Date: 2014-03-11
Type of information: Results
phase: 3
Announcement: results
Company: Bayer HealthCare (Germany) Onyx Pharmaceuticals, an Amgen subsidiary (USA)
Product: Nexavar® (sorafenib)
Action
mechanism: Sorafenib is an oral multi-kinase inhibitor with a distinct profile targeting angiogenic (VEGFR, TIE-2), stromal (PDGFR) and oncogenic (RAF, RET and KIT) receptor tyrosine kinases.
Disease: hepatocellular carcinoma
liver cancer
Therapeutic area: Cancer - Oncology
Country: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Mexico, New Zealand, Peru, Portugal, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, UK, USA
Trial
details: The Phase III, randomized, double-blind, placebo-controlled STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial is an international multicenter study that evaluated the clinical benefit of sorafenib versus placebo as an adjuvant treatment in patients with HCC following potential curative treatment (surgical resection or local ablation). The primary endpoint of the study was recurrence-free survival (i.e., the length of time that a patient survives without recurrence of HCC). Secondary endpoints included time to recurrence of HCC and overall survival. Safety and tolerability were also assessed. More than 1,100 patients were randomized to receive either 400 mg of sorafenib twice daily or matching placebo for four years or until disease recurrence, whichever comes first. (NCT00692770)
Latest
news: * On March 11, 2014, Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, an Amgen subsidiary, have announced that a Phase III trial evaluating sorafenib (Nexavar®) tablets as an adjuvant treatment for patients with hepatocellular carcinoma, a form of liver cancer, who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival. The safety findings were consistent with the known profile of sorafenib. Data from this study will be submitted for presentation at an upcoming scientific congress.
