Real-World Outcomes in Patients With Metastatic Renal Cell Carcinoma Treated With First-Line Nivolumab Plus Ipilimumab in the United States

Abstract

Purpose: Nivolumab plus ipilimumab (NIVO + IPI) is a first-in-class combination immunotherapy for the treatment of intermediate- or poor (I/P)-risk advanced or metastatic renal cell carcinoma (mRCC). Currently, there are limited real-world data regarding clinical effectiveness beyond 12-24 months from treatment initiation. In this real-world study, treatment patterns and clinical outcomes were evaluated for NIVO + IPI in a community oncology setting.

Methods: A retrospective analysis using electronic medical record data from The US Oncology Network examined patients with I/P-risk clear cell mRCC who initiated first-line (1L) NIVO + IPI between January 4, 2018, and December 31, 2019, with follow-up until June 30, 2022. Baseline demographics, clinical characteristics, treatment patterns, clinical effectiveness, and safety outcomes were assessed descriptively. Overall survival (OS) and real-world progression-free survival (rwPFS) were analyzed using Kaplan-Meier methods.

Results: Among 187 patients identified (median follow-up, 22.4 months), with median age 63 (range, 30-89) years, 74 (39.6%) patients had poor risk and 37 (19.8%) patients had Eastern Cooperative Oncology Group performance status score ≥2. Of 86 patients who received second-line therapy, 54.7% received cabozantinib and 10.5% received pazopanib. The median (95% CI) OS and rwPFS were 38.4 (24.7-46.1) months and 11.1 (7.5-15.0) months, respectively. Treatment-related adverse events (TRAEs) were reported in 89 (47.6%) patients, including fatigue (n = 25, 13.4%) and rash (n = 19, 10.2%).

Conclusion: This study provides data to support the understanding of the real-world utilization and long-term effectiveness of 1L NIVO + IPI in patients with I/P-risk mRCC. TRAE rates were low relative to clinical trials.

FIG 1.

Patient selection and attrition. 1L, first-line; EHR, electronic health record; IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; IPI, ipilimumab; mRCC, metastatic renal cell carcinoma; NIVO, nivolumab; RCC, renal cell carcinoma.

FIG 2.

Real-world OS among patients with IMDC I/P-risk mRCC receiving 1L NIVO + IPI combination therapy. 1L, first-line; I/P, intermediate or poor; IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; IPI, ipilimumab; mRCC, metastatic renal cell carcinoma; NIVO, nivolumab; OS, overall survival.

FIG 3.

Real-world PFS among patients with IMDC I/P-risk mRCC receiving 1L NIVO + IPI combination therapy. 1L, first-line; I/P, intermediate or poor; IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; IPI, ipilimumab; mRCC, metastatic renal cell carcinoma; NIVO, nivolumab; PFS, progression-free survival; rw, real-world.

FIG 4.

TRAEs occurring in 2% or more of patients with IMDC I/P-risk mRCC receiving 1L NIVO + IPI combination therapy. ^aIncludes rash and inflamed and irritated nodules along skull. ^bIncludes tiredness. ^cIncludes increased ALT and increased AST; ^dIncludes myalgia, body aches, chest and back discomfort, muscle aches, neck pain, hip pain, and leg pain. ^eIncludes dyspnea and shortness of breath. 1L, first-line; I/P, intermediate or poor; IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; IPI, ipilimumab; LFTs, liver function tests; mRCC, metastatic renal cell carcinoma; NIVO, nivolumab; TRAE, treatment-related adverse event.