Independent Data Monitoring Committee Recommends Resuming Enrollment of Non-Squamous NSCLC Patients in the Motesanib MO... (ent of Research and Development at Amgen...)

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Independent Data Monitoring Committee Recommends Resuming Enrollment of Non-Squamous NSCLC Patients in the Motesanib MONET1 Trial

Date:2/11/2009

ent of Research and Development at Amgen. "This decision gives us confidence we have selected the right patient population to explore the clinical potential of motesanib in non-small cell lung cancer."

"NSCLC continues to be an area where new and effective therapies are needed, and we are optimistic about the potential of motesanib in patients with non-squamous NSCLC," said Nancy Simonian, M.D., chief medical officer, Millennium: The Takeda Oncology Company. "We are pleased with the DMC recommendation and will work with appropriate regulatory agencies and investigators to resume enrollment as soon as possible."

MONET1 (Motesanib NSCLC Efficacy and Tolerability Study) Trial Design

The primary endpoint is overall survival, and secondary endpoints include progression-free survival, objective response rate in patients with measurable disease, duration of response and safety. Patients were randomized 1:1 to receive paclitaxel and carboplatin administered every three weeks with or without 125 mg motesanib taken daily.

About Motesanib

Co-developed by Amgen, Takeda Pharmaceutical Company and Millennium: The Takeda Oncology Company, motesanib is an investigational, highly selective, oral agent that is being evaluated for its ability to inhibit angiogenesis by targeting vascular endothelial growth factor receptors 1, 2 and 3 (VEGFR1-3). It is also under investigation for its potential direct anti-tumor activity by targeting a family of proteins called tyrosine kinases, including platelet-derived growth factor receptor (PDGFR), and stem cell factor receptor (c-kit), two proteins involved in cell proliferation.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to
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Independent Data Monitoring Committee Recommends Resuming Enrollment of Non-Squamous NSCLC Patients in the Motesanib MO...(ent of Research and Development at Amgen...),Health