Date: 2012-05-22
Type of information: Results
phase: 3
Announcement: results
Company: Bayer (Germany) Onyx Pharmaceuticals (USA)
Product: Nexavar® (sorafenib)
Action
mechanism: Nexavar® inhibits processes involved in both the tumor cell and tumor vasculature. In preclinical studies, Nexavar® has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR B, KIT, FLT-3 and RET.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country: North America, South America, Europe, Africa and the Asia-Pacific region, including Japan
Trial
details: The MISSION (Monotherapy admInistration of Sorafenib in patientS wIth nOn-small cell luNg cancer) 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. In both study arms, best supportive care was provided. 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. The study was conducted at more than 150 sites in North America, South America, Europe, Africa and the Asia-Pacific region, including Japan.
Latest
news: Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have announced that a Phase 3 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, did not meet its primary endpoint of improving overall survival. An improvement in the secondary endpoint of progression-free survival (PFS) was observed. The study compared Nexavar plus best supportive care to placebo plus best supportive care. The safety and tolerability data were generally as expected. The data will be presented at an upcoming scientific meeting.
