Breakthrough Skin Cancer Vaccine: Promising Results from Phase II Clinical Trial

The second phase of the clinical trial for a skin cancer vaccine has shown extremely promising results in reducing the risk of death or relapse in patients suffering from the most lethal form of skin cancer. The vaccine, developed by Moderna, is designed to work alongside another immunotherapy treatment called KEYTRUDA, aiding the body in its fight against cancer. Notably, KEYTRUDA is owned by Merck, also known as MSD. The clinical trial, a collaboration between the two pharmaceutical companies, targeted patients with high-risk melanoma (or malignant pigment cell cancer).

Initial data indicates that the combination of both drugs reduces the risk of disease recurrence or death in the following three years by 49%. Simultaneously, the risk of cancer spreading or turning fatal decreased by 62% compared to using KEYTRUDA alone. Kyle Holin, the Vice President of Moderna, expressed great enthusiasm for the strong clinical benefits, marking it as the first treatment to demonstrate significant advantages compared to KEYTRUDA alone.

Margorie Green, the Senior Vice President at Merck Research Laboratories, stated their commitment to advancing research for innovative approaches in the early stages of cancer, combining Merck’s expertise in immune oncology with Moderna’s innovative messenger RNA (mRNA) technology.

Moderna’s mRNA technology also supports the company’s COVID-19 vaccine. The messenger RNA easily enters cells, providing instructions for specific proteins that help combat disease-causing agents. Scientists at Moderna are currently utilizing this concept to harness the body’s immune system to identify and kill cancer cells in a similar way it recognizes and targets infections.

The messenger RNA vaccine designed for the third and fourth stages of melanoma is named mRNA-4157 (or V940). It consists of synthetic messenger RNA code carrying the key to producing up to 34 antigens, training and activating the immune response against tumors in patients.

KEYTRUDA works by enhancing the immune system’s ability to detect and combat cancer cells. The phase IIb clinical trial involved 157 patients who had surgically removed high-risk melanomas. Patients received either the combination treatment or KEYTRUDA alone once every three weeks for approximately one year.

The side effects of the combination treatment were not significantly different from KEYTRUDA alone, with common symptoms affecting about 50% of patients, including fatigue, pain at the injection site, and chills.

The combination therapy proved highly effective, leading the U.S. Food and Drug Administration and the European Medicines Agency to agree to expedite the drug’s approval in the future. The timeline for this approval remains unclear, but scientists are already progressing into the third phase of clinical trials, with results expected by 2029.

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