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Werlenius K, Stragliotto G, Strandeus M, et al. A randomized phase II trial of efficacy and safety of the immunotherapy ALECSAT as an adjunct to radiotherapy and temozolomide for newly diagnosed glioblastoma. Neurooncol Adv. 2021;3(1):vdab156doi: 10.1093/noajnl/vdab156.
Werlenius, K., Stragliotto, G., Strandeus, M., Blomstrand, M., Carén, H., Jakola, A. S., Rydenhag, B., Dyregaard, D., Dzhandzhugazyan, K. N., Kirkin, A. F., Raida, M. K., Smits, A., & Kinhult, S. (2021). A randomized phase II trial of efficacy and safety of the immunotherapy ALECSAT as an adjunct to radiotherapy and temozolomide for newly diagnosed glioblastoma. Neuro-oncology advances, 3(1), vdab156. https://doi.org/10.1093/noajnl/vdab156
Werlenius, Katja, et al. "A randomized phase II trial of efficacy and safety of the immunotherapy ALECSAT as an adjunct to radiotherapy and temozolomide for newly diagnosed glioblastoma." Neuro-oncology advances vol. 3,1 (2021): vdab156. doi: https://doi.org/10.1093/noajnl/vdab156
Werlenius K, Stragliotto G, Strandeus M, Blomstrand M, Carén H, Jakola AS, Rydenhag B, Dyregaard D, Dzhandzhugazyan KN, Kirkin AF, Raida MK, Smits A, Kinhult S. A randomized phase II trial of efficacy and safety of the immunotherapy ALECSAT as an adjunct to radiotherapy and temozolomide for newly diagnosed glioblastoma. Neurooncol Adv. 2021 Oct 22;3(1):vdab156. doi: 10.1093/noajnl/vdab156. eCollection 2021. PMID: 34765977; PMCID: PMC8577524.
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Neurooncol Adv. 2021 Oct 22;3(1):vdab156. doi: 10.1093/noajnl/vdab156. eCollection 2021.

A randomized phase II trial of efficacy and safety of the immunotherapy ALECSAT as an adjunct to radiotherapy and temozolomide for newly diagnosed glioblastoma.

Neuro-oncology advances

Katja Werlenius, Giuseppe Stragliotto, Michael Strandeus, Malin Blomstrand, Helena Carén, Asgeir S Jakola, Bertil Rydenhag, Dorte Dyregaard, Karine N Dzhandzhugazyan, Alexei F Kirkin, Martin K Raida, Anja Smits, Sara Kinhult

Affiliations

  1. Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.
  2. Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
  3. Department of Neurology, Karolinska University Hospital, Stockholm, Sweden.
  4. Department of Oncology, Ryhov Hospital, Jönköping, Sweden.
  5. Sahlgrenska Center for Cancer Research, Department of Laboratory Medicine, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
  6. Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.
  7. Cytovac A/S, Hørsholm, Denmark.
  8. Institute of Neuroscience and Physiology, Department of Clinical Neuroscience, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
  9. Department of Neuroscience, Neurology, Uppsala University, Uppsala, Sweden.
  10. Department of Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.

PMID: 34765977 PMCID: PMC8577524 DOI: 10.1093/noajnl/vdab156

Abstract

BACKGROUND: There is an urgent need for effective treatments against glioblastoma (GBM). In this trial, we investigated the efficacy and safety of an adoptive cell-based immunotherapy.

METHODS: Patients with newly diagnosed GBM were recruited at 4 study sites in Sweden. The patients were randomized 1:2 to receive either radiotherapy (RT), 60 Gy/30 fractions, with concomitant and adjuvant temozolomide (TMZ) only, or RT and TMZ with the addition of Autologous Lymphoid Effector Cells Specific Against Tumor (ALECSAT) in an open-label phase II trial. The primary endpoint was investigator-assessed progression-free survival (PFS). The secondary endpoints were survival and safety of ALECSAT.

RESULTS: Sixty-two patients were randomized to either standard of care (SOC) with RT and TMZ alone (n = 22) or SOC with ALECSAT (n = 40). Median age was 57 years (range 38-69), 95% of the patients were in good performance status (WHO 0-1). There was no significant difference between the study arms (SOC vs ALECSAT + SOC) in PFS (7.9 vs 7.8 months; hazard ratio [HR] 1.28; 95% confidence interval [CI] 0.70-2.36;

CONCLUSION: Addition of ALECSAT immunotherapy to standard treatment with radiochemotherapy was well tolerated but did not improve PFS or OS for patients with newly diagnosed GBM.

© The Author(s) 2021. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.

Keywords: ALECSAT; adoptive cell therapy; glioblastoma; immunotherapy; randomized trial

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