Amgen and Takeda to resume enrollment in Phase III lung cancer study

Monet1 is a Phase III study evaluating motesanib in combination with paclitaxel and carboplatin for the first-line treatment of advanced non-squamous non-small cell lung cancer (NSCLC). Motesanib is part of a co-development program between Amgen, Millennium and Takeda.

The recent data monitoring committee (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.

Roger Perlmutter, executive vice president of R&D at Amgen, said: We endorse the DMC’s decision to include only patients with non-squamous cell tumors in Monet1. 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.