Safety fears derail late-stage Amgen cancer trial

John Carroll — Thu, 20 Nov 2008 10:30:10 -0500

Amgen has been dealt a serious blow to its hopes to develop new cancer therapies. Researchers for Amgen and Takeda suspended enrollment in a late-stage trial for motesanib after tracking a higher death rate among patients taking the oncology drug compared to the control group. The data monitoring committee also recommended that patients with squamous non-small-cell lung cancer stop taking the drug. They did not suggest halting treatment of the non-squamous cancer type.

Analysts have been closely tracking the motesanib trial. Amgen ranked it as one of three cancer trials that were expected to deliver key data in 2009 and 2010. Motesanib works by halting angiogenesis, starving cancer tumors of their blood supply.

"While we are disappointed in this outcome, it is consistent with data seen with some other anti-VEGF therapies and appears to constitute a class effect of these types of agents," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Patient safety is our top priority, hence we have acted quickly to implement the recommendations of the DMC. Working with our development partner, Takeda, we will continue to evaluate the therapeutic potential of motesanib in non-squamous NSCLC and metastatic breast cancer, as well as in other solid tumors."

- read the Amgen release
- read the AP story

Amgen drug positive in cancer trial

John Carroll — Thu, 03 Jul 2008 10:30:36 -0400

Amgen was buoyed by the news that new data demonstrates that motesanib slowed the progression of metastatic thyroid cancer. Out of 93 patients in the study, 49 had a positive response. Volunteers with a BRAF V600E mutation did better than those without the mutation. Report