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“Moderna and Merck Seek Expedited FDA Approval for Groundbreaking Cancer Vaccine”

Moderna and Merck, two leading pharmaceutical companies, have released new data on their experimental vaccine, which shows promising results in treating the most lethal form of skin cancer when used in combination with Merck’s Keytruda. The findings, which were presented at the American Society of Clinical Oncology conference, demonstrate long-lasting efficacy and improved survival rates in patients with this fatal disease.

This news comes as a welcome boost for Moderna, whose biotech company has faced challenges in recent times. The demand for their Covid vaccine, which was their sole commercially available product, plummeted, causing uncertainty among investors. However, the positive results from the midstage trial of their experimental vaccine have restored confidence in the company.

The preliminary findings from December are included in the data presented at the conference. The latest results show that approximately 75% of patients who received the combination treatment were still alive and showed no signs of cancer recurrence after two and a half years. In contrast, only 55.6% of patients who received Keytruda alone survived. This benefit was observed across different patient subgroups, regardless of the characteristics of their tumors.

Researchers believe that this vaccine could be beneficial for patients with various types of melanoma. In fact, after two and a half years, 96% of patients who received the combination treatment survived overall, compared to 90.2% of those who received Keytruda alone.

Marjorie Green, the director of Merck’s worldwide clinical development of cancer, finds the three-year updates particularly exciting due to the longevity of the data. She believes that this new treatment could significantly improve outcomes for patients with severe forms of melanoma.

The vaccine, created using the same mRNA technology as Moderna’s Covid vaccine, is specifically tailored to each patient by analyzing their tumors. It aims to instruct the immune system to recognize and target specific mutations found in cancer cells.

Although the combination treatment has shown promising results, there have been some reported side effects. The most common adverse effects include chills, injection site discomfort, and fatigue. However, these side effects were generally not severe. It was also noted that individuals who received the combination treatment experienced slightly more immune-related adverse events.

The US Food and Drug Administration has designated this cancer vaccine as a revolutionary therapy for melanoma, which will expedite its approval process. Both Merck and Moderna have applied for expedited FDA approval, which will allow for faster access to this potentially life-saving treatment.

Melanoma is the most deadly form of skin cancer, and its incidence has been increasing over the years. The American Cancer Society predicts that 8,000 individuals will die from melanoma in the US this year, with around 100,000 new cases diagnosed.

In addition to melanoma, Merck is also conducting trials to evaluate the vaccine’s efficacy in treating lung cancer and other malignancies. Moderna is focusing on advanced common skin cancer, bladder cancer, and kidney cancer in their research.

Overall, the results from Moderna and Merck’s experimental vaccine offer hope for patients with severe forms of melanoma. The combination treatment has shown significant improvements in survival rates and long-lasting efficacy. As the companies move forward with the FDA approval process, there is optimism that this vaccine could become a revolutionary therapy for melanoma and potentially other types of cancer in the future.