Nexavar disappoints in Ph III liver cancer study

German pharma major Bayer (BAYN: DE) and Onyx Pharmaceuticals, now a subsidiary of US biotech firm Amgen (Nasdaq: AMGN) say that a Phase III trial evaluating Nexavar (sorafenib) as an adjuvant treatment for patients with hepatocellular carcinoma (HCC, 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, which generated sales of 771 million euros ($1.07 billion) in 2013. Data from this study will be submitted for presentation at an upcoming scientific congress, Bayer Healthcare announced today.

“We are disappointed that the trial did not meet its primary endpoint. However, we remain committed to exploring the full potential of sorafenib in all stages of liver cancer,” said Jorg Moller, a member of the Bayer HealthCare executive committee and head of global development. “The outcome announced today does not affect the currently approved indications. Nexavar remains the only approved systemic treatment for unresectable HCC with a proven overall survival benefit,” Dr Moller noted.

STORM 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 (ie, 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 400mg of sorafenib twice daily or matching placebo for four years or until disease recurrence, whichever comes first.