Personalized neoantigen vaccine NEO-PV-01 with chemotherapy and anti-PD-1 as first-line treatment for non-squamous non-small cell lung cancer.

Neoantigens arising from mutations in tumor DNA provide targets for immune-based therapy. Here, we report the clinical and immune data from a Phase Ib clinical trial of a personalized neoantigen-vaccine NEO-PV-01 in combination with pemetrexed, carboplatin, and pembrolizumab as first-line therapy for advanced non-squamous non-small cell lung cancer (NSCLC). This analysis of 38 patients treated with the regimen demonstrated no treatment-related serious adverse events. Multiple parameters including baseline tumor immune infiltration and on-treatment circulating tumor DNA levels were highly correlated with clinical response. De novo neoantigen-specific CD4

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Declaration of interests M.M.A.,research grants (to institution): Genentech, Lilly, Bristol-Myers Squibb, AstraZeneca; consulting/advisory board fees, Genentech, Bristol-Myers Squibb, Merck, AstraZeneca, AbbVie, Neon, Achilles, Maverick, Blueprint Medicine, Hengrui, Syndax, Ariad, Nektar, Gritstone, ArcherDX, Mirati, NextCure, Novartis, EMD Serono, Panvaxal/NovaRx, Foundation Medicine. R.G., advisory role, Precisca Lung, Merck, Jacobio. D.R.S., research grants (to institution), Aeglea, Agios, Apollomics, Arcus, Arrys, Astellas, AstraZeneca, Bayer, BeiGene, Therapeutics, BioNTech RNA Pharmaceuticals, Blueprint Medicine, Boehringer-Ingelheim, Bristol-Myers Squibb, Calithera, Celldex, Clovis, Cyteir, Daiichi Sankyo, Biopharma, Eisai, Elevation Oncology, EMD Serono, Evelo Biosciences, G1, Roche/Genentech, GlaxoSmithKline, GRAIL, Hutchison MediPharma, ImClone Systems, Incyte, ImmunoGen, Ipsen, Janssen, Kronos Bio, Loxo Oncology, MacroGenics, MedImmune, Merck, Molecular Partners, Molecular Template, Nektar, Novartis, Novocure, Oncologie, Pfizer, PTC, PureTech Health, Razor Genomics, Repare, Rgenix, Takeda, Tesaro, Tizona Therapeutics, Transgene, University of Texas Southwestern, Verastem; consulting/advisory board (to institution), Amgen, AstraZeneca, Bristol-Myers Squibb, Curio Science, EMD Serono, Evidera, Exelixis, GlaxoSmithKline, Intellisphere, Ipsen, Janssen, Jazz, Lilly, Mirati, Molecular Templates, Novartis, Novocure, Pfizer, Puma Biotechnology, Regeneron, Roche/Genentech, Sanofi-Aventis. EBG: Consulting or Advisory Role: ABL Bio, Boehringer Ingelheim, Bristol-Myers Squibb, Dracen, Eisai, Eli Lilly, EMD Serono, Gilead, GSK, Merck, Natera, Novartis, Personalis, Regeneron, Sanofi, Shionogi, Xilio; grant/research support, ABL Bio, AstraZeneca, Bristol-Myers Squibb, Dynavax Technologies, EMD Serono, Genentech, Iovance Biotherapeutics, Eli Lilly, Merck, Mirati, Neon, Novartis. R.B.G., Board of Directors, Alkermes plc, Infinity Pharmaceuticals, and Zai Laboratory, and Scientific Advisory Board, Leap Therapeutics; consultant Third Rock Ventures, stockholder and employee of BioNTech US. H.S., employee of Natera, with stock/options to own stock in the company. K.N.B., M.E.B., A.P., J.H.S., V.K., E.E., J.S., S.R., R.V., T.E.S., J.Z.D., M.A.M., K.M., M.S.R., Z.S.K., M.D.M., and L.S., stockholder and either current or past employees of Neon Therapeutics/BioNTech US.