Amgen and Takeda’s NSCLC Drug Fails in Phase III Study

Firms will analyze trial data before deciding on future development prospects for motesanib.

Adding the anticancer candidate motesanib to paclitaxel and carboplatin chemotherapy has no benefit on overall survival for patients with advanced non-squamous NSCLC, according to results from the 1,090-patient Phase III Monet 1 trial. The small molecule drug is being developed by Amgen in partnership with Takeda’s Millennium oncology company and Takeda Pharmaceutical. The firms admit they are disappointed with the Phase III results, but will analyze the trial data before deciding on future research progress in this area.

Motesanib is an orally administered small molecule antagonist of VEGF receptors 1,2, and 3, platelet-derived growth factor receptors and stem cell factor receptors. The drug is separately undergoing Phase II evaluation as first-line therapy for breast cancer.

Takeda paid Amgen $100 million up front as part of a worldwide partnership for the development of motesanib back in 2008. Under terms of the deal Takeda agreed to pay 60% of ongoing clinical development expenses outside Japan, and equally share future non-Japanese profits. Amgen could have received $175 million in success-based milestones for the first two indications, plus double-digit royalties on Japanese sales.