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Presidential Symposium I

696O_PR - Nivolumab + cabozantinib vs sunitinib in first-line treatment for advanced renal cell carcinoma: First results from the randomized phase III CheckMate 9ER trial

Date

19 Sep 2020

Session

Presidential Symposium I

Presenters

Toni Choueiri

Citation

Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Authors

T.K. Choueiri1, T. Powles2, M. Burotto3, M.T. Bourlon4, B. Zurawski5, V.M. Oyervides Juárez6, J.J. Hsieh7, U. Basso8, A.Y. Shah9, C. Suarez10, A. Hamzaj11, C.H. Barrios12, M. Richardet13, D. Pook14, Y. Tomita15, B. Escudier16, J. Zhang17, B. Simsek18, A.B. Apolo19, R.J. Motzer20

Author affiliations

  • 1 Department Of Medical Oncology, Dana-Farber Cancer Institute, The Lank Center for Genitourinary Oncology, 2215 - Boston/US
  • 2 Department Of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, EC1M6BQ - London/GB
  • 3 Department Of Medical Oncology, Bradford Hill Clinical Research Center, 8420383 - Santiago/CL
  • 4 Department Of Hemato-oncology, Urologic Oncology Clinic, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, 14080 - Mexico City/MX
  • 5 Department Of Outpatient Chemotherapy, Professor Franciszek Lukaszczyk Oncology Centre, Bydgoszcz/PL
  • 6 Department Of Medical Oncology, Centro Universitario contra el Cáncer Hospital Universitario “Dr. José Eleuterio González” Universidad Autónoma de Nuevo León, 64460 - Nuevo León/MX
  • 7 Molecular Oncology, Department Of Medicine, Siteman Cancer Center, Washington University School of Medicine, 63110 - St. Louis/US
  • 8 Department Of Oncology, Istituto Oncologico Veneto IOV IRCCS, 35128 - Padova/IT
  • 9 Department Of Genitourinary Medical Oncology, M. D. Anderson Cancer Center, 77030 - Houston/US
  • 10 Vall D’hebron Institute Of Oncology, Vall d’Hebron University Hospital, Universitat Autònoma de Barcelona, 08035 - Barcelona/ES
  • 11 Department Of Medical Oncology, Ospedale San Donato, Istituto Toscano Tumori, 52100 - Arezzo/IT
  • 12 Oncology Research Center, Hospital Sao Lucas, PUCRS, 90610-000 - Porto Alegre/BR
  • 13 Fundacion Richardet Longo, Instituto Oncologico de Cordoba, 5200 - Cordoba/AR
  • 14 Cabrini Monash University Department Of Medical Oncology, Cabrini Health, 3145 - Malvern/AU
  • 15 Departments Of Urology And Molecular Oncology, Graduate School of Medical and Dental Sciences, Niigata University, 951-8510 - Niigata/JP
  • 16 Department Of Medical Oncology, Gustave Roussy, 94805 - Villejuif/FR
  • 17 Department Of Clinical Research, Bristol Myers Squibb, 08540 - Princeton/US
  • 18 Department Of Biostatistics, Bristol Myers Squibb, 08540 - Princeton/US
  • 19 Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, 20892 - Bethesda/US
  • 20 Department Of Medicine, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
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Resources

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Abstract 696O_PR

Background

Results from the phase 3 CheckMate 9ER trial evaluating the checkpoint inhibitor (CPI) nivolumab (N) plus the tyrosine kinase inhibitor (TKI) cabozantinib (C) v sunitinib (S) for first-line (1L) treatment of advanced clear cell renal cell carcinoma (aRCC) are reported. As monotherapies, N and C have demonstrated efficacy and a manageable safety profile in aRCC. C has immunomodulatory properties that may counteract tumor-induced immunosuppression, providing a rationale for combining N+C.

Methods

Patients (pts) were randomized 1:1 (stratified by IMDC risk score, tumor PD-L1 expression, region) to N 240 mg flat dose IV Q2W + C 40 mg PO QD v S 50 mg PO for 4 wk (6-wk cycles) until disease progression or unacceptable toxicity (max N treatment, 2 y). Primary endpoint: progression-free survival (PFS; a ¼ 0.05 final) by blinded independent central review (BICR). Secondary endpoints (hierarchical testing): overall survival (OS; a ¼ 0.011 first interim analysis), objective response rate (ORR; a ¼ 0.05 final) by BICR, and safety.

Results

A total of 651 pts (22.6% favorable risk, 57.6% intermediate risk, 19.7% poor risk; 24.9% PD-L1 _1%) were randomized to N+C (n ¼ 323) v S (n ¼ 328). With 18.1 mo median (10.6 mo minimum) study follow-up, all 3 efficacy endpoints were met. N+C significantly improved PFS (HR 0.51 [95% CI 0.41e0.64], P < 0.0001; median, 16.6 v 8.3 mo) and OS (HR 0.60 [98.89% CI 0.40e0.89]; P ¼ 0.0010; medians not reached) v S, and results were consistent across prespecified IMDC risk and PD-L1 subgroups. ORR (95% CI) was significantly higher with N+C v S (55.7% [50.1e61.2] v 27.1% [22.4e32.3]; P < 0.0001), and 8.0% v 4.6% of pts achieved complete response. Median duration of response was 20.2 v 11.5 mo for N+C v S. Any-grade TRAEs occurred in 96.6% v 93.1% of pts treated with N+C v S (60.6% v 50.9% grade _3). One treatment-related death occurred with N+C v 2 with S. TRAEs led to discontinuation of S in 8.8%, N or C in 15.3%, N+C in 3.1%, N only in 5.6%, and C only in 6.6% of pts.

Conclusions

N+C demonstrated superior PFS, OS, and ORR v S in 1L aRCC. The safety profile of this combination was manageable and consistent with the known singleagent AE profiles of N and C. These results support N+C as a new CPI+TKI option for aRCC pts.

Clinical trial identification

NCT03141177.

Editorial acknowledgement

Professional medical writing assistance was provided by Jen Tyson, PhD, of Parexel, funded by Bristol-Myers Squibb Company.

Legal entity responsible for the study

Bristol-Myers Squibb Company.

Funding

Bristol-Myers Squibb Company (Princeton, NJ), Ono Pharmaceutical Company Ltd. (Osaka, Japan), and Exelixis Inc. (Alameda, CA).

Disclosure

T.K. Choueiri: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Manuscript preparation, Clinical trials grants: BMS; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Manuscript preparation, Clinical trials grants: Exelixis; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses, Manuscript preparation, Clinical trials grants: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Manuscript preparation, Clinical trials grants: Merck; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Manuscript preparation, Clinical trials grants: AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Manuscript preparation, Clinical trials grants: Lilly; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Manuscript preparation, Clinical trials grants: Eisai; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Manuscript preparation, Clinical trials grants: Novartis; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Manuscript preparation, Clinical trials grants: GSK; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Manuscript preparation, Clinical trials grants: EMD Serono; Shareholder/Stockholder/Stock options: Pionyr; Shareholder/Stockholder/Stock options: Tempest. T. Powles: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Exelixis; Honoraria (self), Advisory/Consultancy: Incyte; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy: Merck/MSD; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Seattle Genetics; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Roche. M.T. Bourlon: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses, Slide reviews: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses: Janssen. J.J. Hsieh: Research grant/Funding (self), Sponsered Clinical trial: BMS; Advisory/Consultancy, Research grant/Funding (self), Sponsored Clinical trial: Eisai; Research grant/Funding (self), Sponsored Clinical trial: Calithera; Research grant/Funding (self), Investigator initiated trial and correlate studies: AstraZeneca. U. Basso: Speaker Bureau/Expert testimony, Research grant/Funding (self), Carry out activities of the study: BMS. C. Suarez: Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche/Genentech; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Astellas; Honoraria (self), Advisory/Consultancy: AtraZeneca; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: Eusa; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Ipsen; Honoraria (institution), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Sanofi-Aventis; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme Corp. C.H. Barrios: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Boehringer-Ingelheim; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: GSK; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche/Genentech; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Eisai; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): AstellasPharma; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Covance; Research grant/Funding (institution): Medivation; Research grant/Funding (institution): Merck Serono; Research grant/Funding (institution): PharmMar. D. Pook: Advisory/Consultancy, Commercial Study Finding: BMS; Advisory/Consultancy, Research grant/Funding (self): Pfizer; Research grant/Funding (self): Ipsen. Y. Tomita: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Ono pharmacetical; Honoraria (self): BMS; Honoraria (self), Research grant/Funding (self): Pfizer; Research grant/Funding (institution): Takeda. B. Escudier: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy: Eusa Pharma; Honoraria (self): Roche/Genentech. J. Zhang: Shareholder/Stockholder/Stock options, Full/Part-time employment: BMS. B. Simsek: Shareholder/Stockholder/Stock options, Full/Part-time employment: BMS. R.J. Motzer: Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Eisai; Advisory/Consultancy, Research grant/Funding (institution): Exelixis; Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Advisory/Consultancy: Merck; Advisory/Consultancy: Incyte; Advisory/Consultancy: Lilly. All other authors have declared no conflicts of interest.

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