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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

THOUSAND OAKS, Calif. and CAMBRIDGE, Mass., Feb. 11 and OSAKA, Japan (Feb. 12, 2009) /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN), Millennium: The Takeda Oncology Company, and its parent company Takeda Pharmaceutical Company Limited (TSE:4052) today announced the Independent Data Monitoring Committee (DMC) for the MONET1 trial has recommended the trial resume enrollment of patients with non-squamous non-small cell lung cancer (NSCLC) following a three-month enrollment suspension. MONET1 is a Phase 3 study evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin for the first-line treatment of advanced NSCLC. Motesanib is part of a co-development program between Amgen, Millennium and Takeda.

The recent DMC guidance recommends the trial be re-opened only to patients with non-squamous cell histology. Non-squamous cell NSCLC is a histological subtype of NSCLC representing approximately two-thirds of the study population. Amgen, Millennium and Takeda plan to follow this recommendation which will require modifications to the study design of MONET1. Enrollment will resume once these changes are sanctioned by appropriate global health authorities.

In November 2008 the DMC recommended treatment discontinuation in subjects with squamous histology, and enrollment suspension in subjects with non-squamous histology. This recommendation was based on an observation of higher early mortality rates in the motesanib group compared to the placebo group and a higher incidence of hemoptysis in the squamous population. Patients with non-squamous NSCLC receiving motesanib were allowed to continue treatment during the temporary suspension.

"We endorse the DMC's decision to include only patients with non-squamous cell tumors in MONET1," said Roger M. Perlmutter, M.D., Ph.D., executive vice presid
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SOURCE Amgen
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