Takeda and Amgen NSCLC drug motesanib fails in Ph III

Top-line results from the MONET1 pivotal Phase III trial evaluating motesanib administered in combination with paclitaxel and carboplatin in 1,090 patients with advanced non-squamous non-small cell lung cancer (NSCLC) did not meet its primary objective of demonstrating an improvement in overall survival (OS) (hazard ratio 0.90, 95% CI 0.78 – 1.04, p=0.14).

The drug, which had been forecast to have a peak sales potential of nearly $1 billion a year, is being developed by Amgen (Nasdaq: AMGN) and Millennium, a US subsidiary of Japan’s largest drugmaker Takeda Pharmaceutical (TSE:4502).

"We are disappointed with the results from this trial, but look forward to further analysis of the data which may ultimately help inform future research in this area," said Roger Perlmutter, executive vice president of R&D at Amgen. Nancy Simonian, chief medical officer of Millennium, added “These disappointing results support the need for new treatments to address the unmet need in advanced non-squamous NSCLC.”