We investigated the real-world efficacy of first-line nivolumab plus ipilimumab (NI) and its predictive clinicopathological biomarkers in patients with advanced renal cell carcinoma(aRCC).
We retrospectively analyzed 466 patients with aRCC who started first-line NI between 2019 and 2023 at 21 Korean tertiary hospitals. The primary outcome was objective response rate (ORR). Secondary outcomes were duration of response (DoR), progression-free survival (PFS), overall survival (OS), and identification of practical clinicopathological biomarkers.
Median age of patients was 65 years, and 77.7% were male. ORR was 44.8% including 5.2% of complete response, and median DoR was 39.8 months. Male sex and lung metastasis were predictive markers of objective response, and achieving complete response was significantly associated with a longer DoR (p=0.03). With a median follow-up duration of 23.7 months, the median PFS and OS were 11.5 and 44.2 months, respectively. Full exposure to four cycles of ipilimumab was significantly associated with better PFS and OS. Durable response could significantly predict better OS, whereas multiple metastatic sites (≥4) and poor IMDC risk were two independent predictors for inferior OS. Among the 50 patients who completed 2 years of NI treatment, continuation of nivolumab beyond 2 years has marginally improved OS (p=0.09).
First-line NI showed comparable and competent efficacy in Korean patients with aRCC. We suggest completing full exposure to ipilimumab and durable response as practical predictors of enriched benefits of NI in our real-world.
Cancer research and treatment. 2025 Oct 13 [Epub ahead of print]
Jwa Hoon Kim, Sang Joon Shin, Woo Kyun Bae, Se Hyun Kim, Jin Young Kim, Hyeon-Su Im, In-Ho Kim, Il Hwan Kim, Kwonoh Park, Eo Jin Kim, Mihong Choi, Joo Han Lim, Hyunho Kim, Kyoungmin Lee, Hyo-Jeong Kim, Jungmin Jo, Hyo Jin Lee, Dalyong Kim, Byeong Seok Sohn, Inkeun Park, Ji Hyun Park
Division of Medical Oncology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea., Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea., Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea., Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea., Division of Hemato-Oncology, Keimyung University Dongsan Hospital, Daegu, Korea., Department of Hematology and Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea., Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea., Department of Internal Medicine, Division of Hemato-Oncology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea., Division of Medical Oncology and Hematology, Department of Internal Medicine, Hanyang University Seoul Hospital, Hanyang University College of Medicine, Seoul, Korea., Division of Hematology/Oncology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea., Department of Medical Oncology, The Catholic University of Korea, Uijeongbu ST. Mary's Hospital, Uijeongbu, Korea., Department of Hematology/Oncology, Inha University School of Medicine, Incheon, Korea., Division of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea., Division of Hematology/Oncology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea., Department of Internal Medicine, Division of Hematology-Oncology, Maryknoll Hospital, Busan, Korea., Department of Medical Oncology, Ewha University Mokdong Hospital, Seoul, Korea., Department of Hemato-Oncology, Chungnam National University College of Medicine, Daejeon, Korea., Division of Hematology and Medical Oncology, Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea., Department of Internal Medicine, Inje University Sanggye Paik Hospital, Seoul, Korea., Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Department of Hemato-oncology, KonKuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.