February 17, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
Takeda Pharmaceuticals today announced the company is terminating its Phase III trial of motesanib for the treatment of stage IV non-squamous non-small cell lung cancer (NSCLC) because the drug failed to meet the primary endpoint of the study.
The primary endpoint of the study, called MONET-A, was progression-free survival (PFS) for NSCLC patients who were given motesanib in combination with paclitaxel and carboplatin as compared to those who received placebo in combination with paclitaxel and carboplatin. The company will report the details of the study when full results are available, it said in a statement.
The study, which involved 401 patients in Japan, South Korea, Taiwan and Hong Kong, is the second Phase III trial for which motesanib failed to meet the primary endpoint. That other trial, called MONET-1, involved 900 patients who were given either motesanib combined with paclitaxel and carboplatin or chemotherapy alone. The primary endpoint of this study was overall survival (OS). The results of MONET-1 were reported in 2011.
Takeda describes motesanib as an investigational, orally administered small molecule antagonist of vascular endothelial growth factor receptors one, two and three, platelet-derived growth factor receptors and stem cell factor receptor.
Takeda has not commented on its future plans for motesanib, but PMLIVE is speculating that the drug’s future looks “shaky” because of the two failed trials and complications seen in some patients participating in the trials, namely cardiac events.
Takeda struck a worldwide licensing deal with Amgen in 2012 for rights to develop, manufacture and commercialize motesanib. Under the terms of the agreement, Amgen received an undisclosed amount of money as an upfront payment, as well as eligibility for future milestone payments. The 2012 deal built on an earlier deal signed between the two companies in 2008 for which Takeda paid Amgen $100 million upfront, with possible future milestone payments to reach $175 million, for the Japanese rights to motesanib.
All is not lost for the oncology pipeline at Takeda, however. Last week the company announced topline results from a Phase III trial, called TOURMALINE-MM1, of the company’s blood cancer drug ixazomib. The trial results showed that ixazomib, the first oral proteasome inhibitor, met its primary endpoint of improving progression-free survival for patients with relapsed or refractory multiple myeloma (MM). Patients who received ixazomib plus lenalidomide and dexamethasone lived without their disease worsening for a significantly longer time compared to patients who received placebo plus lenalidomide and dexamethasone. The results are from an interim-analysis of the study.
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