Patient-Reported Outcomes With Nivolumab Plus Cabozantinib in Advanced Renal Cell Carcinoma

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Results of the CheckMate 9ER phase III trial showed significantly improved patient-reported outcomes in quality of life for first-line treatment with nivolumab plus cabozantinib compared with sunitinib for patients with advanced renal cell carcinoma.1 These findings are in line with the previously reported superior clinical efficacy of the novel doublet.2 Earlier this year, the U.S. Food and Drug Administration approved the use of nivolumab in combination with cabozantinib as first-line treatment for patients with advanced renal cell carcinoma.

“Patients reported statistically significant health-related quality-of-life benefits with nivolumab plus cabozantinib vs sunitinib. Treatment with the combination significantly reduced the risk of deterioration in health-related quality-of-life scores, including in disease-related symptoms of kidney cancer. These results suggest that the superior efficacy of nivolumab plus cabozantinib over sunitinib comes with the additional benefit of improved health-related quality-of-life, with acceptable toxicity,” said lead author David Cella, PhD, FASCO, of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago.

The primary results of CheckMate 9ER, presented at the European Society for Medical Oncology Virtual Congress 2020,2 found that nivolumab plus cabozantinib significantly improved key efficacy measures compared with sunitinib, including progression-free survival, overall survival, and objective response rate.

This study will confirm that the superior clinical efficacy of first-line nivolumab plus cabozantinib vs sunitinib is matched with superior quality of life.
— David Cella, PhD, FASCO

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Patients were randomly assigned 1:1 to first-line treatment with 240 mg of intravenous nivolumab every 2 weeks plus 40 mg/d of oral cabozantinib every day (323 patients) vs 50 mg of standard oral sunitinib in 4-week-on, 2-week-off cycles (328 patients) until disease progression or unacceptable toxicity. The doublet met the primary endpoint, with a doubling of progression-free survival in the experimental arm, a median of 16.6 months for the combination compared with 8.3 months for sunitinib, which was statistically significant (P < .0001). The study also met secondary efficacy endpoints of improving overall survival and objective response rate compared with sunitinib in patients with clear cell renal cell carcinoma.

Health-Related Quality of Life: Patient-Reported Outcomes

An in-depth health-related quality-of-life patient-reported outcomes analysis was conducted, including overall comparisons between the treatment groups and the time to confirmed deterioration of quality of life. Patient-reported outcomes were studied in all randomly assigned patients using the Functional Assessment of Cancer Therapy–Kidney Cancer Symptom Index-19 (FKSI-19) and EQ-5D-3L instruments. Patient-reported outcomes assessments at baseline, during on-treatment scheduled visits, and during follow-up visits of both arms were analyzed.

The analysis showed a significantly reduced risk of deterioration in health-related quality-of-life scores, including disease-related symptoms of advanced renal cell carcinoma in patients treated with nivolumab plus cabozantinib vs sunitinib. Patients treated with the combination experienced less treatment burden, with a decreased risk of confirmed deterioration across most measurements compared with sunitinib; these measurements included FKSI-19 total, disease-related symptoms, functional well-being, and EQ-5D-3L visual analog scale scores.

“I think this study will confirm that the superior clinical efficacy of first-line nivolumab plus cabozantinib vs sunitinib is matched with superior quality of life,” said Dr. Cella. “This is particularly striking given that the assessments on the sunitinib arm were done after 2 weeks off the drug in the 4-week/2-week cycle.”

Dr. Cella said the lack of deterioration in health-related quality of life reported by patients after 2 years on therapy was notable. “One thing that surprised me is that, after 2 years on therapy, patients treated with nivolumab and cabozantinib still had not hit the median for definitive deterioration of their FKSI-19 Disease-Related Symptoms score,” he commented. “This suggests that despite the toxicities of treatment, those who remain on therapy maintain good quality of life.” 

DISCLOSURE: The CheckMate 9ER study was funded by Bristol Myers Squibb. Dr. Cella holds an ownership interest in; has served as a consultant or advisor to AbbVie, Asahi Kasei Pharma Corp, Astellas Pharma, Bristol Myers Squibb, GlaxoSmithKline, International Drug Development Institute, Ipsen, MEI Pharma, Novartis, Pfizer, and PledPharma; has received institutional research funding from AbbVie, Bayer, Bristol Myers Squibb, Clovis, Genentech, GlaxoSmithKline, Ipsen, Novartis, Pfizer, PledPharma, and Regeneron; and has been reimbursed for travel, accommodations, or other expenses by Ipsen and PledPharma.


1. Cella D, Choueiri TK, Blum SI, et al: Patient-reported outcomes of patients with advanced renal cell carcinoma treated with first-line nivolumab plus cabozantinib versus sunitinib: The CheckMate 9ER trial. 2021 Genitourinary Cancers Symposium. Abstract 285. Presented February 13, 2021.

2. Choueiri TK, Powles T, Burotto M, et al: 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. Ann Oncol 31(suppl 4):S1159, 2020.


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