A new messenger RNA vaccine developed by Moderna and Merck has been shown to reduce the chance of recurrence or death from melanoma — the most dangerous form of skin cancer — by half after three years when paired with Merck’s antibody medication Keytruda, the companies announced Thursday.
The combination of the treatments cut the risk of recurrence or death by 49 per cent compared with Keytruda alone in the midstage trial, the drugmakers said.
The three-year study involved 157 patients with stage 3 and 4 melanoma, whose tumours were removed before being treated with either the vaccine or drug. The reduction is up from 44 per cent found a year earlier.
“It’s huge,” Melanoma Canada CEO Falyn Katz told Global News of the announcement. “This is a breakthrough.”
The vaccine is custom-made for each recipient based on the DNA sequence of their removed tumour. The vaccine then activates an antitumour immune response “by generating specific T-cell responses based on the unique mutational signature of a patient’s tumor,” Moderna and Merck said in a statement.
Katz said it is the first cancer treatment that uses vaccines that she knows of, and suggests it’s possible vaccines could be used to treat other cancers.
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“Melanoma is often the guinea pig of cancers that are tested with these new treatments,” she said. “A lot of melanoma treatments have gone on to treat breast cancer as well.”
A breast cancer vaccine is currently in early clinical trials.
Katz mentioned that the side effects from the treatment also seem to be reasonable and tolerable for patients.
“The durability of the responses (from the treatment) is really strong, they’re essentially rock solid through this time,” Moderna president Stephen Hoge told Reuters. “This is a pretty significant improvement, a pretty dramatic improvement over standard of care with just Keytruda alone.”
Hoge said though that it may be some time before the companies can file for regulatory approval of the treatment, Moderna is already building a dedicated facility in Massachusetts to produce the vaccine at a commercial scale, which it hopes to finish next year.
“We need to make sure that we have that near completion before we could even contemplate asking for approval,” Hoge said.
He said the companies are engaging with regulators globally on the pathway for approval for the product.
Katz noted that the melanoma treatment could be approved for reimbursement by governments in Canada.
Melanoma kills about 1,200 Canadians every year, she said.
A late-stage trial has already begun for the combination treatment, as well as for non-small cell lung cancer that is currently enrolling patients.
— with files from Reuters.
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