Nexavar failed to improve recurrence-free survival in HCC patients

Hepatocellular carcinoma patients without detectable disease after resection or ablation experienced no improvement in recurrence-free survival after being assigned sorafenib tablets in an investigational trial, according to a press release.

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, co-developers of Nexavar, said the phase 3 STORM trial failed to meet its primary endpoint of improving recurrence-free survival in patients with hepatocellular carcinoma (HCC). In the international, multicenter trial, 1,100 patients were randomly assigned 400 mg sorafenib twice daily or placebo for 4 years or until disease recurrence after they had undergone curative treatment. The drug, approved in the US for treating patients with unresectable HCC, advanced renal cell carcinoma and thyroid carcinoma, maintained its safety profile in the trial.

“While the primary endpoint of this adjuvant trial was not met, Bayer and Onyx remain dedicated to ongoing research in all stages of liver cancer,” Pamela A. Cyrus, MD, vice president of US Medical Affairs, Bayer HealthCare, said in the release. “The outcome today does not affect the currently approved indications.”

Study data will be presented at a future scientific congress, the release said.