Amgen and Millennium, a subsidiary of Takeda Pharmaceutical Company Limited, have suspended enrollment in the phase III Motesanib NSCLC Efficacy and Tolerability Study.
During a planned safety data review, an independent data monitoring committee evaluated data from 600 patients taking treatment for advanced non-small-cell lung cancer (NSCLC). The committee observed higher early mortality rates in the motesanib group compared to the placebo group and recommended stopping enrollment.
The trial was designed to evaluate motesanib (AMG 706) in combination with paclitaxel and carboplatin. The monitoring committee suggested that patients stop taking motesanib if they had squamous NSCLC, due to a higher incidence of hemoptysis.
However, the safety board did not recommend discontinuing motesanib therapy for patients with nonsquamous NSCLC. The DMC will review updated data after three months.
In other news, Amgen announced results of a biomarker analysis that bolstered the efficacy of panitumumab monotherapy (Vectibix) in colon cancer patients with wild-type KRAS tumors who failed all other chemtherapeutic regimens. In patients with non-mutated KRAS tumors, Vectibix signifi cantly increased progression- free survival and quality of life.
The data from the phase III, randomized, controlled trials will be presented at the ASCO 2009 Gastrointestinal Cancers Symposium in San Francisco.