Bayer has filed applications in Europe, the US and Japan seeking approval to expand the scope of its cancer drug regorafenib to include the second-line treatment of liver cancer.
The drug - which Bayer describes as an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumour angiogenesis - is already approved under the brand name Stivarga to treat metastatic colorectal cancer (mCRC) and metastatic gastrointestinal stromal tumors (GIST) in several countries around the globe.
The German drugs giant is now seeking approval for the drug to treat unresectable hepatocellular carcinoma (HCC) after first-line treatment, based on data from the Phase III RESORCE study, in which it showed a statistically significant improvement in overall survival in the target patient population.
The trial investigated the effect of regorafenib in patients with unresectable HCC whose disease had progressed during treatment with Nexavar (sorafenib).
According to the data presented, regorafenib significantly improved overall survival (OS) compared to placebo, with a 2.8-month difference in median OS (10.6 months versus 7.8 months), respectively. Also, the drug was linked with an overall 37 percent reduction in the risk of death, the firm said.
"Approximately 780,000 people are diagnosed with HCC worldwide each year, a number that continues to increase. Regorafenib is the first treatment to successfully deliver an overall survival benefit in the second-line setting for HCC and has the potential to change the treatment paradigm by becoming the new standard of care for patients who progress on sorafenib," noted Dr Jordi Bruix, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, and principal investigator of the RESORCE and SHARP trials.