An experimental skin cancer vaccine is poised for the fast track.

Moderna’s mRNA vaccine for melanoma, in combination with an immunotherapy drug by Merck, received a special “breakthrough therapy” designation from the U.S. Food and Drug Administration (FDA).

That opens the door for expedited development and review. It also shows the promise of mRNA technology to treat the deadliest skin cancer — and potentially, other cancers too.

Peter Yu, MD, physician-in-chief of the Hartford HealthCare Cancer Institute, explains.

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Moderna’s skin cancer vaccine uses mRNA technology.

Many of us associate mRNA technology with COVID-19 vaccines. But long before the pandemic, oncology researchers were studying it as a way to treat cancers — including melanoma.

“Decades of research in the field of cancer got mRNA technology ready for the COVID-19 vaccines,” says Dr. Yu.

These vaccines contain instructions for the immune system, showing it how to launch an attack against something harmful. Cancer cells are harder to recognize than a virus like COVID-19. So, unlike the COVID-19 vaccines, each melanoma vaccine is tailor-made for a specific person.

Moderna’s skin cancer vaccine is personalized.

To create the vaccine, Moderna’s researchers began by taking samples of each patient’s tumors and healthy tissues. Then they analyzed the differences in genetic sequencing.

They used this information to manufacture a vaccine with a custom genetic message.

“The vaccine teaches the immune system to recognize the difference between the person’s cancer and the rest of their body. The immune system will kill the cancer cell, but leave the rest of the body alone,” says Dr. Yu.

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When combined with immunotherapy, Moderna’s skin cancer vaccine shows promise.

Moderna recently shared results from a study that combined its vaccine with Merck’s Keytruda (pembrolizumab), a well-established drug for boosting immune response. Patients with advanced stage melanoma received nine vaccine doses over a year, along with Merck’s immunotherapy drug.

This kind of combination was a first, and the results were compelling. Compared to immunotherapy alone, the vaccine-immunotherapy combo reduced the risk of recurrence or death by 44%.

“The story’s not done yet,” says Dr. Yu, as we wait for longer-term results. “But in the meantime, this study is very encouraging. It really is a milestone.”

The technology has potential for other cancers too.

If Moderna’s vaccine proves safe and effective against melanoma, it opens the door for other cancer vaccines.

“Probably not every cancer is going to respond to the immune system like melanoma,” cautions Dr. Yu. “But other ones that could be good targets are lung cancer and bladder cancer.”

With the FDA’s breakthrough therapy designation, Moderna and Merck said they’ll run a late-stage study of their combination therapy in 2023. To find out if you might be a candidate, talk to your doctor.

Hartford HealthCare offers access to leading-edge cancer clinical trials.

Thanks to a partnership with the Memorial Sloan Kettering Cancer Alliance, more cancer clinical trials and protocols are now available close to home for patients at the Hartford HealthCare Cancer Institute.

“The Institute makes it a priority to connect patients with promising and groundbreaking advances in cancer treatments,” says Dr. Yu. “This is how great things happen.”

To learn more, view the Institute’s current cancer clinical trials and call the Research Line at 860.972.4700.