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Merck and Moderna Will Present Results From Landmark Phase 3 INTerpath-001 Trial for Intismeran Autogene Plus KEYTRUDA® (pembrolizumab) at ESMO 2026 Presidential Symposium

Business Wire•22/10/2026•14:59 ET
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Key Highlights

  • ➤Intismeran plus KEYTRUDA cut recurrence or death risk 42% versus KEYTRUDA alone
  • ➤Two-year RFS rate reached 82.2% versus 70.0% with KEYTRUDA alone
  • ➤Intismeran plus KEYTRUDA reduced distant metastasis or death risk 38%
  • ➤Six-month sensitivity analysis showed 58% lower recurrence or death risk
  • ➤Merck and Moderna are engaging regulatory authorities based on INTerpath-001 data

Expert Statements

Georgina Long, Professor, study principal investigator and medical director of Melanoma Institute Australia; Chair of Melanoma Medical Oncology and Translational Research at the University of Sydney

“The transformative INTerpath-001 results have the potential to make a foundational shift in how we treat patients with earlier-stage melanoma in the adjuvant setting”

Georgina Long, Professor, study principal investigator and medical director of Melanoma Institute Australia; Chair of Melanoma Medical Oncology and Translational Research at the University of Sydney

“For decades, cancer treatment has largely been defined by where a tumor originates in the body. The INTerpath-001 findings support a fundamentally new and individualized approach to treating resected melanoma in the adjuvant setting, one that tailors treatment to the unique mutational signature of a patient’s tumor to enhance an anti-tumor immune response. While these results are in patients with completely resected stage IIB-IV melanoma, they provide valuable insights and will help inform our understanding of intismeran as clinical research continues into other tumor types and across settings.”

Dean Y. Li, President, Merck Research Laboratories

“INTerpath-001 is the first Phase 3 study to demonstrate a clinically meaningful improvement in RFS and DMFS over standard-of-care KEYTRUDA in patients with resected melanoma, setting a new benchmark in the adjuvant setting and representing one of the most significant advances in melanoma treatment since the advent of immunotherapy”

Dean Y. Li, President, Merck Research Laboratories

“These results, building on the body of evidence from the Phase 2b study, strengthen our confidence in the curative potential of intismeran autogene when given in combination with KEYTRUDA. Importantly, these data suggest that, by intervening earlier, this approach may offer a tangible opportunity to change the trajectory of a patient’s cancer.”

Stéphane Bancel, Chief Executive Officer, Moderna

“From the beginning, we believed mRNA technology could make it possible to develop cancer treatments uniquely matched to each patient’s tumor. The INTerpath-001 results mark a defining moment for that vision and show what’s possible when we rethink how medicines are made”

Stéphane Bancel, Chief Executive Officer, Moderna

“These results reinforce our conviction that mRNA has the potential to fundamentally change how we treat cancer.”

Merck and Moderna Will Present Results From Landmark Phase 3 INTerpath-001 Trial for Intismeran Autogene Plus KEYTRUDA(®) (pembrolizumab) at ESMO 2026 Presidential Symposium

Intismeran plus KEYTRUDA significantly reduced the risk of recurrence or death by 42% (HR=0.58 [95% CI, 0.45–0.75]; two-sided p<0.001) compared to KEYTRUDA alone for patients with completely resected stage IIB-IV melanoma

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