An experimental mRNA vaccine, in combination with immunotherapy, exhibits significant promise in addressing high-risk forms of melanoma, according to recent reports from the drugmakers involved in the trial.
Trial Results: Promising Outcomes in High-Risk Melanoma
In a three-year follow-up of participants who had undergone complete removal of stage III or IV melanoma but remained at a high risk of cancer recurrence, those who received the mRNA vaccine from Moderna in conjunction with Merck’s Keytruda immunotherapy demonstrated notable advantages. The joint treatment showcased a 49% reduction in the risk of cancer recurrence or death. Additionally, there was a 62% lower risk of distant tumor cell spread or death compared to those who solely received Keytruda, the companies highlighted in a recent press release.
Progressive Benefits Over Time
The findings built upon the earlier two-year follow-up, which reported a 44% lower risk of recurrence or death and a 65% lower risk of distant metastasis or death among individuals who received both Keytruda and the mRNA vaccine, known as mRNA-4157/V940, compared to those treated solely with Keytruda.
Safety Profile and Adverse Events
However, around a quarter of the trial participants receiving Keytruda alongside the vaccine reported experiencing serious adverse events attributed to the treatment. This figure stood at about 20% for those treated solely with Keytruda. Common side effects associated with the vaccine included fatigue, pain at the injection site, and chills.
Regulatory Status and Future Prospects
The US Food and Drug Administration (FDA) granted a breakthrough therapy designation to mRNA-4157/V940 in combination with Keytruda, acknowledging its potential as a significant advancement over existing therapies. This status expedites the development and review process of drugs aimed at treating severe conditions.
While the data from the Phase 2b trial has not undergone peer review or publication in a professional journal, Moderna and Merck have initiated Phase 3 trials focusing on stage IIB-IV melanoma and non-small-cell lung cancer. Their future plans involve expanding research to encompass a wider spectrum of tumor types.
Melanoma Statistics and Impact
Melanoma, accounting for just 1% of all skin cancers, contributes to a majority of skin cancer-related fatalities, as highlighted by the American Cancer Society. In 2023, it was estimated that nearly 100,000 new melanoma cases would be diagnosed in the US, leading to nearly 8,000 fatalities attributed to the disease.
As research and trials progress, the collaborative efforts between Moderna and Merck offer promising prospects in addressing the challenges posed by high-risk melanoma, potentially reshaping treatment protocols and outcomes for affected individuals.
