PMID- 35377001
OWN - NLM
STAT- MEDLINE
DCOM- 20220930
LR  - 20221004
IS  - 1432-0851 (Electronic)
IS  - 0340-7004 (Print)
IS  - 0340-7004 (Linking)
VI  - 71
IP  - 11
DP  - 2022 Nov
TI  - Evaluation of the efficacy and safety of TAS0313 in adults with recurrent 
      glioblastoma.
PG  - 2703-2715
LID - 10.1007/s00262-022-03184-7 [doi]
AB  - BACKGROUND: TAS0313 is a multi-epitope long peptide vaccine targeting several 
      cancer-associated antigens highly expressed in multiple cancer types, including 
      glioblastoma (GBM). This cohort of a Phase 2 part evaluated the efficacy and 
      safety of TAS0313 in patients with GBM. METHODS: TAS0313 (27 mg) was administered 
      subcutaneously on Days 1, 8 and 15 of Cycles 1 and 2, and Day 1 of subsequent 
      cycles in 21-day cycles. The primary endpoint was the objective response rate 
      (ORR). The secondary endpoints were the disease control rate, progression-free 
      survival (PFS) and 6- and 12-month progression-free survival rates (PFR) and 
      safety. Immunological response was assessed as an exploratory endpoint. RESULTS: 
      The best overall response was partial response in 1 patient, and the ORR (95% CI) 
      was 11.1% (0.3-48.2%) in the per-protocol set (n = 9). A further 3 patients 
      achieved stable disease, for a disease control rate (95% CI) of 44.4% 
      (13.7-78.8%). Median (95% CI) PFS was 1.7 (1.3-NE) months and 6- and 12-month 
      PFRs (95% CI) were 22.2% (3.4-51.3%) each. Common (>/= 20% incidence) 
      treatment-related adverse events (AEs) were injection site reactions (n = 8, 
      80.0%), followed by pyrexia (n = 7, 70.0%), and malaise, injection site erythema 
      and injection site pruritus (n = 2, 20.0% each). There were no grade 4 or 5 
      treatment-related AEs. No deaths occurred during the study. In some patients, 
      TAS0313 treatment was confirmed to increase cytotoxic T lymphocyte and 
      immunoglobulin G levels compared with baseline. CONCLUSION: TAS0313, a 
      multi-epitope long peptide vaccine, demonstrated promising efficacy and 
      acceptable safety in patients with recurrent GBM. CLINICAL TRIAL REGISTRATION: 
      JapicCTI-183824 (Date of registration: Jan 11, 2018).
CI  - (c) 2022. The Author(s).
FAU - Narita, Yoshitaka
AU  - Narita Y
AUID- ORCID: 0000-0003-4303-6006
AD  - Department of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital, 
      5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. yonarita@ncc.go.jp.
FAU - Okita, Yoshiko
AU  - Okita Y
AD  - Department of Neurosurgery, Osaka International Cancer Institute, Osaka, Japan.
AD  - Department of Neurosurgery, Osaka University Graduate School of Medicine, Osaka, 
      Japan.
FAU - Arakawa, Yoshiki
AU  - Arakawa Y
AD  - Department of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, 
      Japan.
LA  - eng
PT  - Journal Article
DEP - 20220404
PL  - Germany
TA  - Cancer Immunol Immunother
JT  - Cancer immunology, immunotherapy : CII
JID - 8605732
RN  - 0 (Cancer Vaccines)
RN  - 0 (Epitopes)
RN  - 0 (Immunoglobulin G)
SB  - IM
MH  - Adult
MH  - *Brain Neoplasms/drug therapy
MH  - Cancer Vaccines
MH  - Epitopes
MH  - *Glioblastoma/drug therapy
MH  - Humans
MH  - Immunoglobulin G
PMC - PMC9519730
OTO - NOTNLM
OT  - Cancer peptide vaccine
OT  - Cancer vaccines
OT  - Glioblastoma
OT  - High-grade glioma
OT  - TAS0313
COIS- YN has received grant support from Taiho Pharmaceutical Co., Ltd to their 
      institution for manuscript preparation, has received grants from Taiho 
      Pharmaceutical Co., Ono Pharmaceutical, Taiho Pharmaceutical Co., Eisai, Daiichi 
      Sankyo, Stella-Pharma, Ohara, Denba and AbbVie to their institution in the past 
      3 years, has received consulting fees from AbbVie in the past 3 years and has 
      received payments or honoraria from Chugai, Ono Pharmaceutical, Daiichi Sankyo, 
      Eisai and Novocure in the past 3 years. YO has no conflicts of interest to 
      disclose. YA has received grant support from Taiho Pharmaceutical Co., Ltd to 
      their institution for manuscript preparation, has received grants from Siemens, 
      Philips, Sanofi, Ono Pharmaceutical, Sanofi, Nihon Medi Physics, Brainlab, Carl 
      Zeiss, Tanabe Mitsubishi, Chugai, Eisai, Merck, Meiji Seika, Daiichi Sankyo, CSL 
      Behring, Takeda, Pfizer, Stryker and Astellas Pharma to their institution in the 
      past 3 years and has received payments or honoraria from Nippon Kayaku, Novocure, 
      UCB Japan, Ono Pharmaceutical, Brainlab, Chugai, Merck, Eisai, Meiji Seika, 
      Daiichi Sankyo, CSL Behring, Integra Japan, Carl Zeiss, Otsuka and AbbVie in the 
      past 3 years.
EDAT- 2022/04/05 06:00
MHDA- 2022/10/01 06:00
PMCR- 2022/04/04
CRDT- 2022/04/04 12:02
PHST- 2021/10/22 00:00 [received]
PHST- 2022/03/01 00:00 [accepted]
PHST- 2022/04/05 06:00 [pubmed]
PHST- 2022/10/01 06:00 [medline]
PHST- 2022/04/04 12:02 [entrez]
PHST- 2022/04/04 00:00 [pmc-release]
AID - 10.1007/s00262-022-03184-7 [pii]
AID - 3184 [pii]
AID - 10.1007/s00262-022-03184-7 [doi]
PST - ppublish
SO  - Cancer Immunol Immunother. 2022 Nov;71(11):2703-2715. doi: 
      10.1007/s00262-022-03184-7. Epub 2022 Apr 4.