Takeda Announces Phase 3 MONET-A Study Evaluating Motesanib (AMG 706) in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer Does Not Meet Primary Endpoint

Cambridge, Mass. and Osaka, Japan, February 17, 2015 – Takeda Pharmaceutical Company Limited (TSE:4502) today announced the primary endpoint of progression-free survival (PFS) was not met in the Phase 3 MONET-A study of patients with stage IV non-squamous non-small cell lung cancer (NSCLC) who were randomized to treatment with investigational motesanib in combination with paclitaxel and carboplatin compared to placebo in combination with paclitaxel and carboplatin. As a result, Takeda has elected to terminate the MONET-A trial, and will report on the full trial results once available. Motesanib is an investigational, orally administered small molecule antagonist of vascular endothelial growth factor receptors 1, 2 and 3, platelet driven growth factor receptors and stem cell factor receptor. 

Takeda is working with trial investigators to ensure patients who participated in the study will receive appropriate therapies.

About the MONET-A Study

MONET-A is a multinational Phase 3, randomized, placebo-controlled, double-blind study examining the efficacy and safety of motesanib when administered with paclitaxel and carboplatin. Patients (n=401) with stage IV or recurrent non-squamous NSCLC were randomized in a 1:1 ratio to either motesanib in combination with paclitaxel and carboplatin or placebo in combination with paclitaxel and carboplatin.

Patients included in the study had a confirmed diagnosis of stage IV non-squamous NSCLC, no prior chemotherapy, molecularly-targeted therapy or immunotherapy (for metastatic disease) and other outlined eligibility criteria.

The primary efficacy endpoint was PFS. Secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response, safety and pharmacokinetics of motesanib and its metabolites when the compound was administered in combination with paclitaxel and carboplatin.

The MONET-A study was initiated among patients in Japan, South Korea, Taiwan and Hong Kong, following the completion of a previous Phase 3 trial, MONET1, which compared motesanib combined with paclitaxel and carboplatin to chemotherapy alone in patients with non-squamous NSCLC. Although the MONET1 trial did not meet its primary objective of demonstrating a statistically significant improvement in OS, a pre-planned analysis revealed significant and consistent findings in the Asian population for ORR, PFS and OS, providing rationale for further investigation. 

About Motesanib

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.

In June, 2012, Takeda obtained an exclusive, worldwide license from Amgen, to develop, manufacture and commercialize motesanib. Amgen received an upfront payment and is eligible to receive milestones and net sales royalties.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

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