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Merck and Moderna Announce Phase 3 INTerpath-001 Trial of Intismeran Autogene Plus KEYTRUDA® Met Endpoints of Recurrence-Free Survival (RFS) and Distant Metastasis-Free Survival (DMFS) in Patients With Completely Resected Stage IIB-IV Melanoma

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  • Merck and Moderna announced positive topline results from the Phase 3 INTerpath-001 trial for intismeran autogene in combination with KEYTRUDA.
  • The combination demonstrated statistically significant and clinically meaningful improvements in recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) compared to KEYTRUDA alone.
  • This represents the first positive Phase 3 readout for an individualized neoantigen therapy (INT) and an mRNA-based cancer therapy.
  • The trial enrolled 1,137 patients with completely resected stage IIB-IV cutaneous melanoma who had not received prior systemic therapy.
  • Intismeran autogene is an mRNA-based individualized neoantigen therapy designed to train the immune system based on the unique mutational fingerprint of each patient's tumor.
  • Safety profiles for the combination were consistent with previously reported studies, with no new safety signals observed.
  • The companies plan to present data at an upcoming international medical meeting and will engage regulators regarding filing submissions.
  • The trial will continue to evaluate other key secondary endpoints, including overall survival (OS).
  • Previous Phase 2b results showed a 49% reduction in the risk of recurrence or death and a 59% reduction in the risk of distant metastasis or death for the combination.
  • The INTerpath program currently consists of nine total Phase 2 and Phase 3 clinical trials across multiple tumor types, including melanoma, NSCLC, bladder cancer, and renal cell carcinoma.
  • KEYTRUDA is an anti-PD-1 therapy approved for various indications, including the adjuvant treatment of Stage IIB, IIC, or III melanoma.
  • Immune-mediated adverse reactions associated with KEYTRUDA include pneumonitis, colitis, hepatitis, endocrinopathies, and dermatologic reactions.
  • Fatal adverse reactions have been reported with KEYTRUDA, including in patients with multiple myeloma when combined with certain regimens.
  • The study was a randomized, double-blind, placebo- and active-comparator-controlled global Phase 3 trial.
  • Patients in the combination arm received intismeran every three weeks for up to nine doses along with KEYTRUDA every six weeks for up to nine cycles.