818P - Analysis of regional differences in the phase 3 METEOR study of cabozantinib (cabo) versus everolimus (eve) in advanced renal cell carcinoma (RCC)

Abstract

In the METEOR study (NCT01865747), patients (pts) with advanced RCC and prior treatment with an antiangiogenic therapy were randomized to receive cabo or eve. Improved progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) were demonstrated in the cabo arm vs the eve arm (Choueiri 2016 JCO suppl abstr 4506). Baseline characteristics and clinical outcomes were evaluated in pts enrolled in three regions: Europe (EU; 19 countries), North America (NA; US, Canada) and Asia Pacific (AP; Australia, South Korea, Taiwan). 658 pts were randomized 1:1 to receive cabo (60 mg qd) or eve (10 mg qd). Stratification factors were MSKCC risk group and number of prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs). Of pts enrolled in METEOR, 320, 240 and 86 came from EU, NA and AP, respectively. Baseline demographic characteristics other than race were similar between regions. Pts with 2 or more prior TKIs were more frequent in EU and NA (31% and 33%) than AP (17%). Prior use of axitinib was rare in AP (1%) compared to EU and NA (17% and 22%). PFS and OS in the cabo arm were prolonged vs eve in all regions, with PFS hazard ratios (HR) of 0.54, 0.50 and 0.43 and OS HRs of 0.67, 0.79 and 0.49 for EU, NA and AP, respectively. The cabo arm ORRs (% [95% CI]) for EU, NA and AP regions were 15% (10–21), 16% (10–24) and 28% (15–45). Adverse event (AE) rates were generally similar across regions. Subsequent treatment with VEGFR-TKI and anti-PD-1/L1 agents was most frequent in NA and least frequent in AP, and at higher frequency in the eve arm versus the cabo arm. Posttrial use of eve in the cabo arm was similar across regions (Table).Tabled 1Subsequent TherapiesEuropeEuropeNorth AmericaNorth AmericaAsia PacificAsia Pacificcabo (n = 167)eve (n = 153)cabo (n = 118)eve (n = 122)cabo (n = 39)eve (n = 47)Any VEGFR TKI, %25502957521Axitinib, %1728223832Sorafenib, %4143606Sunitinib, %41189311Pazopanib, %282704Cabo, %010600Anti-PD-1/PD-L1, %2291330Eve, %304284339 Open table in a new tab Improvements in PFS, OS and ORR for cabo vs eve were measured across all regions in the METEOR trial despite differences in subsequent treatment. No differences in safety were reported.