Phase 3 Study (MONET1) of Motesanib Plus Carboplatin/Paclitaxel (C/P) in Patients with Advanced NSCLC: Asian Subgroup Analysis

ABSTRACT Background MONET1 evaluated OS in patients with NSCLC receiving motesanib (an oral VEGFR 1, 2 and 3, PDGFR and Kit inhibitor) + C/P versus patients receiving placebo + C/P. Analysis of the total population (n = 1090) showed treatment with motesanib + C/P did not significantly improve OS versus C/P alone (primary end point). Here we present a subgroup analysis of Asian patients. Methods Asian patients (Japan, South Korea, Philippines, Hong Kong, Taiwan, Singapore) with stage IIIB/IV or recurrent nonsquamous NSCLC and no prior systemic therapy for advanced NSCLC were analysed. Patients were randomized to up to six 3-week cycles of C (AUC 6 mg/ml min) and P (200 mg/m2) with either motesanib 125 mg QD (Arm A) or placebo QD (Arm B) orally continuously. Results Two hundred twenty-seven Asian patients (including 107 Japanese) with non-squamous NSCLC were randomized (Arm A/B, n = 110/117); 198 had adenocarcinoma (n = 97/101). Median age 60 years (range 30–78); 80% stage IV disease. At analysis, 139 patients had died (118 adenocarcinoma). Patients received a median of 164 days of motesanib versus 125 placebo (versus 106 and 126 in non-Asian patients). The median follow-up was 73 weeks. In arms A/B, median OS was 20.9/14.5 months (P  Conclusions In contrast to non-Asian patients, in the subgroup of Asian patients with advanced non-squamous NSCLC, motesanib plus C/P was associated with increased OS, PFS, and ORR compared with C/P alone, with no excess of treatment-related mortality.