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Individuals with poor- or intermediate-risk advanced sarcomatoid renal cell carcinoma may benefit from better first-line treatment outcomes with nivolumab and ipilimumab than with sunitinib. 

Patients suffering from advanced sarcomatoid renal cell carcinoma (sRCC) have poor prognostic outcomes and limited treatment options. The first-line treatment of sRCC comprises nivolumab with ipilimumab (NIVO+IPI), which has greater efficacy benefits compared to sunitinib (SUN) for intermediate/poor-risk sRCC. A randomized controlled trial demonstrated that first-line treatment with NIVO+IPI is associated with better and longer-lasting responses and long-term survival benefits over the administration of SUN in patients suffering from poor- or intermediate-risk sRCC. These findings are published in the Journal of Immunotherapy of Cancer.  

Survival Benefits of Nivolumab With Ipilimumab Versus SUN

At the minimum 5-year follow-up, the survival benefits of NIVO+IPI were maintained compared to those of SUN in patients suffering from intermediate- or poor-risk sRCC. The median overall survival (OS) in sRCC patients was estimated to be 48.6 and 14.2 months for NIVO+IPI and SUN, respectively. Moreover, these patients had a higher objective response rate (ORR) of 60.8% vs 23.1% and median progression-free survival (PFS) of 26.5 vs 5.5 months.

Tumor PD-L1 Expression Levels and Treatment Outcomes

The efficacy benefits of NIVO+IPI were relatively greater compared to those of SUN at long-term follow-up of sRCC patients, regardless of the levels of expression of tumor PD-L1. In patients with ≥ 1% PD-L1 expression levels, the ORR was 69.4% in patients who received NIVO+IPI, vs 24.2% in patients who received SUN. Compared to this, the ORR was 54.3% for NIVO+IPI vs 20.7% for SUN, corresponding to the baseline expression levels of PD-L1 < 1%.

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Safety-Related Treatment Outcomes of Nivolumab With Ipilimumab Versus SUN

Adverse events (AEs) associated with treatment occurred in 97.3% of patients who received NIVO+IPI and in 96.9% of patients who received SUN. Grades 3–4 AEs occurred in 44.6% and 49.3% of patients treated using SUN and NIVO+IPI, respectively. AEs associated with the discontinuation of the treatment occurred in 21.9% and in 12.3% of patients treated with NIVO+IPI and SUN, respectively. The treatment-related AEs that were more frequent included any-grade gastrointestinal-related, skin-related, hepatic-related, and endocrine-related events.

Treatment-Free Interval in Nivolumab With Ipilimumab Versus SUN

The median treatment-free interval (TFI) in NIVO+IPI and SUN treatment groups was found to be 2.9 and 1.4 months, respectively. The patients who discontinued the treatment had a median TFI of 12.3 and 3.1 months with NIVO+IPI and SUN, respectively.

The long-term analysis of treatment outcomes of first-line treatment of advanced sRCC indicated that NIVO+IPI had better efficacy than SUN, as the standard of care treatment of patients suffering from poor- or intermediate-risk sRCC.


Rini, B. I., Signoretti, S., Choueiri, T. K., McDermott, D. F., Motzer, R. J., George, S., Powles, T., Donskov, F., Tykodi, S. S., Pal, S. K., Gupta, S., Lee, C. W., Jiang, R., & Tannir, N. M. (2022). Long-term outcomes with nivolumab plus ipilimumab versus sunitinib in first-line treatment of patients with advanced sarcomatoid renal cell carcinoma. J Immunother Cancer, 10(12). https://doi.org/10.1136/jitc-2022-005445