Best Of Best Poster Oral Clinical Oncology Society of Australia Annual Scientific Meeting 2017

Overall survival (OS) in METEOR, a randomised phase 3 trial of cabozantinib versus everolimus in patients with advanced renal cell carcinoma (RCC) (#137)

Paul Mainwaring 1 , Thomas Powles 2 , Bernard J Escudier 3 , Nizar M Tannir 4 , Brian I Rini 5 , Hans J Hammers 6 , Frede Donskov 7 , Bruce J Roth 8 , Katriina Peltola 9 , Jae-Lyun Lee 10 , Daniel Yick Chin Heng 11 , Manuela Schmidinger 12 , Dana T Aftab 13 , Colin Hessel 13 , Christian Scheffold 13 , Gisela Schwab 13 , Sumanta K Pal 14 , Thomas E Hutson 15 , Robert J Motzer 16 , Toni K Choueiri 17
  1. ICON Cancer Care, Mater Medical Centre, South Brisbane, Australia
  2. Barts Cancer Institute, Queen Mary University of London, London, United Kingdom
  3. Institut Gustave-Roussy, Villejuif, France
  4. The University of Texas MD Anderson Cancer Center, Houston , TX
  5. Cleveland Clinic Taussig Cancer Institute, Cleveland, OH
  6. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
  7. Aarhus University Hospital, Aarhus, Denmark
  8. Washington University School of Medicine, St. Louis, MO
  9. Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland
  10. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
  11. Tom Baker Cancer Center, University of Calgary, Calgary, AB, Canada
  12. Medical University of Vienna, Vienna, Austria
  13. Exelixis, Inc., South San Francisco, CA
  14. City of Hope, Duarte, CA
  15. Texas Oncology, Dallas, TX
  16. Memorial Sloan Kettering Cancer Center, New York, NY
  17. Dana-Farber/Brigham and Women's Cancer Center, Boston, MA


In the METEOR trial (NCT01865747), cabozantinib showed a statistically significant improvement in progression-free survival (PFS) compared with everolimus in patients with previously treated RCC (median 7.4 vs 3.8 months; HR=0.58, 95% CI 0.45–0.75; P<0.001) and improved the objective response rate. Here we present the final OS results from a second interim analysis.


Patients with measurable clear cell RCC, KPS ≥70, and ≥1 prior VEGFR TKI were randomised 1:1 to cabozantinib (60 mg qd) or everolimus (10 mg qd) stratified by MSKCC risk group and number of prior VEGFR TKIs (1 or ≥2). The study was designed to detect a HR for OS of 0.75 (80% power, 2-sided α=0.04).


From Aug 2013–Nov 2014, 658 pts were randomised. As of 31 Dec 2015, with a minimum follow-up of 13 months, 320 deaths were recorded (140 for cabozantinib and 180 for everolimus). 74 (22%) patients remained on therapy in the cabozantinib arm vs 25 (8%) patients in the everolimus arm. The secondary endpoint of improved OS for cabozantinib-treated patients was met. Median OS was 21.4 months for cabozantinib vs 16.5 months for everolimus, with a 33% reduction in the rate of death (HR 0.67, 95% CI 0.53 to 0.83, P=0.0003). Landmark estimates of survival at 18 months were 58% in the cabozantinib arm vs 47% of the everolimus arm. OS benefit with cabozantinib was observed across all prespecified subgroups including MSKCC risk group, number/type of prior VEGFR TKIs, prior anti-PD-1/PD-L1 treatment, location/extent of tumor metastases, and tumor MET expression level. Serious adverse events (SAEs) were consistent with the safety profile previously reported.


Cabozantinib is the only agent to demonstrate a significant benefit in OS, PFS, and ORR in a Phase 3 trial in this patient population. Cabozantinib is an important new treatment option for these patients.