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Personalized mRNA Vaccine Plus Keytruda Nearly Halves Five‑Year Melanoma Recurrence in Early Study

Personalized mRNA Vaccine Plus Keytruda Nearly Halves Five‑Year Melanoma Recurrence in Early Study
Melanoma is the deadliest form of skin cancer. A new vaccine-drug combo could slash recurring cases

NYU Langone researchers report that adding Moderna’s personalized mRNA vaccine intismeran to Merck’s Keytruda nearly halved the five‑year risk of melanoma recurrence or death in an early study. In 107 U.S. and Australian patients, about 69% of those given the vaccine remained cancer‑free at five years versus 49% treated with Keytruda alone. The combination also cut the risk of metastasis by 59% and improved overall survival by more than 20%. A Phase 3 trial of roughly 1,000 patients is now underway to confirm these findings.

Researchers at NYU Langone’s Perlmutter Cancer Center report that adding Moderna’s personalized mRNA vaccine intismeran to Merck’s immunotherapy Keytruda substantially reduced melanoma recurrence in an early clinical study.

Study Results

Among 107 patients in the United States and Australia whose tumors were surgically removed, nearly 69% of those given the vaccine plus Keytruda remained cancer‑free at five years versus 49% of patients treated with Keytruda alone. NYU Langone summarized this as a 49% reduction in the combined risk of recurrence or death for patients receiving intismeran with Keytruda.

Personalized mRNA Vaccine Plus Keytruda Nearly Halves Five‑Year Melanoma Recurrence in Early Study
A new vaccine-drug combo could help fight recurring melanoma, researchers said Monday. The mRNA vaccine is designed using a patient’s tumor (Getty)

The combination also lowered the risk of the cancer spreading (metastasis) by 59% and produced an overall survival improvement of more than 20% in this study population.

How the Treatment Works

Intismeran is a personalized mRNA vaccine: after surgery researchers sequence each patient’s tumor to identify unique mutations and neoantigens, then manufacture a vaccine intended to stimulate T cells that recognize those abnormal proteins. Keytruda (pembrolizumab) is an immune checkpoint inhibitor that helps T cells detect and attack cancer cells. Together, the two approaches aim to improve long‑term immune surveillance and reduce the chance of recurrence.

Personalized mRNA Vaccine Plus Keytruda Nearly Halves Five‑Year Melanoma Recurrence in Early Study
Skin cancer is the most common form of cancer in the U.S. An estimated 112,000 melanoma cases are expected in 2026 (Getty)

“Our findings also serve as encouragement to cancer researchers globally that mRNA vaccines like intismeran could work well in combination with immunotherapy for other cancers whose high rates of mutations have proven difficult to target,” said Dr. Janice Mehnert, associate director of clinical research at NYU Langone.

Next Steps and Context

These results come from an early study and a larger Phase 3 trial enrolling roughly 1,000 patients is currently underway to confirm the benefit and better define safety and long‑term outcomes. Intismeran is also being evaluated in trials for other cancers, including lung cancer.

Skin cancer is the most common cancer in the United States. The American Cancer Society estimates about 112,000 new melanoma cases and roughly 8,500 deaths from the disease this year.

What This Means For Patients

While promising, these findings are preliminary. Patients should discuss ongoing clinical trials and approved treatment options with their oncology teams. If confirmed in Phase 3, a personalized mRNA vaccine added to immunotherapy could become an important tool to reduce recurrences for some melanoma patients.

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