Toni Choueiri, MD, on What Multidisciplinary Stakeholders Should Know About CheckMate 9ER

In the phase 3 CheckMate 9ER trial, investigators found that nivolumab plus cabozantinib demonstrated improved efficacy and prolonged survival among patients with previously untreated advanced renal cell carcinoma.

Results from the phase 3 CheckMate 9ER trial (NCT03141177) presented at the American Society of Clinical Oncology (ASCO) 2021 Genitourinary Cancer Symposium revealed that nivolumab (Opdivo) plus cabozantinib (Cabometyx) demonstrated improved efficacy and prolonged survival compared with sunitinib (Sutent) among patients with previously untreated advanced renal cell carcinoma (RCC), regardless of sarcomatoid status.1

In an interview with CancerNetwork®, Toni Choueiri, MD, director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber Cancer Institute/Brigham and Women’s Hospital and the Jerome and Nancy Kohlberg Chair and professor of Medicine at Harvard Medical School, explained how these results impact multidisciplinary stakeholders in the oncology community.


During [the Genitourinary Cancers Symposium], we presented the patient-reported outcomes for the combination of cabozantinib [plus] nivolumab versus sunitinib. Recently, that combination was approved in January 2021 by the FDA. [At the meeting, we] presented very extensive and new health-related quality of life instrument measures in this study; FKSI-19 [Kidney Symptom Index 19] and many subsets of FKSI-19, as well EQ-5D-3L, VAS [visual analog scale], and others are all patient-reported outcomes and have been for some time. And I’m glad that these were presented in a comprehensive way.

Like the initial presentation, which had some quality-of-life data during [the European Society for Medical Oncology 2020 Congress],2 this extensive presentation continued to show that the combination of cabozantinib at 40 mg per day and the PD-1 inhibitor nivolumab provided consistent, really healthy quality-of-life benefit over sunitinib with statistically significant differences between the treatment arm favoring the combination. There was a delay in deterioration and significant decreased risk of confirmed deterioration in the health-related quality of life measures and scores, including in disease-related kidney cancer symptoms. If you couple this with the efficacy data that Dr. Motzer updated during ASCO GU 2021, you do have now a superior clinical efficacy with the combination coupled with additional benefit of better health-related quality of life. This supports the acceptable tolerability profile of that combination in advanced renal cell cancer.


1. Motzer RJ, Choueiri TK, Powles T, et al. Nivolumab + cabozantinib (NIVO+CABO) versus sunitinib (SUN) for advanced renal cell carcinoma (aRCC): Outcomes by sarcomatoid histology and updated trial results with extended follow-up of CheckMate 9ER. J Clin Oncol. 2021;39(suppl 6):308. doi: 10.1200/JCO.2021.39.6_suppl.308

2. Choueiri T, Powles T, Burotto M, et al. 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. 2020;31(suppl 4):S1142-S1215. doi: 10.1016/annonc/annonc325