背景:TAS0313是一种多表位长肽疫苗,针对在多种癌症类型中高表达的几种癌症相关抗原,包括胶质母细胞瘤(GBM)。这个2期部分的队列评估了TAS0313在GBM患者中的疗效和安全性。
方法:在周期1和2的第1、8和15天以及21天周期的后续周期的第1天皮下施用TAS0313(27mg)。主要终点是客观缓解率(ORR)。次要终点是疾病控制率,无进展生存期(PFS)和6个月和12个月无进展生存率(PFR)和安全性。免疫反应被评估为探索性终点。
结果:1例患者的最佳总体反应为部分反应,在符合方案组(n=9)中,ORR(95%CI)为11.1%(0.3-48.2%).另有3名患者病情稳定,疾病控制率(95%CI)为44.4%(13.7-78.8%)。中位数(95%CI)PFS为1.7(1.3-NE)个月,6和12个月的PFR(95%CI)分别为22.2%(3.4-51.3%)。常见(发生率≥20%)治疗相关不良事件(AEs)为注射部位反应(n=8,80.0%),其次是发热(n=7,70.0%),和不适,注射部位红斑和注射部位瘙痒(n=2,各20.0%)。没有4级或5级治疗相关的AE。在研究期间没有发生死亡。在一些患者中,与基线相比,TAS0313治疗证实增加细胞毒性T淋巴细胞和免疫球蛋白G水平。
结论:TAS0313,一种多表位长肽疫苗,在复发性GBM患者中显示出有希望的疗效和可接受的安全性。
背景:JapicCTI-183824(注册日期:2018年1月11日)。
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.
CONCLUSIONS: TAS0313, a multi-epitope long peptide vaccine, demonstrated promising efficacy and acceptable safety in patients with recurrent GBM.
BACKGROUND: JapicCTI-183824 (Date of registration: Jan 11, 2018).