Ph III trial of Nexavar in NSCLC patients fails

Singapore: A phase III trial evaluating Nexavar (sorafenib) tablets in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer (NSCLC) whose disease progressed after two or three previous treatments, failed to meet its primary endpoint of improving overall survival.

The study was conducted at more than 150 sites in North America, South America, Europe, Africa and the Asia-Pacific region, including Japan.

Bayer HealthCare Pharmaceuticals, a global healthcare company, and Onyx Pharmaceuticals are carrying out the trial. Nexavar is currently approved in more than 100 countries and is being evaluated by other international study groups, government agencies and individual investigators as well for a range of cancers. The drug is approved in the US for the treatment of patients with unresectable liver cancer and for the treatment of patients with advanced kidney cancer.

In the trial, an improvement in the secondary endpoint of progression-free survival (PFS) was, however, observed. The safety and tolerability data were generally as expected. The data will be presented at an upcoming scientific meeting.

"While we are disappointed that the primary endpoint was not met, we believe the study results will advance the scientific knowledge in lung cancer," said Dr Dimitris Voliotis, vice president, Global Clinical Development Oncology, Bayer HealthCare.

The trial is an international multicenter study that randomized 703 patients with advanced relapsed or refractory non-squamous NSCLC whose disease progressed after two or three previous treatments. Patients were randomized to receive either Nexavar as single agent or placebo. The primary endpoint of the trial was overall survival, and secondary endpoints included progression-free survival, disease control rate, overall response rate, time to progression and quality of life.