Dr Zakharia on Long-Term Benefit With Nivolumab Plus Ipilimumab in ccRCC

“With longer follow-up, we are seeing more of a flip of the OS curve in favor of ipilimumab plus nivolumab in the favorable-risk patient population. That’s why the National Comprehensive Cancer Network [recently added] ipilimumab plus nivolumab as another preferred treatment option for patients with favorable-risk disease [to their guidelines].”

Yousef Zakharia, MD, medical oncologist, vice chair, Genitourinary Malignancy Disease Group, Mayo Clinic Comprehensive Cancer Center; medical director, Experimental Therapeutics Clinic, Mayo Clinic, discusses the long-term benefits of nivolumab (Opdivo) plus ipilimumab (Yervoy) according to risk status in clear cell renal cell carcinoma (ccRCC), according to subgroup data from the phase 3 CheckMate 214 study (NCT02231749).

CheckMate 214 was a pivotal study in metastatic ccRCC comparing the combination of ipilimumab and nivolumab with sunitinib (Sutent) in the first-line setting, Zakharia begins. The trial included 1096 patients and evaluated coprimary end points of objective response rate, progression-free survival, and overall survival (OS) in patients with intermediate- and poor-risk disease, as classified by the International Metastatic RCC Database Consortium. The trial met its primary end points in these patient subgroups, establishing the efficacy of the combination therapy, Zakharia details.

Updated data presented at the 2024 Genitourinary Cancers Symposium revealed that 39.0% of patients with intermediate- and poor-risk disease who received ipilimumab plus nivolumab were alive at 6 years, he reports. This represents a significant improvement over historical outcomes, where intermediate-risk patients typically survived an average of 2 years, and poor-risk patients survived for approximately 6 months, Zakharia expands.

In patients with favorable-risk disease, early data indicated better outcomes with sunitinib compared with ipilimumab and nivolumab, which initially limited the adoption of the combination in the treatment of this subgroup, he continues. However, long-term follow-up data now show a reversal of the OS curves, favoring ipilimumab plus nivolumab in favorable-risk patients, Zakharia notes. As a result, the National Comprehensive Cancer Network has updated its guidelines to include ipilimumab plus nivolumab as a preferred treatment option for this patient population, Zakharia concludes.