebo-controlled phase 3 trial of Cyramza and best supportive care (BSC) compared against placebo and BSC in hepatocellular carcinoma (HCC) patients who were intolerant or that had disease progression while on or following treatment with sorafenib and had a high alpha-fetoprotein (AFP-High).

In 2015, the company started the trial and recruited 292 patients across 20 countries in North America, Asia, Europe and Latin America.

The trials primary end point is overall survival and key secondary endpoints include progression-free survival, objective response rate, quality of life, and safety.

Lilly Oncology global development and medical affairs senior vice president Levi Garraway said: "Advanced liver cancer is an aggressive disease that has a poor prognosis – and for those that have elevated AFP levels, the prognosis is even more dismal.

“The expected survival of these patients is only a few months following first-line treatment if they don't go onto second-line therapy.”

Separately, Eli Lilly has collaborated with Sigilon Therapeutics to develop encapsulated cell therapies for the treatment of type 1 diabetes.

Image: Eli Lilly headquarters. Photo: courtesy of Guanaco152003.