First-line Nivolumab, Ipilimumab Offers Long-term Effectiveness for mRCC

New research evaluating the treatment patterns and outcomes of nivolumab plus ipilimumab for patients with renal cell carcinoma (RCC) who were administered the combination in a community setting was presented at the 2023 International Kidney Cancer Symposium: North America.

While the combination therapy is first-in-class for International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate- or poor (I/P)-risk advanced or metastatic RCC (mRCC), no real-world data exist on the efficacy of the treatment past 12 to 24 months from treatment initiation.

Lead author Gurjyot K. Doshi, MD, of Texas Oncology and the US Oncology Network (USON), and co-authors developed a retrospective analysis of electronic medical record data taken from the USON. Researchers examined data from patients with IMDC I/P-risk clear cell mRCC who initiated first-line (1L) treatment with nivolumab plus ipilimumab between April 2018 and December 2019. Patient outcomes were followed until June 2022.

A total of 187 patients with mRCC who were treated with 1L nivolumab plus ipilimumab were studied for baseline demographic and clinical characteristics, treatment patterns, objective response rate (ORR), time to treatment response (TTR), and treatment-related adverse events (TRAEs), along with overall survival (OS) and real-world progression-free survival (rwPFS). Researchers used Kaplan-Meier methods to conduct their analysis.

The median age of the patient group was 63 years (range, 30 to 89 years). A total of 74 patients (39.6%) had poor risk as classified by the IMDC. The median follow-up rate was 22.4 months (range, 0.7 to 50.2 months).

The median and landmark OS and rwPFS rates at 12, 24, and 36 months were 76.5% and 49.3%, 59.5% and 35.9%, and 50.0% and 33.8%, respectively.

Of the 133 patients with response assessment, the ORR was 42.9% (95% CI, 34.3%-51.7%), and the median TTR was 2.8 months (interquartile range, 2.7-3.3). Among all 187 patients, TRAEs were reported in 89 (47.6%), including fatigue (n=25; 13.4%) and rash (n=19; 10.2%). Of the 86 patients who received second-line therapy, 54.7% received cabozantinib and 10.5% received pazopanib.

This analysis provided data that support the long-term effectiveness of 1L nivolumab plus ipilimumab in patients with IMDC I/P-risk mRCC. TRAE rates were low and remained consistent relative to clinical trials.