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A protein fragment created by a tumour mutation that the immune system has never seen before, so it can attack it without harming normal cells.
Arise from missense mutations, frameshifts, fusions, and splice variants; must be processed and presented on the patient's HLA. Predicted computationally (binding affinity, expression, clonality). The targets of personalised mRNA vaccines and neoantigen-specific TCR-T; higher TMB means more candidates.
Showing the technology this term belongs to: Personalised neoantigen (mRNA) vaccines.
The glossary entry explains the word; the readout page carries the scoring rule, the thresholds approvals use, the companion diagnostics and the tests.
The strongest human evidence that a cancer vaccine can make durable T cells in a tumour with few mutations; the randomised phase 2 IMCODE003 (260 patients, primary completion listed for January 2031) is the test of whether that translates into fewer relapses.
For the first time a randomised trial suggests that a vaccine tailored to an individual's tumour can reduce relapse when combined with immunotherapy, which is a proof of concept for a field that had failed for decades. Nothing changes for patients yet: the trial was small, the confidence interval crossed one, and the phase 3 trial in melanoma (and parallel trials in lung and other cancers) must confirm it. If it does, personalised mRNA vaccines could become a routine adjunct to checkpoint inhibitors after surgery.
Pancreatic cancer was thought to be immunologically inert because of its low mutation burden; this study showed that with the right vaccine platform its few neoantigens can still be targeted. It is the strongest human evidence so far that personalised cancer vaccines can generate durable, tumour-specific immunity, and it justifies the randomised trials now running in pancreatic cancer and melanoma. Benefit is not yet proven, because responders may simply have had more immunogenic tumours.
It is the strongest case that mutation burden is real biology in lung cancer and, at the same time, the clearest demonstration that its threshold is not fixed, which is why it never became a reliable selector.
Because Lynch syndrome tumours make the same abnormal proteins in almost every patient, a single vaccine could in principle be given to carriers before cancer develops. This small trial showed the concept is safe and immunogenic; whether it prevents cancer requires the randomised trials now being planned.
It gives a genetic account of both immunotherapy failures: why some mismatch repair deficient tumours resist, and why the microsatellite-stable majority has no T cells in it to begin with.
It made tumour mutational burden measurable in routine practice and, in the same stroke, showed it is a second axis alongside PD-L1 rather than a replacement for it.
This atlas is the reference for how immune the different cancers are and is widely used to choose which tumours to test immunotherapies in and to interpret immune gene signatures. It shows why immunotherapy responses depend on the tumour's immune context as much as on its tissue.
Shares Timothy A. Chan, Identification of unique neoantigen qualities in long-term survivors of pancreatic cancer, Genomic correlates of immune-cell infiltrates in colorectal carcinoma, Somatic POLE proofreading domain mutation, immune response, and prognosis in colorectal cancer.
Shares What makes a neoantigen actually immunogenic?, Personalised cancer vaccines at commodity cost through fully automated manufacturing, University Cancer Center Mainz (UCT Mainz) / Universitätsmedizin Mainz, Personalised vaccines given only when the blood test turns positive.
Shares Nina Bhardwaj, Nouscom, Vaccinate against the resistance mutation before it takes over, Shared splice-derived neoantigens as off-the-shelf vaccine targets.
Shares Vaccines aimed only at mutations shared by every tumour cell, Personalised cancer vaccines at commodity cost through fully automated manufacturing, Personalised vaccines given only when the blood test turns positive, KEYNOTE-942: a personalised mRNA cancer vaccine plus pembrolizumab after melanoma surgery.
Shares Nouscom, Integrative analyses of colorectal cancer show Immunoscore is a stronger predictor of patient survival than microsatellite instability, Genomic correlates of immune-cell infiltrates in colorectal carcinoma, A frameshift neoantigen vaccine for Lynch syndrome carriers as the first preventive cancer vaccine approval.
Shares Vaccines aimed only at mutations shared by every tumour cell, KEYNOTE-942: a personalised mRNA cancer vaccine plus pembrolizumab after melanoma surgery, Rojas 2023: a personalised mRNA vaccine trained T cells against each patient's pancreatic cancer, and those who responded stayed cancer-free longer, Intismeran autogene.
Shares Integrative analyses of colorectal cancer show Immunoscore is a stronger predictor of patient survival than microsatellite instability, Genomic correlates of immune-cell infiltrates in colorectal carcinoma, Association of distinct mutational signatures with correlates of increased immune activity in pancreatic ductal adenocarcinoma, Genetic mechanisms of immune evasion in colorectal cancer.
Shares Identification of unique neoantigen qualities in long-term survivors of pancreatic cancer, Genomic correlates of immune-cell infiltrates in colorectal carcinoma, Association of distinct mutational signatures with correlates of increased immune activity in pancreatic ductal adenocarcinoma, Somatic POLE proofreading domain mutation, immune response, and prognosis in colorectal cancer.