Patients with metastatic renal cell carcinoma (RCC) have similar overall survival (OS) outcomes when treated with frontline ipilimumab plus nivolumab or frontline axitinib plus pembrolizumab, according to real-world data published in The Oncologist.

Although the study showed similar OS outcomes between the 2 treatment groups, real-world progression-free survival (rwPFS) was superior in the axitinib-pembrolizumab group. In addition, rwPFS and OS outcomes varied according to disease risk.

The study included data from 1506 patients with metastatic clear cell RCC in the Flatiron Health database who were treated with ipilimumab-nivolumab or axitinib- pembrolizumab between 2018 and 2022. 

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The cohort included 547 patients who received axitinib-pembrolizumab and 959 who received ipilimumab-nivolumab. At baseline, the median age was 67 years and 65 years, respectively; 70.2% and 75.0% of patients were men; 8.6% and 5.1% had favorable-risk disease; and 77.1% and 85.2% had intermediate/poor-risk disease. 

The median follow-up was 20.0 months. In the overall cohort, the median rwPFS was significantly longer in the axitinib-pembrolizumab group than in the ipilimumab-nivolumab group — 10.6 months and 6.9 months, respectively (P =.04). 

Among patients with favorable-risk RCC, the median rwPFS was significantly longer in the axitinib-pembrolizumab group than in the ipilimumab-nivolumab group — 25.5 months and 6.9 months, respectively (P =.01). However, there was no significant difference between the groups in rwPFS among patients with intermediate/poor-risk disease — 9.5 months and 6.4 months, respectively (P =.2).

The OS was not significantly different between the treatment groups in the overall cohort. The median OS was 24.3 months with ipilimumab-nivolumab and 28.9 months with axitinib-pembrolizumab (P =.09). At 24 months, the OS was 50.2% and 53.8%, respectively.

OS favored the axitinib-pembrolizumab combination among patients with favorable-risk RCC but not among those with intermediate/poor-risk disease. In the favorable-risk cohort, the median OS was not reached in either treatment group (P =.04). In the intermediate/poor-risk group, the median OS was 23.3 months in both groups (P =.4)

The researchers concluded that there is “no discernible difference” in OS with ipilimumab-nivolumab and axitinib-pembrolizumab. However, among patients with favorable-risk RCC, axitinib-pembrolizumab confers improved rwPFS and OS. 

“Clinicians may have comfort in knowing that real-world data are concordant with the historical trial data and align with guideline recommendations,” the researchers concluded.

Disclosures: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Zarrabi KK, Handorf E, Miron B, et al. Comparative effectiveness of front-line ipilimumab and nivolumab or axitinib and pembrolizumab in metastatic clear cell renal cell carcinoma. Oncologist. Published online October 6, 2022. doi:10.1093/oncolo/oyac195