The European Commission ( EC ) has granted marketing authorization for Stivarga ( Regorafenib ) for the treatment of adult patients with hepatocellular carcinoma ( HCC ) who have been previously treated with Sorafenib ( Nexavar ).
Stivarga is the first and only treatment that has demonstrated a significant improvement in overall survival ( OS ) in second-line hepatocellular carcinoma.
Until now, there was no effective second-line systemic treatment option for liver cancer patients and their treating physicians in Europe.
The approval is based on data from the international, multicenter, placebo-controlled phase III RESORCE [ REgorafenib after SORafenib in patients with hepatoCEllular carcinoma ] trial, which investigated patients with hepatocellular carcinoma whose disease had progressed during treatment with Sorafenib.
In the trial, Regorafenib plus best supportive care was shown to provide a statistically significant and clinically meaningful improvement in overall survival versus placebo plus best supportive care ( BSC ) ( 10.6 vs 7.8 months, respectively [ hazard ratio, HR=0.63; 95% CI 0.50-0.79; p less than 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 is often more difficult to treat than other cancers with an annual mortality rate of 48,000 in the European Union.
Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis ( VEGFR1, -2, -3, TIE2 ), oncogenesis ( KIT, RET, RAF-1, BRAF ), metastasis ( VEGFR3, PDGFR, FGFR ) and tumor immunity ( CSF1R ). ( Xagena )
Source: Bayer, 2017