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Article History

Received: 19 February 2024

Accepted: 10 December 2024

First Online: 5 February 2025

Competing interests

: Bristol-Myers Squibb provided ipilimumab, but no funding support for the clinical trial. D.A.B reports share options in Elephas; advisory board, consulting or personal fees from Cancer Expert Now, Adnovate Strategies, MDedge, CancerNetwork, Catenion, OncLive, Cello Health BioConsulting, PWW Consulting, Haymarket Medical Network, Aptitude Health, ASCO Post and Harborside, Targeted Oncology, Merck, Pfizer, MedScape, Accolade 2nd MD, DLA Piper, AbbVie, Compugen, Link Cell Therapies, Scholar Rock, NeoMorph, Nimbus, Exelixis, AVEO, Eisai and Elephas; and research support from Exelixis and AstraZeneca, outside the submitted work. B.A.M. discloses personal consulting fees from Arcus, Aveo, Bristol-Myers Squibb, Daiichi Sanko, Eisai, Exelixis, Genmab, Gilead, Hexagen, Pfizer and SeaGen, and institutional disclosures for Aveo, Bristol-Myers Squibb, Exelixis, Gilead, Pfizer and SeaGen. N.R.L. is a consultant and has received honoraria from Bayer, Seattle Genetics, Sanofi, Silverback, Fortress Biotech, Synox Therapeutics, Janssen and Astellas pharma, outside the submitted work. K.S. is now an employee and shareholder of Intellia Therapeutics, which has no contribution or affiliation to the work described in this article. S.K. is now an employee of Genentech. S. Sarkizova is now an employee of Moderna and holds stock (as of January 2024). J.B.I. reports receiving consulting fees from AstraZeneca outside the submitted work. S. Signoretti reports receiving commercial research grants from Bristol-Myers Squibb, AstraZeneca, Exelixis, Merck, NiKang Therapeutics and Arsenal Biosciences; is a consultant/advisory board member for Merck, AstraZeneca, Bristol Myers Squibb, CRISPR Therapeutics AG, AACR and NCI; receives royalties from Biogenex; and mentored several non-United States citizens on research projects with potential funding (in part) from non-United States sources/Foreign Components. J.C.A. has served as a consultant for Remix Therapeutics, Ayala Pharmaceuticals, Cellestia, and on the scientific advisory board of NeuAPC, outside the submitted work. S.A.C. is a member of the scientific advisory boards of PTM BioLabs, Seer, StandUp2Cancer and PrognomIQ. I.L. serves as a consultant for PACT Pharma and has stock, is on the board and serves as a consultant for ennov1, and is on the board and holds equity in Nord Bio. G.G. receives research funds from IBM, Pharmacyclics/Abbvie, Bayer, Genentech, Calico, Ultima Genomics, Inocras and Google and is also an inventor on patent applications filed by the Broad Institute related to MSMuTect, MSMutSig, POLYSOLVER, SignatureAnalyzer-GPU, MSEye and MinimuMM-seq. He is a founder, consultant and holds privately held equity in Scorpion Therapeutics; he is also a founder of, and holds privately held equity in, PreDICTA Biosciences. He was also a consultant to Merck. N.H. holds equity in and advises Danger Bio/Related Sciences and Repertoire Immune Medicines, owns equity in BioNtech and receives research funding from Bristol Myers Squibb and Calico Life Sciences. D.S.N. owns stock in Madrigal Pharmaceuticals, outside the submitted work. K.J.L. holds equity in Standard BioTools and is on the scientific advisory board for MBQ Pharma. S.A.S. reports equity in Agenus, Agios Pharmaceuticals, Breakbio, Bristol-Myers Squibb and Lumos Pharma. S.A.S. is a consultant for Imunon and Jivanu therapeutics. E.F.F. is an equity holder in and consultant for BioNTech, an equity holder and scientific advisory board member of BioEntre, and a founder and equity holder of Dionis Therapeutics. C.J.W. is subject to a conflict-of-interest management plan for the reported studies because of her former competing financial interests in Neon Therapeutics, which was acquired by BioNTech. Under this plan, C.J.W. may not access identifiable data for human participants or otherwise participate directly in the Institutional Review Board-approved protocol reported herein. C.J.W.’s contributions to the overall strategy and data analyses occurred on a de-identified basis. Patent applications have been filed on aspects of the described work entitled as follows: ‘Compositions and methods for personalized neoplasia vaccines’ (N.H., E.F.F. and C.J.W.), ‘Methods for identifying tumour specific neoantigens’ (N.H. and C.J.W.), ‘Formulations for neoplasia vaccines’ (E.F.F.) and ‘Combination therapy for neoantigen vaccine’ (N.H., C.J.W. and E.F.F.). The DFCI, the lead site of this trial, has a proprietary and financial interest in the personalized neoantigen vaccine. D.B.K. is a scientific advisor for Immunitrack, a wholly owned subsidiary of Eli Lilly and Company and Breakbio. D.B.K. owns equity in Affimed N.V., Agenus, Armata Pharmaceuticals, Breakbio, BioMarin Pharmaceuticals, Celldex Therapeutics, Editas Medicine, Immunitybio, Lexicon Pharmaceuticals, Summit Therapeutics and Viking Therapeutics. P.A.O. has received research funding from and/or has advised Agenus, Amgen, Armo BioSciences Array, AstraZeneca/MedImmune, Bristol-Meyers Squibb, Celldex, Compass Therapeutics, CytomX, Evaxion, Immunetune, Imunon, LGChem, Merck, Neon Therapeutics (now BioNTechUS), Novartis, Pharmajet, Phio, Pfizer, Oncorus, Roche/Genentech, Servier and Xencor. Committees: NCCN. T.K.C. reports grants, personal fees and non-financial support from Roche and Genentech during the conduct of the study; and reports institutional and/or personal, paid and/or unpaid support for research, advisory boards, consultancy, and/or honoraria from Alkermes, AstraZeneca, Aravive, Aveo, Bayer, Bristol Myers-Squibb, Calithera, Circle Pharma, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, Gilead, IQVA, Infinity, Ipsen, Jansen, Kanaph, Lilly, Merck, Nikang, Nuscan, Novartis, Oncohost, Pfizer, Roche, Sanofi/Aventis, Scholar Rock, Surface Oncology, Takeda, Tempest, Up-To-Date, CME events (Peerview, OncLive, MJH and others), outside the submitted work. Institutional patents filed on molecular alterations and immunotherapy response/toxicity, and ctDNA. Equity: Tempest, Pionyr, Osel, Precede Bio, CureResponse, InnDura Therapeutics, Primium. Committees: NCCN, GU Steering Committee, ASCO/ESMO, ACCRU, KidneyCan, ODAC. Mentored several non-United States citizens on research projects with potential funding (in part) from non-United States sources/Foreign Components. The institution (Dana-Farber Cancer Institute) may have received additional independent funding of drug companies and/or royalties potentially involved in research around the subject matter. G.M., V.C., E.B., C.R.T., A.P.V., C.F., J.F., A.B.A., N.R.S., Y.L., S.L., J.S., S.L.C., M.S.H., O.O., A.M., H.G., C.B.P., M.M., I.C., A.T., J.D.-C., A.A.H., B.S., J.M.S., L.E., L.R.O., S.G. and G.O. have no reported disclosures related to the current work.