A team of Australian researchers has made the ultimate move in the battle to beat melanoma, successfully trialing a combination of new treatments to stop the disease in its tracks and prevent it from spreading or metastasizing to distant organs.
Melanoma is the deadliest form of skin cancer, with one Australian dying from advanced melanoma every five hours.
Ground-breaking results from two international clinical trials conducted by investigators at Melanoma Institute Australia are being presented today at one of the world’s largest medical oncology conferences, the European Society for Medical Oncology (ESMO) 2017 Congress in Spain. The research has also been published in the prestigious New England Journal of Medicine today.
The trials, COMBI-AD and CheckMate 238, proved successful in preventing the spread of disease in Stage III melanoma patients whose tumors had been surgically removed. Until now, these patients were at a high risk (40−70 per cent) of their disease progressing to advanced and fatal melanoma.
“These results will change the way we treat melanoma patients as well as their quality of life,” says study author Professor Georgina Long, Conjoint Medical Director of Melanoma Institute Australia and Chair of Melanoma Medical Oncology and Translational Research at The University of Sydney.
“Until now, Stage III melanoma patients who have had their tumors surgically removed have simply had to play the waiting game, to see if their melanoma would metastasise or spread. Living with such fear severely affected them and their loved ones. “Results from these clinical trials suggest we can stop the disease in its tracks – effectively preventing it from spreading and saving lives. Our ultimate goal of making melanoma a chronic rather than a terminal illness is now so much closer to being achieved,” she said.
In the COMBI-AD trial, patients were randomized to receive a combination of targeted therapies (dabrafenib and trametinib) or placebo for 12 months. Targeted therapies block the action of a particular gene which is a driver for melanoma. It was aimed at patients who are BRAF positive. It not only prevented resected Stage III melanoma from recurring, but it increased overall survival.
The CheckMate 238 trial involved patients with high risk Stage III and Stage IV disease who had had all melanoma surgically removed. They were randomized to be treated with the immunotherapy nivolumab or ipilimumab for 12 months. Immunotherapies reboot the immune system to attack the melanoma cells. Results showed nivolumab decreased the chance of relapse, and it had a superior safety profile over ipilimumab. This benefit was seen in patients regardless of BRAF mutation status. The follow up period is too short to yet determine long-term survival rates.
Research had already shown that targeted and immune therapies can successfully treat patients with advanced (Stage IV) melanoma that could not be removed surgically.
These clinical trials are the first in the world to give the treatments to melanoma patients at an earlier stage of the disease to prevent spread and recurrence.
“These clinical trials show we now have ammunition to prevent melanoma spreading and progressing, which until now was a critical area of disease behavior where we had no control,” Professor Long said.
“This will change how melanoma is treated around the world, as we no longer have to passively wait to see if the melanoma spreads.
“We can now actively and effectively attack the melanoma at an earlier stage, reducing the dreadful anxiety for patients about progressing to a potentially terminal illness and ensuring they have much better outcomes,” she said.