Bayer HealthCare AG and Onyx Pharmaceuticals, Inc announced that the companies have begun enrolling patients in an international phase-III trial to evaluate Nexavar (sorafenib) tablets in patients with non-squamous non-small cell lung cancer (NSCLC) who have failed two or three previous treatments.
"Nexavar has proven efficacy in kidney cancer and liver cancer and we are committed to researching Nexavar in a variety of other solid tumours," said Dimitris Voliotis, vice president, Nexavar Clinical Development, Bayer HealthCare. "Based on strong findings in the phase-II trials, Bayer and Onyx moved to the next phase of development and initiated this phase-III trial evaluating Nexavar in NSCLC."
The MISSION (Monotherapy administration of Sorafenib in patients with non-small cell lung cancer) trial is an international multicenter study that will enrol approximately 850 patients with advanced relapsed or refractory non-squamous cell NSCLC who have failed two or three previous treatments. Patients will be randomized to receive either Nexavar as single agent or placebo. In both treatment arms, best supportive care will be provided. The primary endpoint of this trial is overall survival, and secondary endpoints include progression-free survival and overall response rate. The safety and tolerability of the two treatment groups will also be compared.
The study will be conducted at more than 120 sites in North America, South America, Europe, Africa and the Asia-Pacific region, including Japan. For information about this study, please visit www.clinicaltrials.gov.
"As the leading cause of cancer deaths worldwide, lung cancer is a complex disease that requires new therapeutic options for patients," said Laura Brege, executive vice president and chief operating officer at Onyx Pharmaceuticals. "We are committed to studying Nexavar to understand how it may play a role in the treatment paradigm of this difficult-to-treat disease."
Nexavar, an oral anti-cancer therapy, is currently approved in more than 70 countries for liver cancer and in more than 80 countries for the treatment of patients with advanced kidney cancer.
Onyx Pharma is a biopharmaceutical company committed to improving the lives of people with cancer.