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. 2023 Mar 5;2(2):114–130. doi: 10.1002/cai2.59

Table 2.

Summarization of published phase III clinical trials of immunotherapy of GBM.

Reference Published year Immunotherapy Population Size of interventional group Intervention Size of control group Control Results
Reardon et al. [19] 2020 ICIs rGBM 184 NIVO 185 Bevacizumab mOS: 13.4 versus 14.9 m
mPFS: 6.0 versus 6.2 m
3–4 grades AE: 21.9% versus 25.1%
Omuro et al. [20] 2022 ICIs nGBM, MGMT promoter unmethylation 280 RT+NIVO, adjuvant NIVO 280 STUPP regimen mOS: 28.9 versus 32.1 m
mPFS: 10.6 versus 10.3 m
3–4 grades AE: 18.1% versus 15.2%
Lim et al. [21] 2022 ICIs nGBM, MGMT promoter methylation 358 RT+TMZ+NIVO, adjuvant TMZ+NIVO 358 STUPP regimen+placebo mOS: 9.8 versus 10.0 m
mPFS: 1.5 versus 3.5 m
3–4 grades AE: 52.4% versus 33.6%
Weller et al. [22] 2017 Peptide vaccine nGBM 369 Rindopepimut+TMZ 372 Keyhole hemocyanin+TMZ MRD
mOS: 19.5 versus 19.2 m
mPFS: 8.0 m versus7.4 m
SRD
mOS: 16.1 versus 15.6 m
mPFS: 3.7 versus 3.7 m
Narita et al. [23] 2019 Peptide vaccine rGBM 58 PPV 30 Placebo mOS: 8.4 versus 8.0 m
Liau et al. [24] 2022 DC vaccine nGBM 232 DCVax‐L+TMZ 1366 Historical control mOS: 19.3 versus 16.5 m
rGBM 64 DCVax‐L 640 Historical control mOS: 13.2 versus 7.8 m
Rainov [25] 2000 Virotherapy nGBM 124 Surgery+RT+HSV‐tk+Ganciclovir 124 Surgery+RT mOS: 365  versus 354 d
Westphal et al. [26] 2013 Virotherapy nHGG 119 SOC+ADV‐tk+Ganciclovir 117 SOC mOS: 497 versus 452 d
Cloughesy et al. [27] 2020 Virotherapy rGBM 128 VB‐111+Bevacizumab 128 Bevacizumab mOS: 6.8 versus 7.9 m
mPFS: 3.4 versus 3.7 m
≥3 grades AE: 67.5% versus 39.6%
Timothy F. Cloughesy [91] 2020 Virotherapy rHGG 201 Toca 511+Toca FC 199 SOC (Lomustine/TMZ/Bevacizumab) mOS:11.1 versus 12.2 m

Abbreviations: AE, adverse effects; DC, Dendritic cell; ICIs, immune checkpoint inhibitors; MGMT, O‐6‐methylguanine‐DNA methyltransferase; mOS, median overall survival; mPFS, mdian progression‐free survival; MRD, minimal residual disease; nGBM, newly diagnosed glioblastoma; nHGG, newly diagnosed high‐grade glioma; NIVO, nivolumab; PPV, personalized peptide vaccination; rGBM, recurrent glioblastoma; rHGG, recurrent high‐grade glioma; RT, radiotherapy; SOC, standard of care; SRD, significant residual disease; TMZ, temozolomide.