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An experimental skin cancer vaccine significantly reduced the risk of melanoma returning or spreading in a late-stage clinical trial from Merck and Moderna.
The results mark the first positive phase 3 trial of an mRNA-based personalized cancer therapy, according to the companies.
Known as INTerpath-001, the study evaluated 1,137 patients globally who had surgery to remove high-risk (Stage IIB through Stage IV) melanoma. Patients were randomly assigned to receive either KEYTRUDA plus the personalized vaccine or KEYTRUDA plus placebo.
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Patients who received the combination experienced significantly better “recurrence-free survival,” meaning their cancer was less likely to return than in those who received KEYTRUDA alone.
The combination also significantly improved “distant metastasis-free survival,” a measure of how long patients remained alive without the cancer spreading to distant parts of the body.
“These phase 3 findings represent a pivotal moment for the field of cancer research,” said Stéphane Bancel, CEO of Moderna, in the press release. “For many years, the idea of creating an mRNA treatment designed specifically for an individual patient’s cancer was aspirational. We are now helping turn that vision into a reality.”
How the personalized vaccine works
Unlike traditional vaccines that protect against external viruses, the custom-tailored mRNA vaccine (intismeran autogene) is a therapeutic vaccine given after surgery to train the body to hunt leftover cancer cells.
After a patient undergoes surgery to remove a tumor, doctors sample both the cancerous tissue and healthy cells. Then, advanced algorithms analyze the tumor’s genetic sequence to select up to 34 tumor-specific neoantigens to encode in the personalized treatment.
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Dr. Murad Alam, chief of dermatology at Northwestern Medicine in Chicago, noted that not all melanomas are the same.
“They’re slightly different in every patient, which is why traditional chemotherapies often stop working or don’t work in a particular patient,” he told Fox News Digital. “This is almost individualized immunotherapy, where you’re finding specific issues in a particular patient.”
The individualized approach is designed to direct the immune system toward tumor-specific targets, Alam noted.
“It doesn’t hit normal cells, and it hits the cancer cells very effectively because it’s not just a generic vaccine. It’s one that specifically knows the signs of your cancer and can find it,” he said.
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The goal of this particular vaccine, according to the doctor, is to extend the lives of people who “already have a bad case of the disease.”
It is not intended to prevent melanoma in people who do not have the disease, even if they have a family history that may put them at greater risk, nor is it intended for those with a very small melanoma.
“This is designed for people where the melanoma has grown to the point where it’s threatening not just the local area of the skin, but their whole lives,” Alam said.
The role of AI
Alam also spoke about the role of artificial intelligence in determining which antigens to include in the vaccine so that it is most effective.
“These things are difficult, and historically [they] took a lot of time, and it just wouldn’t be feasible to do this for every individual patient without the power of AI,” he said. “And I’m sure that will become better and better in the future.”
“This is designed for people where the melanoma has grown to the point where it’s threatening not just the local area of the skin, but their whole lives.”
“Here, AI is a tool that allows you in a reasonable amount of time, with a reasonable amount of resources … to come up with a vaccine for that individual person.”
What comes next
Following the successful phase 3 outcome, Merck and Moderna announced plans to engage with regulatory authorities worldwide, including the U.S. Food and Drug Administration, about potential regulatory filings.
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Plans are in the works to test the vaccine technology against other hard-to-treat cancers, including lung, bladder and kidney cancers.
“I think the underlying concept of targeting a particular tumor with the specific markers on that tumor is generalizable, meaning you could do this with different kinds of skin cancer, or different kinds of cancer in general,” Alam agreed. “It’s very exciting.”
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Although the companies said the results were significant and meaningful, the findings are still early and did not reveal how long patients remained cancer-free.
The phase 3 announcement also did not establish whether the treatment ultimately helps patients live longer.
The recurrence-free survival results were also based on investigator assessments rather than an independent central review, the release noted.
The study only looked at people with specific stages of skin melanoma who had surgery and no prior drug treatments, so the results may not apply to other types or stages of cancer.
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Merck said the treatments’ side effects were similar to those seen in earlier studies, with no new safety concerns identified.
Alam reiterated that the vaccine seems to have both a “tremendous benefit [and] good side effect profile.”
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“When you’re getting very strong cancer medications, even when they work, the toll on the patient is often terrible,” he said. “It alters their life during the course of treatment where there’s tremendous suffering.”
“The nice thing about this because it’s so targeted, it doesn’t damage many of your normal cells … so the side effects are really mild — a little fatigue, a little chills, some injection side pain.”
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