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Genitourinary tumours, non-prostate

1798 - Progression-free survival (PFS) by independent review and updated overall survival (OS) results from Alliance A031203 trial (CABOSUN): cabozantinib versus sunitinib as initial targeted therapy for patients (pts) with metastatic renal cell carcinoma (mRCC)


10 Sep 2017


Genitourinary tumours, non-prostate


Cytotoxic Therapy;  Renal Cell Cancer


Toni Choueiri


Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440


T.K. Choueiri1, C. Hessel2, S. Halabi3, B. Sanford3, O. Hahn4, M.D. Michaelson5, M. Walsh6, T. Olencki7, J. Picus8, E.J. Small9, S. Dakhil10, C. Scheffold11, D.J. George12, M.J. Morris13

Author affiliations

  • 1 Genitourinary Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 2 Biostatistics And Clinical Data Management, Exelixis, Inc, South San Francisco/US
  • 3 Alliance Statistics And Data Center, Duke University, Durham/US
  • 4 Alliance Protocol Operations Office, Alliance for Clinical Trials in Oncology, Chicago/US
  • 5 Genitourinary Cancer Center, Massachusetts General Hospital, Boston/US
  • 6 Genitourinary Oncology, Dana-Farber Cancer Institute, Boston/US
  • 7 Internal Medicine, Ohio State University Comprehensive Cancer Center, Columbus/US
  • 8 Siteman Cancer Center, Washington University School of Medicine, St Louis/US
  • 9 Hellen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco/US
  • 10 School Of Medicine, University of Kansas Wichita, Wichita/US
  • 11 Clinical Development, Exelixis, Inc, South San Francisco/US
  • 12 Duke Cancer Institute, Duke University Medical Center, 27710 - Durham/US
  • 13 Medical Oncology, Memorial Sloan Kettering Cancer Center, New York/US


Abstract 1798


Cabozantinib (Cabo), an oral, potent inhibitor of MET, AXL, and VEGFR2, improved investigator-assessed PFS (primary endpoint) compared with sunitinib (Sun) as initial targeted therapy in pts with mRCC of poor or intermediate risk (Choueiri, JCO 2016). Median PFS per investigator was 8.2 months (mo) vs 5.6 mo (HR 0.66, 95% CI 0.46 to 0.95; one-sided p = 0.012) for Cabo vs Sun.


Eligible pts had untreated clear-cell mRCC, ECOG performance status 0-2, and poor or intermediate risk disease per the International mRCC Database Consortium (IMDC) criteria (Heng, JCO 2009). 157 pts were randomized 1:1 to receive Cabo (60 mg QD) or Sun (50 mg QD, 4 weeks on/2 weeks off), stratified by IMDC risk group and the presence of bone metastases (yes vs no). We present PFS analyses per blinded independent radiology committee (IRC), subset analyses by stratification factors and MET expression based on immunohistochemistry (IHC), and an update of OS with a data cutoff of July 1, 2017.


Radiographic images for 156 of 157 enrolled pts were available for assessment by the IRC. PFS per IRC was significantly increased for Cabo compared with Sun (median of 8.6 vs 5.3 mo; HR 0.48, 95% CI 0.31 to 0.74; two-sided p = 0.0008). Subgroup analyses of PFS per IRC based on the stratification factors and tumor MET levels were consistent with results for the overall population. Updated OS analysis with a median follow-up of 30.8 mo and a total of 90 deaths showed a median OS of 26.6 mo for Cabo vs 21.2 mo for Sun (HR 0.79, 95% CI 0.53 to 1.2; two-sided p = 0.27). Safety profiles were consistent with those previously reported. The incidence of all-causality grade 3 or 4 AEs was 68% with Cabo and 65% with Sun. Discontinuations due to AEs occurred for 16 pts in each treatment arm.


Cabo significantly increased PFS per IRC compared with Sun as initial targeted therapy in pts with mRCC. Subgroup analyses were consistent with the overall population results. Previously reported results for PFS per investigator were consistent with results reported here.

Clinical trial identification


Legal entity responsible for the study

Alliance for Clinical Trials in Oncology


NCI, CTEP, Alliance


T.K. Choueiri: Consulting/Advisory: Pfizer, Bayer, Novartis, Merck, BMS, Genentech, Eisai, Prometheus, Cerulean, AstraZeneca, Peloton, Exelixis; Research Funding (Inst): Pfizer, Novartis, Merck, Exelixis, Tracon, BMS, AstraZeneca, Peloton, Genentech, Celldex, Takeda. C. Hessel, C. Scheffold: Employment/Stock Ownership: Exelixis. S. Halabi: Consulting/Advisory: Bayer, Genentech. O. Hahn: Honoraria: Cardinal Health (relative), Via Oncology; Advisory: Pfizer. M.D. Michaelson: Employment: Jounce Therapeutics (relative); Consulting/Advisory: Novartis, Medivation, Pfizer, Exelixis, Eisai; Research Funding (Inst): Pfizer, Eisai, Argos Therapeutics, Millennium, Novartis, Tracon. T. Olencki: Research Funding (Inst): BMS, Pfizer, Tracon. J. Picus: Consulting/Advisory: Novo Nordisk; Research Funding: Novartis, Bioclin, Altor BioScience, Agensys, Oncogenex, Mirati Therapeutics, Astex. E.J. Small: Stock Ownership: Fortis Therapeutics, Harpoon Therapeutics; Consulting/Advisory: Gilead, Dendreon. D.J. George: Consulting/Advisory/Research Funding: Exelixis, Novartis, Pfizer, GSK, Astellas, Innocrin, Genentech, BMS; Consulting/Advisory: Bayer, Dendreon, Medivation, BIND, Sanofi, Progenics, Clovis, Merck; Research Funding: Janssen, Progenics, Astellas, Millennium M.J. Morris: Consulting/Advisory: Bayer, Millennium Pharmaceuticals, Progenics: Research Funding (Inst): Bayer, Sanofi, Janssen, Endocyte All other authors have declared no conflicts of interest.

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