Clinical Management and Outcomes of Immune-Related Adverse Events During Treatment with Immune Checkpoint Inhibitor Therapies in Melanoma and Renal Cell Carcinoma: A UK Real-World Evidence Study

INTRODUCTION: Immune checkpoint inhibitor (ICI) therapy, although effective in treating patients with a variety of advanced malignancies, can result in potentially severe or even fatal immune-related adverse events (irAEs). This study aimed to generate real-world evidence on irAE characteristics, clinical management and clinical outcomes among patients with advanced (unresectable or metastatic) malignant melanoma (a/mMM) or advanced renal cell carcinoma (aRCC) treated with nivolumab (NIVO) and/or ipilimumab (IPI) in the UK.

METHODS: This was a multi-centre, retrospective cohort study of adult patients with a/mMM or aRCC, who received NIVO and/or IPI at one of five specialist treatment centres in the UK between 1 January 2016 and 31 March 2020. The incidence and grading of irAEs were described, as well as time to irAE onset, the management of irAEs and overall survival (OS).

RESULTS: In total, 199 patients were included in the study: 162 with a/mMM and 37 with aRCC. The majority of patients in both a/mMM (75.3%) and aRCC (62.2%) cohorts reported any irAE, while 45.9% and 30.4% in the a/mMM and aRCC cohorts reported grade 3 or 4 irAEs, respectively. Colitis/diarrhoea, skin reactions and hepatitis were most frequently reported, and the predominant treatment prescribed for any irAE was corticosteroids only. Analysis indicated a positive association between the development of an irAE and longer OS.

CONCLUSIONS: Findings from this study support current literature, provide further insights into the characteristics and clinical management of irAEs and support an association between the development of an irAE and improved OS in these patient groups.