Safety and Efficacy of Immune Checkpoint Inhibitors in Patients with Melanoma and Pre-existing Autoimmune Conditions: a Systematic Review and Meta-analysis
| Thursday, August 14, 2025 |
| 10:22 AM - 10:29 AM |
| Ballroom 2 and 3 |
Overview
Dr Sana Haider
Speaker
Dr Sana Haider
Medical Oncologist
Western Sydney University
Safety and Efficacy of Immune Checkpoint Inhibitors in Patients with Melanoma and Pre-existing Autoimmune Conditions: a Systematic Review and Meta-analysis
Abstract
Background:
Melanoma patients with pre-existing autoimmune diseases (AID) have been excluded from pivotal clinical trials of immune checkpoint inhibitors (ICI), due to the risk of AID flare and immune mediated side-effects. In many patients, particularly those without specific BRAF mutations or with progression on targeted therapy, there are limited treatment options. We reviewed the evidence evaluating the safety and efficacy of ICI in melanoma patients with AID, to inform treatment decisions.
Methods:
A comprehensive literature search of Medline, Embase, CINAHL and SCOPUS was performed, using keywords and controlled vocabulary. Studies including melanoma patients with AID were included. Two reviewers used the Preferred Reporting Items for Systematic Reviews and Meta-Analysis reporting guidelines (PRISMA). The following outcomes were assessed: all grade de novo immune related adverse events (irAEs), grade 3 or 4 de novo irAEs, flare of AID, treatment discontinuation owing to adverse effect/s, treatment related mortality and objective response rate.
Results:
32% of patients with AID developed a flare of their disease, with 80% requiring immunosuppression with either corticosteroids or other immunosuppressives. In patients with AID, meta-analysis revealed a higher risk of all grade de novo irAEs (RR 1.16, p=0.0106, 95 % CI 1.01-1.33) but not grade 3 or 4 (RR 1.21, p=0.0663, 95% CI 0.99-1.47), compared to patients without AID. Treatment discontinuation owing to toxicity, treatment related mortality and objective response rate were not different amongst patients with or without AID.
Conclusion:
Melanoma patients with pre-existing AID are at significant risk of flare and de-novo irAE when ICIs are used. Patients with AID had an increased risk of irAEs however these were usually mild to moderate and did not result in treatment related deaths, with no differences in treatment response . Increased risks should be discussed with patients, in addition to close monitoring for flares and treatment related adverse events.
Melanoma patients with pre-existing autoimmune diseases (AID) have been excluded from pivotal clinical trials of immune checkpoint inhibitors (ICI), due to the risk of AID flare and immune mediated side-effects. In many patients, particularly those without specific BRAF mutations or with progression on targeted therapy, there are limited treatment options. We reviewed the evidence evaluating the safety and efficacy of ICI in melanoma patients with AID, to inform treatment decisions.
Methods:
A comprehensive literature search of Medline, Embase, CINAHL and SCOPUS was performed, using keywords and controlled vocabulary. Studies including melanoma patients with AID were included. Two reviewers used the Preferred Reporting Items for Systematic Reviews and Meta-Analysis reporting guidelines (PRISMA). The following outcomes were assessed: all grade de novo immune related adverse events (irAEs), grade 3 or 4 de novo irAEs, flare of AID, treatment discontinuation owing to adverse effect/s, treatment related mortality and objective response rate.
Results:
32% of patients with AID developed a flare of their disease, with 80% requiring immunosuppression with either corticosteroids or other immunosuppressives. In patients with AID, meta-analysis revealed a higher risk of all grade de novo irAEs (RR 1.16, p=0.0106, 95 % CI 1.01-1.33) but not grade 3 or 4 (RR 1.21, p=0.0663, 95% CI 0.99-1.47), compared to patients without AID. Treatment discontinuation owing to toxicity, treatment related mortality and objective response rate were not different amongst patients with or without AID.
Conclusion:
Melanoma patients with pre-existing AID are at significant risk of flare and de-novo irAE when ICIs are used. Patients with AID had an increased risk of irAEs however these were usually mild to moderate and did not result in treatment related deaths, with no differences in treatment response . Increased risks should be discussed with patients, in addition to close monitoring for flares and treatment related adverse events.
Biography
Dr Sana Haider completed her medical degree at Western Sydney University and has trained in medical oncology at Chris O'Brien Lifehouse, Dubbo Base Hospital, Liverpool Hospital and The Kinghorn Cancer Centre.
She has completed a fellowship in phase 1 clinical trials at Liverpool Hospital in NSW in 2021. She is currently a PhD candidate looking at blood and stool-based biomarkers predictive of immune related adverse events in patients with solid malignancies.
She currently works part time in regional Tasmania and has a special interest in thoracic and breast malignancies.
Session Chair
Tim Clay
St John Of God Subiaco Hospital
