Bayer Fast Tracks Nexavar After Positive Drug Trials
Bayer and Onyx Pharmaceuticals said they were stopping a late clinical liver cancer trial with Nexavar in the Asia-Pacific region so patients can get the drug sooner after encouraging results.
A review of the Phase III trial involving 226 patients in China, Korea and Taiwan found that Nexavar improved overall survival in patients with advanced hepatocellular carcinoma, the most common form of liver cancer, they said in a statement.
"Based on the data monitoring committee's recommendation, the trial will be stopped to allow all patients to receive treatment with Nexavar," they said on Monday, adding it would present data from the study at an upcoming meeting.
"These study results confirm that Nexavar's efficacy and tolerability in liver cancer extends across ethnic groups and geographies and suggest that Nexavar could meet a tremendous unmet need for patients and families impacted by this devastating disease," said Ann-Lii Cheng, lead investigator and professor of medicine at National Taiwan University Hospital.
Bayer shares were up 0.7%, compared with the German DAX index's 0.4% gain.
The trial was conducted at the request of Asian health authorities to provide supplemental information on Nexavar's efficacy and safety in Asia-Pacific patient populations.
Martin Possienke, an analyst at Equinet, reiterated his buy rating for Bayer with a share price target of 66 euros.
"Today's announcement underlines that Bayer's pipeline is moving in the right direction," he said, adding that he expected peak sales potential for Nexavar of 1 billion euros.
Nexavar became the first medicine to extend the life of patients with advanced liver cancer in a large study, adding about three months to survival compared with a placebo, according to a trial result released in June.
Bayer and Onyx said last week that U.S. regulators had agreed to review Nexavar as a treatment for liver cancer on a priority basis. It has already been approved to treat advanced kidney cancer.
Hepatocellular carcinoma is responsible for about 90% of the primary malignant liver tumours in adults, Bayer said.
Liver cancer is the sixth most common cancer in the world with over 600,000 cases diagnosed each year. It is the third leading cause of cancer-related deaths globally.