Top-Line Results Announced of Pivotal Phase 3 Motesanib Trial in Advanced Non-Squamous Non-Small Cell Lung Cancer Patients
THOUSAND OAKS, Calif., CAMBRIDGE, Mass. and OSAKA, Japan, March 30, 2011 /PRNewswire/ -- Amgen (Nasdaq: AMGN), Millennium: The Takeda Oncology Company, and Takeda Pharmaceutical Company Limited (TSE: 4502) today announced top-line results from the MONET1 pivotal Phase 3 trial evaluating motesanib administered in combination with paclitaxel and carboplatin in 1,090 patients with advanced non-squamous non-small cell lung cancer (NSCLC). The trial did not meet its primary objective of demonstrating an improvement in overall survival (OS) (hazard ratio 0.90, 95 percent CI 0.78 – 1.04, p=0.14).
"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," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.
"We thank the patients, caregivers, and investigators for their participation and engagement in the clinical evaluation of motesanib worldwide," said Nancy Simonian, M.D., chief medical officer, Millennium. "These disappointing results support the need for new treatments to address the unmet need in advanced non-squamous NSCLC."
Overall, the adverse event profile for motesanib was consistent with that seen in previous motesanib studies in NSCLC. Notable adverse events reported included hypertension, GI events (abdominal pain, diarrhea, nausea, and vomiting), gallbladder events (cholecystitis, gallbladder enlargement), fatigue, and hematological events (neutropenia, thrombocytopenia). Serious adverse events were more frequently reported in the motesanib arm.
Detailed results will be submitted for presentation at an upcoming medical congress.
MONET1 (MOtesanib NSCLC Efficacy and Tolerability Study) is a Phase 3, multicenter, randomized, placebo-controlled, double-blind trial that enrolled more than 1,000 men and women with NSCLC. Patients were randomized to receive either paclitaxel (200 mg/m2 IV Q3W), carboplatin (target AUC of 6 mg/mL x min IV Q3W), and motesanib (125 mg PO QD) or paclitaxel, carboplatin, and placebo. The primary endpoint of the study was OS, and secondary endpoints included progression-free survival (PFS), objective response rate (ORR), association of placental growth factor with OS, duration of response, and safety and tolerability.
Motesanib is an investigational, orally-administered small molecule antagonist of vascular endothelial growth factor receptors 1, 2, and 3, platelet-derived growth factor receptors, and stem cell factor receptor.
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Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. ("Takeda", TSE: 4502) in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, www.millennium.com.
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Posted: March 2011