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

Werlenius, Katja ; Stragliotto, Giuseppe ; Strandeus, Michael ; Blomstrand, Malin ; Caren, Helena LU ; Jakola, Asgeir S. ; Rydenhag, Bertil ; Dyregaard, Dorte ; Dzhandzhugazyan, Karine N. and Kirkin, Alexei F. , et al. (2021) In Neuro-Oncology Advances 3(1).
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... (More)

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; P =. 42) or in median overall survival (OS) (18.3 vs 19.2 months; HR 1.16, 95% CI 0.58-2.31; P =. 67). The treatment groups were balanced in terms of serious adverse events (52.4% vs 52.5%), but adverse events ≥grade 3 were more common in the experimental arm (81.0% vs 92.5%). 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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
adoptive cell therapy, ALECSAT, glioblastoma, immunotherapy, randomized trial
in
Neuro-Oncology Advances
volume
3
issue
1
article number
vdab156
publisher
Oxford University Press
external identifiers
  • pmid:34765977
  • scopus:85126648348
DOI
10.1093/noajnl/vdab156
language
English
LU publication?
yes
id
7acc57ec-7239-44bf-a4eb-f0394e694199
date added to LUP
2022-05-03 11:06:31
date last changed
2024-12-13 08:38:19
@article{7acc57ec-7239-44bf-a4eb-f0394e694199,
  abstract     = {{<p>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; P =. 42) or in median overall survival (OS) (18.3 vs 19.2 months; HR 1.16, 95% CI 0.58-2.31; P =. 67). The treatment groups were balanced in terms of serious adverse events (52.4% vs 52.5%), but adverse events ≥grade 3 were more common in the experimental arm (81.0% vs 92.5%). 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. </p>}},
  author       = {{Werlenius, Katja and Stragliotto, Giuseppe and Strandeus, Michael and Blomstrand, Malin and Caren, Helena and Jakola, Asgeir S. and Rydenhag, Bertil and Dyregaard, Dorte and Dzhandzhugazyan, Karine N. and Kirkin, Alexei F. and Raida, Martin K. and Smits, Anja and Kinhult, Sara}},
  keywords     = {{adoptive cell therapy; ALECSAT; glioblastoma; immunotherapy; randomized trial}},
  language     = {{eng}},
  number       = {{1}},
  publisher    = {{Oxford University Press}},
  series       = {{Neuro-Oncology Advances}},
  title        = {{A randomized phase II trial of efficacy and safety of the immunotherapy ALECSAT as an adjunct to radiotherapy and temozolomide for newly diagnosed glioblastoma}},
  url          = {{http://dx.doi.org/10.1093/noajnl/vdab156}},
  doi          = {{10.1093/noajnl/vdab156}},
  volume       = {{3}},
  year         = {{2021}},
}