Liver cancer patients gospel! Bayer submits Stivarga listing application for targeted anti-cancer drug to global regulators for second-line treatment of advanced hepatocellular carcinoma

German pharmaceutical giant Bayer (Bayer) recently announced that it has submitted a new regulatory application for the targeted anti-cancer drug Stivarga(regorafenib, regorafenib) to the world's three major pharmaceutical markets (the United States, Japan and the European Union), seeking approval to Stivarga second-line treatment for patients with unresectable hepatocellular carcinoma (HCC). Stivarga, an oral multikinase inhibitor, is currently approved in more than 90 countries for the treatment of metastatic colorectal cancer (mCRC) and in more than 80 countries for the treatment of metastatic gastrointestinal stromal tumor (mGIST). The Stivarga was developed by Bayer and jointly promoted by Bayer and Onyx (now part of Amgen).

The regulatory submission Stivarga second-line treatment of unresectable hepatocellular carcinoma (HCC) is based on comparative data RESORCE in phase III clinical studies. The study was conducted in 573 patients with unresectable hepatocellular carcinoma (HCC) who progressed during treatment with Bayer anticancer drug dojimei (Nexavar, common name: sorafenib, sorafenib). The efficacy and safety of Stivarga combined with best supportive care (BSC) were investigated and compared with placebo + BSC. Data show that compared with placebo + BSC treatment group, Stivarga + BSC treatment group has significantly prolonged overall survival (OS) (median OS:10.6 months vs 7.8 months; HR 0.63; 95% CI:0.50-0.79; p<0.001), and significantly reduced mortality by 37%, reaching the main goal of the study. The safety and tolerability profile of the Stivarga in this study was consistent with the known clinical attributes of the drug. The relevant data were released at the 18th World Gastrointestinal Cancer Congress (WCGC) held in Barcelona, Spain, in June this year.

In recent years, the incidence of liver cancer has continued to increase worldwide, and there is currently only one approved systemic therapy for liver cancer (I. e. Bayer's Dogemet Nexavar), and there is no clinically proven or approved second-line treatment for advanced hepatocellular carcinoma (HCC). Stivarga the strong efficacy of HCC RESORCE in Phase III studies will provide a second clinically proven treatment option for physicians, healthcare providers and patients.

In addition to the primary endpoint, the study also met all secondary endpoints (assessed by mRECIST [Modified Response Evaluation Criteria in Solid Tumors] and RECIST 1.1 criteria). Compared with placebo + BSC treatment group, Stivarga + BSC treatment group significantly prolonged progression-free survival (median PFS:3.1 months vs 1.5 months, HR = 0.46[95% CI:0.37-0.56],p<0.001) and time to disease progression (median TTP:3.2 months vs 1.5 months, HR = 0.44[95% CI:0.36-0.55], P <0.001), the disease control rate (DCR, including complete response, partial response, stable disease) was significantly improved (65.2 vs 36.1, p<0.001), and the overall response rate (complete response + partial response) was significantly improved (10.6 vs 4.1, p = 0.005). All values for secondary endpoints were assessed based on mRECIST criteria.

The safety and tolerability profile of the Stivarga in this study was consistent with the known clinical attributes of the drug. The most common adverse events (grade 3 or higher) in the Stivarga treatment group were hypertension (15.2 percent in the Stivarga group vs 4.7 percent in the placebo group), hand-foot skin reactions (12.6 percent vs 0.5 percent), fatigue (9.1 percent vs 4.7 percent), and diarrhea (3.2 percent vs 0 percent).

For a large liver cancer country like China, its emergence has brought good news to the majority of liver cancer patients. However, considering that Stivarga applied for a patent in the United States in 2004 and did not go public until 2012, and there is no listing in mainland China until now, I am afraid we have to wait patiently.

Liver cancer: the second leading cause of cancer-related deaths, and China is a large country for liver cancer.

Hepatocellular carcinoma (HCC) is the most common type of liver cancer, accounting for 70-85% of all liver cancer cases. Liver cancer is the sixth leading cancer worldwide and the second leading cause of cancer-related deaths. It is estimated that more than 780000 cases of liver cancer are diagnosed each year worldwide (more than 395000 in China, 52000 in the European Union and 30000 in the United States), and the diagnosis rate continues to rise. In 2012, about 746000 people died of liver cancer worldwide, including 383000 deaths in China, 48000 in the European Union and 24000 in the United States.

Stivarga is an oral multikinase inhibitor that blocks several pro-angiogenic VEGF receptor tyrosine kinases that play an important role in tumor angiogenesis. In addition to VEGFR 1-3, the drug also inhibits a variety of kinases in various cancer and tumor microenvironments, including TIE-2,RAF-1,BRAF V600,KIT, RET, PDGFR and FGFR, each of which regulates tumor growth, stromal microenvironment formation and disease progression individually and in combination.

Sorafenib is an oral anti-cancer therapy that has been shown in a number of clinical trials to inhibit a variety of pro-proliferative and angiogenic kinases, thereby inhibiting tumor growth. It is mainly used for the treatment of hepatocellular carcinoma, renal cell carcinoma and differentiated thyroid cancer.

News source:http://news.bioon.com/article/6692267.html

This news was re-edited and reorganized by the Huaxun team and added analytical comments.