Phase 3 Study of Motesanib for NSCLC
Amgen and Millennium announced results from its Phase 3 study of motesanib administered in combination with paclitaxel and carboplatin for the treatment of non-squamous non-small cell lung cancer. MONET1 (MOtesanib NSCLC Efficacy and Tolerability Study) is a multicenter, randomized, placebo-controlled, double-blind trial that enrolled 1,090 patients with NSCLC. Patients were randomized to receive either motesanib (125mg PO daily) + paclitaxel (200mg/m2 IV every 3 weeks) + carboplatin (target AUC of 6mg/mL/min IV every 3 weeks) or paclitaxel + carboplatin + placebo. The trial did not meet its primary objective of demonstrating an improvement in overall survival (hazard ratio 0.90, 95% CI 0.78–1.04, p=0.14).
Motesanib is an orally administered, small molecule antagonist of vascular endothelial growth factor receptors 1, 2, and 3, platelet-derived growth factor receptors, and stem cell factor receptor.