维奈克拉(Venetoclax) - 药物靶点：Bcl-2_在研适应症：复发性套细胞淋巴瘤，难治性套细胞淋巴瘤，难治性慢性淋巴细胞白血病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

VENCLYXTO、Venetoclax (JAN/USAN/INN)、维奈妥拉

+ [15]

靶点

Bcl-2

作用方式

抑制剂

作用机制

Bcl-2抑制剂(细胞凋亡调控因子Bcl-2抑制剂)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [7]

在研适应症

复发性套细胞淋巴瘤难治性套细胞淋巴瘤难治性慢性淋巴细胞白血病+ [130]

非在研适应症

侵袭性非霍奇金淋巴瘤复发性B细胞淋巴瘤难治性B细胞淋巴瘤+ [23]

原研机构

Genentech, Inc.

AbbVie, Inc.

在研机构

AbbVie, Inc.

The University of Texas MD Anderson Cancer CenterHoffmann-La Roche, Inc.

+ [31]

非在研机构

Janssen Scientific Affairs LLCJanssen Research & Development LLC

Janssen Pharmaceuticals, Inc.

权益机构

The University of Texas MD Anderson Cancer Center

Astex Pharmaceuticals, Inc.

Tolero Pharmaceuticals, Inc.

+ [4]

最高研发阶段批准上市

首次获批日期

美国 (2016-04-11),

慢性淋巴细胞白血病

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、附条件批准 (中国)、孤儿药 (澳大利亚)、特殊审批 (中国)

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结构/序列

分子式C45H50ClN7O7S

InChIKeyLQBVNQSMGBZMKD-UHFFFAOYSA-N

CAS号1257044-40-8

关联

718

项与维奈克拉相关的临床试验

NCT06317662

/ Recruiting临床2期IIT

A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged [R]) or without a KMT2A gene rearrangement (KMT2A-germline [G]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs 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. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.

开始日期2026-01-20

申办/合作机构

National Cancer Institute

NCT06770257

/ Withdrawn临床2期IIT

A Randomized Phase ll Study Evaluating the Efficacy and Safety of Combination Therapy of Daunorubicin, Cytarabine Liposomes and Venetoclax Versus Combination Therapy of Azacitidine and Venetoclax in Newly Diagnosed AML Patients Not Eligible for Intensive Chemotherapy

Daunorubicin, Cytarabine Liposomes(CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.) is a dual-drug liposomal encapsulation of cytarabine and daunorubicin at a fixed 5:1 synergistic molar ratio.
This is a phase 2, randomized, controlled study in patients who are >= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for intensive induction therapy.
In this study, patients will be randomized by 1:1:1 to receive Daunorubicin, Cytarabine Liposomes + Venetoclax(14d) or Daunorubicin, Cytarabine Liposomes + Venetoclax(21d) or Venetoclax + Azacitidine.
Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit.

开始日期2025-12-10

申办/合作机构

石药集团中诺药业（石家庄）有限公司

NCT06917911

/ Not yet recruiting临床2期IIT

Phase II Study of Cytarabine + Daunorubicin (7 + 3) + Gemtuzumab Ozogamicin vs. Cytarabine + Daunorubicin (7 + 3) + Venetoclax for the Treatment of Newly Diagnosed Core Binding Factor Acute Myeloid Leukemia (CBF-AML) in Younger Adults: A MyeloMATCH Substudy

This phase II MyeloMATCH treatment trial compares the effect of venetoclax to gemtuzumab ozogamicin, when given with cytarabine and daunorubicin ("7+3" regimen), for the treatment of patients with core binding factor acute myeloid leukemia (CBF-AML). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to an antitumor antibiotic drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as cytarabine and daunorubicin 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. Giving venetoclax with cytarabine and daunorubicin may have fewer side effects and be as effective or better than the combination with gemtuzumab ozogamicin in treating patients with core binding factor AML.

开始日期2025-11-20

申办/合作机构

National Cancer Institute

100 项与维奈克拉相关的临床结果

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100 项与维奈克拉相关的转化医学

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100 项与维奈克拉相关的专利（医药）

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5,251

项与维奈克拉相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Significant prognostic improvement in elderly patients with acute myeloid leukemia treated with hypomethylating agents and venetoclax: outcomes from a retrospective real-world analysis

Article

作者: Zheng, Jing ; Wu, Yong ; Wu, Lanlan ; Chen, Yi ; Zhou, Jiayi ; Wu, Zhengjun ; Cai, Ruyu ; Wang, Zhengyang

OBJECTIVE:

This investigation aim to analyze the clinical features and therapeutic outcomes of elderly patients with acute myeloid leukemia (AML).

METHOD:

We conducted a retrospective analysis of the clinical and cytogenetic profiles of patients aged 60 years and older diagnosed with AML at the Fujian Medical University Union Hospital from 2016 to 2024.

RESULTS:

Our study cohort included 846 patients, with a median age of 67 years. The median duration of response (DOR) was 15.8 months, with 1-year, 3-year, and 5-year DOR rates of 55.3%, 23.4%, and 13.1%, respectively. The median overall survival (OS) was 21.8 months, with corresponding 1-year, 3-year, and 5-year OS rates of 58.7%, 41.2%, and 30.0%. Patients who received the azacitidine and venetoclax treatment protocol exhibited a complete remission (CR) rate of 57.1% and a minimal residual disease (MRD) - negative rate of 34.1%. These rates were comparable to the 59.2% CR rate and 39.4% MRD-negative rate observed in patients treated with intensive chemotherapy, and were superior to those with other low-intensity regimens. Compared to the treatment outcomes achieved at our center prior to 2016, when chemotherapy was the predominant treatment modality, which were characterized by a CR rate of 42.7%, a median OS of 9.2 months, and a mere 5-year OS rate of 13.5%, the remission rate and long-term survival of elderly patients with AML have been remarkable improved.

CONCLUSION:

The integration of hypomethylating agents and venetoclax into the treatment paradigm for elderly patients with AML has significantly enhanced survival rates.

2025-12-31·Hematology

Identification of t(X;1)(q28;q21) generating a novel GATAD2B::MTCP1 gene fusion in CMML and its persistence during progression to AML

Article

作者: Chen, Yu ; Zhu, Yi-yan ; Liu, Yi-zi ; Hou, Chun-xiao ; Zhang, Zhi-yu ; Chen, Su-ning ; Wang, Qian ; Zhang, Feng-hong

OBJECTIVE:

Hematological malignancies often involve chromosomal translocations and fusion genes that drive disease progression. While MTCP1 is well-known in T-cell prolymphocytic leukemia (T-PLL), its role in myeloid neoplasms is less understood. This report presents the first identification of the t(X;1)(q28;q21) translocation leading to the GATAD2B::MTCP1 fusion in acute myeloid leukemia (AML) transformed from chronic myelomonocytic leukemia (CMML).

METHODS:

The karyotypes were described according to the International System for Human Cytogenetic Nomenclature 2009. We performed targeted next-generation sequencing (NGS) on a panel of 172 genes commonly mutated in hematological malignancies (Supplemental Table 1), using an Illumina platform. RNA sequencing was conducted on total RNA extracted from bone marrow, also using the Illumina platform. The GATAD2B::MTCP1 fusion gene was confirmed by reverse transcription-polymerase chain reaction (RT-PCR) and Sanger sequencing, with specific primers for the fusion transcript (GATAD2B-F: CCTCTTTTTTTCGACGCC; MTCP1-R: ACTGAGCACAACACTTACGC).

RESULTS:

The GATAD2B::MTCP1 fusion results from a breakpoint on 1q21 within GATAD2B exon 1 and Xq28 within MTCP1 exon 2. The patient with the GATAD2B::MTCP1 fusion exhibited disease progression from CMML to AML. Despite achieving initial remission with venetoclax-based therapy and allo-HSCT, the patient relapsed and died.

CONCLUSIONS:

We propose that the GATAD2B::MTCP1 fusion upregulates MTCP1 expression rather than generating a fusion protein, thereby contributing to transformation and relapse in AML. Further investigations are needed to elucidate the precise role of this fusion event in myeloid malignancies.

2025-12-31·CANCER BIOLOGY & THERAPY

Targeting the IKZF1/BCL-2 axis as a novel therapeutic strategy for treating acute T-cell lymphoblastic leukemia

Article

作者: Li, Jun ; Ye, Chunmei ; Li, Hui ; Li, Juan

OBJECTIVES:

Acute T-cell lymphoblastic leukemia (T-ALL) is a severe hematologic malignancy with limited treatment options and poor long-term survival. This study explores the role of IKZF1 in regulating BCL-2 expression in T-ALL.

METHODS:

CUT&Tag and CUT&Run assays were employed to assess IKZF1 binding to the BCL-2 promoter. IKZF1 overexpression and knockdown experiments were performed in T-ALL cell lines. The effects of CX-4945 and venetoclax, alone and in combination, were evaluated in vitro and in vivo T-ALL models.

RESULTS:

CUT&Tag sequencing identified IKZF1 binding to the BCL-2 promoter, establishing it as a transcriptional repressor. Functional assays demonstrated that IKZF1 overexpression reduced BCL-2 mRNA levels and increased repressive histone marks at the BCL-2 promoter, while IKZF1 knockdown led to elevated BCL-2 expression. CX-4945, a CK2 inhibitor, could reduced BCL-2 levels in T-ALL cells. Notably, knockdown of IKZF1 partially rescued the CX-4945-induced repression of BCL-2. These results underscore the CK2-IKZF1 signaling axis as a key regulator of BCL-2 expression. In vitro, CX-4945 enhanced the cytotoxicity of venetoclax, with the combination showing significant synergistic effects and increased apoptosis in T-ALL cell lines. In vivo studies with cell line-derived xenograft (CDX) and patient-derived xenograft (PDX) models demonstrated that CX-4945 and venetoclax combined therapy provided superior therapeutic efficacy, reducing tumor burden and prolonging survival compared to single-agent treatments.

CONCLUSIONS:

IKZF1 represses BCL-2 in T-ALL, and targeting the CK2-IKZF1 axis with CX-4945 and venetoclax offers a promising therapeutic strategy, showing enhanced efficacy and potential as a novel treatment approach for T-ALL.

1,468

项与维奈克拉相关的新闻（医药）

22 小时之前

·氨基观察

Bcl-2抑制剂大变局

氨基观察-创新药组原创出品作者 | 蔡九随着国产创新药的崛起，全球创新药既有格局正加速迎来挑战与重塑。以Bcl-2抑制剂赛道为例，尽管艾伯维的维奈克拉凭借先发优势占据全球市场主导地位，且该领域因技术门槛极高被视为“难攻之城”，但国内药企并未望而却步，反而以雄心壮志加速追赶，率先“上岸”者已近在眼前。亚盛医药的新型Bcl-2选择性抑制剂APG-2575（Lisaftoclax）在去年年底已向CDE递交新药上市申请并获纳入优先审评，目前正处于获批倒计时阶段。值得关注的是，国内药企早已跨越“盲目跟随”的阶段，所遵循的是以技术创新驱动市场突破的底层逻辑。也正因此，不管是患者还是投资者，对国产Bcl-2抑制剂都有较高期待。例如，领跑者APG-2575过去已经展现了全面的疗效和安全性优势，有best-in-class潜力。如今看来，这些国产分子也并没有辜负市场期待。亚盛医药2025年ASCO大会上披露的最新数据显示，APG-2575针对维奈克拉治疗失败患者仍然展现了极为强劲的疗效，进一步颠覆了市场对其潜在“更好”的认知。这继续推升了APG-2575的市场关注度。在6月6日亚盛医药举办的2025 年ASCO年会解读会上，氨基君观察到，参会的机构分析师与投资者不仅人数众多，且展现出极高的关注热情。提问环节中，他们围绕APG-2575 的竞争壁垒、后续研发节点等核心议题展开了层层深入的追问。越来越多的人已经意识到，Bcl-2抑制剂赛道变局将至。/ 01 /继续刷新战斗力认知对于APG-2575的战斗力，市场早有认知。在2021年，APG-2575就率先开始探索r/r CLL/SLL患者的临床。根据公司2023年ASH年会上公布的数据，APG-2575在既往接受过深度治疗、且BTK经治的CLL患者中疗效显著。结果表明，在45例r/r CLL患者中，ORR和CR/CRi分别为73.3%和24.4%，CR/CRi率随剂量水平的增加呈上升趋势，mPFS为18.53个月，第30个月时的OS发生率为86.3%。上述患者近半数接受过>=3线治疗，基线较差，APG-2575仍展现出高缓解率的特点，凸显了其竞争力。2024年11月，APG-2575递交上市申请，有望成为全球第二款获批的Bcl-2抑制剂。而最新公布的ASCO数据，则是在更多维度证明了APG-2575的潜力。该Ib/II期临床试验，主要评估APG-2575联合去甲基化药物阿扎胞苷，治疗初治（TN）或既往接受过维奈克拉治疗的髓系恶性肿瘤患者。数据的最大亮点在于，针对维奈克拉治疗失败的患者，APG-2575仍展现出极为强劲的疗效。在28例既往维奈克拉耐药的复发/难治性 AML/混合表型急性白血病（MPAL）患者中，22 例疗效可评估，总反应率（ORR）为 31.8%。值得关注的是，这是Bcl-2抑制剂领域首次通过临床数据证实同类药物可克服相互间耐药性，被市场视为开创性突破——尤其71%的应答患者携带TP53突变或复杂核型，这类患者通常临床治疗难度极大。这一数据不仅刷新了市场对APG-2575治疗潜力的认知，更为整个Bcl-2抑制剂赛道提供了 “克服耐药性” 的新范式，其临床价值与行业意义均被高度期待。当然，除了针对维奈克拉治疗失败患者，APG-2575在其它难治患者以及新诊患者中，均展示了强大的活性。在新诊断的AML/MPAL中，ORR达到83.3%，在新诊断的MDS/CMML中为80%。R/R队列显示，AML/MPAL的ORR为43.2%，MDS/CMML的ORR为50%，与当前标准旗鼓相当或可能更好。上述数据充分表明，APG-2575填补难治领域临床空白的能力此前被显著低估，尤其是结合其安全性优势综合考虑后。/ 02 /安全性优势的再验证Bcl-2抑制剂后来者的破局：疗效是基础，但更重要的是安全性风险的降低。众所周知，维奈克拉面临肿瘤溶解综合征（TLS）、给药剂量繁琐等痛点，制约了Bcl-2抑制剂的临床应用拓展。而APG-2575之所以让市场充满期待，核心在于其具备潜在安全性优势——TLS发生概率极低，无需采用每周剂量递增方案，用药方案更灵活，患者应答速度更快。亚盛医药在今年ASCO上公布的，治疗初治（TN）或既往接受过维奈克拉治疗的髓系恶性肿瘤患者 Ib/II期临床数据，则是再次验证了其安全性优势。在临床设计方面，APG-2575继续展现同类最优的剂量窗口。剂量窗是指药物能够有效治疗疾病且安全性可控的剂量范围，最大耐受剂量数值越高，代表药物的耐受性越好、治疗潜力越强。在上述Ib/II期临床中，试验共设置2个部分：第1部分以递增剂量（200、400、600或800mg每天一次 [QD]）给药；第2部分评估200、400或600mgQD的安全性和有效性。并且，临床结果显示，高剂量组APG-2575也能较好的平衡治疗效果和安全性。根据公司相关人士在解读会上透露，600mgQD剂量将会是髓系恶性肿瘤3期临床考虑的剂量之一。而维奈克拉需通过繁琐的剂量爬坡，最终治疗剂量上限仅为400mg，相较之下，APG-2575的竞争力显著凸显。其次，APG-2575常见不良反应主要体现在血液学事件，非血液学毒性不常见，且绝大多数不良事件都可控制、可恢复、可耐受，进一步佐证了其安全性优势。在同类药物的临床研究中，因为毒副作用导致患者不耐受，一直是临床痛点。上述安全性数据表明，APG-2575能够为患者带来更优疗效和更持续的治疗周期，推动髓系恶性肿瘤向“慢性病管理”目标更进一步，这必然会进一步提升市场的期待值。/ 03 /对于未来的更高期待作为具备Best-in-Class潜力的分子，APG-2575 的市场上限令人遐想。当前研究布局与公布的成果显示，其目标不仅是追赶维奈克拉，更在于“维奈克拉能覆盖的群体，它能做得更好；维奈克拉不能覆盖的群体，APG-2575也能覆盖。凭借安全性和给药优势，APG-2575一方面展现了满足Bcl-2抑制剂主战场CLL/SLL领域更多患者需求。其联合阿可替尼治疗CLL/SLL的潜力显著。公司此前公布的2期研究结果显示，APG-2575与阿卡替尼联用治疗初治CLL/SLL患者的ORR达100%，在R/R CLL/SLL中的ORR仍达98%。不管在治疗CLL/SLL还是R/R CLL/SLL中，APG-2575联合疗法均可能最佳选择更重要的是，联合治疗保持了与APG-2575单药治疗相当的安全性：临床TLS发生率低、后遗症小，主要为临床易于管理的低级别血液学不良事件。此外，APG-2575联合BTKi的给药方案更简洁便利，采用每日梯度剂量递增给药，改进了维奈克拉联合方案特有的BTKi单药导入期，可更快进入联合治疗阶段，综合优势进一步凸显。基于此，针对BTK抑制剂耐药CLL/SLL患者、一线治疗初治CLL/SLL患者的多项全球注册3期研究均已开展。另一方面，APG-2575在MDS、R/R MM等维奈克拉尚未覆盖的领域也展现出极佳疗效。例如，亚盛医药在2024 年ASH 大会上口头汇报了APG-2575用于R/R MM或AL淀粉样变性患者的临床试验数据：在既往接受过多线治疗的36例可评估患者中，总ORR达63.9%， VGPR率达 30.6%，mPFS高达9.7个月。安全性方面，APG-2575在800-1200mg剂量下与其他药物联用时仍表现出良好耐受性，且未发生药物相互作用（DDI）。该研究是全球首个Bcl-2抑制剂在高剂量下长时间使用的研究报告。基于积极的表现，在AML和MDS适应症领域，lisaftoclax也均有全球注册3期临床正在开展。若能兑现全适应症布局，APG-2575在为全球患者提供更优选择的同时，销售峰值有望远超维奈克拉。这也预示了一点，Bcl-2抑制剂的下半场会更加精彩。PS：欢迎扫描下方二维码，添加氨基君微信号交流。

ASCO会议优先审批临床结果申请上市临床1期

2025-06-06

·研发客

亚盛医药：从纳斯达克IPO到8次亮相ASCO

// • lisaftoclax有克服维奈克拉耐药的潜力；• lisaftoclax联合阿扎胞苷已在既往研究中呈现出治疗多种髓系恶性肿瘤患者的潜力；• alrizomadlin治疗晚期腺样囊性癌的ORR为16.7%，DCR为100%；• 去年亚盛医药总收入同比增长342%，奥雷巴替尼在中国市场销售强劲。“这是国际首次报告一种Bcl-2抑制剂克服另一种Bcl-2抑制剂耐药的临床研究，说明lisaftoclax（APG-2575）有望在髓系恶性肿瘤治疗领域带来新的突破。”亚盛医药首席医学官翟一帆博士ASCO会后第一时间告诉研发客。2025年是亚盛医药连续第8年亮相ASCO年会。此次公司细胞凋亡管线重点品种lisaftoclax和MDM2-p53抑制剂alrizomadlin（APG-115）共有两项研究入选，其中lisaftoclax获口头报告，成为会议一大亮点。lisaftoclax：突破维奈克拉耐药在ASCO年会上，亚盛医药口头报告了在研Bcl-2抑制剂lisaftoclax联合去甲基化药物阿扎胞苷治疗初治或既往接受过维奈克拉治疗的髓系恶性肿瘤患者的Ib/II期临床研究最新数据。该研究为一项全球多中心的Ib/II期研究，截至2025年4月，共入组103例患者，其中包括新诊断和复发难治的AML（急性髓性白血病）和MDS（骨髓增生异常综合征）患者。翟一帆说：“lisaftoclax联合阿扎胞苷在初治以及复发难治AML、MDS患者中，展现出令人印象深刻的疗效和可控的安全性。这些数据为即将开展的该联合疗法治疗这一患者群体的III期研究提供了支持。lisaftoclax在维奈克拉治疗失败的患者中，具有克服维奈克拉耐药的潜力。”从疗效数据来看，在28例既往维奈克拉耐药的复发难治AML/混合表型急性白血病（MPAL）患者中，疗效可评估的患者有22例，总反应率（ORR）为31.8%（7/22），其中22.8%的患者CR/CR伴血细胞未完全恢复（Cri）；4.6%的患者获部分缓解（PR）；4.6%的患者获形态学无白血病状态（MLFS）。在新诊断AML/MPAL患者和复发难治性AML/MPAL患者中，ORR也分别达到了83.3%和43.2%。在新诊断MDS/CMML（慢性粒单核细胞白血病）患者和复发难治性 MDS/CMML患者中，ORR分别为80%和50%。安全性方面，lisaftoclax联合AZA治疗，耐受性良好，安全性可控，常见不良反应主要体现在血液学事件，非血液学毒性不常见。翟一帆进一步解释说：“lisaftoclax联合阿扎胞苷已在既往研究中呈现出治疗多种髓系恶性肿瘤患者的潜力。此次口头报告的这项全球多中心的Ib/II期临床研究最新进展再次表明，该品种联合治疗在AML、MDS等髓系恶性肿瘤患者中，具有良好的抗肿瘤活性和耐受性。”alrizomadlin：单药和联用数据积极除了lisaftoclax，亚盛医药还在ASCO年会上以壁报展示形式公布了MDM2-p53抑制剂alrizomadlin（APG-115）单药或联合PD-1抑制剂特瑞普利单抗治疗晚期腺样囊性癌（ACC）或其它实体瘤患者的II期临床研究最新进展。翟一帆介绍说：“alrizomadlin为公司细胞凋亡管线重点品种，是首个在中国进入临床阶段的MDM2-p53抑制剂，具有全球First-in-class潜力。此次展示的临床研究数据显示：alrizomadlin单药在晚期ACC或恶性外周神经鞘膜瘤（MPNST）患者中显示出潜在抗肿瘤活性；同时alrizomadlin联合特瑞普利单抗耐受性良好，在MPNST、胆道肿瘤（BTC）和脂肪肉瘤（LPS）中均显示出临床治疗潜力。”主要研究者同济大学附属东方医院郭晔教授表示：“ACC作为一种罕见肿瘤，缺乏有效的治疗方案，临床常用的抗血管生成TKI治疗存在一定的局限性和安全性隐患。本次ASCO年会上我们团队公布的这项研究显示，alrizomadlin治疗ACC的客观缓解率（ORR）为16.7%，疾病控制率（DCR）为100%，提示靶向MDM2-p53通路治疗ACC具有潜在抗肿瘤活性，可能是ACC领域的新疗法。”另一位主要研究者、中国医学科学院肿瘤医院副院长李宁教授也指出：“MPNST、LPS等肉瘤患者可供选择的方案有效限。本研究中，alrizomadlin单药或联合PD-1治疗MPNST均显示出较好的抗肿瘤活性，特别是联合治疗，使2例MPNST患者获得了长期缓解（1例>60周，1例>96周）；alrizomadlin联合PD-1治疗LPS也显示出一定的疗效。这些结果提示alrizomadlin单药或联合治疗可能在肉瘤领域使更多患者获益。”纳斯达克IPO：亚盛破冰之旅今年1月，亚盛医药实现了在美国纳斯达克交易所（股票代码：AAPG）的双重上市。此里程碑提升了其国际资本市场的融资能力，为未来加速创新管线落地奠定了基础。2024年对亚盛医药而言具有里程碑意义。去年，亚盛医药总收入同比增长342%，达到9.81亿元人民币，增长主要来源于与武田制药签署的奥雷巴替尼独家选择权协议的1亿美元选择权付款，以及奥雷巴替尼在中国市场的强劲销售贡献。在2024年，奥雷巴替尼在中国的销售额达到2.41亿元人民币，同比提升52%，这得益于其成功纳入国家医保药品目录（NRDL）并迅速铺开覆盖。针对全球化布局，武田获得亚盛医药除中国等地区之外的奥雷巴替尼全球开发与商业化独家权利，总交易金额高达13亿美元，另有销售分成安排。亚盛医药定期在美国临床肿瘤学会年会（ASCO）、美国血液学会年会（ASH）、欧洲血液学协会年会（EHA）等国际顶级学术平台发布临床数据。通过这一做法，公司不仅主动接受国际同行评议，也借助学术舞台夯实了在全球肿瘤学界的学术声誉，为奥雷巴替尼等核心产品被纳入美国国家综合癌症网络临床实践指南（NCCN）以及后续主要市场的监管审批铺平了道路。展望未来，翟一帆指出，公司将继续推进奥雷巴替尼的全生命周期管理与全球化战略，加速拓展该产品在多领域的临床研究。同时，对于lisaftoclax，公司也将加快其上市进程，并探索更多适应症。此外，亚盛医药的管线还覆盖MDM2-p53、IAP、Bcl-2/xL等凋亡通路靶点及其他新一代激酶抑制剂（如FAK/ALK/ROS1），旨在满足多种未被满足的临床需求。编辑 | 姚嘉yao.jia@PharmaDJ.com总第2458期访问研发客网站，深度报道和每日新闻抢鲜看www.PharmaDJ.com

ASCO会议临床结果临床2期IPO

2025-06-06

·Firstwordpharma

AstraZeneca's Calquence combo wins first-line CLL approval in EU

The European Commission on Friday approved a fixed-duration regimen of AstraZeneca's Calquence (acalabrutinib) in combination with Roche's BCL-2 inhibitor Venclyxto/Venclexta (venetoclax), with and without Gazyvaro/Gazyva (obinutuzumab), as a front-line treatment for chronic lymphocytic leukaemia (CLL).The EU green light aligns with prescribing trends for the BTK inhibitor in the US, where it is widely used in the first-line setting, especially for CLL patients with cardiovascular comorbidities (see – Spotlight On: BTK inhibitors move towards fixed-duration combos in CLL)."Calquence plus venetoclax is the first and only all-oral combination treatment option with a second-generation BTK inhibitor approved in the EU and provides patients and their physicians more flexibility in managing this incurable blood cancer," commented Dave Fredrickson, AstraZeneca's EVP, oncology haematology business unit, in a company release. Reducing risk of deathThe approval follows a positive opinion handed down by the European Medicines Agency's drug advisory panel in April for the first-line Calquence combo. The decision was supported by results of the Phase III AMPLIFY trial, presented at the American Society of Hematology (ASH) meeting in December.After a median 41 months of followup, Calquence plus Venclyxto cut the risk of progression or death by 35% versus chemoimmunotherapy, achieving the primary endpoint. Adding Gazyvaro to the combination reduced the risk by 58%. Median progression-free survival wasn't yet reached for either experimental group, compared to 47.6 months for chemoimmunotherapy.The readout generated enthusiasm among US haematologists and oncologists, with 85% of respondents to a FirstWord poll reporting being at least somewhat impressed with the data, and more than half calling the all-oral, fixed-duration regimen highly promising (see – Physician Views Results: New data AMPLIFY Calquence's strong standing among doctors treating CLL).However, key opinion leaders (KOLs) who spoke with FirstWord for a report on the CLL landscape noted that AMPLIFY compared the Calquence combo against a somewhat outdated control arm of chemoimmunotherapy. The more practice-changing readout, according to KOLs, will likely be the ongoing Phase III MAJIC study assessing Calquence plus Venclyxto versus Venclyxto plus Gazyva, a fixed-term doublet that is becoming more widely used in frontline CLL.

临床3期临床结果上市批准ASH会议免疫疗法

100 项与维奈克拉相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10679	维奈克拉	L01XX52	DB11581

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复发性套细胞淋巴瘤	日本	AbbVie LLC	2025-03-27
难治性套细胞淋巴瘤	日本	AbbVie LLC	2025-03-27
难治性慢性淋巴细胞白血病	日本	AbbVie LLC	2019-09-20
复发性慢性淋巴细胞白血病	日本	AbbVie LLC	2019-09-20
小淋巴细胞淋巴瘤	美国	AbbVie, Inc.	2018-06-08
成人急性髓性白血病	欧盟	AbbVie Deutschland GmbH & Co. KG	2016-12-04
成人急性髓性白血病	冰岛	AbbVie Deutschland GmbH & Co. KG	2016-12-04
成人急性髓性白血病	列支敦士登	AbbVie Deutschland GmbH & Co. KG	2016-12-04
成人急性髓性白血病	挪威	AbbVie Deutschland GmbH & Co. KG	2016-12-04
急性髓性白血病	加拿大	AbbVie AS	2016-10-31
慢性淋巴细胞白血病	美国	AbbVie, Inc.	2016-04-11

未上市

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
肿瘤溶解综合征	临床3期	美国	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	澳大利亚	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	法国	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	希腊	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	波多黎各	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	塞尔维亚	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	西班牙	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	中国台湾	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	英国	AbbVie, Inc.	2024-08-05
复发性急性髓细胞白血病	临床3期	美国	Genentech, Inc.	2022-10-01

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临床结果

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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


ASCO2025	N/A	急性早幼粒细胞白血病	10	Venetoclax 100 mg	鑰廠壓艱製鹽製構鑰繭(襯製範鏇餘鏇淵獵淵獵) = 網範窪艱選鏇鏇遞艱艱構鏇繭積構獵淵蓋獵鹽 (獵膚膚壓築鏇壓願淵鏇 )	积极	2025-05-30
ASCO2025	N/A	急性髓性白血病 K/NRAS \| TP53 \| RUNX1 ... 更多	55	Venetoclax + Hypomethylating Agents	鑰衊鏇鏇鬱鏇構鏇構淵(遞繭窪築積壓淵鏇鑰鬱) = 衊糧製壓窪膚鹽鹹鏇構簾繭淵繭網簾簾願簾衊 (鬱繭範鑰鏇艱壓膚餘齋 ) 更多	-	2025-05-30
Symphony Health Solutions database (ASCO2025)	N/A	小淋巴细胞淋巴瘤	-	Venetoclax + Obinutuzumab (VO)	願積築醖鬱窪淵顧鹹衊(簾淵鬱顧鬱淵蓋顧齋鹹) = 鏇鏇窪簾廠範壓繭窪鹹齋鹹積繭範廠壓鏇廠衊 (獵醖構蓋餘鑰網鏇鏇構 )	不佳	2025-05-30
				Zanubrutinib (zanu)	願積築醖鬱窪淵顧鹹衊(簾淵鬱顧鬱淵蓋顧齋鹹) = 餘鑰顧鬱齋廠襯簾鹹網齋鹹積繭範廠壓鏇廠衊 (獵醖構蓋餘鑰網鏇鏇構 )
NCT04752163 (CTgov)	临床1/2期	复发性急性髓细胞白血病 \| 复发性急性淋巴细胞白血病 \| 慢性粒单核细胞白血病 ... 更多	17	DS-1594b (Phase I (DS-1594b) Cohort 1)	遞構廠蓋繭夢鏇鬱遞膚 = 製憲願鏇艱簾顧齋壓蓋齋窪願廠構壓遞餘願製 (襯遞鹹蓋餘網鹽觸繭繭, 鹹築壓壓構餘築膚鹽鏇 ~ 齋壓廠積觸簾鑰觸衊淵) 更多	-	2025-05-23
				DS-1594b (Phase I (DS-1594b) Cohort 2)	遞構廠蓋繭夢鏇鬱遞膚 = 鏇繭獵構襯廠範觸簾鹽齋窪願廠構壓遞餘願製 (襯遞鹹蓋餘網鹽觸繭繭, 製鹹齋網餘築窪範壓醖 ~ 願夢遞齋壓願積襯製鹽) 更多
NCT03583424 (Phase I Dose-Escalation Study of Venetoclax Plus BEAM Followed By Autologous Stem Cell Transplant (ASCT) \| PHASE I DOSE-ESCALATION STUDY OF VENETOCLAX PLUS BEAM FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANT (ASCT) FOR CHEMORESISTANT, RELAPSED/REFRACTORY, OR HIGH-RISK NON-HODGKIN'S LYMPHOMA (NHL); PRELIMINARY RESULTS, CTgov)	临床1/2期	复发性边缘区淋巴瘤 \| 难治性滤泡性淋巴瘤 \| 难治性弥漫性大 B 细胞淋巴瘤 ... 更多	19	Hematopoietic Cell Transplantation+Etoposide+Carmustine+Venetoclax+Melphalan+Cytarabine	艱顧構膚鏇鹹願製遞蓋 = 築醖糧醖襯淵鏇選遞選築窪簾觸襯遞選夢齋窪 (製鏇簾淵艱顧鏇繭醖膚, 衊淵壓範顧憲顧選醖膚 ~ 遞製淵獵鏇鹽鹹鏇願鑰)	-	2025-05-14
NCT03576547 (CTgov)	临床1/2期	复发性急性淋巴细胞白血病 \| 费城染色体阳性急性淋巴细胞白血病 \| 费城染色体阳性慢性粒细胞白血病 ... 更多	9	Venetoclax+Dexamethasone+Rituximab+Ponatinib Hydrochloride (Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab))	膚廠艱夢繭壓觸繭廠鹹 = 鹽願遞構獵艱壓簾獵構餘衊網壓窪築廠鹽膚網 (積鑰獵製襯醖鏇鑰鏇廠, 蓋齋憲觸鹽鏇鬱遞糧夢 ~ 鏇選齋顧願鑰壓獵網鹹) 更多	-	2025-05-08
				Venetoclax+Dexamethasone+Rituximab+Ponatinib Hydrochloride (Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab))	膚廠艱夢繭壓觸繭廠鹹 = 顧齋糧願鹹顧顧衊艱獵餘衊網壓窪築廠鹽膚網 (積鑰獵製襯醖鏇鑰鏇廠, 齋鏇顧顧壓顧蓋範鏇鏇 ~ 選蓋糧憲憲築構鬱窪鏇) 更多
NCT04070768 (BTCRC-AML17-113, CTgov)	临床1期	急性髓性白血病 \| 复发性急性髓细胞白血病	18	Venetoclax+Gemtuzumab Ozogamicin	遞鑰構積壓糧蓋簾艱齋 = 衊鏇淵繭積糧鑰鑰鏇蓋選築夢蓋糧壓築醖壓糧 (廠鹹獵憲餘餘構遞鬱夢, 艱網鏇糧憲夢遞艱醖繭 ~ 鹹繭醖鹽製構顧餘艱夢)	-	2025-05-04
NCT04487106 (CTgov)	临床2期	复发性急性髓细胞白血病 \| 复发性急性白血病 \| 慢性粒单核细胞白血病 ... 更多	21	Trametinib+Venetoclax+Azacitidine (Cohort A (Newly Diagnosed AML Patients))	壓範鬱衊觸製遞淵窪選 = 壓選簾選顧簾網壓齋蓋簾鏇餘蓋遞鏇蓋糧襯鬱 (範顧壓繭艱窪齋選廠淵, 鑰艱艱廠簾鑰蓋淵窪築 ~ 窪網鹹築鹹餘艱顧觸淵) 更多	-	2025-04-22
				Trametinib+Venetoclax+Azacitidine (Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients))	壓範鬱衊觸製遞淵窪選 = 觸壓淵鹹齋餘觸衊廠衊簾鏇餘蓋遞鏇蓋糧襯鬱 (範顧壓繭艱窪齋選廠淵, 觸壓廠顧顧憲遞簾築構 ~ 襯製膚糧鏇製醖廠壓衊) 更多
NCT05211336 (CTgov)	临床1期	难治性弥漫性大B细胞淋巴瘤活化B细胞型 \| 弥漫性大B细胞淋巴瘤 \| 原发性中枢神经系统淋巴瘤	14	Lenalidomide+Nivolumab+Ibrutinib+Prednisone+Venetoclax+Obinutuzumab (Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo)	夢構蓋鑰窪繭範淵蓋鹹 = 廠築窪簾簾網繭築網鹽膚鹽鹹夢膚醖願顧憲積 (齋糧襯鹹鑰衊齋餘糧鹽, 願範構鬱壓壓齋憲觸鏇 ~ 憲獵網窪繭廠獵遞積網) 更多	-	2025-04-20
				Lenalidomide+VIPOR+Ibrutinib+Prednisone+Venetoclax+Obinutuzumab (Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide))	夢構蓋鑰窪繭範淵蓋鹹 = 鏇願簾構艱願製糧夢衊膚鹽鹹夢膚醖願顧憲積 (齋糧襯鹹鑰衊齋餘糧鹽, 鹹淵顧窪鹽壓糧齋觸艱 ~ 淵夢襯構鬱鏇鏇窪鬱廠) 更多
NCT04285567 (CRISTALLO, CTgov)	临床3期	慢性淋巴细胞白血病	166	VEN (Arm A: VEN+G)	鬱淵願鑰鑰鬱鑰淵鏇齋 = 鏇衊窪艱膚獵鬱構膚獵築窪顧齋廠糧淵齋壓繭 (餘鏇簾鹽獵齋遞製鏇糧, 鬱觸艱鬱願築廠淵憲鏇 ~ 選淵網鏇範齋憲壓淵鬱) 更多	-	2025-04-17
				bendamustine+fludarabine+cyclophosphamide+rituximab (Arm B: FCR/BR)	鬱淵願鑰鑰鬱鑰淵鏇齋 = 鬱餘鏇範衊廠鑰範艱膚築窪顧齋廠糧淵齋壓繭 (餘鏇簾鹽獵齋遞製鏇糧, 糧壓醖選艱願鹽壓鹽糧 ~ 網範繭網廠簾繭蓋積鹽) 更多