Takeda initiates Phase III lung cancer trial in four Asian countries

Oct 03, 2012 (Datamonitor via COMTEX) -- Takeda Pharmaceutical Company Limited and Millennium: The Takeda Oncology Company have announced that Takeda Bio Development Center Limited has initiated a Phase III clinical trial in Japan, Hong Kong, South Korea and Taiwan, evaluating motesanib in combination with chemotherapy in patients with advanced non-squamous non-small cell lung cancer, or NSCLC. Motesanib is an investigational, 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. Takeda's decision to initiate this new Phase III trial is based on the prospectively-defined Asian subgroup analysis of the MONET1 pivotal Phase III trial evaluating motesanib in 1,090 patients with advanced NSCLC. Although the MONET1 trial did not meet its primary objective of demonstrating a statistically significant improvement in overall survival (OS), an exploratory analysis revealed significant and consistent findings in the Asian population for OS, progression-free survival, and objective response rate. The results of the Asian subgroup analysis were presented at the annual meeting of the American Society of Clinical Oncology (ASCO). Takeda also announced that Takeda and Amgen have entered into a new agreement which provides Takeda with the rights to independently develop, manufacture and commercialize motesanib. In 2008, the two companies had entered into a co-development and profit share arrangement for motesanib, under which Takeda had the development and commercialization rights to motesanib in Japan and the two companies were to share profits outside of Japan. Amgen will receive an up-front payment and is eligible to receive milestones and net sales royalties. Specific financial terms of the new agreement were not disclosed. "Based on the encouraging results of the Asian subgroup analysis of the MONET1 study presented at ASCO, we are pleased to initiate the Phase III clinical trial of motesanib in this Asian patient population," said Karen Ferrante, M.D., Chief Medical Officer, Millennium: The Takeda Oncology Company. http://www.datamonitor.com Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon