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Motesanib failed to improve OS in NSCLC
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Results from the MONET1 pivotal phase 3 trial of motesanib, an investigational drug for the treatment of advanced nonsquamous non–small cell lung cancer, demonstrate that the drug did not improve OS, according to Amgen, Millennium: The Takeda Oncology Company, and Takeda Pharmaceutical Company Limited.
In the Motesanib NSCLC Efficacy and Tolerability Study (MONET1), motesanib was administered combined with paclitaxel and carboplatin in 1,090 patients with advanced NSCLC. The primary endpoint was improved OS; however, the trial did not meet this objective (HR=0.9; 95% CI, 0.78-1.04).
According to a company press release, the adverse event profile for motesanib — an orally administered small molecule antagonist of VEGF receptors 1, 2 and 3, platelet-derived growth factor receptors and stem cell factor receptor — was consistent with that seen in previous motesanib studies in NSCLC. Adverse events included hypertension, abdominal pain, diarrhea, nausea, vomiting, cholecystitis, gallbladder enlargement, fatigue, neutropenia and thrombocytopenia. Serious adverse events were more common in the motesanib arm.
Comprehensive results will be submitted for presentation at an upcoming meeting.
MONET1 is a phase 3, multicenter, randomized, placebo-controlled, double blind trial. Patients were randomly assigned to paclitaxel (200 mg/m2 IV every 3 weeks), carboplatin (target area under the curve of 6 mg/mL plus minimum IV every 3 weeks) and motesanib (125 mg orally once per day), or paclitaxel, carboplatin and placebo. The primary endpoint was OS; secondary endpoints included PFS, objective response rate, association of placental growth factor with OS, duration of response, and safety and tolerability.
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