更新于：2024-07-08
Itacitinib
伊他替尼
更新于：2024-07-08
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)终止 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟) |
结构
分子式C26H23F4N9O |
InChIKeyKTBSXLIQKWEBRB-UHFFFAOYSA-N |
CAS号1334298-90-6 |
关联
80
项与 伊他替尼 相关的临床试验A Phase II Study of Itacitinib in Patients With Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors
Phase 1a/1b Study of Itacitinib (INCB039110) for Cytokine Release Syndrome Prevention and Minimization of Immunosuppression Following Nonmyeloablative Related Partially HLA-mismatched Peripheral Blood Stem Cell Transplant (PBSCT) With High-dose Posttransplantation Cyclophosphamide in Older Patients (Age 60 Years)
A Phase 2, Single-Arm, Open-Label Study Using Itacitinib as Pre-Modulation in Patients With Diffuse Large B-Cell Lymphoma (DLBCL) Receiving CAR-T-Cell Therapy
100 项与 伊他替尼 相关的临床结果
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100 项与 伊他替尼 相关的转化医学
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100 项与 伊他替尼 相关的专利（医药）
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47
项与 伊他替尼 相关的文献（医药）2023-12-19Cancer research communications
Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study
Article
作者: Munster, Pamela ; Lakshminarayanan, Mani ; O'Day, Steven ; Bowman, Jill ; Jones, Mark ; Kirkwood, John M ; Villaruz, Liza C ; Mettu, Niharika B ; Cho, Daniel C ; Gibney, Geoffrey T ; Hodi, F Stephen ; Iannotti, Nicholas ; Smith, Michael
Abstract:
Purpose::
This phase Ib open-label, multicenter, platform study (NCT02646748) explored safety, tolerability, and preliminary activity of itacitinib (Janus kinase 1 inhibitor) or parsaclisib (phosphatidylinositol 3-kinase δ inhibitor) in combination with pembrolizumab [programmed death-1 (PD-1) inhibitor].
Experimental Design::
Patients with advanced or metastatic solid tumors with disease progression following all available therapies were enrolled and received itacitinib (Part 1 initially 300 mg once daily) or parsaclisib (Part 1 initially 10 mg once daily; Part 2 all patients 0.3 mg once daily) plus pembrolizumab (200 mg every 3 weeks).
Results::
A total of 159 patients were enrolled in the study and treated with itacitinib (Part 1, n = 49) or parsaclisib (Part 1, n = 83; Part 2, n = 27) plus pembrolizumab. The maximum tolerated/pharmacologically active doses were itacitinib 300 mg once daily and parsaclisib 30 mg once daily. Most common itacitinib treatment-related adverse events (TRAE) were fatigue, nausea, and anemia. Most common parsaclisib TRAEs were fatigue, nausea, diarrhea, and pyrexia in Part 1, and fatigue, maculopapular rash, diarrhea, nausea, and pruritus in Part 2. In patients receiving itacitinib plus pembrolizumab, four (8.2%) achieved a partial response (PR) in Part 1. Among patients receiving parsaclisib plus pembrolizumab, 5 (6.0%) achieved a complete response and 9 (10.8%) a PR in Part 1; 5 of 27 (18.5%) patients in Part 2 achieved a PR.
Conclusions::
Although combination of itacitinib or parsaclisib with pembrolizumab showed modest clinical activity in this study, the overall response rates observed did not support continued development in patients with solid tumors.
Significance::
PD-1 blockade combined with targeted therapies have demonstrated encouraging preclinical activity. In this phase I study, patients with advanced solid tumors treated with pembrolizumab (PD-1 inhibitor) and either itacitinib (JAK1 inhibitor) or parsaclisib (PI3Kδ inhibitor) experienced limited clinical activity beyond that expected with checkpoint inhibition alone and showed little effect on T-cell infiltration in the tumor. These results do not support continued development of these combinations.
2023-12-06Advances in hematology
Novel Pharmacological Treatment Options of Steroid-Refractory Graft-versus-Host Disease
Review
作者: Chattaraj, Asmi ; Laek, Babray ; Khan, Rafiullah ; Wahab, Ahsan ; Proskuriakova, Ekaterina ; Ali, Rimsha ; Garg, Chandi ; Shah, Mitali ; Kovalenko, Iuliia ; Seyedroudbari, Sara ; Golubykh, Konstantin ; Saleem, Tabinda ; Mirza, Taaha
Background. Graft-versus-host disease (GVHD) is a potentially fatal complication of allogeneic hematopoietic stem cell transplant. The mainstay of treatment is corticosteroids, which are ineffective in 30–50% of cases. Steroid-refractory GVHD (SR-GVHD) confers a poor prognosis, with high mortality rates despite appropriate therapy. While there is no reliable treatment for SR-GVHD, a variety of novel therapeutic options are slowly emerging and have yet to be examined simultaneously. Objectives. This review evaluates the potential of novel therapeutic options, as well as their efficacy and safety, for the treatment of SR-GVHD. Study Design. The literature search was conducted in PubMed, Cochrane, and Embase, employing MeSH terms and keywords. The studies had to be prospective phases 1, 2, or 3. We excluded retrospective and nonoriginal studies. Results. While the only approved drug for acute GVHD is ruxolitinib with an impressive overall response rate of 73.2% and a complete response of 56.3%, several monoclonal antibodies and other agents are currently under investigation, offering promising results. These include anti-CD2, anti-CD147, IL-2 antagonist, a mixture of anti-CD3 and anti-CD7 antibodies, anti-CD25, monoclonal antibody to a4b7 on T-cells, anti-CD26, pentostatin, sirolimus, denileukin diftitox, infliximab, itacitinib, and alpha-1 antitripsin. However, the toxicities associated with these novel drugs need further investigation. For chronic GVHD, approved options include ruxolitinib with an ORR of up to 62%, ibrutinib with an ORR of up to 77%, and belumosudil with an ORR of up to 77%. Meanwhile, emerging treatments include tyrosine kinase inhibitors such as nilotinib, rituximab, and low-dose IL-2, as well as axatilimab and pomalidomide. Conclusion. While their efficacy needs to be better evaluated through large-scale, multicenter, randomized clinical trials, these novel agents show potential and could provide a better alternative for SR-GVHD treatment in the future.
2023-10-03Expert opinion on investigational drugs
Novel Janus-kinase (JAK) Inhibitors in Myelofibrosis
Review
作者: Kilic, Berkay ; Ipek, Yildiz ; Gunay, Ulgar Boran ; Eskazan, Ahmet Emre
INTRODUCTION:
JAK inhibitors (JAKis), used in the treatment of myelofibrosis, have entered standard treatment, providing significant improvements in spleen size and symptom burden. Although splenomegaly provides a reduction and some improvement in cytopenia, there is still a way to go. Novel JAKis are being investigated to overcome barriers to treatment access, such as therapeutic challenges, intolerance, and unresponsiveness.
AREAS COVERED:
This review includes the current status of JAKi treatment for myelofibrosis, mainly focusing on investigational JAKis; jaktinib, lestaurtinib, itacitinib, gandotinib, BMS-911543, ilginatinib, TQ05105, and flonoltinib maleate. MEDLINE and clinicaltrials.gov were screened to identify all completed or active studies on this topic. The outcomes of the preclinical studies and clinical trials are presented and discussed for each drug.
EXPERT OPINION:
In patients with myelofibrosis, momelotinib was effective in treating anemia, whereas jaktinib was effective in both anemia and Total Symptom Score (TSS). More phase 3 studies are needed to provide more precise evidence. The increasing variety of JAKis will allow for more personalized treatment options for myelofibrosis in the future. The potential impact on disease progression, molecular responses, and the duration of this response will become important parameters for future evaluations of these drugs.
100 项与 伊他替尼 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 急性移植物抗宿主病 | 临床3期 | 美国 | 2017-07-19 | |
| 急性移植物抗宿主病 | 临床3期 | 澳大利亚 | 2017-07-19 | |
| 急性移植物抗宿主病 | 临床3期 | 奥地利 | 2017-07-19 | |
| 急性移植物抗宿主病 | 临床3期 | 比利时 | 2017-07-19 | |
| 急性移植物抗宿主病 | 临床3期 | 捷克 | 2017-07-19 | |
| 急性移植物抗宿主病 | 临床3期 | 芬兰 | 2017-07-19 | |
| 急性移植物抗宿主病 | 临床3期 | 法国 | 2017-07-19 | |
| 急性移植物抗宿主病 | 临床3期 | 德国 | 2017-07-19 | |
| 急性移植物抗宿主病 | 临床3期 | 希腊 | 2017-07-19 | |
| 急性移植物抗宿主病 | 临床3期 | 以色列 | 2017-07-19 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 112 | Itacitinib+Kymriah (Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah) | 膚窪積遞鹽繭遞簾鏇壓(餘鏇醖製積繭遞積簾簾) = 願憲窪範網鏇積糧衊醖 築壓鏇餘壓鹽製製繭糧 (鹹築衊糧顧範觸齋襯鹹, 鏇積網網觸獵積夢齋憲 ~ 壓鹹衊鬱顧製範膚構選) 更多 | - | 2024-03-26 | ||
Itacitinib+Tecartus (Part 1: Itacitinib 200 mg QD + Tecartus) | 膚窪積遞鹽繭遞簾鏇壓(餘鏇醖製積繭遞積簾簾) = 遞鬱憲獵襯鏇齋襯網網 築壓鏇餘壓鹽製製繭糧 (鹹築衊糧顧範觸齋襯鹹, 鹽顧蓋鹹製繭願選鹽壓 ~ 積鑰鬱選壓鹹醖網壓壓) 更多 | ||||||
临床2期 | 3 | 願糧夢鹹醖鹹製齋簾襯(獵夢顧糧壓夢夢鹽衊網) = 鏇醖襯襯夢鏇遞窪鏇蓋 夢淵齋醖鹽夢鬱積蓋艱 (觸醖鹹鹽簾繭顧製簾襯, 蓋醖繭淵範夢繭簾齋鹽 ~ 衊遞醖醖網衊淵網壓衊) 更多 | - | 2024-01-22 | |||
临床1期 | 159 | 夢選鹹蓋遞蓋醖廠築淵(餘夢遞簾蓋窪繭鏇願觸) = Most common itacitinib treatment-related adverse events (TRAE) were fatigue, nausea, and anemia. 襯餘鹹膚蓋糧鑰願觸觸 (糧願廠蓋獵選齋窪壓築 ) 更多 | 不佳 | 2023-12-19 | |||
N/A | 42 | 壓蓋選鏇遞衊鏇獵窪糧(積夢鹽鏇夢壓製淵積積) = 餘遞選淵蓋窪獵積網築 繭鏇糧遞遞淵繭築積獵 (製餘窪膚蓋遞壓艱窪壓, 69% ~ 93%) 更多 | - | 2023-12-10 | |||
临床2期 | 47 | 鹽憲顧選夢鹽窪醖廠窪(範獵繭鬱顧糧鹽觸餘憲): P-Value = 0.003 | - | 2023-12-09 | |||
Placebo | |||||||
临床1期 | 1 | 觸餘顧繭餘築鏇膚糧鑰(廠鏇蓋艱廠襯夢齋廠憲) = 壓遞顧衊繭醖衊範繭淵 衊願鏇鏇網襯餘構鑰簾 (夢衊繭夢製壓構選顧鏇, 選衊膚淵廠遞憲襯憲製 ~ 鏇淵餘鏇淵鬱淵遞觸壓) 更多 | - | 2023-09-22 | |||
临床2期 | 23 | 繭醖醖獵繭觸鏇鏇鹹襯(顧壓顧願遞範窪製廠獵) = 窪觸廠淵繭憲廠糧遞淵 獵選繭製鏇選築觸膚夢 (膚襯餘顧願簾衊積齋遞, 顧鹽選衊餘獵鏇廠鑰醖 ~ 鹹願襯廠鑰鏇淵顧鹽餘) 更多 | - | 2023-09-13 | |||
临床1/2期 | 33 | (Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD) | 艱餘淵構廠鏇廠鹹餘構(窪糧窪網膚窪遞淵壓選) = 獵襯簾獵窪窪積鑰製網 糧壓齋鬱願遞壓糧製築 (襯襯糧齋觸窪糧淵鏇築, 醖選願廠窪網鹹遞選範 ~ 夢鏇鑰構蓋鬱襯獵廠繭) 更多 | - | 2023-06-15 | ||
(Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD) | 艱餘淵構廠鏇廠鹹餘構(窪糧窪網膚窪遞淵壓選) = 糧築憲齋鏇衊憲醖範範 糧壓齋鬱願遞壓糧製築 (襯襯糧齋觸窪糧淵鏇築, 窪築憲顧餘鏇鑰艱鑰蓋 ~ 構範襯廠簾構簾網繭選) 更多 | ||||||
临床1/2期 | 2 | Corticosteroids+Itacitinib | 築構範範鬱鹹選夢鹹壓(選餘壓選網範選築膚鑰) = 廠願膚簾遞遞願積襯簾 鹹襯醖獵廠艱齋繭願衊 (壓憲壓鏇獵繭鏇膚積鹹, 艱築襯鏇網願遞壓積顧 ~ 簾選壓鑰獵選獵顧積窪) 更多 | - | 2023-02-21 | ||
临床2期 | 70 | 膚襯廠艱製壓鬱壓構憲(鏇構範範築繭夢廠鬱蓋) = 簾觸顧鏇鬱齋鹽蓋鏇夢 衊範醖憲餘襯淵糧鑰憲 (艱繭膚艱糧鏇夢鏇獵築, 選鬱鬱構壓淵鏇鏇艱鹹 ~ 餘鑰觸製網衊衊艱網網) 更多 | - | 2023-02-06 |
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