Moderna to Present Phase 3 Intismeran Autogene Data in Adjuvant Melanoma at ESMO Presidential Symposium
核心洞察
Moderna will present full Phase 3 data for its mRNA-based individualized neoantigen therapy intismeran autogene at ESMO Congress 2026 in Madrid on October 24.
The INTerpath-001 trial tested intismeran plus pembrolizumab versus pembrolizumab alone in resected stage IIB-IV melanoma (搜索) and met its primary endpoint.
Recurrence-free survival is the primary endpoint, and the hazard ratio remains the key missing metric for assessing the magnitude and durability of benefit.
Moderna will present the full Phase 3 results for its investigational mRNA-based individualized neoantigen therapy intismeran autogene on October 24, during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026, held October 23-27 in Madrid, Spain. The company confirmed the presentation details on September 21.
The abstract, designated LBA1, covers INTerpath-001, a Phase 3 study of intismeran autogene plus pembrolizumab versus pembrolizumab alone for the adjuvant treatment of resected stage IIB-IV melanoma (搜索). Georgina V. Long of Sydney, Australia, will present the data at 4:30 PM CEST (10:30 AM EDT) on Saturday, October 24. The Presidential Symposium format is reserved for cutting-edge cancer research.
Moderna and Merck (搜索), known as MSD outside the United States and Canada, jointly develop intismeran autogene. In August the companies announced that the late-stage trial met its primary endpoint, without disclosing the full results at that time.
What the Full Dataset Will Add
Recurrence-free survival (RFS) is the study's primary endpoint. The hazard ratio for RFS is the metric clinicians and analysts are waiting for, since it quantifies the magnitude of benefit in adjuvant melanoma (搜索). The general consensus cited in the reporting is a hazard ratio of 0.65, which would correspond to a 35% reduction in the risk of the cancer returning, according to UBS analyst Michael Yee.
Without the hazard ratio and other data, it is "difficult to assess the magnitude, durability and commercial relevance of benefit in adjuvant melanoma (搜索)," Citi's Geoff Meacham told investors in August.
How the Individualized Therapy Works
Intismeran autogene uses an approach distinct from mainstream cancer treatments. A patient's tumor is surgically removed and then sequenced, allowing researchers to identify which mutated proteins are expressed on the cancer cells. Using those mutations, also called neoantigens, the researchers construct an mRNA strand unique to that patient. The personalized treatment is administered alongside pembrolizumab (Keytruda), which helps trigger the body's immune response against remaining cancer cells after surgery.
Additional Abstracts in Pancreatic and Lung Cancer
Two further abstracts on intismeran autogene were accepted for poster presentation at the congress. Abstract 3151P reports results from a Phase 1 study of adjuvant intismeran autogene plus FOLFIRINOX in resectable pancreatic ductal adenocarcinoma (搜索), presented by David J. Pinato of London, United Kingdom, on Sunday, October 25, from 12:00 to 12:45 PM CET.
Abstract 2550TiP describes INTerpath-014, a Phase 3 study of adjuvant intismeran autogene plus subcutaneous pembrolizumab or intismeran monotherapy versus placebo in completely resected high-risk stage I non-small cell lung cancer (搜索). Charu Aggarwal of Philadelphia, United States, will present the trial-in-progress poster on Monday, October 26, from 12:00 to 12:45 PM CET.
Moderna will host a live webcast on Saturday, October 24, at 7:00 PM CEST (1:00 PM EDT), with a replay archived on the company's website for at least 30 days.