By Linda Carroll and Reynolds Lewis —
NBC News
In 2019, Gary Keblish received a stunned diagnosis from his surgeon.
The flat, dark-brown mole he'd had on his back for as long as he could remember had turned into an advanced, life-threatening melanoma.
“I felt numb,” the Brooklyn professor, now 61, said in an interview.
Fortunately, Keblish was able to sign up for a small clinical trial to test a preventative vaccine that could prevent the disease from coming back.
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The trial focused on a personalized vaccine using mRNA technology that used mutations to target mutations unique to the patient's cancer, but not the body's healthy cells.
All trial participants would receive the immunotherapy drug Keytruda (pembrolizumab), the standard treatment for high-risk melanoma patients like Keblish.
Two-thirds of the participants would also receive the vaccine.
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Keblish was one of those who received
the vaccine, which teaches the body's immune system to recognize cancer cells
as different from normal cells so that, together with the immunotherapeutic drug, it can attack them.
After two years, Keblish's cancer has not come back.
The benefits of a personalized vaccine
This Sunday the results of the phase 2 trial were presented at the annual meeting of the American Association for Cancer Research, which showed that the combination of the vaccine and immunotherapy reduces the risk of recurrence by almost half.
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This is the first randomized, controlled trial to show the benefits of this type of cancer vaccine, according to lead investigator Dr. Jeffrey Weber, deputy director of the NYU Langone Perlmutter Cancer Center and professor of medicine at the Grossman School of Medicine in New York. NYU university.
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To test the efficacy of the vaccine, the international team of researchers recruited
157 melanoma patients
whose tumors had been surgically removed and who were at high risk of their cancers recurring.
Of these, 50 received only the immunotherapy medication and the other 107 also received the personalized vaccine.
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One way cancer evades the immune system is to trick the body into thinking the threat has passed, at which point the natural braking system kicks in to prevent the immune system from being constantly activated.
Weber likens how pembrolizumab works to cutting a stuck brake cable on a car so it can move forward.
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Once the braking system has been partially disabled, "the immune system works really well," Weber said, adding that the downside of "cutting the brake cable" is that the immune system stays on and some people end up with inflammation and something similar to an autoimmune disease.
Another way that cancer can avoid being destroyed is through mutations, so that the soldiers of the immune system stop recognizing it as a threat.
Gary Keblish. Courtesy Paul Keblish
That's where the personalized mRNA vaccine comes into play.
After removing a patient's tumor, doctors identify specific proteins in that tumor and in no other cell in the body.
Up to 34 proteins from a patient's tumor were then targeted by the vaccine.
In the trial, 40% of patients who received the immunotherapy drug alone had a cancer recurrence during the two years of follow-up.
By comparison, 22.4% of patients who received the drug plus the vaccine had a recurrence, a difference of 44% between the two groups.
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According to Dr. Antoni Ribas, professor of medicine at the University of California, Los Angeles and director of the Tumor Immunology Program at the UCLA Jonsson Comprehensive Cancer Center, the new results are significant.
"This is the first time that a cancer vaccine has been shown to have this level of benefit,
close to a 50% reduction in the risk of relapse," Ribas said. "It tells us that these vaccines really work and can activate an immune response against the patient's own cancer.
The trial results are "very exciting," said Thomas Marron, director of the Tisch Cancer Institute's Early Phase Trials Unit and associate professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“Once the tumor is removed, we know that it can recur because small microscopic fragments have traveled to another part of the body and have settled there,” he explains.
Recurrence usually appears quickly, between six months and two years.
The beauty of the vaccine in this study is that
it targets up to 34 mutations,
Marron explains.
“It's like shooting 34 times on goal.
You're teaching the immune system to recognize 34 different things that are unique to that cancer."
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The researchers hope that the Phase 3 trial, scheduled to start this summer, will yield similar results.
With follow-up and monitoring, it could take at least two years before the data is registered with the Food and Drug Administration (FDA) and up to three years before it is approved for use in patients, Weber said.
Still, it's an exciting advance in the field of cancer vaccines, especially to stop melanoma, the deadliest form of skin cancer, experts say.
The study is "important because it is the first randomized study of a cancer vaccine with a clinically meaningful endpoint: preventing tumors from coming back," said Dr. Margaret Callahan, director of research for the Immunotherapy Program at Memorial Sloan. Kettering, who expressed cautious optimism about the results.
“This is an exciting development in the field of cancer vaccines, a field in which it is very difficult to progress,” he said.