Nexavar fails recurrence target
Phase-III tests using oncology drug Nexavar as an adjuvant therapy for liver cancer failed to meet a recurrence-free survival target. Partners Bayer and Amgen's Onyx division announced the results Tuesday, and said they will detail results of the STORM clinical trial at a scientific conference.
Amgen funds 50% of Nexavar R&D costs and co-promotes the drug with Bayer in the US through its own sales force and medical science liaisons.
The 1,100 patient trial assessed cancer patients who appeared cancer-free after surgical resection or ablation. These patients received 400mg of sorafenib or a placebo for four years, or until the cancer returned. The drug was one of Bayer's top-selling pharmaceuticals in 2013, earning $1 billion in 2013, behind contraceptive Yaz, which ranked fourth among last year's best sellers. While on Bayer's hit-list, higher US prices helped keep sales high, yet still slipped 2.7% compared to sales in 2012.
The drug's approved indications include advanced renal cell carcinoma (2005) and unresectable hepatocellular carcinoma (2007). The FDA approved Nexavar for locally recurrent or metastatic, progressive differentiated thyroid cancer refractory to iodine under priority review in November.