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 president 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.
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.
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 manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
Located in Osaka, Japan, Takeda Pharmaceutical Company Limited (TSE:4502) 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 striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, http://www.takeda.com.
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Limited in May 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, http://www.millennium.com.
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