Ph III motesanib trial suspended on deaths

Enrollment in the Phase III MONET1 trial evaluating motesanib (AMG 706) plus paclitaxel and carboplatin for the first-line treatment of advanced, non-small cell lung cancer has been suspended after a safety data review of 600 patients indicated higher death rates than the placebo group.

The agent was originated by US biotechnology major Amgen and is being developed with Japanese drug giant Takeda. The companies said that the study's independent Data Monitoring Committee also recommended that squamous NSCLC patients immediately discontinue motesanib as a higher incidence of hemoptysis was seen. The DMC did not recommend discontinuation of motesanib therapy for the patients with non-squamous NSCLC and will review updated data after three months.

In a note to investors, Rodman & Renshaw analyst Christopher James said the news is clearly disappointing because the agent is considered a future growth driver for Amgen's cancer drug revenues. On the day of the announcement, November 19, shares in the firm fell 6.5% to $50.13. "While we are disappointed in this outcome, it is consistent with data seen with some other anti-[vascular endothelial growth factor] therapies and appears to constitute a class effect of these types of agents," said Roger Perlmutter, executive vice president of R&D at Amgen.