This breakthrough could potentially offer a new lease of life for patients suffering from advanced melanoma.
The clinical trials, conducted with 157 patients diagnosed with advanced melanoma, demonstrated a "statistically significant improvement in survival before the cancer returned," according to a statement from the Hackensack Meridian John Theurer Cancer Center in New Jersey, a participant in the trials.
The vaccine was administered in conjunction with Merck’s immunotherapy drug, Keytruda. Dr. Marc Siegel, a clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, explained, "Keytruda is a checkpoint inhibitor, meaning it blocks an enzyme that the cancer cell uses to become invisible to the immune system." Siegel, who was not involved in the vaccine trials, further elaborated on the efficacy of Keytruda, stating that it works well with certain types of highly mutagenic cancers, including melanoma, often eliciting a very effective response. However, he cautioned that the cancer could mutate, becoming resistant to the drug and the immune response.
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The patients involved in the trials, all of whom had undergone surgery to remove their cancer, were administered the experimental mRNA vaccine along with Keytruda. The results were promising, with a 44% reduction in the risk of death or recurring disease compared to those who did not receive the vaccine, according to the companies.
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Dr. Andrew Pecora, an oncologist and researcher at the Hackensack Meridian John Theurer Cancer Center, who has been involved in the clinical trials since their inception, hailed the results as "truly game-changing, groundbreaking stuff." He noted that while immunotherapy has proven effective in about half of cancer patients, the other half often fail to present the tumor proteins to the immune system for recognition and elimination.
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The Moderna vaccine, Pecora explained, is revolutionizing the immune system’s ability to recognize and kill melanoma. The vaccine is personalized to each patient’s specific tumor, overcoming the limitations of a generic cancer vaccine. The process involves taking a piece of the patient's tumor, identifying the mutated or changed parts of the tumor's DNA, and creating a personalized mRNA vaccine that targets those changes.
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"The simultaneous use of an mRNA vaccine seems to show improved regression and remission of metastatic melanoma," Siegel said, expressing optimism about the potential of combined therapies.
According to the Melanoma Research Foundation, nearly 187,000 Americans were expected to be diagnosed with melanoma in 2023, with more than 97,600 projected to die from the disease. The Moderna vaccine is now entering Phase 3 trials, with researchers working to determine its path to FDA approval. Trial participants have reported no side effects beyond those experienced with immunotherapy, Pecora said, predicting potential approval within the next year or two.
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The hope is that this breakthrough will also be applied to other forms of cancer beyond melanoma. Melanoma, the deadliest form of skin cancer, is fast-growing and can spread to any organ. In 2023, more than 97,600 Americans are expected to be diagnosed with invasive melanoma, and 7,990 are projected to die from the disease. This new vaccine could potentially change these grim statistics, offering hope to countless patients.
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