Amgen and Takeda Pharmaceutical Co have suffered a setback after the firms announced that they are suspending enrolment in a late-stage study of experimental cancer drug motesanib.

The companies said that enrollment in the Phase III MONET1 trial evaluating motesanib (also known as AMG 706) in combination with paclitaxel and carboplatin for the first-line treatment of advanced non-small cell lung cancer has been temporarily halted following a planned safety data review of 600 patients by the study's independent Data Monitoring Committee. The DMC found higher early mortality rates among patients taking the compound compared with those in the placebo group.

The committee also advised that those with squamous NSCLC should stop taking the drug "based on an observation of a higher incidence of haemoptysis”, though it did not recommend that motesanib therapy be discontinued in subjects with the non-squamous form of the disease. The companies noted that the committee will review updated data from the trial after three months.

Roger Perlmutter, Amgen’s executive vice president of R&D, stated that "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." He added that “patient safety is our top priority, hence we have acted quickly to implement the recommendations of the DMC”, adding that the firms continue to evaluate the potential of motesanib in non-squamous NSCLC and metastatic breast cancer, as well as in other solid tumours.

Amgen shares fell 6.5% to $50.13 on the news, which is unsurprising seeing as motesanib was seen as a future growth driver for the firm, according to Christopher James, an analyst at Rodman & Renshaw. However, in a research note, he wrote that “Amgen's pipeline remains full with compounds the company can leverage and provide future growth for the oncology franchise''.

Most of the enthusiasm about Amgen’s pipeline surrounds denosumab, which is expected to be filed with the US Food and Drug Administration for post-menopausal osteoporosis by the end of 2008 or early 2009. The company added that it should report 17 key Phase II and III study results in 2009 and 2010, including data for denosumab in oncology, plus AMG 386 and AMG 655 for “various cancer indications”.