Phase III RESORCE trial of Stivarga (regorafenib) reports overall survival improvements in unresectable hepatocellular carcinoma- Bayer HealthCare

Bayer announced that results from the Phase III RESORCE trial show that Stivarga (regorafenib) tablets achieved a median overall survival improvement in patients with unresectable hepatocellular carcinoma (HCC) who progressed after treatment with Nexavar (sorafenib) tablets. The study found that patients taking Stivarga had a median overall survival of 10.6 months versus 7.8 months for placebo plus best supportive care. In addition to the primary endpoint of the study, all secondary endpoints, which were assessed by modified Response Evaluation Critieria in Solid Tumors (mRECIST) and RECIST 1.1 criteria, were also met.

Median progression-free survival was 3.1 months in patients taking regorafenib vs 1.5 months in the control group. Median time to progression was 3.2 vs 1.5 months. Disease control rate (composed of complete or partial response and stable disease) was 65.2% vs 36.1%, respectively. Overall response rates (complete and partial response) were 10.6% vs 4.1%, respectively. In the study, safety and tolerability were generally consistent with the known profile of regorafenib. The most common grade (at least 3) treatment-emergent adverse events occurring more frequently in the regorafenib group (regorafenib vs placebo group) were hypertension (15.2% vs 4.7%), hand-foot skin reaction (12.6% vs 0.5%), fatigue (9.1% vs 4.7%), and diarrhea (3.2% vs 0%).

Bayer plans to submit data from the RESORCE 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. Results will be presented during the European Society of Medical Oncology (ESMO) 18th World Congress on Gastrointestinal Cancer.