Elpamotide(Elpamotide) - 药物靶点：VEGFR2_在研适应症：不能切除性胰腺癌，胰腺继发性恶性肿瘤_专利_临床

概要

基本信息

药物类型

合成多肽

别名

Elpamotide (JAN/INN)、Vegfr2-169 peptide vaccine

+ [1]

靶点

VEGFR2

作用机制

VEGFR2拮抗剂(血管内皮细胞生长因子受体2拮抗剂)、血管生成抑制剂

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病

在研适应症

不能切除性胰腺癌胰腺继发性恶性肿瘤

非在研适应症

胆道癌

原研机构

OncoTherapy Science, Inc.

在研机构

OncoTherapy Science, Inc.

Wakayama Medical UniversityShizuoka Cancer Center

非在研机构-

最高研发阶段临床2/3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式C47H76N16O13

InChIKeyZAJHBCDPAUKEPU-GIKXZWSFSA-N

CAS号673478-49-4

序列信息

Sequence Code 70993

来源: *****

关联

5

项与 Elpamotide 相关的临床试验

JPRN-UMIN000006436 / CompletedN/A

Continuous administration trial of Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer - Continuous administration trial of Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer

开始日期2011-10-01

申办/合作机构

OncoTherapy Science, Inc.

JPRN-UMIN000005133 / Completed

Continuous administration trial of PEGASUS-PC Study (Phase2/3 study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer) - Continuous administration trial of PEGASUS-PC Study

开始日期2011-03-01

申办/合作机构

OncoTherapy Science, Inc.

JPRN-UMIN000002500 / Completed临床2期

Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer - Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer

开始日期2009-10-01

申办/合作机构

OncoTherapy Science, Inc.

100 项与 Elpamotide 相关的临床结果

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100 项与 Elpamotide 相关的转化医学

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100 项与 Elpamotide 相关的专利（医药）

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8

项与 Elpamotide 相关的文献（医药）

2017-03-04·Acta Oncologica2区 · 医学

Gemcitabine mono-therapy versus gemcitabine plus targeted therapy in advanced pancreatic cancer: a meta-analysis of randomized phase III trials

2区 · 医学

Review

作者: Capozzi, Monica ; Tafuto, Salvatore ; Avallone, Antonio ; Botti, Gerardo ; Ottaiano, Alessandro ; De Divitiis, Chiara ; De Stefano, Alfonso

BACKGROUNDPrognosis of advanced pancreatic cancer is dismal and the novel targeted therapies, albeit successfully used to treat many advanced tumors, have shown modest results. We performed a meta-analysis in order to quantify the effect size on survival of adding targeted therapy to single agent gemcitabine.METHODSRandomized phase III trials comparing gemcitabine mono-therapy versus gemcitabine plus a targeted agent in first-line treatment of advanced pancreatic cancer designed on survival as primary outcome were selected. Search was done through Medline and the registry of the NIH. Keywords used for searching were 'pancreas', 'pancreatic', 'gemcitabine'. Study quality was assessed with MERGE criteria. Findings were depicted in classical Forest plots. Publication bias was evaluated by the construction of funnel plot.RESULTSNine studies met the meta-analysis inclusion criteria including 4564 patients. The target therapies were: erlotinib, cetuximab, rigosertib, elpamotide, bevacizumab, aflibercept, axitinib, masitinib and ganitumab. There was no statistically significant heterogeneity among the nine trials (p = 0.77). The hazard ratio (HR) of the pooled analysis was 0.998 (CI 95%: 0.932-1.068). Subgroup meta-analysis was also performed in anti-EGFR and anti-angiogenesis trials: the pooled HR were 0.94 (CI 95%: 0.705-1.175) and 1.055 (CI 95%: 0.913-1.197), respectively.CONCLUSIONSThe present meta-analysis does not show significant improvements in survival for targeted drugs in advanced pancreatic cancer. The possible reason of these results could be linked to the biology of pancreatic cancer as well as to the absence of predictive factors.

2015-07-01·Cancer Science2区 · 医学

Randomized phase II/III clinical trial of elpamotide for patients with advanced pancreatic cancer: PEGASUS‐PC Study

2区 · 医学

ArticleOA

作者: Ikeda, Masafumi ; Okusaka, Takuji ; Mizuno, Nobumasa ; Tsunoda, Takuya ; Ohashi, Yasuo ; Tani, Masaji ; Ishii, Hiroshi ; Furukawa, Masayuki ; Ueno, Hideki ; Fukutomi, Akira ; Togashi, Yosuke ; Miyazawa, Motoki ; Yamaue, Hiroki ; Ohkawa, Shinichi ; Boku, Narikazu ; Yamao, Kenji ; Maguchi, Hiroyuki ; Nishio, Kazuto

Gemcitabine is a key drug for the treatment of pancreatic cancer; however, with its limitation in clinical benefits, the development of another potent therapeutic is necessary. Vascular endothelial growth factor receptor 2 is an essential target for tumor angiogenesis, and we have conducted a phase I clinical trial using gemcitabine and vascular endothelial growth factor receptor 2 peptide (elpamotide). Based on the promising results of this phase I trial, a multicenter, randomized, placebo‐controlled, double‐blind phase II/III clinical trial has been carried out for pancreatic cancer. The eligibility criteria included locally advanced or metastatic pancreatic cancer. Patients were assigned to either the Active group (elpamotide + gemcitabine) or Placebo group (placebo + gemcitabine) in a 2:1 ratio by the dynamic allocation method. The primary endpoint was overall survival. The Harrington–Fleming test was applied to the statistical analysis in this study to evaluate the time‐lagged effect of immunotherapy appropriately. A total of 153 patients (Active group, n = 100; Placebo group, n = 53) were included in the analysis. No statistically significant differences were found between the two groups in the prolongation of overall survival (Harrington–Fleming P‐value, 0.918; log–rank P‐value, 0.897; hazard ratio, 0.87, 95% confidence interval [CI], 0.486–1.557). Median survival time was 8.36 months (95% CI, 7.46–10.18) for the Active group and 8.54 months (95% CI, 7.33–10.84) for the Placebo group. The toxicity observed in both groups was manageable. Combination therapy of elpamotide with gemcitabine was well tolerated. Despite the lack of benefit in overall survival, subgroup analysis suggested that the patients who experienced severe injection site reaction, such as ulceration and erosion, might have better survival.

2015-04-01·Investigational New Drugs3区 · 医学

Phase II trial of combination therapy of gemcitabine plus anti-angiogenic vaccination of elpamotide in patients with advanced or recurrent biliary tract cancer

3区 · 医学

Article

作者: W. Ichikawa ; T. Ajiki ; H. Maguchi ; J. Furuse ; S. Ohkawa ; K. Hakamada ; Y. Sasaki ; N. Mizuno ; M. Yamamoto ; T. Ioka ; H. Yamaue ; T. Yamaguchi ; Masato Matsuyama ; K. Eguchi ; Y. Ohashi ; M. Ikeda ; H. Ishii ; M. Miyazaki

SummaryBackground Elpamotide is an HLA-A*24:02-restricted epitope peptide of vascular endothelial growth factor receptor 2 (VEGFR-2) and induces cytotoxic T lymphocytes (CTLs) against VEGFR-2/KDR. Given the high expression of VEGFR-2 in biliary tract cancer, combination chemoimmunotherapy with elpamotide and gemcitabine holds promise as a new therapy. Patients and Methods Patients with unresectable advanced or recurrent biliary tract cancer were included in this single-arm phase II trial, with the primary endpoint of overall survival. Survival analysis was performed in comparison with historical control data. The patients concurrently received gemcitabine once a week for 3 weeks (the fourth week was skipped) and elpamotide once a week for 4 weeks. Results Fifty-five patients were registered, of which 54 received the regimen and were included in the full analysis set as well as the safety analysis set. Median survival was 10.1 months, which was longer than the historical control, and the 1-year survival rate was 44.4 %. Of these patients, injection site reactions were observed in 64.8 %, in whom median survival was significantly longer (14.8 months) compared to those with no injection site reactions (5.7 months). The response rate was 18.5 %, and all who responded exhibited injection site reactions. Serious adverse reactions were observed in five patients (9 %), and there were no treatment-related deaths. Conclusion Gemcitabine and elpamotide combination therapy was tolerable and had a moderate antitumor effect. For future development of therapies, it will be necessary to optimize the target population for which therapeutic effects could be expected.

100 项与 Elpamotide 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09995	-	-	DB16152

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
不能切除性胰腺癌	临床3期	日本	Wakayama Medical University	2013-02-01
不能切除性胰腺癌	临床3期	日本	Shizuoka Cancer Center	2013-02-01
不能切除性胰腺癌	临床3期	-	OncoTherapy Science, Inc.	2013-02-01
胰腺继发性恶性肿瘤	临床3期	日本	Wakayama Medical University	2013-02-01
胰腺继发性恶性肿瘤	临床3期	-	OncoTherapy Science, Inc.	2013-02-01
胰腺继发性恶性肿瘤	临床3期	日本	Shizuoka Cancer Center	2013-02-01
胆道癌	临床2期	日本	OncoTherapy Science, Inc.	-