Merck and Moderna's mRNA Cancer Vaccine Hits Phase 3 Milestone in Melanoma Trial
Merck and Moderna have announced that their personalized mRNA cancer vaccine, intismeran autogene, combined with Merck's Keytruda, has met both primary and secondary endpoints in the Phase 3 INTerpath-001 trial. The study involved over 1,100 patients with stage IIB-IV melanoma who had undergone surgical tumor removal.
The vaccine works by identifying up to 34 unique neoantigens from each patient's tumor through machine learning algorithms and encoding them into a single mRNA construct. This is then delivered via intramuscular injection to train the immune system to recognize cancer markers specific to that patient's disease.
The trial showed statistically significant improvements in recurrence-free survival and distant metastasis-free survival compared to Keytruda alone. The manufacturing process, which takes weeks from biopsy to administration, has a success rate of over 99% for patients whose neoantigen design succeeded.
The INTerpath program is expanding to include nine Phase 2 and Phase 3 clinical trials evaluating intismeran in combination with Keytruda across multiple tumor types. The companies plan to present full data from INTerpath-001 at an upcoming international medical meeting and intend to engage with regulators on filing submissions.