33: Real- World Treatment Patterns and Outcomes of Patience Receiving First- Line Nivolumab plus Ipilimumab for Relapsed or Metastatic Renal Cell Carcinoma (mRCC)

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

Methods: A retrospective analysis of electronic medical record data from The US Oncology Network examined patients with IMDC I/P-risk clear cell mRCC who initiated first-line (1L) NIVO+IPI between 4/1/2018 and 12/31/2019, followed until 6/30/2022. Baseline demographic and clinical characteristics, treatment patterns, objective response rate (ORR), time to treatment response (TTR), and treatment-related adverse events (TRAEs) were examined descriptively. Overall survival (OS) and RW progression-free survival (rwPFS) were analyzed using Kaplan-Meier methods. Provider-documented response and progression were captured from progress notes.

Results: Overall, 187 patients with mRCC treated with 1L NIVO+IPI were identified. Median age was 63 (range, 30-89) years, and 74 (39.6%) patients had IMDC poor risk. Median follow-up was 22.4 (range, 0.7-50.2) months. Median and landmark OS and rwPFS at 12, 24, and 36 months are summarized in the table below. Of 133 patients with response assessment, ORR was 42.9% (95% CI, 34.3-51.7%) and median TTR was 2.8 (interquartile range, 2.7-3.3) months. Among all 187 patients, TRAEs were reported in 89 (47.6%), including fatigue (n=25; 13.4%) and rash (n=19; 10.2%). Of 86 patients with 2L therapy, 54.7% received cabozantinib and 10.5% received pazopanib.

Conclusions: This RW study provides data to support the long-term effectiveness of 1L NIVO+IPI in patients with IMDC I/P-risk mRCC and is generally consistent with clinical trial results. TRAE rates were low relative to clinical trials.