Frontiers in Oncology (Jun 2022)

A Prospective, Cohort Study of SITOIGANAP to Treat Glioblastoma When Given in Combination With Granulocyte-Macrophage Colony-Stimulating Factor/Cyclophosphamide/Bevacizumab/Nivolumab or Granulocyte-Macrophage Colony-Stimulating Factor/Cyclophosphamide/Bevacizumab/Pembrolizumab in Patients Who Failed Prior Treatment With Surgical Resection, Radiation, and Temozolomide

  • Daniela A. Bota,
  • Daniela A. Bota,
  • Daniela A. Bota,
  • Thomas H. Taylor,
  • Thomas H. Taylor,
  • Naomi Lomeli,
  • Xiao-Tang Kong,
  • Xiao-Tang Kong,
  • Xiao-Tang Kong,
  • Beverly D. Fu,
  • Beverly D. Fu,
  • Axel H. Schönthal,
  • Samuel Singer,
  • Deborah T. Blumenthal,
  • Frank M. Senecal,
  • Helena Linardou,
  • Evangelos Rokas,
  • Dimitris G. Antoniou,
  • Virgil E. J. C. Schijns,
  • Thomas C. Chen,
  • Thomas C. Chen,
  • Thomas C. Chen,
  • Joseph Elliot,
  • Apostolos Stathopoulos,
  • Apostolos Stathopoulos,
  • Apostolos Stathopoulos,
  • Apostolos Stathopoulos

DOI
https://doi.org/10.3389/fonc.2022.934638
Journal volume & issue
Vol. 12

Abstract

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BackgroundGlioblastoma (GBM) is the most common primary, malignant brain tumor in adults and has a poor prognosis. The median progression-free survival (mPFS) of newly diagnosed GBM is approximately 6 months. The recurrence rate approaches 100%, and the case-fatality ratio approaches one. Half the patients die within 8 months of recurrence, and 5-year survival is less than 10%. Advances in treatment options are urgently needed. We report on the efficacy and safety of a therapeutic vaccine (SITOIGANAP: Epitopoietic Research Corporation) administered to 21 patients with recurrent GBM (rGBM) under a Right-to-Try/Expanded Access program. SITOIGANAP is composed of both autologous and allogeneic tumor cells and lysates.MethodsTwenty-one patients with rGBM received SITOIGANAP on 28-day cycles in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), cyclophosphamide, bevacizumab, and an anti-programmed cell death protein-1 (anti-PD-1) monoclonal antibody (either nivolumab or pembrolizumab).ResultsThe mPFS was 9.14 months, and the median overall survival (mOS) was 19.63 months from protocol entry. Currently, 14 patients (67%) are at least 6 months past their first SITOIGANAP cycle; 10 patients (48%) have received at least six cycles and have a mOS of 30.64 months and 1-year survival of 90%. The enrollment and end-of-study CD3+/CD4+ T-lymphocyte counts strongly correlate with OS.ConclusionsThe addition of SITOIGANAP/GM-CSF/cyclophosphamide to bevacizumab and an anti-PD-1 monoclonal antibody resulted in a significant survival benefit compared to historic control values in rGBM with minimal toxicity compared to current therapy.

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