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This cohort of a Phase 2 part evaluated the efficacy and safety of TAS0313 in patients with GBM.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>TAS0313 (27\u00a0mg) 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The best overall response was partial response in 1 patient, and the ORR (95% CI) was 11.1% (0.3\u201348.2%) in the per-protocol set (<jats:italic>n<\/jats:italic>\u2009=\u20099). A further 3 patients achieved stable disease, for a disease control rate (95% CI) of 44.4% (13.7\u201378.8%). Median (95% CI) PFS was 1.7 (1.3\u2013NE) months and 6- and 12-month PFRs (95% CI) were 22.2% (3.4\u201351.3%) each. Common (\u2265\u200920% incidence) treatment-related adverse events (AEs) were injection site reactions (<jats:italic>n<\/jats:italic>\u2009=\u20098, 80.0%), followed by pyrexia (<jats:italic>n<\/jats:italic>\u2009=\u20097, 70.0%), and malaise, injection site erythema and injection site pruritus (<jats:italic>n<\/jats:italic>\u2009=\u20092, 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>TAS0313, a multi-epitope long peptide vaccine, demonstrated promising efficacy and acceptable safety in patients with recurrent GBM.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Clinical trial registration<\/jats:title>\n                <jats:p>JapicCTI-183824 (Date of registration: Jan 11, 2018)<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00262-022-03184-7","type":"journal-article","created":{"date-parts":[[2022,4,4]],"date-time":"2022-04-04T06:03:52Z","timestamp":1649052232000},"page":"2703-2715","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Evaluation of the efficacy and safety of TAS0313 in adults with recurrent glioblastoma"],"prefix":"10.1007","volume":"71","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4303-6006","authenticated-orcid":false,"given":"Yoshitaka","family":"Narita","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshiko","family":"Okita","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshiki","family":"Arakawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,4,4]]},"reference":[{"issue":"1","key":"3184_CR1","doi-asserted-by":"publisher","first-page":"11622","DOI":"10.1038\/s41598-020-68011-4","volume":"10","author":"MTC Poon","year":"2020","unstructured":"Poon MTC, Sudlow CLM, Figueroa JD, Brennan PM (2020) Longer-term (\u2265\u00a02 years) survival in patients with glioblastoma in population-based studies pre- and post-2005: a systematic review and meta-analysis. 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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\u00a0years 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\u00a0years.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All patients provided written informed consent to participate in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"The clinical study protocol, investigator\u2019s brochure, a sample informed consent form and other study-related documents were reviewed and approved by the local of all study sites. Each investigator conducted the study according to applicable local or regional regulatory requirements and in accordance with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation Harmonised Tripartite Guideline for Good Clinical Practice and Institutional Review Board regulations.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}}]}}