Expected to treat liver cancer and stomach cancer, Lilly new drug harvest positive clinical results
April 08, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, Eli Lilly and Company published the top-line positive data of Cyramza (ramucirumab) as a single-therapy second-line treatment of hepatocellular carcinoma (HCC) in a clinical phase III study of REACH-2. To date, Cyramza has shown survival benefits for four invasive, refractory tumor types in Phase 3 clinical studies, including monotherapy as a gastric cancer and HCC.
HCC is the most common type of liver cancer and the third-ranked cancer killer, affecting 500,000 people worldwide, with the highest incidence in Asia and Africa. About half of patients with advanced HCC have high levels of alpha-fetoprotein (AFP), and such patients tend to have a poor prognosis. AFP is a protein produced in the early development of the fetus and is also produced in the liver as well as various tumors (including HCC).
Cyramza is a fully human monoclonal antibody to vascular endothelial growth factor receptor 2 (VEGFR2) that binds to and blocks the activation of VEGFR2. Previously, the drug has been approved in the United States and Europe for the treatment of gastric or gastroesophageal adenocarcinoma with no chemotherapy or chemotherapy, and non-small cell lung cancer. Cyramza is currently evaluating the efficacy of more than 12,000 patients in more than 708 clinical trials worldwide, in addition to being a monotherapy, in combination with other anticancer therapies to study the efficacy of multiple tumor types.
The current REACH-2 is a global, randomized, double-blind, placebo-controlled phase 3 clinical trial comparing Cyramza and placebo in disease progression to or intolerance to sorafenib. Efficacy of AFP serum levels (≥400 ng/mL, primary liver cancer-specific markers) in liver cancer patients. The trial began in 2015 with a total of 292 patients enrolled in 20 countries around the world, the first phase 3 HCC trial in a population of patients classified by biomarker testing. The results showed that the study reached the primary end point of overall survival (OS), and the secondary endpoint of progression-free survival (PFS), and the safety data was consistent with previous results.
â–² Eli Lilly and Company is in the stage 3 tumor line (Source: Eli Lilly Official Website)
Dr. Levi Garraway, senior vice president of global development and medical affairs at Lilly's Cancer, said in a statement: "Advanced liver cancer is an invasive disease with a poor prognosis, and for patients with elevated AFP levels, the prognosis is even more Oops. If there is no second-line treatment, the expected survival of these patients after first-line treatment is only a few months. Because of this, Eli Lilly's results on REACH-2 and Cyramza's potential to benefit patients in this situation Inspired."
Lilly said it plans to submit the drug to the regulatory agency for applications for indications such as HCC in the middle of this year. We are looking forward to its good news and hope to bring the gospel to patients with advanced liver cancer as soon as possible!
Reference materials:
[1] Lilly's Cyramza successful in late-stage liver cancer study
[2] Lilly Announces CYRAMZA® (ramucirumab) Phase 3 REACH-2 Study in Second-Line Hepatocellular Carcinoma Patients Met Overall Survival Endpoint
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