Moderna's mRNA Tech Shows Potential Beyond Vaccines with Keytruda Combo

A Phase 3 study of individualized neoantigen therapy intismeran has shown promising results in combination with Keytruda, a treatment for melanoma patients. The trial, known as Interpath-001, demonstrated improved recurrence-free survival and distant metastasis-free survival compared to Keytruda alone.

Moderna shares rose nearly 150% on August 19 after the study's positive readout, while Merck's stock increased over 10%. This success is significant for Moderna as it validates the potential of its mRNA technology beyond vaccines. The decline in COVID-19 vaccine demand and uncertain US vaccine policy environment have forced the company to prioritize its most promising programs.

The trial focused on high-risk melanoma patients at the adjuvant stage, which affects approximately 30,000 individuals in the United States and European Union. However, the study's positive outcome bodes well for ongoing intismeran trials, including those for adjuvant lung cancer, which impacts over 100,000 people in both regions.

While the magnitude of benefit is not yet disclosed, a positive readout at this first interim analysis is seen as a good sign. Merck and Moderna likely designed the trial with a high statistical bar for an early readout. In the past, five-year phase 2b data showed a 49% reduction in the risk of recurrence or death.

Morningstar has raised its fair value estimates for both Merck and Moderna after increasing its intismeran sales forecast to $16.8 billion by 2035. The profits from this program will be split equally between the partners. Morningstar also increased its assumed probability of approval for intismeran in melanoma and lung cancer.