KENILWORTH (NJ) (dpa-AFX) - Merck (MRK) and Moderna (MRNA) announced detailed results from the Phase 3 INTerpath-001 trial showing that the investigational personalized cancer vaccine intismeran autogene, when combined with KEYTRUDA (pembrolizumab), significantly improved outcomes in patients with high-risk melanoma following surgery.
Melanoma is one of the deadliest forms of skin cancer. Even after complete surgical removal, many patients remain at risk of the disease returning or spreading to distant organs such as the lungs, liver or brain.
The Phase 3 INTerpath-001 study enrolled 1,137 patients with completely resected stage IIB-IV melanoma. Patients received either intismeran plus KEYTRUDA or KEYTRUDA alone for approximately one year.
At a median follow-up of 24.6 months, the combination reduced the risk of cancer recurrence or death by 42% compared with KEYTRUDA alone. The treatment also reduced the risk of distant metastasis or death by 38%. The two-year recurrence-free survival rate was 82.2% for patients receiving the combination versus 70.0% for those receiving KEYTRUDA alone.
A pre-specified analysis showed that benefits became more pronounced after completion of the vaccine immunization phase. After six months, intismeran plus KEYTRUDA reduced the risk of recurrence or death by 58% and reduced the risk of distant metastasis or death by 50% compared with KEYTRUDA alone.
Intismeran is an individualized mRNA-based cancer vaccine created using each patient's tumor sample. The therapy is designed to train the immune system to recognize and attack tumor-specific mutations unique to an individual's cancer.
According to the companies, the safety profile of the combination was generally consistent with earlier studies, with no new safety signals observed. The most common treatment-related adverse events included fever, injection-site pain and fatigue.
The findings are scheduled to presented during the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026 and have been accepted for publication in the New England Journal of Medicine.
Merck and Moderna said they are discussing the results with regulatory authorities and continue to advance the broader INTerpath clinical development program, which includes multiple Phase 2 and Phase 3 studies across melanoma, lung cancer and other tumor types.
MRK has traded between $82.01 and $156.92 over the past year. The stock closed Thursday's trading at $147.24, down 1.76%.
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