Amgen’s Trouble in Lung Cancer Trials (AMGN)
Amgen (NASDAQ: AMGN) and Takeda Pharmaceutical Company Limited’s Millennium Pharma have issued some disappointing news on the lung cancer front. The companies have announced that enrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin as a first-line treatment of advanced non-small cell lung cancer has been temporarily suspended.
This follows a planned safety data review of 600 patients by the study’s independent Data Monitoring Committee. Motesanib is part of a broad co-development program between Amgen and Takeda.
The monitoring committe recommended that enrollment in the study be suspended. This is based on an observation of higher early mortality rates in the motesanib group compared to the placebo group.
The committee recommended that the squamous patients with immediately discontinue motesanib therapy based on an observation of a higher incidence of hemoptysis, but it did not recommend for the non-squamous patients to discontinue motesanib therapy.
Here are the full details from Amgen.
Jon C. Ogg
November 19, 2008