Key insights
- Merck and Moderna's Phase 3 trial for their melanoma drug combination showed a 42% reduction in recurrence or death risk compared to KEYTRUDA alone. The combination also reduced the risk of distant metastasis or death by 38%. While overall survival data is immature, a favorable trend is observed. Adverse events were slightly higher in the combination arm. These positive results are expected to advance regulatory discussions and further development.
Merck (MRK) and Moderna (MRNA) announced Phase 3 trial results showing that intismeran autogene combined with KEYTRUDA (pembrolizumab) reduced the risk of recurrence or death by 42% compared to KEYTRUDA alone in patients with completely resected stage IIB-IV melanoma.
The INTerpath-001 trial enrolled 1,137 patients who were randomized 2:1 to receive intismeran plus KEYTRUDA or placebo plus KEYTRUDA for approximately one year. After a median follow-up of 24.6 months, the combination also reduced the risk of distant metastasis or death by 38% compared to KEYTRUDA alone. The two-year recurrence-free survival rate was 82.2% for the combination versus 70.0% for KEYTRUDA alone.
A pre-specified sensitivity analysis found that after the six-month intismeran immunization regimen was completed, the combination reduced the risk of recurrence or death by 58% compared to KEYTRUDA alone. During the first six months, efficacy was comparable between the two arms.
Overall survival data are not yet mature, though the companies stated a favorable trend has been observed. The study remains ongoing.
Treatment-related adverse events occurred in 95.8% of patients receiving the combination versus 90.0% receiving KEYTRUDA alone. Grade 3-5 adverse events occurred in 14.2% and 13.4% of patients, respectively. The most common adverse events in the combination arm were pyrexia (52.2%), injection site pain (51.0%), and fatigue (38.5%).
Intismeran is an investigational mRNA-based individualized neoantigen therapy designed using a patient’s tumor sample to generate an anti-tumor immune response. The companies said they are engaging with regulatory authorities based on the data.
The results will be presented at the European Society for Medical Oncology Congress 2026 Presidential Symposium and have been accepted for publication in The New England Journal of Medicine. The INTerpath clinical development program currently includes nine Phase 2 and Phase 3 trials across multiple tumor types, including three ongoing Phase 3 trials in non-small cell lung cancer.
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