The approval marks first treatment advance in nearly a decade and is based on data from the Phase III RESORCE study, in which Bayer's Stivarga® (regorafenib) demonstrated significant improvement in overall survival in hepatocellular carcinoma (HCC) patients previously treated with Nexavar® (sorafenib) / Nexavar is the only approved first-line treatment and Stivarga the only approved second-line therapy in Europe and the United States for patients with HCC
The approval for the first treatment advance in nearly 10 years is based on data from the Phase III RESORCE research.
European Commission (EC) has granted marketing authorization for Bayer's Stivarga® (regorafenib) for the treatment of adult patients with HCC who have been previously treated with Nexavar® (sorafenib). Stivarga is the first and only treatment that has demonstrated a significant improvement in overall survival (OS) in second-line HCC. This marks the third major approval in five months for Stivarga, with the product also gaining approval in the U.S. and Japan for second-line treatment of HCC in April and June, respectively.
"Until now, there was no effective second-line systemic treatment option for liver cancer patients and their treating physicians in Europe. With the EU approval of Stivarga in HCC, the outlook could significantly improve for patients with HCC, as they have now for the first time, a treatment plan with two approved therapies involving the use of Stivarga directly after Nexavar," said Dr. Jordi Bruix, lead investigator for the RESORCE trial, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Spain.
The approval is based on data from the international, multicenter, placebo-controlled Phase III RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma; NCT 01774344] trial, which investigated patients with HCC whose disease had progressed during treatment with Nexavar. In the trial, regorafenib plus best supportive care (BSC) was shown to provide a statistically significant and clinically meaningful improvement in OS versus placebo plus BSC (10.6 vs. 7.8 months, respectively, (HR 0.63; 95% CI 0.50-0.79; p<0.0001)), which translates to a 37% reduction in the risk of death over the trial period. Adverse events observed in the RESORCE trial were generally consistent with the known safety profile of regorafenib. The most common treatment-emergent adverse events were hand-foot skin reaction, diarrhea, fatigue and hypertension.
"Liver cancer is often diagnosed late and difficult to treat, but the EU approval of Stivarga for HCC marks the first treatment advance for patients in nearly a decade. Bayer continues to support the liver cancer community and is committed to ongoing research in the field, as well as continuing to pursue additional regulatory filings for Stivarga across the world," said Robert LaCaze, Executive Vice President and Head of the Oncology Strategic Business Unit at Bayer.
Liver cancer is often more difficult to treat than other cancers with an annual mortality rate of 48,000 in the EU. Globally, it is the second leading cause of cancer-related deaths.
Additional regulatory filings for Stivarga in HCC are under review in other countries around the world, including China. The product was approved in the U.S. and Japan for second-line treatment of HCC in April and June, respectively. Stivarga is already approved in more than 90 countries worldwide, including the U.S., Japan, China and countries in the EU, for the treatment of metastatic colorectal cancer. Stivarga is also approved in more than 80 countries globally, including the U.S., Japan, China and countries in the EU, for the treatment of metastatic gastrointestinal stromal tumors.
About Hepatocellular Carcinoma
Hepatocellular carcinoma, or HCC, is the most common form of liver cancer representing approximately 70-85 percent of liver cancer worldwide. Liver cancer is the sixth mos...
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