Sustained Treatment-Free Survival in RCC Seen With Nivolumab and Ipilimumab


Nivolumab monotherapy plus salvage nivolumab/ipilimumab demonstrated superior treatment-free survival rates among patients with advanced renal cell carcinoma, especially in patients with favorable risk profiles.

Kidneys, adrenal glands, genitourinary system: © Leo Viktorov -

Kidneys, adrenal glands, genitourinary system: © Leo Viktorov -

Monotherapy with nivolumab (Opdivo) and salvage nivolumab/ipilimumab (Yervoy) in nonresponder patients with advanced renal cell carcinoma (aRCC) demonstrated notable treatment-free survival (TFS) and toxicity-free TFS, according to a subgroup analysis of the phase 2 HCRN GU16-260 study (NCT03117309).1

At 36 months, 68.3% of the 128 patients with clear cell aRCC were alive following first-line nivolumab monotherapy and salvage nivolumab plus ipilimumab. These were patients who experienced disease progression. This included 96.8% of patients with favorable risk profiles and 56.6% with intermediate- or poor-risk profiles. The mean TFS at 36 months for the overall population was 9.4 months, and 65.6% of favorable-risk and 27.1% of intermediate-/poor-risk patients were alive and had not received subsequent systemic treatments.

According to authors of the study published in the Journal for ImmunoTherapy of Cancer, “TFS can be used as a novel clinical trial end point that complements commonly used efficacy measures such as median [progression-free survival (PFS)], median overall survival [OS], objective response rate, and duration of response. TFS is particularly evident with immunotherapy, as the majority of tumor responses are durable and can be maintained after treatment stops.”

The 36-month mean OS was 29.9 months (95% CI, 27.9-31.8) for the overall population. In patients with favorable-risk profiles, the mean OS was 35.7 months (95% CI, 35.3-36.2) compared with 27.4 months (95% CI, 24.9-29.9) in the intermediate- to poor-risk profile group.

Similar TFS advantages were observed in CheckMate 214 (NCT02231749). In the phase 3 CheckMate 214 trial, which investigated nivolumab plus ipilimumab vs sunitinib (Sutent) in patients with aRCC, 86% of patients who experienced a complete response sustained that response. At 30 months, 55% of these responders were alive and did not receive subsequent systemic treatment.2 Comparatively, similar TFS was not observed with sunitinib, which is a VEGFR tyrosine kinase inhibitor-based therapy, where the mean TFS was 4.4 months at the 60-month follow-up point.

These findings support the idea that this immunotherapy could be a “functional cure,” according to study authors, which surveyed patient data identifies as the most favorable outcome for aRCC.1

“This ability to stop treatment and remain free of subsequent treatment initiation for extended periods of time is of particular benefit to favorable-risk patients, many of whom are asymptomatic from their disease at the time of treatment initiation and, thus, could have their quality of life negatively impacted by the side effects of prolonged treatment,” study authors concluded.

1. Atkins MB, Jegede OA, Haas NB, et al. Treatment-free survival outcomes from the phase II study of nivolumab and salvage nivolumab/ipilimumab in advanced clear cell renal cell carcinoma (HCRN GU16-260-Cohort A). J Immunother Cancer. 2024;12(4):e008293. Published 2024 Apr 11. doi:10.1136/jitc-2023-008293
2. Tannir NM, McDermott DF, Escudier B, et al. Overall survival and independent review of response in Checkmate 214 with 42-month follow-up: first-line nivolumab + ipilimumab (N+I) versus sunitinib (S) in patients (Pts) with advanced renal cell carcinoma (aRCC). J Clin Oncol, 2020;38(6):609. doi:10.1200/JCO.2020.38.6_suppl.609
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