Abstract Code: IUC26628-89

Real-World Outcomes of Adjuvant Pembrolizumab in Renal Cell Carcinoma: A Single-Centre Experience   

1. Okuma ¹, C. Nwankwo ¹, M. Cortez ¹, M. Chipuriro ¹, K. Kumar ¹

(1) James Cook University Hospital, Middlesbrough – United Kingdom

Background:

The KEYNOTE-564 trial demonstrated that adjuvant Pembrolizumab significantly improved disease-free survival (DFS) in patients with high-risk renal cell carcinoma (RCC) following nephrectomy. The objective of this study is to evaluate real-world outcomes of adjuvant pembrolizumab and compare them with clinical trial data. 

Methods:

This was a retrospective, single-centre analysis of patients with RCC treated with adjuvant pembrolizumab following nephrectomy from December 2022 to October 2025, with censoring date of 15^th May 2026. Data collected included baseline demographics, tumour characteristics, treatment exposure, and immune-related adverse events (irAEs). Time to event analyses were calculated from day 1 of cycle 1 to date of event or censoring date.

Results:

A total of 57 patients were included, with a median age of 63 years (range 39–80), and 68.4% were male. All patients had an ECOG performance status of 0 or 1. Disease was predominantly locally advanced, with 86.1% of patients having pT3 tumours. There was a near-equal distribution between Leibovich’s high-risk (49.1%) and intermediate-risk (49.2%) disease.

At a median follow-up of 23.8 months, median disease-free survival (DFS) was not reached, and 78.7% of patients remained disease-free. Treatment-related toxicity was observed in 64.9% of patients, and grade ≥3 adverse events reported in only 14%. The most common irAEs were hypothyroidism (19.2%), skin rash (17.3%), pneumonitis (11.5%), colitis (7.7%), and adrenal insufficiency (7.7%). 49.1% of patients completed planned course of treatment at the time of analysis. 29.9% discontinued due to toxicity, 12.2% due to disease progression, and only 8.8% of patients had ongoing treatment at the time of censoring.

In the pembrolizumab arm of the KEYNOTE 564 trial, 78.2% were disease free at 24 months, 79.1% had any grade iRAEs, 18.6% had grade ≥3 iRAEs, and 21.1% discontinued therapy due to adverse event of any cause.

Conclusion:

This study demonstrated comparable efficacy and safety of adjuvant pembrolizumab in routine clinical setting with the KEYNOTE 564 trial. Longer follow-up and larger sample sizes are required to evaluate overall survival benefit, and the long-term impact of iRAEs in this group of patients.