Merck & Co Inc（MRK）資訊與事件MRKMerck & Co Inc

Merck and Moderna's Therapy Reduces Melanoma Recurrence Risk by 42%

Merck (MRK) and Moderna (MRNA) announced detailed positive recurrence-free survival and distant metastasis-free survival results from the Phase 3 INTerpath-001 trial evaluating intismeran autogene, a novel investigational mRNA-based individualized neoantigen therapy being jointly developed by Merck and Moderna, in combination with KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant treatment for patients with completely resected stage IIB-IV melanoma. These late-breaking results will be presented for the first time during Presidential Symposium I at the European Society for Medical Oncology Congress 2026, were selected for an official ESMO Press Briefing and have been accepted for publication in The New England Journal of Medicine. At the primary pre-specified analysis, after a median follow-up of 24.6 months, intismeran in combination with KEYTRUDA significantly reduced the risk of recurrence or death by 42%. Intismeran plus KEYTRUDA also significantly reduced the risk of distant metastasis or death by 38% compared to KEYTRUDA alone. The improvements observed in RFS and DMFS were generally consistent across pre-specified patient subgroups. Overall survival data are not yet mature, but a favorable trend in OS with intismeran plus KEYTRUDA has been observed. The study remains ongoing to further evaluate OS and other key endpoints. The safety profile of intismeran plus KEYTRUDA was generally consistent with previously reported studies of the combination, and no new safety signals were observed. Based on these data, we are engaging with regulatory authorities. The efficacy of the intismeran immunization plus KEYTRUDA in the first six months was comparable with KEYTRUDA alone for risk of recurrence or death and risk of distant metastasis or death. At six months, following the intismeran immunization regimen, a pre-specified sensitivity analysis of the primary endpoint showed the addition of intismeran plus KEYTRUDA reduced the risk of recurrence or death by 58% and reduced the risk of distant metastasis or death by half compared to KEYTRUDA alone. In a pre-specified sensitivity analysis of the modified intent-to-treat population, which excluded participants who did not receive at least one dose of intismeran or placebo as planned, intismeran plus KEYTRUDA reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 45% compared to KEYTRUDA alone.

Merck's Keytruda Receives Traditional FDA Approval

On October 16, 2026, the Food and Drug Administration granted traditional approval to Merk's pembrolizumab, or Keytruda, or pembrolizumab and berahyaluronidase alfa-pmph, or Keytruda Qlex, for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Previously, pembrolizumab received accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic TMB-H, defined as greater than or equal to10 mutations/megabase, solid tumors. This approval converts the accelerated approval to traditional approval and amends the TMB-H indication to define TMB-H as greater than or equal to13 mut/Mb, as efficacy to support traditional approval was not confirmed in patients with TMB of 10 to less than13 mut/Mb. The prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.

Moderna Shares Drop 25% Following Data Leak

Shares of Moderna (MRNA) are down about 25% in afternoon trading while shares of partner Merck (MRK) are down 3% following the alleged leak of embargoed Phase 3 data for a personalized mRNA melanoma vaccine, intismeran autogene, in combination with Keytruda, that is scheduled to be presented at the ESMO medical meeting.