Melanoma trial rewrites rulebook on immunotherapy and surgery
03 June 2024
A landmark clinical trial has shown that combination immunotherapy before surgery dramatically improves outcomes in advanced melanoma and will likely change practise.
Peter Mac was a major recruitment site for the NADINA trial, which overall enrolled more than 420 patients with melanoma whose cancer had spread to their lymph nodes.
The highly anticipated results of this Phase III clinical trial were just presented during the Plenary session at the American Society of Clinical Oncology (ASCO) annual scientific conference underway in Chicago, USA.
The trial compared patients given a combination immunotherapy (ipilimumab plus nivolumab) before surgery, to those who received only nivolumab after surgery which is the standard-of-care.
Event-free survival was 83.7% in the before-surgery group at 12 months after treatment, compared to 57.2% among patients who had immunotherapy after surgery. Notably, 58% of patients in the before-surgery group who achieved a major response did not go on to need additional immunotherapy.
The trial was led by the Melanoma Institute Australia (MIA) and the Netherlands Cancer Institute with cancer hospitals in Europe, Australia and the USA supporting recruitment. Australian patients made up a third of all those recruited globally.
Professor Shahneen Sandhu led recruitment at Peter Mac and says the results were: “transformative for advanced melanoma and will a lead to similar approaches being evaluated in multiple other tumour types”.
“These data support the use of immunotherapy before surgery as opposed to following surgery for patients with resectable, high-risk stage III melanomas.”
MIA surgeon Assoc Prof Alex van Akkooi says: “This trial has flipped the traditional ‘surgery then drugs’ rationale on its head, and melanoma patients across the world will now benefit”.
MIA Co-Medical Director Professor Georgina Long AO adds “the next step is to refine who gets what immunotherapy before surgery as some patients will need combination and others will not”.
“Combination neoadjuvant, or pre-surgery, immunotherapy should now be considered a new standard of treatment for higher-risk Stage III melanoma, and should also now be clinically evaluated for use across the wider oncology field,” Prof Long says.
Last year, the NADINA trial was named by Nature Medicine as one of the 11 clinical trials most likely to impact global medicine in the coming year. The trial results were also simultaneously published in the New England Journal of Medicine.
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About Peter Mac
Peter MacCallum Cancer Centre is a world leading cancer research, education and treatment centre and Australia’s only public health service dedicated to caring for people affected by cancer.