A personalized mRNA therapy passes a phase 3 melanoma trial for the first time

Pharmaceutical giants Merck and Moderna have announced that their personalized mRNA therapy, intismeran autogene, has successfully passed a phase 3 melanoma trial for the first time. This breakthrough marks a first for an mRNA-based cancer treatment to achieve positive results at such a significant stage. The trial, named INTerpath-001, involved 1,137 melanoma patients with completely resected stage IIB to IV melanoma and no prior systemic treatment.

Participants were randomly assigned in a 2:1 ratio, with one group receiving intismeran combined with pembrolizumab (Keytruda) and the other group receiving pembrolizumab alone, the standard treatment for this condition. The primary endpoint of the trial measured recurrence-free survival, while the secondary endpoint focused on distant metastasis-free survival.

Both endpoints demonstrated statistically significant and clinically meaningful improvements over the standard pembrolizumab treatment alone, though no exact figures were disclosed. The therapy works by analyzing each patient's resected tumor to identify unique mutations specific to their cancer and designing a tailored mRNA therapy to train the immune system to recognize and attack any returning malignant cells.

Merck and Moderna plan to present the full data at an international medical meeting and begin discussions with regulators regarding approval. Marisol Soengas, head of the melanoma group at Spain's National Cancer Research Centre, expressed cautious optimism about the potential of this therapy, while Luis Álvarez-Vallina cautioned about the technology's cost and its applicability to other cancer types, as melanoma is a highly immunogenic tumor.

Following the trial's success, Moderna's shares increased by over 90% in early New York trading, reaching around 120 dollars, while Merck gained between 7% and 12%, according to various agencies.