Adjuvant immunotherapy in high-risk resectable melanoma: A real-world experience

Abstract

Adjuvant immunotherapy with nivolumab or pembrolizumab represents the current standard of care for resected high-risk Stage III and IV malignant melanoma. However, data on its real-world outcomes and efficacy beyond clinical trials are limited. We evaluated the data of high-risk Stage III and IV melanoma patients treated with adjuvant immunotherapy in two hospitals in Western Australia, Australia. The study involved the retrospective collection and analysis of data from 95 eligible patients treated with nivolumab or pembrolizumab. These patients were planned to receive 1 year of immunotherapy, with treatment continuing until disease recurrence, unacceptable toxicity, or voluntary withdrawal. Our evaluation focused on overall survival (OS), recurrence-free survival (RFS), and distant metastasis-free survival (DMFS), along with safety outcomes. The findings of our study indicated a 2-year RFS of 73%, a DMFS of 73%, and an OS of 94%. Treatment-related adverse events were observed in 63.1% of patients, with cutaneous manifestations being the most common treatment-related toxicity and gastrointestinal tract issues being the most common higher-grade immune-related adverse event. Importantly, these findings do not significantly differ from the landmark clinical trials, CheckMate-238 and KEYNOTE-054. In conclusion, adjuvant immune checkpoint inhibitor therapy administered for up to 1 year in high-risk Stage III and IV melanoma demonstrates a comparable efficacy and toxicity profile in real-world settings to that observed in the pivotal trials.