1156P - Immune-related adverse events in a nationwide cohort of melanoma patients treated with adjuvant anti-PD1: Seasonal variation and association with outcome

Background

The introduction of immune checkpoint inhibitors (ICIs) has transformed the treatment of advanced melanoma. However, treatment comes with the risk of immune-related adverse events (irAEs). Especially now that immunotherapy has moved to the adjuvant setting, doctors and patients must weigh potential benefits versus risks based on as much available information as possible. Real-world data are essential for decision-making.

Methods

A nationwide study on irAEs in Danish real-world patients treated with adjuvant anti-PD1 therapy for resected stage III-IV melanoma from 2018-2022. Data were retrieved from two national databases, the IMMUNOTOX database and the Danish Metastatic Melanoma Database (DAMMED).

Results

Data from 792 patients were included. The majority of patients were male (55%) with a median age of 62 (range 16-88) at time of first treatment. In total, 697 patients (88%) experienced an irAE, the most common being fatigue (44%). Low-grade irAEs (grades 1-2) were very common, whereas different subtypes of severe irAEs (grades 3-5) were observed in 0.3-4%. In total, 121 patients (15.3%) experienced severe irAEs out of which five patients (0.6%) died due to irAE. Having at least one irAE was associated with a lower risk of melanoma relapse. Seasonal variation was observed with more frequent debut of organ-specific (gastrointestinal, ocular, musculoskeletal, and thyroid) irAEs during summer, while mild skin toxicities were more frequent in the winter period.

Conclusions

In this nationwide cohort of real-world adjuvant melanoma patients, we observe that having any grade of irAEs, as well as a severe irAE, is slightly more frequent compared to clinical phase III trials and comparable to previously published real-world studies. Further, the risk of relapse from melanoma is lower among patients experiencing an irAE. Finally, significant seasonal variation in irAE incidence was observed.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

E. Ellebæk: Financial Interests, Personal, Invited Speaker: Pierre Fabre, BMS, Novartis, MSD, Pfizer; Other, Travel and conference expenses: MSD, Pierre Fabre. R.B. Holmstroem: Non-Financial Interests, Personal, Invited Speaker, Talk on Immune-related adverse events: Best Practice Nordic. M. Donia: Financial Interests, Personal, Invited Speaker, Teaching: Novartis, Roche; Financial Interests, Personal, Other, Advisor: Achilles Therapeutics; Non-Financial Interests, Other, Sub-investigator of clinical trial with connected translational research: Bristol Myers Squibb; Non-Financial Interests, Personal, Proprietary Information, Proprietary data access: Bristol Myers Squibb; Non-Financial Interests, Personal, Proprietary Information, Proprietary Data Access: Genentech; Other, Chairman of the Melanoma and Non-melanoma Skin Cancer Scientific Committee: Danish Medicines Council (Medicinrådet). C.A. Haslund: Financial Interests, Personal, Invited Speaker: MSD, GSK, BMS; Financial Interests, Institutional, Local PI: BMS, Tesaro, MSD, IO Biotech, Chimerix, Incyte; Financial Interests, Institutional, Coordinating PI: GSK, Celgene Aps. L. Bastholt: Non-Financial Interests, Advisory Role, Scientific Committee under Danish Medicines Agency regarding new Treatments of Melanoma, Skin Cancer and Thyroid Cancer: Danish Medicines Agency. I. Svane: Financial Interests, Personal, Advisory Board: BMS, Pierre Fabre, Novartis; Financial Interests, Personal, Invited Speaker: MSD, Pierre Fabre, Novartis, Roche, BMS; Financial Interests, Personal, Writing Engagement: MSD; Financial Interests, Personal, Stocks/Shares, Cofounder and Founder warrants: IO Biotech; Financial Interests, Institutional, Research Grant: Adaptimmune, Enara Bio, Lytix Biopharma, TILT Biotherapeutics; Financial Interests, Institutional, Funding: Evaxion; Non-Financial Interests, Principal Investigator: BMS, Novartis, Roche, TILT Biotherapeutics, Lytix Biopharma. All other authors have declared no conflicts of interest.