Evidence to move therapy earlier in melanoma

Targeted therapies and immunotherapies have an earlier role to play in the management of melanoma, according to interim findings from two international studies in predominantly stage III resected disease.

The findings, presented this week at the European Society for Medical Oncology (ESMO) Annual Congress, suggest patients should not have to wait for recurrence before accessing the therapies.

The COMBI-AD trial, led by Professor Georgina Long from the Melanoma Institute Australia, found adjuvant dabrafenib plus trametinib reduced the recurrence rate and improved overall survival in patients with resected stage III BRAF-mutated melanoma.

The three-year relapse-free survival rate was 58% following the combination treatment compared to 39% with placebo. Three-year overall survival was 86% in the treated group compared to 77% in the controls.

Professor Richard Scolyer, co-medical director at the Institute said the evidence that targeted therapies could prevent progression to more advanced, potentially fatal stage IV disease was welcome news for the 40% of melanoma patients with oncogenic BRAF mutations.

“Previously, patients with resected high-risk stage lll disease basically had to play the waiting game to see if the melanoma recurred. They had regular imaging etcetera to try and detect disease recurrence as early as possible, but were not offered active therapy.”

He told the limbic the drugs were currently funded for stage IV melanoma but not for stage lll.

“Quite rightly the government requires evidence to make decisions about whether drugs should be funded and these clinical trials provide important evidence for the government to consider.”

The CheckMate 238 trial showed treatment with nivolumab decreased the chance of relapse over ipilimumab in patients with high-risk stage III and stage IV resected disease.

One-year recurrence-free survival was 70.5% with nivolumab and 60.8% with ipilimumab however the follow-up period has been insufficient to determine longer-term survival rates.

“In each of the trials the patients received therapy for a year and the plan is to follow them up for five years so there is more data to play out yet.”


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