MISSION

The Group aims to improve the clinical care of patients suffering with cutaneous or ocular (eye) melanoma, and to increase knowledge about melanoma acquisition and progression. Group sub-committees focus on topics including epidemiology, early stage melanoma, surgery, pathology and systemic therapy (adjuvant and for advanced disease).

PRACTICE CHANGING RESEARCH

Melanoma: Understanding the rising threat

Melanoma, the deadliest skin cancer, has increased rapidly in incidence over the last 50 years, becoming the 19th most common cancer globally, with 320,000 new cases and 55,000 deaths in 2020. Following Australia and New Zealand, European countries exhibit the highest melanoma rates, with approximately 144,000 yearly cases and 27,000 related deaths [a] [b] [c] 28

Challenges in treating stage III melanoma

Melanoma originates in skin melanocytes, the cells that produce the dark pigment melanin, and spreads via metastasis. Stage III melanoma patients often undergo surgery to remove the primary tumour and nearby metastasised lymph nodes, but this does not assure a cancer-free outcome, as they face a high risk of recurrence.

28 Sung, H. et al.Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin71, 209–249 (2021).

Unlocking the potential of ipilimumab: a high dose approach in melanoma treatment

Ipilimumab is an antibody-based drug that works as an immune checkpoint inhibitor and thereby increases anti-tumour immune responses. It was approved in 2011 for the treatment of advanced melanoma, at a dose of 3 mg per kilogram of body weight.38 39 The EORTC 18071 study is based on research suggesting the potential for a higher dose to have improved efficacy (although at the cost of more toxic effects)40 41,42. It  aimed to evaluate the effect of treating high-risk stage III melanoma patients with ipilimumab at a dose of 10 mg per kilogram after surgery, as compared with giving a placebo, to remove their primary tumour and nearby/affected lymph nodes.

EORTC study confirms long term survival benefits and quality of life for patients

The study showed a significant (over ten percent) increase in cancer recurrence-free survival with high-dose ipilimumab treatment after five years, as compared with placebo42. Even though there were adverse effects reported with ipilimumab, overall, the drug did not have a negative effect on the patients’ health-related quality of life43. After seven years, ipilimumab still showed durable recurrence-free survival as well as overall survival benefit, with an 8.7% absolute difference for overall survival44.

Study coordinator:  Prof. Alexander Eggermont

37 Eggermont, A. M. M. et al. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): A randomised, double-blind, phase 3 trial. Lancet Oncol 16, 522–530 (2015).

38 Hodi, F. S. et al. Improved Survival with Ipilimumab in Patients with Metastatic Melanoma. New England Journal of Medicine 363, 711–723 (2010).

39 Robert, C. et al. Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma. New England Journal of Medicine 364, 2517–2526 (2011).

40 Wolchok, J. D. et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol 11, 155–164 (2010).

41 Schadendorf, D. et al. Pooled analysis of long-term survival data from phase II and phase III trials of ipilimumab in unresectable or metastatic melanoma. Journal of Clinical Oncology 33, 1889–1894 (2015).

42 Eggermont, A. M. M. et al. Prolonged Survival in Stage III Melanoma with Ipilimumab Adjuvant Therapy. New England Journal of Medicine 375, 1845–1855 (2016).

43 Coens, C. et al. Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial. Lancet Oncol 18, 393–403 (2017).

44 Eggermont, A. M. M. et al. Adjuvant ipilimumab versus placebo after complete resection of stage III melanoma: long-term follow-up results of the European Organisation for Research and Treatment of Cancer 18071 double-blind phase 3 randomised trial. Eur J Cancer 119, 1–10 (2019).

STUDY INFORMATION
PUBLICATION

Empowering the immune system: Pembrolizumab’s role in melanoma treatment

Pembrolizumab – an antibody-based drug– has been shown to stimulate the body’s immune system to remove any remaining melanoma cells. The EORTC KEYNOTE-054 study looked at the effect of treating stage III melanoma patients with pembrolizumab after surgery, as compared to giving a placebo.

Sustained patient benefits: Pembrolizumab’s long-term impact on recurrence-free survival

The study found that pembrolizumab significantly reduced the risk of melanoma recurrence or death by over 40% after 1.25 years45, leading to EMA and FDA approvals in 2018 and 2019 for its use in high-risk stage III melanoma patients. After 3.5 years, pembrolizumab maintained a 65% recurrence-free survival rate, a 16% improvement over the placebo group46. Given these results, pembrolizumab therapy provides a clear and sustained relapse-free survival benefit for stage III melanoma patients and is considered a viable treatment option.

Study coordinator: Prof. Robert Caroline 

45 Eggermont, A. M. M. et al. Adjuvant Pembrolizumab versus Placebo in Resected Stage III Melanoma. New England Journal of Medicine NEJMoa1802357 (2018) doi:10.1056/NEJMoa1802357.
46 Eggermont, A. M. M. et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial. Lancet Oncol 22, 643–654 (2021).

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PUBLICATION

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