Moderna (MRNA +142%) and Merck (MRK +11.3%) announced this morning that the Phase 3 INTerpath-001 trial of intismeran autogene plus KEYTRUDA met its primary and key secondary endpoints in high-risk melanoma.
Merck and Moderna Phase 3 INTerpath-001 topline data show V940 plus Keytruda met primary and key secondary endpoints in melanoma
- Trial enrolled patients with completely resected Stage IIB-IV melanoma receiving adjuvant intismeran autogene (V940) plus KEYTRUDA
- Merck and Moderna plan to engage regulators on filing submissions for the V940 and KEYTRUDA combination regimen
- The combination is the first and only regimen to demonstrate statistically significant and clinically meaningful improvements in both recurrence-free survival and distant metastasis-free survival compared with KEYTRUDA alone in this setting.
- The readout also marks the first positive Phase 3 trial for an individualized neoantigen therapy and an mRNA-based cancer therapy, providing major validation for Moderna's mRNA platform beyond infectious disease and potentially opening a meaningful new opportunity in oncology. As a result, MRNA shares are surging on the results.
- The results are supporting broader enthusiasm around precision medicine, computational biology and personalized therapeutics, with the landmark Phase 3 readout providing an important clinical proof point for highly individualized treatment approaches.
- Precision medicine and next-generation biotech names trading higher include Tempus AI (TEM +22.2%), BioNTech (BNTX +20.4%), Ginkgo Bioworks (DNA +15.3%), Prime Medicine (PRME +13.4%), Recursion Pharmaceuticals (RXRX +9.6%).
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