German conglomerate Bayer AG (BYR.L,BAYRY.PK,BAYZF.PK) on Thursday announced that a Phase III trial of Nexavar (sorafenib) met primary endpoint of improving progression-free survival in patients with radioactive idine refractory differentiated thyroid cancer.
Nexavar is an oral anti-cancer therapy co-developed by Bayer HealthCare unit's U.S. division, Bayer HealthCare Pharmaceuticals Inc., and U.S. drugmaker Onyx Pharmaceuticals, Inc. (ONXX).
The study, called DECISION, evaluated the efficacy and safety of the drug compared to placebo. Secondary endpoints included overall survival, time to progression, response rate and duration of response. Bayer noted that the safety and tolerability were generally consistent with the known profile of Nexavar.
According to the company, papillary and follicular types of thyroid cancer are classified as "differentiated" and account for vast majority of thyroid cancers. The majority of differentiated thyroid cancers are treatable, while RAI-refractory, locally advanced, or metastatic disease is more difficult to treat and is associated with a lower survival rate.
Bayer said it plans to submit these data as the basis for marketing authorization of Nexavar in the treatment of RAI-refractory differentiated thyroid cancer. The companies will present the detailed efficacy and safety analysis from this study at an upcoming medical meeting.
Dimitris Voliotis, MD, Vice President, Global Clinical Development Oncology, Bayer HealthCare, said, "Effective treatment options are urgently needed for patients with RAI-refractory differentiated thyroid cancer. We are pleased that the results of this study demonstrate that Nexavar may provide a treatment option for these patients."
Nexavar is currently approved in more than 100 countries worldwide for liver cancer and for the treatment of patients with advanced kidney cancer. In Europe, Nexavar is approved for treating hepatocellular carcinoma and for patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of other cancers.
In May last year, Nexavar had failed to meet its primary endpoint in a late-stage study evaluating its potential in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer.
On Frankfurt's Xetra, Bayer shares are currently trading at 71.87 euros, up 0.10 euros or 0.14 percent.
by RTT Staff Writer
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