Moderna and Merck report melanoma vaccine cuts recurrence risk in trial of 1,137 patients
A phase III study of the mRNA-based melanoma vaccine intismeran autogene showed a statistically significant reduction in the chance of disease recurrence or spread, according to results released by Moderna and Merck.
Moderna and Merck announced Wednesday that a late-stage trial involving 1,137 participants demonstrated that their experimental melanoma vaccine, intismeran autogene, lowered the odds of cancer returning or metastasizing after surgical removal. The data, presented as top-line results, marked the first positive efficacy signal for the mRNA-based therapy, which has been under development for more than a decade.
The findings arrived amid lingering skepticism from investors and some analysts, who have called for additional data before drawing firm conclusions. While the trial’s interim analysis suggests a benefit, the companies said they will continue to monitor safety and efficacy as the study progresses toward final reporting.
"None of us believed it," said Stephen Hoge, president of Moderna, recalling internal doubts before the results were disclosed. He added that the moment the data were seen felt like a turning point for the program.
The vaccine’s development has faced technical and logistical challenges, including the need to manufacture personalized mRNA formulations and deliver them under pandemic-era constraints. If confirmed in the final analysis, the results could represent a significant advance for mRNA technology beyond infectious disease applications.