A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer | Zendy

Patrick A. Ott | Zendy; Siwen HuLieskovan | Zendy; Bartosz Chmielowski | Zendy; Ramaswamy Govindan | Zendy; Aung Naing | Zendy; Nina Bhardwaj | Zendy; Kim Margolin | Zendy; Mark M. Awad | Zendy; Matthew D. Hellmann | Zendy; W. Marston Linehan | Zendy; Terence W. Friedlander | Zendy; Meghan E. Bushway | Zendy; Kristen N. Balogh | Zendy; Tracey Sciuto | Zendy; Victoria Kohler | Zendy; Samantha Jane Turnbull | Zendy; Rana H. Besada | Zendy; Riley R. Curran | Zendy; Benjamin Trapp | Zendy; Julian Scherer | Zendy; Asaf Poran | Zendy; Dewi Harjanto | Zendy; Dominik Barthelme | Zendy; Ying S. Ting | Zendy; Jesse Z. Dong | Zendy; Yvonne Ware | Zendy; Yu-Ting Huang | Zendy; Zhengping Huang | Zendy; Amy Wanamaker | Zendy; Lisa D. Cleary | Zendy; Melissa A. Moles | Zendy; Kelledy Manson | Zendy; Joel Greshock | Zendy; Zakaria Khondker | Zendy; Ed Fritsch | Zendy; Michael S. Rooney | Zendy; Mark DeMario | Zendy; Richard B. Gaynor | Zendy; Lakshmi Srinivasan | Zendy

Open Access

A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer

Author(s) -

Patrick A. Ott,

Siwen HuLieskovan,

Bartosz Chmielowski,

Ramaswamy Govindan,

Aung Naing,

Nina Bhardwaj,

Kim Margolin,

Mark M. Awad,

Matthew D. Hellmann,

W. Marston Linehan,

Terence W. Friedlander,

Meghan E. Bushway,

Kristen N. Balogh,

Tracey Sciuto,

Victoria Kohler,

Samantha Jane Turnbull,

Rana H. Besada,

Riley R. Curran,

Benjamin Trapp,

Julian Scherer,

Asaf Poran,

Dewi Harjanto,

Dominik Barthelme,

Ying S. Ting,

Jesse Z. Dong,

Yvonne Ware,

Yu-Ting Huang,

Zhengping Huang,

Amy Wanamaker,

Lisa D. Cleary,

Melissa A. Moles,

Kelledy Manson,

Joel Greshock,

Zakaria Khondker,

Ed Fritsch,

Michael S. Rooney,

Mark DeMario,

Richard B. Gaynor,

Lakshmi Srinivasan

Publication year - 2020

Publication title -

cell

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 26.304

H-Index - 776

eISSN - 1097-4172

pISSN - 0092-8674

DOI - 10.1016/j.cell.2020.08.053

Subject(s) - immunogenicity , immunology , cancer vaccine , lung cancer , cancer , cytotoxic t cell , biology , immunotherapy , cd8 , melanoma , regimen , bladder cancer , cancer immunotherapy , t cell , cancer research , oncology , antigen , immune system , medicine , biochemistry , in vitro

Neoantigens arise from mutations in cancer cells and are important targets of T cell-mediated anti-tumor immunity. Here, we report the first open-label, phase Ib clinical trial of a personalized neoantigen-based vaccine, NEO-PV-01, in combination with PD-1 blockade in patients with advanced melanoma, non-small cell lung cancer, or bladder cancer. This analysis of 82 patients demonstrated that the regimen was safe, with no treatment-related serious adverse events observed. De novo neoantigen-specific CD4 + and CD8 + T cell responses were observed post-vaccination in all of the patients. The vaccine-induced T cells had a cytotoxic phenotype and were capable of trafficking to the tumor and mediating cell killing. In addition, epitope spread to neoantigens not included in the vaccine was detected post-vaccination. These data support the safety and immunogenicity of this regimen in patients with advanced solid tumors (Clinicaltrials.gov: NCT02897765).

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