PHASE 3 STUDY (MONET1) OF MOTESANIB PLUS CARBOPLATIN/PACLITAXEL (C/P) IN PATIENTS WITH ADVANCED NSCLC: ASIAN SUBGROUP ANALYSIS

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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 < 0.05) and median PFS 7.0/5.3 months (P < 0.001); ORR was 62/27% (P < 0.001). In non-Asian patients (arms A/B, n = 431/432), median OS was 10.9/10.7 months and median PFS 5.5/5.4 months (both P = n/s); ORR were 34/25% (P < 0.05). Motesanib/placebo-related AEs seen in 94/74% of patients, respectively, and Gr ≥ 3-related AEs in 48/22% of patients. Most common emergent AEs were (Arm A/B) alopecia (78/76%), diarrhea (63/33%), and nausea (55/43%); gallbladder disorders (Gr 1–2) were seen in 9/2% of patients. Gr ≥3 AEs more frequent in Arm A versus B included neutropenia (36/22%) and hypertension (13/3%). Emergent Gr5 events are seen in (Arm A/B) 5/4% of patients, versus 16/11% in non-Asian patients.

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.

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