Bayer says its Stivarga improved overall survival in liver cancer in late-stage trials
pharmafile | June 30, 2016 | News story | Research and Development, Sales and Marketing | Bayer, Stivarga, drug trial, liver cancer
German pharma and crop sciences giant Bayer (ETR: BAYN) said late-stage trials for its drug to treat liver cancer showed a median overall survival.
The company said the study showed Stivarga had a median overall survival of 10.6 months versus 7.8 months for placebo and supportive care in Phase III studies.
Bayer plans to submit data from the study as the basis for marketing authorization of regorafenib in the treatment of unresectable HCC in the U.S. and other markets worldwide in 2016.
Jordi Bruix, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, said: “The global incidence of liver cancer continues to increase and has more than tripled in the US over the last three decades, and currently there are no proven or approved systemic second-line treatment options for patients with advanced HCC. The improvement in overall survival seen with regorafenib in the RESORCE study signals the addition of a potential option in this treatment setting.”
In the US, Stivarga is indicated for the treatment of metastatic colorectal cancer (CRC). It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST).
Hepatocellular carcinoma (HCC) is the most common form of liver cancer and represents 70-85% percent of liver cancer worldwide. Liver cancer is the fifth most common cancer in men and seventh most common in women. More than 780,000 cases of liver cancer are diagnosed worldwide each year and the incidence rate is increasing. In 2012, about 746,000 people died of liver cancer including about 383,000 in China, 48,000 in the European Union, and 24,000 in the US.
Anjali Shukla
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