Moderna, Merck's Custom Cancer Vaccine Wins Phase 3 Trial

Moderna and Merck have announced that their Phase 3 trial of an individualized mRNA cancer therapy has met its primary endpoints in patients with resected high-risk melanoma. The study, known as INTerpath-001, found that combining the personalized vaccine, intismeran autogene, with Keytruda significantly improved recurrence-free survival and distant metastasis-free survival compared to standard Keytruda monotherapy.

The Phase 3 trial enrolled 1,137 adults with high-risk stage IIB, IIC, III, or IV cutaneous melanoma following surgery. Patients in the investigational group received up to nine doses of intismeran autogene alongside approximately one year of Keytruda, while the control group received placebo injections with Keytruda alone.

The findings suggest that personalized mRNA therapy could move beyond its experimental promise and become a practical addition to postoperative melanoma treatment. The results also reinforce earlier results from the Phase 2b KEYNOTE-942 study, which showed that adding intismeran autogene to Keytruda reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 59%.