Nexavar, a drug co-developed by Bayer HealthCare Pharmaceuticals Inc. and U.S. drugmaker Onyx Pharmaceuticals, Inc. (ONXX), has 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, the companies said Tuesday.
The drug is already approved in the U.S. and many other countries to treat patients with unresectable liver cancer and advanced kidney cancer.
The phase 3 study, dubbed MISSION, compared Nexavar (sorafenib) plus best supportive care to placebo plus best supportive care. The primary endpoint was improving overall survival.
The international multicenter study randomized 703 patients with the type of lung cancer, abbreviated NSCLC, whose disease progressed after two or three previous treatments. Patients were randomized to receive either Nexavar as single agent or placebo.
Dimitris Voliotis, vice president, Global Clinical Development Oncology, Bayer HealthCare stated, "While we are disappointed that the primary endpoint was not met, we believe the study results will advance the scientific knowledge in lung cancer."
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a unit of the German conglomerate Bayer AG (BAYRY.PK,BAYZF.PK).
The secondary endpoints of the study included progression-free survival, disease control rate, overall response rate, time to progression and quality of life. The companies said an improvement in the secondary endpoint of progression-free survival was also observed.
The study was conducted at more than 150 sites in North America, South America, Europe, Africa and the Asia-Pacific region, including Japan.
Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of cancers.
On Frankfurt's Xetra, Bayer shares are currently trading at 51.78 euros, down 0.02 percent, on a volume of 657 thousand shares.
Onyx shares closed Monday's regular trading at $42.82 on the Nasdaq.
by RTT Staff Writer
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