Efficacy of Opdivo-Yervoy combo confirmed in Korean patients with advanced renal cell carcinoma

The efficacy of Bristol-Myers Squibb and Ono Pharmaceutical’s Opdivo (ingredient: nivolumab) in combination with Yervoy (ingredient: ipilimumab) as a first-line treatment for advanced renal cell carcinoma (RCC) in Korean patients has been confirmed in a real-world clinical study.

The study, called RENOIR, evaluated the combination treatment's efficacy in real clinical settings and was presented at the European Society for Medical Oncology (ESMO) 2024 annual meeting in Barcelona, Spain, in September.

The study, led by Professors Park Ji-hyun of the Department of Hematology and Oncology at Konkuk University Medical Center and Kim Jwa-hoon of the Department of Hematology and Oncology at Korea University Anam Hospital, analyzed clinical data from 455 Korean patients diagnosed with advanced or metastatic RCC.

The research, conducted by the Korean Cancer Study Group (KCSG) under its Genitourinary Cancer Subcommittee, covered data collected from 20 medical centers across Korea between 2018 and 2022.

The study primarily assessed the objective response rate (ORR), with secondary endpoints including progression-free survival (PFS) and overall survival (OS). Notably, 98 percent of the study population consisted of patients classified as intermediate or poor-risk according to the International Metastatic RCC Database Consortium (IMDC) risk score.

The findings revealed an ORR of 41.5 percent, with a complete response (CR) rate of 4.8 percent and a partial response (PR) rate of 36.7 percent. Stable disease (SD) was observed in 31.2 percent of patients, bringing the disease control rate (DCR) to 72.6 percent. The median duration of response was 8.4 months, while the median PFS and OS were 13.5 months and 51.5 months, respectively.

Key predictive factors for better outcomes included male sex, the presence of lung metastases, and a history of nephrectomy, all of which were associated with significantly better treatment responses.

In contrast, the use of antibiotics before starting treatment with the Opdivo-Yervoy combination was linked to poorer survival outcomes. Additionally, patients who completed the full four cycles of treatment demonstrated significantly longer PFS and OS compared to those who underwent only one to three cycles.

“The study is a five-year retrospective analysis of the efficacy of the Opdivo-Yervoy combination therapy in Korean patients with intermediate or high-risk advanced renal cell carcinoma who had no prior treatment experience,” the two professors said. “The study confirmed consistent efficacy indicators when compared to the long-term follow-up results of previous clinical trials for renal cell carcinoma.”

Notably, the RENOIR study holds significant value as a real-world analysis that reflects the actual clinical setting, including a more diverse patient population with various factors, they added.

The two researchers stressed that these encouraging efficacy results were consistently reproduced, even when compared to prospective clinical trials that were conducted under strict protocols with a highly selected patient group.

"The long-term response to first-line treatment with the Opdivo-Yervoy combination leads to an improvement in overall survival, and important clinical factors for achieving such long-term responses were identified,” they said. “This is significant as it can help identify patients who are likely to respond effectively to the first-line Opdivo-Yervoy combination therapy.”

Meanwhile, Opdivo was first approved in Korea in October 2018 for use in combination with Yervoy as a first-line treatment for intermediate- or poor-risk advanced RCC.

Since September 2021, it has also been covered by insurance for patients with clear-cell RCC classified as intermediate- or high-risk according to the IMDC risk score.