# Real‐Life Cohort of Patients With Resected High‐Risk Melanoma Treated by Adjuvant Anti‐PD1 Therapy

## TL;DR

This study examines outcomes of high-risk melanoma patients treated with anti-PD1 therapy, finding that nearly half experienced recurrences and ulceration was a key predictor of recurrence risk.

## Contribution

The study identifies ulceration as the only significant predictive factor for recurrence in high-risk melanoma patients treated with adjuvant anti-PD1 therapy in a real-life cohort.

## Key findings

- 43% of patients experienced at least one recurrence, with locoregional recurrence being most common.
- Ulceration was identified as a significant predictive factor for recurrence, associated with decreased recurrence-free survival.
- Recurrence-free survival at 24 months was 64%, and overall survival was 84% at 24 months.

## Abstract

Programmed cell death protein‐1 (PD1) antibodies are currently the standard treatment for resected high‐risk melanoma, yet recurrence rate remains high.

This real‐life observational study aimed to describe the outcomes of patients with resected high‐risk melanoma following adjuvant anti‐PD1 immunotherapy and identify factors associated with recurrence risk.

A total of 235 patients with resected stage III/IV melanoma treated with adjuvant nivolumab or pembrolizumab were included. Imaging scans and cerebral imaging were performed every 12 weeks to detect recurrences. Adverse events were collected. Univariate and multivariate analyses were performed to identify predictive factors of recurrence. Overall survival (OS) and recurrence‐free survival (RFS) were estimated.

Among the 235 patients, 103 experienced at least one recurrence (43%); first recurrences were predominantly locoregional (47%). The predictive factor for recurrence identified by multivariate analysis was ulceration (RR 2,03, 95% CI [1,20; 2,86]). RFS was estimated at 75% [70–81] at 12 months and at 64% [58–71] at 24 months. RFS at 12 months was significantly lower in patients with ulcerations (RFS at 83%) compared to those without ulceration (RFS at 66%), p < 0.01. Overall survival (OS) was estimated at 91% [87%–94%] at 12 months and 84% [79%–89%] at 24 months. The OS after a first recurrence was estimated at 69% [60%–80%] at 12 months and decreased to 43% [32%–57%] at 24 months. After a first locoregional recurrence, surgery with a year of adjuvant immunotherapy (40%) was the favoured therapeutic approach. For distant recurrences, clinical trial enrolment was preferred (21%). Double curative immunotherapy was the preferred strategy for cerebral recurrences (30%).

In this cohort, nearly half of the patients underwent recurrences and RFS at 24 months was 64%. The RFS and OS data were comparable o those reported in the pivotal study Ulceration was the only significant predictive factor for recurrence, associated with decreased RFS at 24 months.

This real‐life study based on 235 patients treated with adjuvant anti‐PD1 therapy provides a comprehensive view of the outcomes and factors associated with recurrence in patients with resected high‐risk stage III/IV melanoma. Ulceration emerged as the only significant predictive factor for recurrence and was associated with a decrease in recurrence‐free survival at 24 months.