Dr Tan on the Role of Nivolumab/Ipilimumab in Favorable-Risk Advanced RCC

Alan Tan, MD, genitourinary oncology and melanoma specialist, Vanderbilt-Ingram Cancer Center, assistant professor of medicine, Division of Hematology Oncology, Vanderbilt University Medical Center, discusses the evolving treatment paradigm for patients with favorable-risk advanced renal cell carcinoma (RCC), emphasizing the role of nivolumab (Opdivo) plus ipilimumab (Yervoy).

The combination of nivolumab and ipilimumab was approved by the FDA in 2018 for the first-line treatment of adult patients with intermediate or poor risk advanced, based on data from the phase 3 CheckMate 214 trial (NCT02231749). However, in July 2024, an update to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for kidney cancer added nivolumab plus ipilimumab as a preferred regimen for patients with favorable-risk disease.

Traditionally, patients with favorable-risk RCC have primarily been treatment with immuno-oncology (IO)/TKIs combinations, Tan notes. However, long-term data from CheckMate 214 demonstrated that among patients with favorable-risk RCC, the combination of nivolumab and ipilimumab generated a median overall survival of 52.7 months (95% CI, 45.8-64.5) compared with 37.8 months (95% CI, 31.9-43.8) for sunitinib (Sutent; HR, 0.82; 95% CI, 0.60-1.13). At 90 months, the OS rate was 42.8% for nivolumab/ipilimumab vs 34.4% for sunitinib.

Tan emphasizes that patient selection is critical when deciding between IO/IO or IO/TKI combination regimens in the first-line setting for patients with advanced RCC.. For patients with a high disease burden and symptomatic presentation who may be in need of a rapid response, combining IO with a TKI may be necessary to achieve rapid disease control and improve survival outcomes, Tan says. In contrast, patients who are not immediately symptomatic and are more likely to benefit from a gradual response may be suitable candidates an IO/IO combination, he continues.

Among patients from CheckMate 214 who were still alive, a proportion were off therapy and maintaining disease control, underscoring the potential for nivolumab plus ipilimumab to improve long-term outcomes for this patient population, Tan concludes.