mRNA-4157 (skin cancer vaccine)

2023: Creating a vaccine that reduces the risk of skin cancer recurrence by 44%

On April 16, 2023, Moderna and Merck developed a cancer vaccine that showed promise in a key study, reducing the risk of recurrence or death by 44%.

About 79% of melanoma patients in the 157-person study were cancer-free after 18 months, according to drugmakers. Patients received personalized mRNA-4157 (V940) therapy from Moderna in combination with Merck's Keytruda cancer drug. Compared to 62% of patients treated with Keytruda alone, which is a statistically significant and clinically significant improvement, the companies said in a joint statement.

Moderna, Merck develop cancer vaccine

The treatment had only mild side effects, such as fatigue, the companies said. In 2023, Moderna and Merck will begin a phase 3 study and extend the treatment to other tumor types, such as non-small cell lung cancer.

The results further support the potential of mRNA as individualized neoantigene therapy for positive effects in patients with high-risk resected melanoma! The observed deep reduction in the risk of disease-free survival suggests that this combination could be a new means of potentially extending the lives of patients with high-risk melanoma, "Kyle Holen, senior vice president and head of Moderna's therapeutic and oncology drug development, said in a statement.

The combination treatment has been identified by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) as breakthrough therapy, and additional data on the study will be presented at an upcoming medical meeting and published in a peer-reviewed publication, health care companies said.^[1]

2022: Results of clinical trials of vaccine obtained

In mid-December 2022, Moderna announced the preliminary results of the second phase of clinical trials of the RNA vaccine against melanoma. A study with one and a half hundred sick volunteers shows that the new drug increases the chances of curing aggressive skin cancer by almost 50%. Merck also participated in the creation of the vaccine.

A candidate called mRNA-4157/V940 is a personalized mRNA therapy that is tailored to neoantigens found in a patient's tumor. This approach represents a pivot to the cancer vaccines that erupted in the 2010s. By analyzing a patient's tumor, identifying mRNAs capable of triggering an immune response and enclosing molecules in lipid nanoparticles, Merck and Moderna hope to achieve improved results.

Moderna has created a vaccine against skin cancer.

Merck and Moderna have presented clinical evidence that this approach works. The researchers enrolled 157 people with stage 3 or 4 melanoma in an open-label phase 2b trial to obtain either mRNA-4157 and Keytruda or a checkpoint inhibitor alone after complete surgical resection.

Adding mRNA-4157 reduced the risk of relapse or death by 44% compared to taking Keytruda alone. The results, which the partners called the first demonstration of the effectiveness of cancer treatment with mRNA in a randomized clinical trial, set the stage for the transition to phase 3 and extension to other cancers.

Merck and Moderna plan to discuss the findings with regulators to begin a phase 3 study on melanoma next year and "rapidly expand it to other tumor types." Repeating success in Phase 3 will open up one market for partners, but a successful extension of the indications will be required to unlock the full value of mRNA-4157. And this can be a difficult task.

Melanoma is a particularly immunoreactive tumor, as evidenced by evidence that tumors can spontaneously regress, as well as the status of this disease as an initial testing ground for cancer immunotherapy from the very beginning of the development of this area. As Merck and Moderna move on to other indications, they may see the impact of the mRNA-4157 diminish. However, the melanoma data is encouraging for the Merck-Moderna partnership, as well as competitors developing a similar therapy.^[2]

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