Amgen/Takeda resume motesanib development

The Independent Data Monitoring Committee for the MONET1 trial, evaluating motesanib (AMG 706) - which was originated by US  biotechnology giant Amgen and is under development with partners Takeda,  Japan's largest drugmaker, and its US affiliate Millennium, has  recommended the study resume enrollment of patients with non-squamous  non-small cell lung cancer following a three-month suspension on adding  subjects. MONET1 is a Phase III study evaluating motesanib (AMG 706) in  combination with paclitaxel and carboplatin as a first-line treatment of  advanced NSCLC.

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

Last November, the DMC recommended treatment discontinuation in  subjects with squamous histology, and enrollment suspension in subjects  with non-squamous histology (Marketletter December 1, 2008). 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.