BAYER AG (Leverkusen DEU) now has Phase 3 results which suggest its Stivarga product is an effective treatment for a common form of liver cancer known as hepatocellular carcinoma (HCC).
The new data come from the RESORCE trial, which showed that Stivarga (regorafenib) was able to improve overall survival in HCC patients whose disease was unsuitable for surgery and had progressed despite earlier treatment with Nexavar (sorafenib), Bayer’s already-approved drug for liver cancer.
Stivarga is already labeled for the treatment of colorectal cancer and gastrointestinal stromal tumors (GIST) and has been cited as a growth product for Bayer but saw sales dip in the first-quarter, due mainly to increased competition in the U.S. where it declined 24%.
Overall the product brought in 67 million euros in the first three months of the year, 4 million less than a year ago, and a new indication in liver cancer could restore some of its growth momentum. Meanwhile, Bayer is also looking for a boost from the launch of the drug in Germany–Europe’s largest market–in the latter half of this year.
“Effective treatment options are urgently needed for patients with liver cancer,” said Joerg Moeller, Bayer’s pharma head, who noted that Stivarga could now sit alongside Nexavar as “the second proven systemic option for the treatment of liver cancer.”
Nexavar is still growing strongly, with sales rising almost 10% in the first quarter to reach 213 million euros, and remains the only FDA-approved systemic therapy available for advanced HCC. However, despite its ability to improve clinical outcomes, the average overall survival for HCC remains between seven and 11 months.
Bayer has indicated that it will submit data from the RESORCE study as the basis for a marketing application for Stivarga in the treatment of inoperable HCC before the end of the year. HCC is the most common form of liver cancer and represents approximately 70-85% of all cases worldwide. Liver cancer is the sixth most common cancer in the world and the second leading cause of cancer-related deaths globally.
Bayer closed the week down 3% at 97.77 euros in Frankfurt.