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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.
Ott, Patrick A; Hu-Lieskovan, Siwen; Chmielowski, Bartosz; Govindan, Ramaswamy; Naing, Aung; Bhardwaj, Nina; Margolin, Kim; Awad, Mark M; Hellmann, Matthew D; Lin, Jessica J; Friedlander, Terence; Bushway, Meghan E; Balogh, Kristen N; Sciuto, Tracey E; Kohler, Victoria; Turnbull, Samantha J; Besada, Rana; Curran, Riley R; Trapp, Benjamin; Scherer, Julian; Poran, Asaf; Harjanto, Dewi; Barthelme, Dominik; Ting, Ying Sonia; Dong, Jesse Z; Ware, Yvonne; Huang, Yuting; Huang, Zhengping; Wanamaker, Amy; Cleary, Lisa D; Moles, Melissa A; Manson, Kelledy; Greshock, Joel; Khondker, Zakaria S; Fritsch, Ed; Rooney, Michael S; DeMario, Mark; Gaynor, Richard B; Srinivasan, Lakshmi.
Afiliación
  • Ott PA; Dana Farber Cancer Institute, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA. Electronic address: patrick_ott@dfci.harvard.edu.
  • Hu-Lieskovan S; Department of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
  • Chmielowski B; Department of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
  • Govindan R; Washington University School of Medicine, St. Louis, MO, USA.
  • Naing A; Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Bhardwaj N; Tisch Cancer Institute, Icahn School of Medicine, New York, NY, USA.
  • Margolin K; Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, CA, USA.
  • Awad MM; Dana Farber Cancer Institute, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA.
  • Hellmann MD; Memorial Sloan Kettering Cancer Center, New York, NY, USA.
  • Lin JJ; Cancer Center, Massachusetts General Hospital, and Harvard Medical School, Boston, MA, USA.
  • Friedlander T; Department of Medicine, Division of Hematology and Oncology, University of California, San Francisco, San Francisco, CA, USA.
  • Bushway ME; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Balogh KN; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Sciuto TE; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Kohler V; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Turnbull SJ; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Besada R; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Curran RR; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Trapp B; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Scherer J; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Poran A; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Harjanto D; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Barthelme D; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Ting YS; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Dong JZ; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Ware Y; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Huang Y; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Huang Z; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Wanamaker A; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Cleary LD; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Moles MA; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Manson K; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Greshock J; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Khondker ZS; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Fritsch E; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Rooney MS; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • DeMario M; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Gaynor RB; Neon Therapeutics/BioNTech US, Cambridge, MA, USA.
  • Srinivasan L; Neon Therapeutics/BioNTech US, Cambridge, MA, USA. Electronic address: lakshmi.srinivasan@biontech.us.
Cell ; 183(2): 347-362.e24, 2020 10 15.
Article en En | MEDLINE | ID: mdl-33064988
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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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Vacunas contra el Cáncer / Medicina de Precisión / Inmunoterapia Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Cell Año: 2020 Tipo del documento: Article
Texto completo
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Vacunas contra el Cáncer / Medicina de Precisión / Inmunoterapia Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Cell Año: 2020 Tipo del documento: Article