Superior clinical outcomes and QoL with nivolumab plus cabozantinib in RCC

Patients with renal cell carcinoma (RCC) treated with nivolumab plus cabozantinib demonstrated both superior clinical outcomes and superior health-related quality of life outcomes compared with patients treated with sunitinib. This was found in an in-depth analysis of the CheckMate 9ER trial.

The CheckMate 9ER trial (NCT03141177) is a phase 3, open-label, randomised controlled trial investigating whether nivolumab combined with cabozantinib is a safe and effective intervention compared with sunitinib in patients with previously untreated advanced or metastatic RCC [1]. Included patients (n=651) were randomised to nivolumab plus cabozantinib (n=323) or sunitinib (n=328) as first-line therapy until either progression of the cancer or unacceptable toxicity, with a maximum treatment duration of 2 years.

Primary and secondary outcomes were reported previously and published recently, with the primary aim of progression-free survival being superior for nivolumab plus cabozantinib after a median follow-up of 18.1 months (HR 0.51; P<0.0001) [2,3]. Both key secondary outcome measures overall survival (OS) and objective response rate (ORR) were superior in the nivolumab plus cabozantinib group (HR 0.60; OS, P=0.001; ORR, P<0.0001).

The current analysis, presented by Prof. David Cella (Robert H. Lurie Comprehensive Cancer Centre, Northwestern University, Illinois, USA), focused on in-depth health-related quality of life patient-reported outcomes, utilising 2 instruments: the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19) and the 3-level version of the EuroQol-5 Dimensions scale (EQ-5D-3L) [1]. Participants in both study arms were invited to complete the questionnaires at baseline (>93% completion rate) and common on-treatment and follow-up visits (≥80% completion rate).

Participants receiving nivolumab plus cabozantinib reported a smaller treatment burden than those receiving sunitinib. Patients in the nivolumab plus cabozantinib treatment arm had both a decreased risk of confirmed deterioration and a delay in deterioration. Patients in the nivolumab plus cabozantinib arm demonstrated a significantly better FKSI-19 total score (mean change 2.9; P<0.0001) and subscale scores of disease-related symptoms (DRS; mean change 1.55; P<0.0001), DRS-physical, DRS-emotional, and functional well-being (P<0.05 for all subscores). EQ-5D-3L scores were in favour of nivolumab plus cabozantinib compared with sunitinib for both utility index (mean change 0.05; P=0.0005) and visual analogue scale (mean change 3.26; P=0.0011).

Overall, these results demonstrated that patients with untreated advanced or metastatic RCC can benefit from both favourable clinical outcomes and improved quality of life when treated with nivolumab plus cabozantinib instead of sunitinib.

1. Cella D, et al. Patient-reported outcomes of patients with advanced renal cell carcinoma (aRCC) treated with first-line nivolumab plus cabozantinib versus sunitinib: The CheckMate 9ER trial. Abstract 285, ASCO Genitourinary Cancers Symposium, 11–13 February 2021.
2. Choueiri TK, et al. Presentation 6960, ESMO Virtual Congress 2020, 19–21 September.
3. Choueiri TK, et al. N Engl J Med 2021, 4 March; 384:829–841.

 

Copyright ©2021 Medicom Medical Publishers



Posted on 24 March 202118 June 2021