Long Explains the Process of Individualizing Neoantigen Therapy in Melanoma

In an interview at the 2026 ESMO Congress, Georgina V. Long, AO, BSc, PhD, MBBS, discusses the phase 3 INTerpath-001 study (NCT05933577), focusing on how the individualized neoantigen therapy intismeran autogene is designed and deployed to patients with resectable melanoma to prevent recurrence. She also addresses the trial’s global scale and the practical steps needed before the approach can reach patients.

Intismeran is built from each patient’s own tumor, Long explains. Next-generation sequencing (NGS) identifies mutations found in the tumor but not in the patient’s normal cells. Those mutations are also absent from other patients’ cancers, so the resulting neoantigen list is unique to that individual.

The candidate neoantigens are then ranked computationally to predict which will produce the strongest antitumor response. The ranking accounts for clonality, expression, and the patient’s major histocompatibility complex (MHC) class I and class II profile. Up to 34 of the top-ranked neoantigens are encoded into a single synthesized mRNA, packaged in a lipid nanoparticle, and injected into the patient.

INTerpath-001 randomly assigned 1,137 patients with stage IIB to IV melanoma at 157 sites worldwide; Long says enrollment was among the fastest she has seen. In her view, that pace addresses the question of whether a fully individualized therapy can be delivered at a global scale.

In the trial, the process from tumor tissue to injection took about 6 to 8 weeks. Long says the main challenge sits at the treatment site: providing enough tumor tissue for NGS. She does not expect this to be a major obstacle for oncologists, as tissue requirements have grown steadily over the past 2 decades, and clinicians have repeatedly adapted. The work therefore depends on site infrastructure, particularly coordination with pathology to supply adequate samples. She says institutions are accustomed to solving that kind of problem and identifies it as the area that needs attention as the therapy moves forward.

Long says health authorities around the world will need to examine and scrutinize the data from INTerpath-001 as each will decide on approval. The approval of intismeran aims to bring a new level of targeted therapy to patients with cancer.