Moderna and Merck announce positive phase 3 results for mRNA melanoma therapy

Moderna and Merck have announced positive results from a phase 3 clinical trial for an experimental mRNA-based therapy, intismeran autogene, designed to prevent the recurrence of melanoma.

The study involved over 1,100 patients with high-risk cutaneous melanoma who had undergone surgical tumor removal. The treatment, which functions as a personalized immunotherapy rather than a traditional preventive vaccine, was administered in combination with Keytruda (pembrolizumab). The combination therapy met its primary objectives, showing improvements in recurrence-free survival and metastasis-free survival compared to using Keytruda alone.

The personalized approach involves analyzing the genetic mutations of a patient's specific tumor to identify up to 34 abnormal proteins. An mRNA vaccine is then produced to instruct the patient's immune system to recognize and destroy cells carrying those specific characteristics. While the results are considered a significant milestone in oncology, the full data set has not yet been published or subjected to independent peer review; detailed findings are expected at a future medical conference.