Bayer’s liver cancer drug meets primary endpoint in late stage trial

pharmafile | May 5, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Bayer, Stivarga, late stage trial, liver cancer, phase III, regorafenib, trial 

Bayer has announced positive results from a late-stage trial evaluating Stivarga (regorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

The drug met its primary endpoint of statistically significant improvement in overall survival in the Phase III trial. Hepatocellular carcinoma is the most common form of liver cancer, and liver cancer as a whole is the second leading cause of cancer-related deaths worldwide. In 2012, alone, it was estimated that 746,000 people died from the disease.

Dr Joerg Moeller, head of development at Bayer’s pharmaceutical division, says: “Effective treatment options are urgently needed for patients with unresectable liver cancer. With sorafenib having been the only systemic option for the treatment of unresectable HCC since 2007, regorafenib could now become the second proven systemic option.”

Bayer entered into an agreement with Amgen subsidiary, Onyx Pharmaceuticals, in 2011 under which Onyx receives a royalty on all global net sales of the drug in oncology. Stivarga was approved by the FDA in 2012 for the treatment of patients with metastatic colorectal cancer.

Bayer indicates that full trial data will be presented at an upcoming scientific conference. The Phase III trial results are expected to form the basis for marketing authorisation for regorafenib in the treatment of unresectable HCC in 2016.

Sean Murray

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