# A Minimum 3‐Year Follow‐Up of Nivolumab‐Plus‐Ipilimumab in Japanese Patients With Advanced or Metastatic Renal Cell Carcinoma: A Final Analysis of the J‐ENCORE Study

## TL;DR

This study analyzed long-term outcomes of a cancer treatment combining nivolumab and ipilimumab in Japanese patients with advanced kidney cancer.

## Contribution

It provides real-world evidence of long-term efficacy and safety of the treatment over three years in a Japanese patient population.

## Key findings

- 38.4% of patients had a real-world objective response to the treatment.
- Median overall survival was 60.2% of patients surviving at least 36 months.
- Treatment-related adverse events occurred in 78.5% of patients, with no new safety concerns.

## Abstract

The J‐ENCORE study is a Japanese multicenter, prospective observational study involving patients with advanced or metastatic renal cell carcinoma treated with nivolumab‐plus‐ipilimumab combination as first‐line treatment. Interim 1‐ and 2‐year reports demonstrated efficacy and safety comparable to those of the CheckMate 214 trial, with sustained effects after nivolumab‐plus‐ipilimumab discontinuation, and explored outcome‐associated factors. This final analysis of a minimum 3‐year observation summarized long‐term outcomes, including real‐world second progression‐free survival and overall survival, and explored outcome‐associated factors.

Real‐world objective response rate, response duration, real‐world progression‐free survival, overall survival, treatment‐related adverse events, and real‐world second progression‐free survival were evaluated. Outcome‐associated factors were explored.

The study included 274 patients (68.2% aged ≥ 65 years; 42.0%, poor risk) from 37 sites, with a median follow‐up of 47.4 (range, 36.5–59.0) months. Real‐world objective response rate was 38.4%, with 30.5% maintaining ≥ 36 months response duration. Median real‐world progression‐free survival and second progression‐free survival were 9.7 and 30.1 months, respectively, and 60.2% of patients survived for ≥ 36 months. Treatment‐related adverse events of any grade, grade 3/4, and grade 5 occurred in 78.5%, 43.1%, and 1.1% of patients, respectively. No new treatment‐related adverse events or increased frequencies were reported since the previous interim analyses. Multivariable analyses identified associations between overall survival and age, lactate dehydrogenase levels, and C‐reactive protein levels, with favorable prognosis in patients with none or one of these factors.

We demonstrated long‐term real‐world outcomes of nivolumab‐plus‐ipilimumab. Our findings support prescriptions of nivolumab‐plus‐ipilimumab in real‐world clinical practice.

UMIN Clinical Trials Registry: UMIN000036772 and ClinicalTrials.gov: NCT04043975