ASCO GU 2022: Final Overall Survival Analysis and Organ-Specific Target Lesion Assessments with Two-Year Follow-up in CheckMate 9ER: Nivolumab plus Cabozantinib Versus Sunitinib for Patients with Advanced Renal Cell Carcinoma

( The 2022 GU ASCO Annual meeting included a renal cell carcinoma (RCC) session featuring work from Dr. Thomas Powles and colleagues presenting final overall survival results from the CheckMate 9ER trial of nivolumab plus cabozantinib versus sunitinib for patients with advanced RCC. First-line nivolumab plus cabozantinib demonstrated superiority over sunitinib in the primary analysis of the phase 3 CheckMate 9ER trial (NCT03141177; 10.6 months minimum follow-up1) in patients with advanced RCC. On the basis of this data, nivolumab plus cabozantinib is recommended as a new standard of care for first-line treatment of advanced RCC. At GU ASCO 2022, Dr. Powles reported on the preplanned final overall survival (OS) analysis with updated efficacy and safety in intent-to-treat patients, and an exploratory assessment of target lesions by organ site after extended follow-up.

Patients with advanced RCC (clear cell component) were randomized to nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily vs sunitinib 50 mg once daily (4 weeks of 6-week cycles). The primary endpoint was RECIST v1.1–defined progression-free survival (PFS) by blinded independent central review (BICR) in intention to treat patients. Secondary endpoints in this trial included OS, objective response rate (ORR) by BICR, and safety. The preplanned final OS analysis was set to occur after observing 254 events. Maximal reduction of target lung, lymph node, kidney, and liver lesions were evaluated per BICR via post hoc exploratory analyses.

After 25.4 months minimum follow-up (median, 32.9 months – nearly double the length of follow-up compared to the primary analysis) for OS in intention to treat patients, a total of 271 OS events occurred, and nivolumab plus cabozantinib continued to demonstrate OS improvement vs sunitinib (N = 323 vs 328; median 37.7 vs 34.3 months; HR 0.70, 95% CI 0.55–0.90):

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PFS (median 16.6 vs 8.3 months; HR 0.56, 95% CI 0.46–0.68) benefits were also maintained with nivolumab plus cabozantinib vs sunitinib:

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ORR (55.7%, 95% CI 50.1–61.2 vs 28.4%, 95% CI 23.5–33.6) benefits were also maintained with nivolumab plus cabozantinib vs sunitinib, and 12.4% (nivolumab plus cabozantinib) vs 5.2% (sunitinib) of patients had a complete response: 

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Median duration of response was 23.1 months with nivolumab plus cabozantinib vs 15.1 months with sunitinib. A higher percentage of patients experienced any reduction and ≥30% reduction from baseline with nivolumab plus cabozantinib vs sunitinib kidney (45.2% vs 29.7%), liver (47.7% vs 33.3%), lung (75.9% vs 46.4%), lymph node (74.4% vs 47.8%), and bone (55.6% vs 20.0%) target lesions, despite generally similar median diameters of target lesions at baseline between the arms:

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Among all treated patients, 97.2% (nivolumab plus cabozantinib; N = 320) vs 93.1% (sunitinib; N = 320) had a treatment-related adverse event of any grade (65.0% vs 54.1% had a grade ≥ 3 treatment-related adverse event).

Dr. Powles concluded his presentation of the updated OS results of the CheckMate 9ER trial with the following summary statements:

  • With a median follow-up for OS of 32.9 months, nivolumab plus cabozantinib continued to provide survival improvement vs sunitinib among intention to treat patients in the final OS analysis
  • Additionally, PFS and ORR benefits with nivolumab plus cabozantinib were sustained with minimum 2-year follow-up
  • A higher proportion of patients experienced tumor shrinkage benefit with nivolumab plus cabozantinib vs sunitinib across all four organ sites assessed
  • No new safety signals emerged with extended follow-up in either arm
  • These results highlight nivolumab plus cabozantinib as a first-line treatment for patients with advanced RCC

Presented by: Thomas Powles, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, London, United Kingdom

Co-Authors: Toni Choueiri, Mauricio Burotto, Bernard Escudier, Maria Bourlon, Amishi Yogesh Shah, Cristina Suárez, Alketa Hamzaj, Camillo Porta, Christopher Hocking, Elizabeth R Kessler, Howard Gurney, Yoshihiko Tomita, Jens Bedke, Joshua Zhang, Burcin Simsek, Christian Scheffold, Andrea B. Apolo, Robert J. Motzer 

Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, Thursday Feb 17 – Saturday Feb 19, 2022 


  1. Choueiri TK, Powles T, Burotto M, et al. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2021 Mar 4;384(9):829-841.
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