Optimising malignant melanoma management in Europe
EUMelaReg collects health information to improve care and treatment for patients with skin cancer.
Sustaining and fostering collaboration between academia and industry
for the collection of baseline, treatment and outcome data of representative samples of malignant melanoma patients of major European countries.
Building the most comprehensive skin cancer registry in the world
EUMelaReg collects real-world data on melanoma patients throughout Europe and integrates them in a data warehouse.

Five EUMelaReg Posters Presented at ESMO in Madrid

We are delighted that five EUMelaReg projects were selected for presentation at this year’s ESMO Congress in Madrid. A special thank you to all our collaborators for their valuable contributions!

Here’s a brief overview of the five projects:

Effectiveness of Dabrafenib plus Trametinib as second-line therapy in comparison to first line in BRAFV600 mutated metastatic melanoma patients. A EUMelaReg real-world study

This retrospective study evaluated the effectiveness of Dabrafenib/Trametinib in 2L following progression on 1L immune checkpoint inhibitors in comparison to Dabrafenib/Trametinib in 1L in BRAFV600 mutated patients with non-resectable stage III or metastatic stage IV cutaneous melanoma retrieved from the EUMelaReg registry. Primary objective was OS from start of 2L Dabrafenib/Trametinib therapy. Secondary objective included OS, PFS, ORR, and TOT for 2L compared to 1L Dabrafenib/Trametinib therapy.

In summary, our results show that failure of 1L immune checkpoint inhibitors did not adversely affect the effectiveness of subsequent Dabrafenib/Trametinib therapy. These findings indicate preserved clinical activity and survival outcomes of Dabrafenib/Trametinib when used in 2L, supporting its robustness and sequencing flexibility in routine clinical practice.

Real-world treatment patterns in metastatic melanoma: Comparison of data from the Central and South Eastern European Registry (CSEEREG) and the Danish Metastatic Melanoma Database (DAMMED)

This retrospective study evaluated the association between access to novel melanoma therapies and survival outcomes by comparing data from the CSEEREG (patients from Bosnia-Herzegovinian, Croatian and Serbian melanoma centers) with the DAMMED (patients from all Danish melanoma patients) registry. Patients with metastatic melanoma were stratified by Period 1 (01.01.2017 to 31.12.2019) and Period 2 (01.01.2020 to 31.12.2023) based on the initiation of 1L treatment for their metastatic disease. Objectives included the assessment of the impact on OS of 1L and the comparison of demographic and prognostic differences in CSEEREG vs DAMMED patients.

In summary, this is the first study showing significant differences in treatment patterns and OS between patients with metastatic melanoma in selected European countries. After matching for significant prognostic factors clear OS differences were observed, indicating that restricted access to therapies negatively affects survival outcomes.

MELASITE: UV Exposure Pattern as a Clinical Surrogate for Immunotherapy Response in Advanced Melanoma

This retrospective study evaluated whether UV exposure pattern of the primary melanoma independently predicts response and survival following immune checkpoint inhibition in advanced cutaneous melanoma and explored the biological basis of this association by evaluating its interaction with BRAF status and tumor mutational burden. Patients with advanced cutaneous melanoma who were treated with immune checkpoint inhibitors were retrieved from the EUMelaReg registry and classified according to the UV exposure pattern of the primary tumor into chronically sun-exposed (CSE), intermittently sun-exposed (ISE), and sun-protected (SP) groups. Study endpoints included ORR, PFS, and OS.

In summary, primary melanoma UV exposure pattern was strongly and independently associated with immunotherapy outcomes: CSE, ISE and SP melanoma showed a clear gradient in ORR, PFS and OS. A corresponding tumor mutational burden gradient was observed across UV exposure groups, supporting a biological basis for the differences in immune checkpoint inhibitors sensitivity. The UV exposure gradient in PFS and OS was pronounced among BRAF wild-type patients but was absent in BRAF-mutant melanoma. We hypothesize that BRAF signaling may partly override the immunogenic advantage associated with UV-induced mutational burden. Primary melanoma UV exposure groups define biologically and clinically distinct diseases and may serve as a clinically accessible surrogate for tumor immunogenicity, particularly in BRAF wild-type.

Impact on survival of early discontinuation of immune checkpoint inhibitors after objective response in melanoma

This retrospective study evaluated patients from the EUMelaReg registry who were treated with 1L immune checkpoint inhibitors between 2019 and 2024 with a best overall response of CR or PR before end of treatment in Denmark compared to other European countries. Objectives included comparison of survival outcomes among patients with melanoma who achieve an objective response to immune checkpoint inhibitors therapy and either discontinue treatment early based on response or continue treatment in Denmark compared to other European countries.

In summary, Danish patients with immune checkpoint inhibitors-induced objective response were discontinued earlier than patients of the pan-European control cohort. Danish patients and the European control cohort showed similar PFS. Comparability of OS was compromised by a shorter follow-up in the control cohort. Findings confirm that early discontinuation following objective response can be pursued without compromising durability of response.

Decision Making on Adjuvant Anti-PD1 Treatment in Stage IIB/IIC Melanoma in Europe. -DECIDE-II-

In this prospective observational study, we evaluated the acceptance of adjuvant anti-PD-1 treatment and the characteristics of patients with completely resected stage IIB/IIC cutaneous melanoma in routine clinical practice. Primary objectives were to describe adjuvant anti-PD1 treatment rates, factors influencing physician or tumor board recommendations, and patient motivations for declining recommended/offered adjuvant therapy. Secondary objectives were to examine patient-related, socioeconomic, and disease-specific factors associated with treatment recommendations and decisions. Patient demographics and data influencing treatment decisions were assessed using the EQ-5D-5L, SDM-Q-9, DECLINE and NOTOFFER questionnaires at baseline prior to treatment.

In summary, our study shows that acceptance of adjuvant anti-PD1 in stage IIB/IIC melanoma is limited, driven primarily by higher age and comorbidities. Beside age as the main determinant, quality of the shared decision making seems crucial. These findings highlight a gap between clinical trial populations and real-world patients, underscoring the need for tailored benefit-risk communication in older patients.