Bayer has claimed on May 4, 2016, in Berlin that it has observed an increased overall survival rate among liver cancer patients treated with Stivarga (Regorafenib). This claim is based on the data and the results of the phase III clinical trials performed on the patients of hepatocellular carcinoma (HCC).
The trials were stopped after the study met its primary end point i.e., a significant increase in overall survival rate. Bayer now plans to submit the data this year to the health authorities like FDA in order to seek approval and expand the spectrum of Stivarga’s (Regorafenab) use in hepatocellular carcinoma patients.
Stivarga For Liver Cancer
The study was named as RESORCE phase III clinical trials. The overall objectives of the study were to monitor the survival rate, safety and efficacy of Stivarga in the patients suffering from hepatic carcinoma. The main characteristic feature of those patients was the progression of their disease after they were treated with Nexavar (Sorafenib). This drug is a chemotherapeutic agent that is indicated for its use in hepatocellular carcinoma (HCC) patients. It was observed that the safety and effectiveness of Stivagra was identical to the known safety profile of the drug. There was an increase in the overall survival for the HCC patients on Stivarga therapy as compared to the patients who received placebo.
On the basis of the results of the study, Bayer now plans to submit the findings to the concerned healthcare authorities in 2016 to get approval and market authorization for Stivarga use in HCC patients. The detailed report of the RESORCE phase III clinical trials will also be presented in a scientific congress soon.
Dr Joerg Moeller, an Executive Committee Member of Bayer AG’s Pharmaceutical Division and Head of the Global Development, said, “Effective treatment options are urgently needed for the patients with liver cancer.” He further stated, “With Sorafenib having been a major advance in the treatment of unresectable HCC, Regorafenib could now become the second proven systemic option for the treatment of liver cancer. We would like to thank the patients and the study investigators for their contributions and participation in this study.”
About the RESORCE, Phase III Clinical Trials
The clinical trials were assigned a name RESORCE, assigned on the basis of REgorafenib administered to the patients after SORafenib suffering from hepato-CEllular carcinoma. These phase III clinical trials were double blinded, randomized, multi-centered and placebo-controlled. 573 patients were selected for the study and were randomized in the ratio of 2:1. The diseased state of all the patients with hepatic cellular carcinoma (HCC) progressed after they received therapy with Sorafenib. These were divided into two groups. One of the groups received Regorafenib plus best support care (BSC) therapy while the other was administered with placebo plus best support care (BSC) therapy.
In the first group, a dose of 160mg of Regorafenib was administered at a frequency of once daily. This administration continued for three consecutive weeks and one week off. The other group was administered with placebo for continuous 28 days in order to complete one full treatment cycle. The primary end point of the trials was calculation of the overall survival in both study groups. The secondary end points of the study included estimation of the progression free survival, objective response and control rates. The other parameters like safety and effectiveness of the study were also closely examined. After the accomplishment of the end points, the trials were stopped and an increase in the overall survival rate was observed in the group treated with Regorafenib.
If the company gets the market authorization on the basis of the clinical data to increase the scope of the use of it’s already FDA approved drug Regorafenib, then it can actually provide healthcare professions with another treatment option for HCC patients. Currently, Sorafenib is the only FDA approved drug that is exclusively used for treating HCC patients. This addition can add new dimensions to the limited therapeutic options available.
Stivarga is the registered brand name of Regorafenib. This drug is marketed by Bayer Healthcare worldwide which is a German multinational company with a worth of US$ 126.4 billion. It was approved by FDA in 2012, for the oral treatment of colo-rectal cancers and advanced gastrointestinal stromal tumors. This drug is a multi-kinase enzyme inhibitor and acts by inhibiting those enzymes that are involved in the promotion of cancerous cell growth. The drug is now available in 90 countries worldwide including United States and Europe. The major indications for the use of this drug are metastatic colorectal cancers (mCRC) and metastatic gastrointestinal stromal tumors (GIST). This drug can also be administered in those mCRC patients who fail to respond to the previous anti-cancer therapies like Imatinib and Sunitinib.
About HCC (Hepatocellular Carcinoma)
The hepatocellular carcinoma is one of the most common types of the liver carcinoma. Almost 70-85% of the total liver cancer cases constitute this type of cancer. Almost 30,000 new cases of liver cancer are registered every year in the United States. The number of new liver cancer cases worldwide is above 780,000 each year. The rate of prevalence of the disease is currently on a high. Almost 746,000 patients died in 2012 due to liver cancer around the globe. In the United States, 24,000 patients lost their lives due to this deadly disease in 2012.