New hope may be on the horizon for melanoma patients in the form of a novel skin cancer vaccine.
This week, Moderna announced that its new vaccine has shown promising results in clinical trials.
Among 157 patients with advanced melanoma, the vaccine led to "statistically significant improvement in survival before the cancer returned," according to a statement from Hackensack Meridian John Theurer Cancer Center in New Jersey, which has been participating in the clinical trials.
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In the study, the vaccine was used in combination with Merck’s immunotherapy drug, Keytruda.
"Keytruda is a checkpoint inhibitor, meaning it blocks an enzyme that the cancer cell uses to become invisible to the immune system," said Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, was not involved in the vaccine trials.
"Keytruda works well in certain kinds of highly mutagenic cancers, including melanoma, and there is often a very effective response," Siegel told Fox News Digital.
"But the cancer can then mutate away from the impact of the drug and once again become resistant to an immune response."
The patients who took the experimental mRNA vaccine along with Keytruda — all of whom previously had surgery to remove their cancer — saw a 44% reduction in the risk of death or recurring disease compared to those who did not take the vaccine, the companies said.
"This is truly game-changing, groundbreaking stuff," said Dr. Andrew Pecora, an oncologist and researcher at the Hackensack Meridian John Theurer Cancer Center, who has been involved in the clinical trials since they began.
Immunotherapy has been shown to be effective in about half of cancer patients, Pecora noted — but for the other half, the proteins of the tumor are not properly presented to the immune system to be recognized and killed.
"In those cases, the melanoma is kind of hiding out or it doesn't express proteins that well, so the immune system doesn't recognize the proteins as foreign," Pecora told Fox News Digital in a phone interview.
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The Moderna vaccine is "revolutionizing" the immune system’s ability to recognize and kill the melanoma, he said.
The vaccine, which Pecora described as "miraculous," is personalized to each patient’s specific tumor.
"You and I may have melanoma, but my melanoma may be very different than yours even though it looks exactly the same under the microscope, because the DNA changes that occurred in mine are different than yours," he told Fox News Digital.
That means a generic cancer vaccine wouldn’t work for everyone, Pecora said.
With the new vaccine, the scientist takes a piece of the person's tumor and precisely determines what parts of the DNA of the tumor are mutated or changed, and then creates a personalized mRNA vaccine that targets those changed pieces of DNA, the doctor said.
"We can literally vaccinate the person against their tumor-specific proteins, overcoming one of the limitations of current immunotherapy," he said.
"The simultaneous use of an mRNA vaccine seems to show improved regression and remission of metastatic melanoma," Siegel said.
"I think this shows real promise for combined therapies."
The vaccine is now entering Phase 3 trials, as the researchers work to determine how and when it will receive FDA approval.
The trial participants have not reported any side effects other than what they experienced with immunotherapy, Pecora said.
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"It could be approved as soon as the next year or two," he predicted.
The hope is that this breakthrough will also be applied to other forms of cancer beyond melanoma.
The deadliest form of skin cancer, melanoma is fast-growing and can spread to any organ.
In 2023, nearly 187,000 Americans were expected to be diagnosed with melanoma, according to the Melanoma Research Foundation.
More than 97,600 of those will be diagnosed with invasive melanoma, and 7,990 Americans are expected to die from the disease in 2023.
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