Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2017

Regional differences in the phase 3 METEOR study of cabozantinib (cabo) versus everolimus (eve) in advanced renal cell carcinoma (RCC) (#183)

Paul Mainwaring 1 , Nizar M Tannir , Thomas Powles , Robert J Motzer , Frederic Rolland , Gwanaëlle Gravis , Michael Staehler , Michael Rink , Margitta Retz , Tibor Csoszi , John A McCaffrey , Ugo De Giorgi , Claudia Caserta , Sergey Cheporov , Emilio Esteban Gonzalez , Ignacio Duran , James G Larkin , William Berg , Douglas O Clary , Bernard Escudier , Toni K Choueiri
  1. ICON Cancer Care, Mater Medical Centre, South Brisbane, Australia

Aims:

In METEOR (NCT01865747), patients with advanced RCC and prior treatment with antiangiogenic therapy were randomised to 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. Baseline characteristics and outcomes were evaluated in patients enrolled in: Europe (EU; 19 countries), North America (NA; US, Canada) and Asia Pacific (AP; Australia, South Korea, Taiwan).

Methods:

658 patients were randomised 1:1 to cabo (60 mg qd) or eve (10 mg qd). Stratification factors were MSKCC risk group and number of prior VEGFR-TKIs.

Results:

Of patients enrolled, 320, 240 and 86 came from EU, NA and AP, respectively. Baseline characteristics other than race were similar between regions. Patients with ≥2 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; PFS hazard ratios (HR): 0.54, 0.50 and 0.43; OS HRs 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 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. Post-trial use of eve in the cabo arm was similar across regions.

Conclusions:

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.

This abstract (818P) was presented at ESMO 2016, all rights reserved.