Phase 1 Study of FLAG-Ida With Pivekimab Sunirine (PVEK [IMGN632]) for Adults With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms

This phase I trial finds the best dose of PVEK when given together with fludarabine, cytarabine, granulocyte colony-stimulating factor (G-CSF), and idarubicin, (FLAG-Ida) regimen and studies the effectiveness of this combination therapy in treating patients with newly diagnosed adverse risk acute myeloid leukemia (AML) and other high-grade myeloid neoplasms. PVEK is a monoclonal antibody linked to a chemotherapy drug. PVEK is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD123 receptors, and delivers the chemotherapy drug to kill them. Chemotherapy drugs, such as idarubicin, fludarabine, high-dose cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. G-CSF helps the bone marrow make more white blood cells in patients with low white blood cell count due to cancer treatment. Giving PVEK with the FLAG-Ida regimen may be a safe and effective treatment for patients with acute myeloid leukemia and other high-grade myeloid neoplasms.

开始日期2023-12-18

申办/合作机构

Fred Hutchinson Cancer Research Center

[+1]

NCT05320380

/ Withdrawn临床1/2期IIT

A PedAL/EuPAL Phase 1/2 Trial of IMGN632 in Pediatric Patients With Relapsed or Refractory Leukemia

This phase I/II trial finds the highest safe dose of IMGN632 that can be given with other chemotherapy without causing severe side effects, studies what kind of side effects IMGN632 may cause, and determines whether IMGN632 is a beneficial treatment for leukemia in children that has come back after treatment or is difficult to treat. IMGN632 is a monoclonal antibody linked to a chemotherapy drug. IMGN632 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD123 receptors, and delivers the chemotherapy drug to kill them. Giving IMGN632 with other chemotherapy may cause the leukemia to stop growing or to shrink for a period of time.

开始日期2023-08-01

申办/合作机构

The Children's Oncology Group Foundation, Inc.

[+2]

NCT04086264

/ Active, not recruiting临床1/2期

A Phase 1b/2 Study of IMGN632 as Monotherapy or Combination With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia

This is an open-label, multicenter, Phase 1b/2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in participants with relapsed and frontline CD123-positive AML.

开始日期2019-11-06

申办/合作机构

AbbVie, Inc.

100 项与 Pivekimab Sunirine 相关的临床结果

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100 项与 Pivekimab Sunirine 相关的转化医学

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100 项与 Pivekimab Sunirine 相关的专利（医药）

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项与 Pivekimab Sunirine 相关的文献（医药）

2025-01-01·HemaSphere

Article

作者: Lock, Richard B. ; Bult, Carol J. ; Jocoy, Emily L. ; Mohamed, Sara M. A. ; Gifford, Andrew J. ; Evans, Kathryn ; Zweidler‐McKay, Patrick A. ; Philip, Vivek M. ; Lakshmikanthan, Sribalaji ; Neuhauser, Steven ; Smith, Malcolm A. ; Watts, Ben ; Earley, Eric J. ; Erickson, Stephen W. ; Stearns, Timothy M. ; Smith, Christopher M. ; Teicher, Beverly A. ; Chuang, Jeffrey H.

Abstract:

Antibody–drug conjugates (ADCs) combining monoclonal antibodies with cytotoxic payloads are a rapidly emerging class of immune‐based therapeutics with the potential to improve the treatment of cancer, including children with relapse/refractory acute lymphoblastic leukemia (ALL). CD123, the α subunit of the interleukin‐3 receptor, is overexpressed in ALL and is a potential therapeutic target. Here, we show that pivekimab sunirine (PVEK), a recently developed ADC comprising the CD123‐targeting antibody, G4723A, and the cytotoxic payload, DGN549, was highly effective in vivo against a large panel of pediatric ALL patient‐derived xenograft (PDX) models (n = 39). PVEK administered once weekly for 3 weeks resulted in a median event‐free survival (EFS) of 57.2 days across all PDXs. CD123 mRNA and protein expression was significantly higher in B‐lineage (n = 65) compared with T‐lineage (n = 25) ALL PDXs (p < 0.0001), and mice engrafted with B‐lineage PDXs achieved significantly longer EFS than those engrafted with T‐lineage PDXs (p < 0.0001). PVEK treatment also resulted in significant clearance of human leukemia cells in hematolymphoid organs in mice engrafted with B‐ALL PDXs. Notably, our results showed no direct correlation between CD123 expression and mouse EFS, indicating that CD123 is necessary but not sufficient for in vivo PVEK activity. Importantly, a PDX with very high CD123 cell surface expression but resistant to in vivo PVEK treatment, failed to internalize the G4723A antibody while remaining sensitive to the PVEK payload, DGN549, suggesting a novel mechanism of resistance. In conclusion, PVEK was highly effective against a large panel of B‐ALL PDXs supporting its clinical translation for B‐lineage pediatric ALL.

2024-03-01·The Lancet. Oncology

Article

作者: Lane, Andrew A ; Du, Yining ; Zweidler-McKay, Patrick A ; Todisco, Elisabetta ; Pemmaraju, Naveen ; Konopleva, Marina Y ; Wang, Eunice S ; DeAngelo, Daniel J ; Malcolm, Kara E ; Papadantonakis, Nikolaos ; Thompson, James E ; Kantarjian, Hagop M ; Montesinos, Pau ; Sloss, Callum M ; Sweet, Kendra L ; Bedse, Gaurav ; Daver, Naval G ; Torres-Miñana, Laura ; Watkins, Krystal

BACKGROUND:

Pivekimab sunirine (IMGN632) is a first-in-class antibody-drug conjugate comprising a high-affinity CD123 antibody, cleavable linker, and novel indolinobenzodiazepine pseudodimer payload. CD123 is overexpressed in several haematological malignancies, including acute myeloid leukaemia. We present clinical data on pivekimab sunirine in relapsed or refractory acute myeloid leukaemia.

METHODS:

This first-in-human, phase 1/2 dose-escalation and dose-expansion study enrolled participants aged 18 years or older at nine hospitals in France, Italy, Spain, and the USA with CD123+ haematological malignancies (Eastern Cooperative Oncology Group performance status of 0-1); participants reported here were in a cohort of participants with acute myeloid leukaemia who were refractory to or had relapsed on one or more previous treatments for acute myeloid leukaemia. The 3 + 3 dose-escalation phase evaluated two dosing schedules: schedule A (once every 3 weeks, on day 1 of a 3-week cycle) and fractionated schedule B (days 1, 4, and 8 of a 3-week cycle). The dose-expansion phase evaluated two cohorts: one cohort given 0·045 mg/kg of bodyweight (schedule A) and one cohort given 0·090 mg/kg of bodyweight (schedule A). The primary endpoints were the maximum tolerated dose and the recommended phase 2 dose. Antileukaemia activity (overall response and a composite complete remission assessment) was a secondary endpoint. The study is ongoing and registered with ClinicalTrials.gov, NCT03386513.

FINDINGS:

Between Dec 29, 2017, and May 27, 2020, 91 participants were enrolled (schedule A, n=68; schedule B, n=23). 30 (44%) of schedule A participants were female and 38 (56%) were male; 60 (88%) were White, six (9%) were Black or African American, and two (3%) were other races. Pivekimab sunirine at doses of 0·015 mg/kg to 0·450 mg/kg in schedule A was administered in six escalating doses with no maximum tolerated dose defined; three dose-limiting toxicities were observed (reversible veno-occlusive disease; 0·180 mg/kg, n=1 and 0·450 mg/kg, n=1; and neutropenia; 0·300 mg/kg, n=1). Schedule B was not pursued further on the basis of comparative safety and antileukaemia findings with schedule A. The recommended phase 2 dose was selected as 0·045 mg/kg once every 3 weeks. At the recommended phase 2 dose (n=29), the most common grade 3 or worse treatment-related adverse events were febrile neutropenia (three [10%]), infusion-related reactions (two [7%]), and anaemia (two [7%]). Treatment-related serious adverse events occurring in 5% or more of participants treated at the recommended phase 2 dose were febrile neutropenia (two [7%]) and infusion-related reactions (two [7%]). Among 68 participants who received schedule A, one death (1%) was considered to be treatment-related (cause unknown; 0·300 mg/kg cohort). At the recommended phase 2 dose, the overall response rate was 21% (95% CI 8-40; six of 29) and the composite complete remission rate was 17% (95% CI 6-36; five of 29).

INTERPRETATION:

Pivekimab sunirine showed single-agent activity across multiple doses, with a recommended phase 2 dose of 0·045 mg/kg once every 3 weeks. These findings led to a phase 1b/2 study of pivekimab sunirine plus azacitidine and venetoclax in patients with CD123-positive acute myeloid leukaemia.

FUNDING:

ImmunoGen.

2024-01-01·Revista espanola de patologia : publicacion oficial de la Sociedad Espanola de Anatomia Patologica y de la Sociedad Espanola de Citologia

Diagnóstico clínico-patológico de la neoplasia de células dendríticas plasmocitoides blásticas: reporte de 3 casos

作者: Llavador, Margarita ; Rienda, Iván ; Martínez-Cózar, Vicent ; Torres-Navarro, Ignacio

Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare disease with a poor prognosis. It frequently affects the skin; indeed, dermal lesions may be the first clinical manifestation. We report three cases of BPDCN where the patients presented with skin lesions and describe the clinical, histopathological and immunohistochemical findings, its molecular characteristics and metastatic work-up. One of the patients remains in a clinical trial with IMGN632, a molecule directed against CD123, while the other two patients died after different therapeutic regimens. BPDCN is a complex diagnostic challenge which, together with its poor prognosis, requires close clinical-pathological cooperation in order to accelerate its diagnosis and offer early therapeutic alternatives with drugs directed against specific molecular targets.

项与 Pivekimab Sunirine 相关的新闻（医药）

2025-10-02

·医药速览

艾伯维CD123 ADC，I/II期结束就BLA

艾伯维于2025年9月30日宣布，已向美国FDA提交了Pivekimab sunirine（PVEK）的生物制品许可申请（BLA）。PVEK是一种用于治疗母细胞性浆细胞样树突状细胞肿瘤（BPDCN）的在研疗法，这是一种罕见且侵袭性强的血液癌症，兼具白血病和淋巴瘤的特征。该申请基于全球I/II期CADENZA试验的数据，该试验评估了PVEK在BPDCN患者中的安全性和有效性。目前，BPDCN的一线治疗通常包括高强度化疗，随后常进行干细胞移植，但无论是新诊断还是复发/难治性病例，对于创新疗法的需求仍然很高。PVEK是一种靶向CD123的抗体药物偶联物（ADC），旨在将杀癌剂直接递送至表达CD123蛋白的细胞，而CD123蛋白在BPDCN中呈现高表达。 ADC基本信息：Pivekimab sunirine 是一种靶向 CD123 的抗体-药物偶联物（ADC），由新型高亲和力抗 CD123 抗体 G4723A 和 DNA 烷化剂载荷 DGN549（一种吲哚并苯二氮䓬假二聚体）组成。PVEK的工作原理是直接攻击引起BPDCN的未成熟血细胞，并释放一种毒素杀死这些细胞，防止它们不受控制地生长。抗体序列 Heavy chain 氨基酸 QVQLVQSGAEVKKPGASVKVSCKASGYIFTSSIMHWVRQAPGQGLEWIGYIKPYNDGTKYNEKFKGRATLTSDRSTSTAYMELSSLRSEDTAVYYCAREGGNDYYDTMDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLCLSPG Light chain 氨基酸 DIQMTQSPSSLSASVGDRVTITCRASQDINSYLSWFQQKPGKAPKTLIYRVNRLVDGVPSRFSGSGSGNDYTLTISSLQPEDFATYYCLQYDAFPYTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 毒素为PBD dimer,连接子为MC-AA, DAR 2。同样用到PBD的还有Zynlonta(ADCT-402)，靶向CD19 ，用于治疗I/r大B细胞淋巴瘤(LBCL)成人患者，PBD由于毒性太强更适合于血液瘤，且DAR值不能太高。 BPDCN的治疗选择有限，目前只有1种经批准的BPDCN治疗方法。BPDON患者可以用其他更常见的血癌的化疗药物进行治疗。然而，化疗是一种积极的治疗方法，由于对健康细胞造成的损伤，许多BPDCN患者无法忍受，因此会产生一些副作用. Pivekimab sunirine（PVEK）的临床实验只做了I/II期，入组一共179人，I/II期结束就BLA，且为一线治疗急性髓系白血病，急性淋巴细胞白血病，母细胞性浆细胞样树突细胞肿瘤。看似很轻松容易，实际上2017年12月就开始首次登记，受试者研究用时也长达2829天（7年多），所以罕见病适应症长时间的研究是足够的。 CADENZA研究调查了PVEK在使患者缓解（减少BPDCN的体征和症状）方面的有效性以及PVEK治疗的安全性。对两组BPDCN患者进行了研究：（1）33名之前未接受过BPDCN治疗的患者，称为一线患者，以及（2）51名之前接受过BPCCN治疗但疾病复发的患者，被称为复发或难治性患者（R/R）。剂量0.045mg/kg。一线de novo病人的CR+CRc为75%，ORR 80%, 所以一线病人CR+CRc为70%，ORR 85%，R/R病人CR+CRc为14%，ORR35%. PVEK主要的独行是一些皮肤和骨髓毒性，具有可管理的安全性，患者在PV/EK治疗期间所经历的有害影响是可以治疗的，并且不会阻止患者继续治疗。综上所述，PVEK是一个有潜力的治疗BPDCN的创新药物。 2023年11月，艾伯维以101亿美元收购ADC领域先驱ImmunoGen，重磅产品Elahere已经帮其盈利不少，十年磨一剑，PVEK将再次“亮剑”。推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。 ©2021 医药速览保留所有权利往期链接 “小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记 PROTAC技术| 抗体药物| 抗体药物偶联-ADC 核酸疫苗 | CAR技术| 化学生物学温馨提示医药速览公众号目前已经有近12个交流群（好学，有趣且奔波于医药圈人才聚集于此）。进群请扫描上方二维码，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。简单操作即可星标⭐️医药速览，第一时间收到我们的推送 ①点击标题下方“医药速览” ②至右上角“...” ③点击“设为星标

抗体药物偶联物临床2期临床1期临床结果

2025-09-30

·药明康德

降低恶化风险近80%，默沙东潜在重磅疗法登《新英格兰医学杂志》；突破性ADC疗法递交上市申请……

降低疾病恶化风险近80%，默沙东潜在重磅疗法登《新英格兰医学杂志》默沙东（MSD）今日宣布，3期临床试验HYPERION取得积极结果。该试验评估了Winrevair（sotatercept）对比安慰剂（两组均联合基础治疗）在新近确诊的肺动脉高压（PAH）成人患者中的疗效，患者功能分级（FC）为II或III，且具有中度或高度疾病进展风险。在研究中，Winrevair将临床恶化事件的风险降低了76%（HR=0.24，95% CI，0.14-0.41，p<0.0001）。该复合终点包括全因死亡、非预期与PAH相关≥24小时住院、房间隔造口术（atrial septostomy）、肺移植或PAH恶化。Winrevair的安全性特征总体与既往试验中观察到的结果一致。该研究结果已在2025年欧洲呼吸学会（ERS）大会上公布，并同步发表于《新英格兰医学杂志》。在HYPERION研究中，Kaplan-Meier曲线早期即出现分离，随机化后6周内即可观察到治疗获益。结果显示，接受Winrevair治疗的患者中有10.6%（n=17/160）发生至少一次临床恶化事件，而安慰剂组该比例为36.9%（n=59/160）。在所有预先设定的亚组中，Winrevair均展现一致的治疗效果，包括特发性PAH患者、合并结缔组织疾病的患者、接受双重基础治疗的患者、接受三重基础治疗的患者，以及基于REVEAL Lite 2和COMPERA 2.0风险评估工具判定为中度或中低度风险的患者。 Winrevair是一款“first-in-class”的IIA型激活素受体（ActRIIA）融合蛋白。它将ActRIIA经过改造的细胞外域与抗体的Fc端融合在一起，可以阻断激活素与细胞膜上的受体结合，从而降低激活素介导的信号传导。在临床前实验中，它可以逆转肺动脉壁和右心室的重塑。Winrevair在2024年3月获得美国FDA的批准，用于治疗肺动脉高压。艾伯维提交CD123靶向ADC上市申请艾伯维（AbbVie）今日宣布，已向美国FDA提交生物制品许可申请（BLA），以寻求批准其在研抗体偶联药物（ADC）pivekimab sunirine（PVEK），用于治疗母细胞性浆细胞样树突细胞肿瘤（BPDCN）。此次申请主要基于1/2期临床试验CADENZA的数据，该研究是一项全球性研究，旨在评估PVEK在BPDCN中的安全性和有效性。 BPDCN是一种罕见且侵袭性极强的血液癌症，兼具白血病和淋巴瘤的特征。患者通常表现为皮肤病变，该疾病常扩散至骨髓、中枢神经系统和淋巴结。其一线治疗通常为高强度化疗，随后常进行干细胞移植。对于新确诊患者以及既往治疗后复发或难治的患者而言，对更多创新疗法的需求非常迫切。 PVEK是一款靶向CD123的ADC，正在开发用于治疗血液系统恶性肿瘤，包括BPDCN和急性髓系白血病（AML）。CD123在BPDCN中高水平过表达，使其成为理想的治疗靶点。PVEK已获得FDA授予的突破性疗法认定，用于治疗BPDCN。治疗痛风，新锐完成2.05亿美元A轮融资 Crystalys Therapeutics今日宣布完成2.05亿美元A轮融资，以支持其满足痛风患者重大未被满足医疗需求的使命。本轮融资将用于推动公司核心项目dotinurad的全球性3期临床研究。Dotinurad是一款新一代、每日一次口服的URAT1抑制剂，在治疗痛风方面具有潜在“best-in-class”的安全性和有效性。Dotinurad已在多项临床研究中展现出强劲疗效和明确的安全性特征。痛风是最常见的炎性关节炎类型之一，是一种高度致残的疾病，特点是一个或多个关节出现突然、严重的疼痛、肿胀、发红和压痛。该疾病源于体内尿酸过多，导致尿酸晶体沉积和炎症，在慢性或治疗不足的患者中可发展为痛风石型痛风。 Dotinurad正在作为二线疗法开发，旨在降低尿酸水平、减少痛风发作并控制痛风石。Dotinurad最初由富士药品（Fuji Yakuhin）开发，已在日本、中国、菲律宾和泰国获批。Crystalys正在推进dotinurad的全球性3期临床试验，以期实现监管批准和商业化上市。参考资料： [1] AbbVie Submits Biologics License Application (BLA) to U.S. FDA for Pivekimab sunirine (PVEK) - an Investigational Antibody-Drug Conjugate (ADC) to Treat Rare Cancer with Limited Treatment Options. Retrieved September 30, 2025, from https://www.prnewswire.com/news-releases/abbvie-submits-biologics-license-application-bla-to-us-fda-for-pivekimab-sunirine-pvek---an-investigational-antibody-drug-conjugate-adc-to-treat-rare-cancer-with-limited-treatment-options-302570103.html [2] WINREVAIR™ (sotatercept-csrk) Reduced the Risk of Clinical Worsening Events by 76% Compared to Placebo in Patients Recently Diagnosed With PAH on Background Therapy in Phase 3 HYPERION Trial. Retrieved September 30, 2025, from https://www.businesswire.com/news/home/20250930429500/en/WINREVAIR-sotatercept-csrk-Reduced-the-Risk-of-Clinical-Worsening-Events-by-76-Compared-to-Placebo-in-Patients-Recently-Diagnosed-With-PAH-on-Background-Therapy-in-Phase-3-HYPERION-Trial [3] Crystalys Therapeutics Launches with $205M Series A Financing to Transform the Treatment of Gout. Retrieved September 30, 2025, from https://www.prnewswire.com/news-releases/crystalys-therapeutics-launches-with-205m-series-a-financing-to-transform-the-treatment-of-gout-302569747.html 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

抗体药物偶联物临床结果临床3期突破性疗法

2025-09-30

·news.abbvie.com

AbbVie Submits Biologics License Application (BLA) to U.S. FDA for Pivekimab sunirine (PVEK) - an Investigational Antibody-Drug Conjugate (ADC) to Treat Rare Cancer with Limited Treatment Options

Oncology R&D News – BLA based on data from the global Phase 1/2 CADENZA trial NORTH CHICAGO, Ill., Sept. 30, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced submission of a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of investigational Pivekimab sunirine (PVEK) for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). The submission is based on data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of PVEK in BPDCN. BPDCN is a rare and aggressive blood cancer that has features of both leukemia and lymphoma. Patients typically present with skin lesions and the disease often spreads to the bone marrow, central nervous system and the lymph nodes. First-line treatments are typically intensive chemotherapy and often followed by stem cell transplant. The need for additional and innovative treatment is high for both newly diagnosed patients and for those whose prior treatments have resulted in relapsed or refractory disease. PVEK is a CD123-targeting Antibody-Drug Conjugate (ADC) in clinical development for hematological malignancies (blood cancers), including BPDCN and acute myeloid leukemia (AML). ADCs are designed to deliver potent cancer cell death-inducing agents called 'payloads' directly to the cancer cells expressing a specific protein. CD123 (IL-3Rα) is a protein overexpressed in BPDCN, making it an ideal target for therapy. "Meaningful innovations in cancer research and treatment are happening every day. It is important that these innovations reach patients who desperately need them, including those with rare cancers who have limited options," said Roopal Thakkar, executive vice president, research and development and chief scientific officer, AbbVie. "We look forward to next steps in the regulatory process for our latest Antibody-Drug Conjugate (ADC), our first ADC in blood cancer, and how it may advance treatment for those living with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)." About the CADENZA Trial CADENZA is a Phase 1/2 multicenter, open-label study designed to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing schedule for PVEK monotherapy and to assess the safety, tolerability, PK, immunogenicity, and antileukemia activity of PVEK when administered to subjects with CD123+ hematologic malignancies (including subjects with BPDCN, AML, and others). About Pivekimab Sunirine (PVEK) PVEK is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML). PVEK is currently being evaluated as monotherapy for patients with BPDCN and in combination with Vidaza® (azacitidine) and Venclexta® (venetoclax) for patients with untreated and relapsed/refractory AML. In October 2020, the FDA granted PVEK Breakthrough Therapy designation in relapsed/refractory BPDCN. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. U.S. Media: Ilke Limoncu Ilke.limoncu@abbvie.com Investors: Liz Shea liz.shea@abbvie.com SOURCE AbbVie

抗体药物偶联物突破性疗法免疫疗法

100 项与 Pivekimab Sunirine 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
Blastic浆细胞样树突状细胞肿瘤	申请上市	美国	AbbVie, Inc.	2025-09-30
复发性 B 细胞急性淋巴细胞白血病	临床2期	-	ImmunoGen, Inc.	2023-08-01
复发性混合表型急性白血病	临床2期	-	ImmunoGen, Inc.	2023-08-01
难治性急性髓细胞白血病	临床2期	-	ImmunoGen, Inc.	2023-08-01
难治性 B 细胞急性淋巴细胞白血病	临床2期	-	ImmunoGen, Inc.	2023-08-01
难治性混合表型急性白血病	临床2期	-	ImmunoGen, Inc.	2023-08-01
难治性 T 急性淋巴细胞白血病	临床2期	-	ImmunoGen, Inc.	2023-08-01
复发性急性髓细胞白血病	临床2期	-	ImmunoGen, Inc.	2023-08-01
CD123阳性急性髓性白血病	临床2期	美国	AbbVie, Inc.	2018-01-02
CD123阳性急性髓性白血病	临床2期	法国	AbbVie, Inc.	2018-01-02

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03386513 (CADENZA, ASCO2025) 人工标引	临床1/2期	Blastic浆细胞样树突状细胞肿瘤 Interleukin-3 Receptor Subunit Alpha Positive	84	Pivekimab sunirine 0.045 mg/kgPivekimab sunirine 0.045 mg/kg (1L treatment)	糧觸鹽願齋壓範醖壓鏇(膚鹹膚鏇積獵顧淵鑰網) = 憲壓糧艱艱齋範膚壓構餘蓋遞網鬱鑰鏇繭壓顧 (廠築醖齋餘顧衊鹽窪膚, 51.3 ~ 84.4) 更多	积极	2025-05-30
NCT03386513 (CADENZA, ASCO2025) 人工标引	临床1/2期		84	Pivekimab sunirine 0.045 mg/kgPivekimab sunirine 0.045 mg/kg (relapsed/refractory pts received 1-3 lines)	糧觸鹽願齋壓範醖壓鏇(膚鹹膚鏇積獵顧淵鑰網) = 衊選鏇鑰壓積積繭選襯餘蓋遞網鬱鑰鏇繭壓顧 (廠築醖齋餘顧衊鹽窪膚 ) 更多	积极	2025-05-30
NCT03386513 (CADENZA, EHA2025)	临床1/2期	Blastic浆细胞样树突状细胞肿瘤 CD123 (IL-3Rα)	84	Pivekimab Sunirine (PVEK) 0.045 mg/kg	齋構膚壓衊顧構淵艱淵(餘餘積顧積廠壓鏇醖壓) = 願艱繭鏇鏇鏇簾遞獵餘蓋獵觸鏇糧壓膚艱鬱鏇 (窪鏇壓壓齋鹽範窪憲顧, 51.3 ~ 84.4) 更多	积极	2025-05-22
EHA2024	临床1/2期	CD123阳性急性髓性白血病 CD123-positive	-	Pivekimab sunirine (PVEK)	壓壓醖衊鏇願齋構廠築(鹹遞窪築遞夢觸艱糧範) = 簾鑰壓簾鬱齋鑰廠選簾鬱膚顧簾鹽窪憲築簾簾 (繭繭範顧網蓋廠襯憲顧 )	-	2024-05-14
NCT03386513 (Literature) 人工标引	临床1/2期	急性髓性白血病 Interleukin-3 Receptor Subunit Alpha Positive	91	IMGN632	範壓鹹鹽鹹蓋衊簾選遞(製顧積蓋醖鹹壓範襯範) = 廠淵繭網範獵觸壓獵醖簾願襯齋醖製壓廠襯餘 (鏇艱鑰構壓構願繭膚鏇 ) 更多	积极	2024-03-01
ASH2023	临床1/2期	急性髓性白血病	50	Pivekimab Sunirine (PVEK)	醖築餘顧積餘蓋鹽網繭(廠衊鬱觸衊壓鹽壓餘積) = 願願廠夢夢簾襯網醖繭壓積鏇繭遞壓餘築獵襯 (積憲夢鬱網範夢積繭鹹 ) 更多	-	2023-12-10
NCT04086264 (ASH 12022 \| ASH 22022) 人工标引	临床1/2期	复发性急性髓细胞白血病	71	Azacitidine+Venetoclax+Pivekimab Sunirine	網糧遞願繭鏇淵壓鑰鹽(簾觸遞簾醖鬱壓製艱鏇) = 膚襯衊糧鑰艱鏇醖鹹齋鑰範觸鹹淵築鏇餘顧觸 (選遞簾構構襯願艱壓膚 ) 更多	积极	2022-11-15
NCT04086264 (AML-262, Pubmed \| Clin Lymphoma Myeloma Leuk)	临床1/2期	复发性急性髓细胞白血病	-	Pivekimab sunirine (PVEK)	壓簾襯繭襯壓鑰艱築膚(選顧膚簾積鹹鏇壓觸築) = IRRs were reported in 33% (n=17, one grade 4) of patients given 1 dose of dexamethasone (8 mg) as premedication (n=51); these IRRs were most frequently tachycardia and chills, with no anaphylactic reactions reported. Following the data cut-off, there was a second grade 4 IRR, and the prophylactic regimen was increased with two additional doses of dexamethasone on the day prior to the PVEK dose. The IRR rate has dropped to 8% (3 of 38), with no grade 3+; all were grades 1-2 that resolved with limited intervention (P<0.01) 壓鹽糧膚襯獵積積夢糧 (築衊鹹餘積構艱範遞製 )	-	2022-10-01
NCT03386513 (CADENZA, Corporate Publications) 人工标引	临床1/2期	Blastic浆细胞样树突状细胞肿瘤	10	pivekimab (de novo patients)	壓願廠襯鏇鑰襯鑰餘鏇(網顧網窪齋積蓋襯簾襯) = 鑰夢願壓願願蓋淵醖壓鏇獵齋憲顧積窪蓋願簾 (獵製鏇窪觸夢選齋積築 )	积极	2022-08-31
NCT03386513 (CADENZA, Corporate Publications) 人工标引	临床1/2期	Blastic浆细胞样树突状细胞肿瘤	10	pivekimab (PCHM patients)	憲顧夢衊鑰糧選衊製廠(願鹹窪憲築淵積壓觸鹽) = 鹹衊鏇範願鑰獵艱選淵鏇遞鏇構窪醖顧鹹襯網 (鹹築糧繭淵蓋糧構鹹鏇 )	积极	2022-08-31
NCT04086264 (AML-367, SOHO2020)	临床1/2期	急性髓性白血病 CD123	-	IMGN632	鏇鑰遞壓糧築齋糧製醖(壓襯鑰鹽鬱築網鬱願網) = 窪壓糧鹹範憲遞醖艱鏇窪糧顧鏇壓觸繭構鏇鬱 (製壓獵鏇鑰遞範願餘鏇 ) 更多	-	2020-09-01
NCT04086264 (AML-367, SOHO2020)	临床1/2期	急性髓性白血病 CD123	-	Azacitidine	鏇鑰遞壓糧築齋糧製醖(壓襯鑰鹽鬱築網鬱願網) = 糧醖糧鬱選膚醖鏇遞願窪糧顧鏇壓觸繭構鏇鬱 (製壓獵鏇鑰遞範願餘鏇 ) 更多	-	2020-09-01
NCT03386513 (EHA2019)	临床1期	急性髓性白血病	179	IMGN632 plus venetoclax	淵壓簾壓構糧艱鑰積壓(艱製鹹簾構願艱製鑰夢) = 簾網糧夢獵齋願憲製獵夢鏇獵獵膚憲觸簾蓋壓 (鏇壓艱積襯憲範網衊艱 ) 更多	-	2019-06-14