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Proffered paper session - Immunotherapy of Cancer

2963 - A Personal Neoantigen Vaccine, NEO-PV-01, with anti-PD1 Induces Broad De Novo Anti-Tumor Immunity in Patients with Metastatic Melanoma, NSCLC, and Bladder Cancer


22 Oct 2018


Proffered paper session - Immunotherapy of Cancer


Clinical Research;  Tumour Immunology;  Immunotherapy

Tumour Site

Melanoma;  Urothelial Cancer


Patrick Ott


Annals of Oncology (2018) 29 (suppl_8): viii400-viii441. 10.1093/annonc/mdy288


P.A. Ott1, R. Govindan2, A. Naing3, T.W. Friedlander4, K. Margolin5, J.J. Lin6, N. Bhardwaj7, M.D. Hellman8, L. Srinivasan9, J. Greshock9, M. Moles9, R.B. Gaynor10, M.J. Goldstein10, S. Hu-Lieskovan11

Author affiliations

  • 1 Medical Oncology, Dana Farber Cancer Institute, 02215 - Boston/US
  • 2 Internal Medicine, Division Of Oncology, Washington University in St. Louis, St. Louis/US
  • 3 Division Of Oncology, MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 4 Department Of Medicine, UCSF, San Francisco/US
  • 5 Medical Oncology, City of Hope National Medical Center, Duarte/US
  • 6 Department Of Medicine, Massachusetts General Hospital, Boston/US
  • 7 Department Of Medicine, Mt. Sinai School of Medicine, New York/US
  • 8 Department Of Medicine, Memorial Sloan Kettering Cancer Center, New York/US
  • 9 Research & Development, Neon Therapeutics, Inc., Cambridge/US
  • 10 Research & Development, Neon Therapeutics, Inc., 02139 - Cambridge/US
  • 11 Medical Oncology, UCLA/JCCC, Los Angeles/US


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Abstract 2963


Neoantigens arise from DNA mutations in cancer cells and are important targets for T cells. Adjuvant therapy with a personal neoantigen vaccine induced T cell responses in melanoma (mel) patients and suggested synergy with anti-PD1 mAbs (Ott et al, Nature 2017). NEO-PV-01 is a personal neoantigen vaccine of up to 20 peptides (14-35 amino acids) designed based on bioinformatic analysis of a patient’s neoantigen and HLA profile. We report clinical and immune data of NEO-PV-01 in combination with nivolumab (nivo) in metastatic cancer.


NT-001 is a single-arm, phase 1b study of NEO-PV-01 with nivo in advanced mel, NSCLC, or bladder cancer. Patients begin nivo at Week 0 and at Week 12 receive NEO-PV-01 vaccine plus adjuvant Poly-ICLC in a prime-boost format. The primary endpoint is safety; secondary endpoints include overall response rate (ORR) and response conversion rate. Comprehensive immune assessments are performed throughout with biopsies at Weeks 0, 12 and 24.


31 patients received at least one vaccination by the data cut and 19 had completed the full vaccine course. Vaccine-related AEs were mild (e.g., grade 1/2 injection site reactions and flu-like symptoms), with no vaccine-related SAEs. For post vaccination patients, the ORR was 52.6% (n = 10), with 2 mel and 1 NSCLC patient having response conversions. 13 patients remain on treatment (11 mel, 1 NSCLC, 1 bladder). Immune analysis was completed on 9 patients (including all 3 tumor types). Ex vivo neoantigen-specific CD4 and CD8 T cell responses against >60% of vaccine peptides were polyfunctional and of a memory phenotype. Epitope spreading post-vaccination (T cell responses to neoantigens not in the vaccine but in the patient’s tumor) was observed in 4 of 6 patients analyzed. In a subset of patients, pathologic review of pre- vs post-vaccine biopsies showed decreased tumor cellularity following vaccination.


Treatment with NEO-PV-01 and nivo has minimal toxicity and promising clinical activity. NEO-PV-01 is effective in inducing broad de novo neoantigen-specific immune responses in patients with metastatic cancers.

Clinical trial identification


Legal entity responsible for the study

Neon Therapeutics, Inc.


Neon Therapeutics, Inc.

Editorial Acknowledgement


P.A. Ott: Consulting: Neon, BMS, Merck, Novartis, Pfizer, Roche/Genentech, Celldex, CytomX. R. Govindan: Consulting and honorarium: Genentech; Advisory board: Genentech, Pfizer, Nektar, Inivata, NeoHealth, BMS. A. Naing: Research funding: NCI, EMD Serono, MedImmune, Healios Onc. Nutrition, Atterocor, Amplimmune, Armo Biosciences, Karyopharm Therapeutics, Incyte, Novartis, Regeneron, Baxter (spouse). T.W. Friedlander: Advisory board: Genetech, Pfizer, AstraZeneca; Research funding: Novartis, Incyte, Janssen. J.J. Lin: Honorarium: Chugai, Boehringer-Ingelheim. N. Bhardwaj: Advisory board: Neon Therapeutics, Inc. M.D. Hellman: Advisory board: Genentech/Roche, BMS, AstraZeneca, Merck, Janssen, Norvartis, Mirati, Shattuck Labs; Research support: BMS. L. Srinivasan, J. Greshock, M. Moles, R.B. Gaynor, M.J. Goldstein: Employee: Neon Therapeutics, Inc. S. Hu-Lieskovan: Consulting: Amgen, Merck, Genmab, Xencor; Research support: BMS, Merck, Vaccinex. All other authors have declared no conflicts of interest.

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