Amgen and partner Takeda Pharmaceutical Co have suffered a setback with the news that their investigational oncology agent motesanib has failed in a late-stage trial for lung cancer.
The firms announced top-line results from a 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. The trial did not meet its primary objective of demonstrating an improvement in overall survival and serious adverse events were more frequently reported in the motesanib arm; detailed results will be submitted for presentation at an upcoming medical congress.
Roger Perlmutter, head of R&D at Amgen, said "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". Nancy Simonian, chief medical officer at Takeda's oncology subsidiary Millennium, added that "these disappointing results support the need for new treatments to address the unmet need in advanced non-squamous NSCLC".
No decision has been made yet about conrinuing development but analysts following Amgen are not too concerned as expectations about the prospects of motesanib have been pretty low.
Vectibix combo rejection appealed in Europe
Meantime Amgen has asked the European Medicines Agency to re-examine a negative opinion placed recently on expanding use of its cancer treatment Vectibix (panitumumab).
Earlier this month, the agency's Committee For Medicinal Products for Human Use recommended against approving Vectibix in combination with chemotherapy for patients with wild-type KRAS metastatic colorectal cancer (mCRC). The treatment is currently approved as monotherapy for mCRC patients when standard chemotherapy is no longer effective.