AsianScientist (Jul. 27, 2012) – Takeda Pharmaceutical Company Limited and subsidiary, Millennium, announced yesterday the initiation of a Phase 3 clinical trial involving 400 patients across Japan, Hong Kong, South Korea, and Taiwan.
The study, initiated by Takeda Bio Development Center Limited, will evaluate motesanib in combination with chemotherapy in patients with advanced non-squamous non-small cell lung cancer (NSCLC).
Motesanib (development code: AMG 706) 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 3 trial is based on the prospectively-defined Asian subgroup analysis of the MONET1 pivotal Phase 3 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 overall survival, 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), held June 1-5, 2012, in Chicago, Illinois, USA.
“Based on the encouraging results of the Asian subgroup analysis of the MONET1 study presented at ASCO, we are pleased to initiate the Phase 3 clinical trial of motesanib in this Asian patient population,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium: The Takeda Oncology Company.
Takeda also announced a new agreement with Amgen which provides Takeda with the exclusive worldwide rights to independently develop, manufacture, and commercialize motesanib.
In 2008, the two companies had entered into a global co-development and profit share arrangement for motesanib, under which Takeda had the exclusive 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.
Source: Takeda Pharmaceuticals.
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