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Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer
Date:11/19/2008

THOUSAND OAKS, Calif., Nov. 19 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) and Millennium: The Takeda Oncology Company, a subsidiary of Takeda Pharmaceutical Company Limited (TSE: 4052), today announced that enrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin for the first-line treatment of advanced non-small cell lung cancer (NSCLC) has been temporarily suspended following a planned safety data review of 600 patients by the study's independent Data Monitoring Committee (DMC). Motesanib is part of a broad co-development program between Amgen and Takeda.

The DMC recommended that enrollment in the study, which allowed both squamous and non-squamous NSCLC patients, be suspended based on an observation of higher early mortality rates in the motesanib group compared to the placebo group. In addition, the DMC recommended that the patients with squamous NSCLC immediately discontinue motesanib therapy based on an observation of a higher incidence of hemoptysis. The DMC did not recommend discontinuation of motesanib therapy for the patients with non-squamous NSCLC. The DMC will review updated data after three months.

Amgen, in collaboration with Takeda Bio Development Center, is implementing both of the DMC's recommendations and notifying worldwide regulatory agencies, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMEA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), as well as motesanib clinical investigators.

"While we are disappointed in this outcome, it is consistent with data seen with some other anti-VEGF therapies and appears to constitute a class effect of these types of agents," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "P
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SOURCE Amgen
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