Policy & Regulation
Eli Lilly and Company reports improvement in primary endpoint of overall survival in patients with hepatocellular carcinoma under REACH-2 study
21 January 2019 -

Healthcare company Eli Lilly and Company (NYSE:LLY) disclosed on Friday that the REACH-2 study of CYRAMZA (ramucirumab) showed a statistically significant improvement in the primary endpoint of overall survival (OS) in patients with AFP-High hepatocellular carcinoma (HCC) , also known as liver cancer.

REACH-2 is a global, randomised, double-blind, placebo-controlled Phase 3 study of CYRAMZA and best supportive care (BSC) compared to placebo and BSC in hepatocellular carcinoma (HCC) patients with a high alpha-fetoprotein (AFP-High), defined as an AFP of ≥400 ng/ml, stated the company.

The company added the safety profile observed in the REACH-2 study was consistent with the single-agent CYRAMZA in patients with HCC. Additionally, in a pooled analysis comprised of all AFP-High HCC patients across both the REACH-2 and REACH studies, CYRAMZA treatment resulted in an improvement in median OS.

On the primary endpoint of OS, the treatment with the company's CYRAMZA significantly improved the OS of patients compared to placebo. The median OS was 8.5 months with CYRAMZA when compared to 7.3 months with placebo.

According to the company, CYRAMZA is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C and VEGF-D. CYRAMZA inhibited angiogenesis in an in vivo animal model.

Additionally, the global Phase 3 REACH-2 study of CYRAMZA as a single agent in the second-line treatment of people with AFP-High hepatocellular carcinoma (HCC) were published online in The Lancet Oncology as well as presented at the 2019 Gastrointestinal Cancers Symposium in San Francisco, disclosed the company.

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