Moderna shares surge as Merck-Moderna mRNA melanoma vaccine meets Phase 3 endpoint

Merck and Moderna reported that their personalized mRNA cancer vaccine, combined with Merck’s Keytruda, slowed melanoma recurrence in a Phase 3 study. The interim analysis showed a statistically significant improvement over Keytruda alone, supporting the combo for adjuvant treatment.

The INTerpath-001 trial enrolled 1,137 patients who had surgery to remove cutaneous melanoma. Participants were randomized in a 2:1 ratio to receive the vaccine plus Keytruda or Keytruda monotherapy for about a year. The vaccine, known as intismeran autogene (V940 or mRNA-4157), is designed to target multiple tumor antigens.

Following the announcement, Moderna’s share price jumped roughly 90% in pre-market trading. The companies said they will discuss the data with the U.S. Food and Drug Administration and plan to pursue regulatory approval. Analysts called the result a surprisingly positive development that exceeded expectations.