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news.Amgen and Millennium, the Takeda oncology company, a subsidiary of Takeda Pharmaceutical Company, have announced that enrollment in the Phase III Monet1 trial evaluating motesanib in combination with paclitaxel and carboplatin for the first-line treatment of advanced non-small cell lung cancer has been temporarily suspended following a planned safety data review of 600 patients by the study's independent data monitoring committee.
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Motesanib is part of a broad co-development program between Amgen and Takeda. The data monitoring committee(DMC) recommended that enrollment in the study, which allowed both squamous and non-squamous non-small cell lung cancer (NSCLC) patients, be suspended based on an observation of higher early mortality rates in the motesanib group compared to the placebo group.
In addition, the DMC recommended that the patients with squamous NSCLC immediately discontinue motesanib therapy based on an observation of a higher incidence of hemoptysis. The DMC did not recommend discontinuation of motesanib therapy for the patients with non-squamous NSCLC. The DMC will review updated data after three months.
Amgen, in collaboration with Takeda Bio Development Center, is implementing both of the DMC’s recommendations and notifying worldwide regulatory agencies, including the FDA, European Medicines Agency, and Japan’s Pharmaceuticals and Medical Devices Agency, as well as motesanib clinical investigators.
Roger Perlmutter, executive vice president of R&D at Amgen, said: “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.”