- Intismeran autogene with KEYTRUDA reduced recurrence or death risk by 49% in high-risk melanoma.
- Eight Phase 2 and 3 trials are ongoing for various tumor types.
- Further data will be presented at a future medical conference.
Study Overview
Moderna and Merck have released five-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study. The study evaluates intismeran autogene, an investigational mRNA-based individualized neoantigen therapy, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with high-risk melanoma following complete resection.
Key Findings
The combination treatment reduced the risk of recurrence or death by 49% compared to KEYTRUDA alone, with a hazard ratio of 0.510 and a 95% confidence interval of 0.294–0.887. The one-sided nominal p-value was 0.0075, indicating a statistically significant improvement in recurrence-free survival.
Future Plans
Moderna and Merck plan to present further data from follow-up analyses of the study’s primary and secondary endpoints at an upcoming medical conference. The companies are also conducting eight Phase 2 and Phase 3 clinical trials across multiple tumor types, including melanoma, non-small cell lung cancer, bladder cancer, and renal cell carcinoma.
