Abstract 74P
Background
Adjuvant immunotherapy has been widely implemented for resected stage III melanoma since 2018. However, its impact on overall survival (OS) and melanoma-specific survival (MSS) remains uncertain. OS and MSS data from pivotal phase III trials of adjuvant anti-PD-1 therapy vs placebo has yet to be reported. Here, we present OS and MSS data from a national population-based cohort diagnosed with stage III melanoma before and after the introduction of adjuvant therapy.
Methods
Data were obtained from national Danish registries. The study cohort consisted of patients diagnosed with first-time, resectable stage III melanoma before and after the introduction of adjuvant anti-PD-1 therapy (November 2018), covering January 2016 to June 2018 (pre-cohort) and January 2019 to December 2020 (post-cohort). Patients were followed until August 12, 2024. Propensity score matching (PSM) was used to adjust for baseline characteristics (sex, age, AJCC8 stage and Charlson Comorbidity Index).
Results
475 and 567 patients were included in the pre- and post-cohort, respectively. In the post-cohort, 306 (54%) patients received anti-PD-1 therapy (adjuvant cohort) and 4 (0.7%) received BRAF/MEK inhibitors as adjuvant treatment. No differences in later first-line metastatic therapies were observed between the cohorts not receiving adjuvant therapy. Median follow-up was 87 months for the pre-cohort and 55 months for the post-cohort. In the post- vs. pre-cohort, the 4-year OS was 78.9% and 77.5% (HR 0.86, 95% CI 0.68-1.1, P=0.24) and the 4-year MSS was 85.1% and 83.4% (HR 0.83, 95% CI 0.62-1.12, P=0.223). In a subanalysis of the adjuvant cohort vs. pre-cohort, after PSM (n=306 in each), the HR for OS was 0.65 (95% CI 0.47-0.91, P=0.012), while the HR for MSS was 0.70 (95% CI 0.48-1.02, P=0.063).
Conclusions
This is the longest observation of real-world patients with stage III melanoma in the modern era of adjuvant immunotherapy. Comparison of survival curves after PSM cannot exclude a survival benefit of adjuvant anti-PD-1 therapy in the long run.
Legal entity responsible for the study
The authors.
Funding
Danish Cancer Society Copenhagen University Hospital, Herlev and Gentofte, Herlev Dansk Kræftforskningsfond Lizzi og Mogens Staal Fonden Køben Kjær Født la Cour-holmes Fond Marie og Børge Kroghs Fond.
Disclosure
M.B. Weitemeyer: Financial Interests, Personal and Institutional, Research Funding, Funding to conduct a descriptive report of stage II/III melanoma patients in DK, covering my salary: MSD DK; Financial Interests, Personal, Speaker, Consultant, Advisor, Oral presentation of descriptive data on Danish stage II/III melanoma at an advisory board meeting: MSD DK. M. Donia: Financial Interests, Personal, Other, Advisor: Achilles Therapeutics; Financial Interests, Personal, Other, Advisor (not for pharmaceutical companies): Guidepoint Global LLC, Alphasights; Other, Personal, Other, Chairman of the Melanoma and Non-melanoma Skin Cancer Scientific Committee: Danish Medicines Council (Medicinrådet). N.M. Helvind: Financial Interests, Personal, Speaker, Consultant, Advisor, Speaker: MSD DK. L. Bastholt: Non-Financial Interests, Personal, Advisory Role, Scientific committee under Danish Medicines Agency regarding new treatments of melanoma, skin cancer and thyroid cancer; Danish Medicines Agency. I.M. Svane: Financial Interests, Personal, Advisory Board: Novartis, Mendus, Instil Bio; Financial Interests, Personal, Invited Speaker: MSD, BMS, Sanofi, Takeda; 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, Asgard Therapeutics, IO Biotech; Financial Interests, Institutional, Funding: Evaxion; Financial Interests, Institutional, Other, drug for investigator driven trial: BMS; Non-Financial Interests, Personal, Principal Investigator: BMS, Roche, TILT Biotherapeutics, Lytix Biopharma, Novartis, Immunocore, MSD. L. Rosenkrantz Hölmich: Other, Institutional, Research Funding, Funding to conduct a descriptive report of stage II/III melanoma patients in DK: MSD DK. E. Ellebaek: Financial Interests, Personal, Invited Speaker: Pierre Fabre, BMS, Novartis, MSD, Pfizer; Other, Personal, Other, Travel and conference expenses: MSD, Pierre Fabre. All other authors have declared no conflicts of interest.
Resources from the same session
7P - ACOX2 disturbs the stability of MRE11-RAD50-NBS1 complex and shapes activated immune tumor microenvironment in clear cell renal cell carcinoma
Presenter: Shiqi Ye
Session: Poster Display session
Resources:
Abstract
9P - CXCR6+PD-1- Tissue Resident memory T cells are associated with poor prognosis in patients with metastatic colorectal cancer
Presenter: Emilien Laloy
Session: Poster Display session
Resources:
Abstract
10P - Tumor-infiltrating lymphocytes and tertiary lymphoid structures in oral cavity squamous cell carcinoma in non-smokers and non-drinkers: Predict clinical outcome
Presenter: Israa Laklouk
Session: Poster Display session
Resources:
Abstract
11P - Tumor-infiltrating lymphocytes on routine H&E staining with automated quantification predict outcomes in resectable non-small cell lung cancer
Presenter: Guus Heuvel
Session: Poster Display session
Resources:
Abstract
12P - Epithelial-mesenchymal transition facilitates response to AXL/PD-1 inhibition in relapsed mesothelioma
Presenter: Essa Baitei
Session: Poster Display session
Resources:
Abstract
14P - Integrated genomic analysis of whole genomes to derive a biomarker of durable response to immunotherapy in melanoma
Presenter: Irene Lobon
Session: Poster Display session
Resources:
Abstract
15P - Verteporfin might potentiate the effects of anti-PD-1 therapy in melanoma-bearing mice model
Presenter: Szonja Kovács
Session: Poster Display session
Resources:
Abstract
16P - Immune checkpoint blockade and HLA-related epistasis in melanoma: Genetic determinants of response and toxicity
Presenter: Martin Little
Session: Poster Display session
Resources:
Abstract
17P - Identification PD-L1-associated lncRNA biomarkers for immunoregulation in ovarian cancer
Presenter: Hee Jung Kim
Session: Poster Display session
Resources:
Abstract
19P - Genetic profiling of early triple-negative breast cancer patients with an indication for neoadjuvant pembrolizumab
Presenter: Bogdan Popescu
Session: Poster Display session
Resources:
Abstract