ASCO 2023: Health-Related Quality of Life (HRQoL) of Risk-Based Patient Subgroups with Advanced Renal Cell Cancer (aRCC) Treated with Nivolumab plus Cabozantinib vs Sunitinib in the CheckMate 9ER Trial

( The 2023 American Society of Clinical Oncology (ASCO) cancers symposium held in San Francisco, CA between February 16th and 18th was host to a kidney and bladder cancers poster session. Dr. David Cella presented the patient reported outcomes (PROs) from the CheckMate 9ER trial evaluating health-related quality of life (HRQoL) of IMDC risk-based patient subgroups with advanced renal cell cancer (RCC) treated with nivolumab plus cabozantinib versus sunitinib.

CheckMate 9ER is a phase 3, randomized, open-label trial of nivolumab (240 mg every 2 weeks) plus cabozantinib (40 mg once daily) versus sunitinib (50 mg once daily for 4 weeks of each 6-week cycle) in adult patients with previously untreated clear-cell, advanced RCC.1

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This trial included 651 patients with 323 and 328 patients randomized to the nivolumab plus cabozantinib and sunitinib arms, respectively. Updated analysis presented at ASCO GU 2023, demonstrated that at a median follow-up of 44 months, combination nivolumab plus cabozantinib was associated with PFS (median 16.6 versus 8.4 months) and OS (49.5 versus 35.5 months) benefits.

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Assessment of PROs from the CheckMate 9ER trial has previously demonstrated that combination nivolumab + cabozantinib improved or maintained HQoL versus sunitinib. In this report, Dr. Cella and colleagues performed an exploratory analysis of HRQoL outcomes from CheckMate 9ER, stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk grouping.

Patients were grouped into either IMDC favorable (score= 0) or intermediate/poor risk baseline groups (score= 1-6). HRQoL was evaluated using Functional Assessment of Cancer Therapy–Kidney Symptom Index (FKSI-19). Serial changes from baseline through week 151 were analyzed using mixed-model repeated measures, to account for the repeated nature of longitudinal measurements within the same individuals. Differences were quantified using least square means. Bother due to treatment side effects (FKSI-19 item GP5) was assessed using a generalized estimating equations model, with response dichotomized as (i) minimal (“not at all” or “a little bit”) or notable (“somewhat”, “quite a bit”, or “very much”). Time to confirmed deterioration was evaluated using Cox proportional hazards models.

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HRQoL benefits from baseline to week 151, as quantified by FKSI-19 scores, were observed in intermediate/poor risk patients receiving nivolumab + cabozantinib (n=505), but not in those with favorable risk disease receiving combination treatment (n=146), when compared to patients in the sunitinib arm.

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Longitudinal analysis of FKSI-19 total scores demonstrated that HRQoL declined from baseline through week 151 in favorable-risk patients in both the nivolumab +cabozantinib and sunitinib arms. Conversely, in the intermediate/poor-risk subgroup, HRQoL improved through week 151 in the nivolumab + cabozantinib arm but decreased from baseline in the sunitinib arm.

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Patients were less likely to be bothered by side effects of nivolumab + cabozantinib, as compared to sunitinib, regardless of risk grouping:

  • Intermediate/poor risk: Odds ratio (OR): 0.50, 95% CI: 0.34 – 0.75)
  • Favorable risk: OR: 0.51, 95% CI: 0.28 – 0.91


With regards to time to confirmed deterioration, analysis of the FKSI-19 scores demonstrated:

  • Intermediate/poor risk: Nivolumab + cabozantinib arm had lower deterioration rates compared to sunitinib arm
  • Favorable risk: Similar deterioration rates for both treatment arms

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Dr. Cella and colleagues concluded that, compared to sunitinib, combination nivolumab + cabozantinib improved or maintained HRQoL in intermediate/poor risk patients and was associated with less side effect bother in all subgroups. No significant differences between the two treatment arms were observed for favorable risk patients.

Presented by: David Cella, PhD, Director, Institute for Public Health and Medicine (IPHAM) - Center for Patient-Centered Outcomes, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL

Written by: Rashid Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, Fri, June 2 – Tues, June 6, 2023.


  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.
  2. Cella D, Motzer RJ, Suarez C, et al. Patient-reported outcomes with first-line nivolumab plus cabozantinib versus sunitinib in patients with advanced renal cell carcinoma treated in CheckMate 9ER: an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Jan 12;23(2):292-303.