A Phase 2, Open-label, Single-Arm Clinical Trial to Investigate the Efficacy and Safety of Oral Tazemetostat for the Treatment of Adult Participants Age 18 and Over With Relapsed/Refractory Follicular Lymphoma Lacking the EZH2 Gain-of-Function (GOF) Mutation

The purpose of this research study is to learn about the effectiveness and safety of the study drug, tazemetostat, in adults with relapsed/refractory follicular lymphoma whose tumours do not have an "EZH2 gain-of-function" genetic mutation. Follicular lymphoma is a blood cancer. It affects white blood cells called lymphocytes. White blood cells normally help to fight infections, but when you have follicular lymphoma, the blood cells can form tumours in your body. 'Relapsed/refractory' follicular lymphoma means the disease has either not improved or is getting worse (progressing) during or after previous treatment.
Tazemetostat already has approval in the United States for the treatment of adult patients with relapsed/refractory follicular lymphoma with or without the "EZH2" mutation who have no satisfactory alternative treatment options.
This study is being conducted to better understand the effectiveness in patients whose tumours do not have an "EZH2 gain-of-function" genetic mutation and who previously received therapies commonly used in the U.S. in your body.
'Relapsed/refractory' follicular lymphoma means the disease has either not improved or is getting worse (progressing) during or after previous treatment.
Tazemetostat already has approval in the United States for the treatment of adult patients with relapsed/refractory follicular lymphoma with or without the "EZH2 gain-of-function" mutation who have no satisfactory alternative treatment options. This study is being conducted to better understand the effectiveness in patients whose tumours do not have an "EZH2" genetic mutation and who previously received therapies commonly used in the U.S.
In this study, all participants will receive the study drug. It will be taken by mouth (orally), as a tablet, twice daily. The sizes and number of tumours according to scan results will be collected as well as results of safety tests (such as physical examinations and laboratory tests).
The study consists of 4 periods:
* Screening period may take up to 4 weeks and require at least 1 visit.
* Treatment period will require 2 visits for each of the first 2 months, followed by 1 visit every month for the remainder of the first 12 months, followed by 1 visit every 3 months (except for women of childbearing potential [WOCBP], who will continue to have a pregnancy testing every month) until unacceptable toxicity, disease progression, or the start of new systemic anticancer therapy, whichever is first.
* Safety follow-up period will last for 1 month after the last dose of tazemetostat, and it will end with 1 visit or telephone call.
* Long-term follow-up period is only for participants who stop taking tazemetostat while their disease continues to respond; this period will last until disease progression, start of new cancer treatment, or death from any cause, whichever is first, and will require a visit every 3 months.
Tazemetostat will be provided to participants who tolerate it for as long as their disease does not progress.
Participants may be transferred to another study or program after about 2 years for continued treatment with tazemetostat or for long-term follow-up. Patients may withdraw consent to participate at any time.

开始日期2025-09-02

申办/合作机构

Epizyme, Inc.

[+1]

NCT06824701

/ Not yet recruiting临床1期IIT

A Phase 1b Study of Tazemetostat in Combination With Zanubrutinib and Anti-CD20 Monoclonal Antibody in Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphomas

The purpose of this clinical trial is to learn if the study drug Tazemetostat combined with Zanubrutinib and anti-CD20 monoclonal antibody is safe and effective in treating patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma.

开始日期2025-06-01

申办/合作机构

University of Utah

[+1]

NCT06575686

/ Recruiting临床2期IIT

A Phase 2 Study of Epcoritamab Plus Tazemetostat for Treatment of Relapsed/Refractory Follicular Lymphoma

This phase II trial tests the safety, side effects and effectiveness of epcoritamab and tazemetostat in treating patients with grade I-IIIa follicular lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Epcoritamab is a bispecific monoclonal antibody that binds to two different antigens on the surface of cancer cells that may help the body's immune system attack the cancer and may interfere with the ability of the cancer cells to grow and spread. Tazemetostat, a EZH2 inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving epcoritamab and tazemetostat may be safe, tolerable and/or effective in treating patients with relapsed or refractory grade I-IIIa follicular lymphoma.

开始日期2025-03-11

申办/合作机构

City of Hope National Medical Center

[+1]

100 项与氢溴酸他泽司他相关的临床结果

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100 项与氢溴酸他泽司他相关的转化医学

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100 项与氢溴酸他泽司他相关的专利（医药）

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471

项与氢溴酸他泽司他相关的文献（医药）

2025-12-01·FUNCTIONAL & INTEGRATIVE GENOMICS

Polycomb repressive complex 2 (PRC2) pathway’s role in cancer cell plasticity and drug resistance

Review

作者: Tabari, Mohammad Amin Khazeei ; Khan, Haroon ; Javan, Alireza ; Larsen, Danaé S ; Rezaee, Aryan ; Heidari, Mohammad Mahdi ; Sanaye, Pantea Majma ; Hadipour, Mahboube ; Goleij, Pouya ; Daglia, Maria

Polycomb Repressive Complex 2 (PRC2) is a central regulator of gene expression via the trimethylation of histone H3 on lysine 27. This epigenetic modification plays a crucial role in maintaining cell identity and controlling differentiation, while its dysregulation is closely linked to cancer progression. PRC2 silences tumor suppressor genes, promoting cell proliferation, metastasis, epithelial-mesenchymal transition, and cancer stem cell plasticity. Enhancement of zeste homolog 2 (EZH2) overexpression or gain-of-function mutations have been observed in several cancers, including lymphoma, breast, and prostate cancers, driving aggressive tumor behavior and drug resistance. In addition to EZH2, other PRC2 components, such as embryonic ectoderm development (EED) and suppressor of zeste 12, are essential for complex stability and function. EED, in particular, enhances EZH2 activity and has emerged as a therapeutic target. Inhibitors like MAK683 and EED226 disrupt EED's ability to maintain PRC2 activity, thereby reducing H3K27me3 levels and reactivating tumor suppressor genes. Valemetostat, a dual inhibitor of both EZH2 and EED, has shown promising results in aggressive cancers like diffuse large B-cell lymphoma and small-cell lung cancer, underlining the therapeutic potential of targeting multiple PRC2 components. PRC2's role extends beyond gene repression, as it contributes to metabolic reprogramming in tumors, regulating glycolysis and lipid synthesis to fuel cancer growth. Furthermore, PRC2 is implicated in chemoresistance, particularly by modulating DNA damage response and immune evasion. Tazemetostat, a selective EZH2 inhibitor, has demonstrated significant clinical efficacy in EZH2-mutant cancers, such as non-Hodgkin lymphomas and epithelioid sarcoma. However, the compensatory function of enhancer of zeste homolog 1 (EZH1) in some cancers requires dual inhibition strategies, as seen with agents like UNC1999 and Tulmimetostat, which target both EZH1 and EZH2. Given PRC2's multifaceted role in cancer biology, its inhibition represents a promising avenue for therapeutic intervention. The continued development of PRC2 inhibitors and exploration of their use in combination with standard chemotherapy or immunotherapy has great potential for improving patient outcomes in cancers driven by PRC2 dysregulation.

2025-08-01·BRAIN BEHAVIOR AND IMMUNITY

EZH2-mediated suppression of TIMP1 in spinal GABAergic interneurons drives microglial activation via MMP-9-TLR2/4-NLRP3 signaling in neuropathic pain

Article

作者: Pan, Yinbing ; Wu, Xuefeng ; Wu, Xudong ; Liu, Wentao ; Hu, Fan ; Guo, Haiyue ; Yang, Shuo ; Jiang, Chun-Yi ; Wan, Li

Effective management of neuropathic pain remains a significant challenge due to the limited understanding of its underlying mechanisms. We found that the FDA-approved enhancer of zeste homolog 2 (EZH2) inhibitor, EPZ6438, can prevent the development of neuropathic pain caused by chronic constriction injury (CCI). Therefore, we utilized EPZ6438 as a probe to investigate the molecular events involved in the early stage of neuropathic pain. RNA-seq analysis reveals that EPZ6438 significantly upregulates Timp1 transcription in the spinal cord of mice. As a specific endogenous inhibitor of MMP-9, tissue inhibitor of metalloproteinase 1 (TIMP1) levels significantly decrease in the cerebrospinal fluid of both neuropathic pain patients and the CCI rat models. Importantly, intrathecal administration of mouse recombinant TIMP1 protein (rmTIMP1) reverses CCI-induced mechanical and thermal hyperalgesia. Mechanistically, substance P released from primary sensory neurons suppresses TIMP1 in spinal GABAergic interneurons by elevating EZH2 expression, which enhances H3K27me3 enrichment at the Timp1 promoter. Blocking spinal NK1R effectively prevents the downregulation of TIMP1 and alleviates CCI-induced hyperalgesia. The imbalance between TIMP1 and MMP-9 leads to NLRP3 activation in spinal microglia and increases IL-1β maturation via TLR2/4 pathway. TIMP1 injection eliminates MMP-9-induced NLRP3 activation and blocks hyperalgesia, suggesting that TIMP1 is a critical gatekeeper in preventing neuroinflammation during neuropathic pain development.

2025-06-01·JOURNAL OF CELLULAR AND MOLECULAR MEDICINE

Dual Targeting EZH2 and Histone Deacetylases in Human Uterine Sarcoma Cells Under Both 2D and 3D Culture Conditions

Article

作者: Omran, Mervat M. ; Al‐Hendy, Ayman ; Yang, Qiwei ; Vafaei, Somayeh ; Alkhrait, Samar

ABSTRACT:

Uterine sarcoma is strongly associated with poor prognosis. However, its treatment options remain limited. Tazemetostat is a potent and selective EZH2 inhibitor with limited clinical application. Entinostat is one of the strong inhibitors for HDAC1 and HDAC3. This study aimed to assess the effect of dual targeting of EZH2 and HDACs on the phenotype of uterine sarcoma cells in both 2D and 3D culture systems. The uterine sarcoma cell line (MES‐SA) was treated with varying concentrations of tazemetostat and/or entinostat for 24, 48 and 72 h. For 3D culture conditions, the cells were combined with Matrigel and seeded in V‐bottom plates and incubated for 5 days. Cell proliferation, cell cycle progression and apoptosis were evaluated. Additionally, the RNA expression, IHC staining, wound healing assay, DNMT and HDAC activity measurements were conducted. Our data showed that single‐inhibitor treatment with entinostat or tazemetostat significantly increased the cytotoxicity and significantly enhanced apoptosis concomitantly. Furthermore, both inhibitors induced cell cycle arrest in 2D and 3D culture conditions. We also demonstrated that entinostat, but not tazemetostat, suppressed the wound healing in the 2D culture. The combination treatment showed a significantly superior effect compared to single‐agent treatment. Our studies demonstrate that treatment with either entinostat or tazemetostat alone showed a potent anti‐uterine sarcoma effect in 2D and 3D culture conditions. Importantly, the combination of entinostat and tazemetostat produced superior therapeutic effects, suggesting that dual targeting EZH2 and HDACs may provide a promising treatment option for this aggressive cancer.

173

项与氢溴酸他泽司他相关的新闻（医药）

2025-06-23

·ioncology

EHA & ICML中国强音丨赵维莅教授团队LBA研究引领淋巴瘤治疗新方向，多项成果亮相国际舞台

点击蓝字关注我们编者按2025年欧洲血液学会（EHA）年会与国际恶性淋巴瘤会议（ICML）相继在米兰与卢加诺召开，聚焦全球血液肿瘤学的最新进展。上海交通大学医学院附属瑞金医院赵维莅教授团队携多项研究成果重磅亮相国际舞台，全面覆盖弥漫大B细胞淋巴瘤、滤泡性淋巴瘤、套细胞淋巴瘤及外周T细胞淋巴瘤等多个亚型，充分展现中国团队在机制探索、精准分型、免疫治疗及真实世界研究等方面的持续深耕与系统布局。其中，关于泽布替尼联合来那度胺和利妥昔单抗（ZR2）治疗高龄体弱DLBCL患者的PEARL研究更是入选ICML大会LBA摘要（Latest Breakthrough Abstract）报告，显示其与标准减量化疗（R-miniCHOP）疗效相当，有望成为化疗替代方案，标志着中国原创治疗策略的重大突破。GUIDANCE-02研究探索基于遗传亚型指导的一线个体化治疗模式，也正在国内多中心稳步推进，反映出从科研设计到临床转化的高质量闭环。本期特整理这些研究的核心亮点，带您一览淋巴瘤领域的前沿进展。弥漫大B细胞淋巴瘤01摘要号：ICML#LBA2标题：Zanubrutinib plus lenalidomide and rituximab versus R-miniCHOP in unfit or frail patients with newly diagnosed diffuse large B-cell lymphoma aged 70 years or older中文标题：泽布替尼联合来那度胺和利妥昔单抗与R-miniCHOP用于治疗70岁及以上新诊断不适合强化治疗或虚弱弥漫大B细胞淋巴瘤患者的对比研究类型：LBA第一作者：许彭鹏研究结论：本研究（PEARL）结果显示，ZR2方案（泽布替尼联合来那度胺和利妥昔单抗）在完全缓解率上与R-miniCHOP相当，且两组基线特征平衡，提示ZR2方案有望成为70岁及以上新诊断不适合强化治疗或虚弱弥漫大B细胞淋巴瘤（DLBCL）患者一种有效且潜在更安全的无化疗治疗选择。02摘要号：ICML#OT05（在研临床试验）标题：GUIDANCE-02: A multi-center randomized phase 3 study of genetic subtype-guided immunochemotherapy in diffuse large B-cell lymphoma中文标题：GUIDANCE-02研究：一项基于遗传亚型指导免疫化疗治疗弥漫大B细胞淋巴瘤的多中心、随机、III期临床研究类型：口头报告第一作者：赵维莅研究进展：GUIDANCE-02是一项正在进行的、多中心、随机、III期临床研究，旨在评估基于遗传亚型指导的免疫化疗方案（R-CHOP-X）相较于标准R-CHOP在新诊断的中高危弥漫大B细胞淋巴瘤（DLBCL）患者中的疗效和安全性。研究采用38基因分类算法“LymphPlex” 对患者进行分型，并根据不同亚型个性化添加靶向药物（如奥布替尼、来那度胺或地西他滨）。主要终点为无进展生存期（PFS），目前已在中国58家中心已经完成1100例入组，结果有望进一步推动DLBCL的精准治疗策略。03摘要号：EHA#PS1956标题：INTERIM ANALYSIS OF POMALIDOMIDE PLUS RITUXIMAB, IFOSFAMIDE, CARBOPLATIN, AND ETOPOSIDE (PR-ICE) IN RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA: A PHASE I/II STUDY (PRIDE STUDY)中文标题：泊马度胺联合利妥昔单抗、异环磷酰胺、卡铂和依托泊苷（PR-ICE）治疗复发/难治性弥漫性大B细胞淋巴瘤的Ⅰ/Ⅱ期研究的中期分析（PRIDE研究）类型：壁报第一作者：许彭鹏研究结论：复发/难治性弥漫大B细胞淋巴瘤（R/R DLBCL）治疗选择有限，预后较差。本研究显示，PR-ICE方案在R/R DLBCL患者中展现出较高的疗效与可接受的安全性。泊马度胺与R-ICE联合的确定最大耐受剂量（MTD）在临床上诱导了显著的完全缓解率。这些结果支持将PR-ICE作为R/R DLBCL挽救治疗方案进行进一步研究。04摘要号：EHA#PF916标题：POSITRON EMISSION TOMOGRAPHY-ADAPTED THERAPY IN LOW-RISK DIFFUSE LARGE B-CELL LYMPHOMA: 4-YEAR RESULTS OF A RANDOMIZED, PHASE III, NON-INFERIORITY TRIAL中文标题：低危弥漫大B细胞淋巴瘤PET-CT调整的治疗：一项随机、III期、非劣效性试验的4年随访结果类型：壁报第一作者：施晴研究结论：本研究显示，对于中期PET-CT阴性的低危、非巨块型弥漫大B细胞淋巴瘤（DLBCL）患者，4个周期的R-CHOP方案加4个周期的利妥昔单抗方案可提供与6个周期的R-CHOP方案加2个周期的利妥昔单抗方案相当的长期临床疗效。该PET-CT调整性治疗策略在保证持续缓解的同时，有望减少化疗强度，为低危DLBCL的治疗管理提供了新思路。05摘要号：ICML#294标题：Clinical practice pattern and outcomes in DLBCL with distinct genetic subtypes: a large-scale real-world study from China中文标题：不同基因亚型弥漫大B细胞淋巴瘤的临床实践模式与治疗结局：中国大规模真实世界研究类型：壁报第一作者：许彭鹏研究结论：本项中国大规模真实世界研究显示，弥漫大B细胞淋巴瘤（DLBCL）具有高度遗传异质性，不同分子亚型在治疗模式和临床结局上呈现出显著差异。尽管R-CHOP仍为主要一线方案，但部分患者接受了靶向治疗、CAR-T或自体移植等强化治疗。研究结果为推进基因分型指导下的精准治疗提供了重要依据，有望优化DLBCL的治疗策略与预后管理。06摘要号：EHA#PS2162标题：HIGH EFFICACY AND SAFETY OF A NOVEL ANTI-CD20 CAR-T CELL THERAPY, LY007 IN RELAPSED OR REFRACTORY B-CELL NON-HODGKIN LYMPHOMA中文标题：新型抗CD20 CAR-T细胞疗法LY007在复发或难治性B细胞非霍奇金淋巴瘤中的高效性和良好安全性类型：壁报第一作者：盛凌霜研究结论：LY007在最高剂量水平（DL3）下显示出良好的安全性、可观的疗效及稳健的药代动力学特征，未观察到剂量限制性毒性（DLT）、神经毒性或≥3级细胞因子释放综合征 (CRS)。LY007的生物利用度 (BOR) 达到91.7%，包括高肿瘤负荷、既往接受过CD19 CAR-T治疗和自体干细胞移植 (ASCT) 的患者。07摘要号：EHA#PF971标题：SAFETY AND EFFECTIVENESS OF BRENTUXIMAB VEDOTIN IN CHINESE CD30-POSITIVE LYMPHOMA ADULTS: AN INTERIM ANALYSIS FROM BRAVE STUDY中文标题：维布妥昔单抗在中国CD30阳性淋巴瘤成人患者中的安全性和有效性：BRAVE研究的中期分析类型：壁报第一作者：蔡铭慈研究结论：本研究结果进一步支持维布妥昔单抗(BV)联合化疗在CD30阳性淋巴瘤治疗中疗效确切、耐受性良好，是一种有价值的治疗选择。BRAVE研究仍在持续进行中，后续将公布长期随访结果。套细胞淋巴瘤01摘要号：EHA#PS1969标题：ORELABRUTINIB PLUS BENDAMUSTINE-RITUXIMAB (OBR) VERSUS BENDAMUSTINE-RITUXIMAB (BR) IN TRANSPLANT-INELIGIBLE, INTERMEDIATE- TO HIGH-RISK MANTLE CELL LYMPHOMA (MCL)中文标题：奥布替尼联合苯达莫司汀-利妥昔单抗（OBR）与苯达莫司汀-利妥昔单抗（BR）治疗不适合移植的中高危套细胞淋巴瘤（MCL）患者的对比研究类型：壁报第一作者：王黎研究结论：免疫化疗仍是套细胞淋巴瘤（MCL）的标准治疗方案，但携带高危特征，如TP53突变、母细胞样或多形性组织学亚型，或高MCL国际预后指数[MIPI]评分（伴Ki-67增殖指数[Ki-67%]>30%）的患者预后较差。本研究初步数据表明，OBR方案较BR方案可减少高危MCL患者的疾病进展事件。后续将公布疗效、安全性及生物标志物的更多研究结果。滤泡性淋巴瘤01摘要号：EHA#PS1906标题：NATIONWIDE SURVEY OF THE JOURNEY OF PATIENTS LIVING WITH FOLLICULAR LYMPHOMA IN CHINA: REAL-WORLD INSIGHTS AND ANALYSIS中文标题：中国滤泡性淋巴瘤患者诊疗旅程的全国性调研：真实世界见解与分析类型：壁报第一作者：赫洋研究结论：本研究首次在全国范围内系统调研了中国滤泡性淋巴瘤（FL）患者的真实诊疗旅程，发现患者在不同治疗阶段的目标和需求存在明显差异，初治阶段以治愈和延长生存为主，复发后则更关注避免复发和治疗选择；影响治疗决策的主要因素包括疗效、安全性及经济负担；信息获取渠道也随病程进展由网络转向专业医疗人员。该研究为优化患者管理、制定个体化支持策略提供了重要的真实世界依据。02摘要号：EHA#PF897、ICML#178标题：CLINICAL CHARACTERISTICS AND MOLECULAR HETEROGENEITY IN FOLLICULAR LYMPHOMA WITH EXTRANODAL INVOLVEMENT中文标题：结外受累滤泡性淋巴瘤患者的临床特征与分子异质性分析类型：壁报第一作者：李悦驰研究结论：本研究发现，多发结外侵犯（ENI）是滤泡性淋巴瘤患者接受利妥昔单抗联合化疗时的重要不良预后因素，相关基因突变（如KMT2D、CREBBP、CARD11、STAT6）及免疫通路下调可能在其中发挥作用；但在接受利妥昔单抗联合来那度胺（R2）免疫治疗的患者中，ENI对预后的负面影响不再显著，提示免疫治疗有望克服ENI带来的不良影响，并为机制导向的个体化治疗提供了新的思路。外周T细胞淋巴瘤01摘要号：ICML#62标题：A Phase II Trial of Pembrolizumab Concurrent with Radiotherapy for Frail Patients with Newly Diagnosed Early-stage Natural Killer/T-cell Lymphoma (IELSG50)中文标题：帕博利珠单抗联合放疗治疗新诊断早期虚弱自然杀伤/T细胞淋巴瘤患者的Ⅱ期临床试验（IELSG50）类型：口头报告第一作者：钟慧娟研究结论：NK/T细胞淋巴瘤（NKTCL）是一种侵袭性极高的淋巴瘤，常与EB病毒感染和免疫检查点高表达相关。对于不适合化疗的患者，治疗选择有限。免疫检查点抑制剂已在复发/难治性NKTCL中展现出疗效。本研究显示，帕博利珠单抗联合放疗在新诊断、早期、虚弱NKTCL患者中展现出良好的疗效和安全性，尤其适用于中高危患者。免疫检查点抑制剂有望作为早期NKTCL一线治疗的替代策略。02摘要号：ICML#163标题：Tazemetostat plus Amdizalisib in Relapsed/Refractory Peripheral T-cell Lymphoma Patients with Diverse Genomic Signatures: Results from a Phase 2 Study中文标题：他泽司他联合Amdizalisib 治疗具有不同基因组特征的复发或难治性外周T细胞淋巴瘤患者：一项Ⅱ期研究结果类型：口头报告第一作者：程澍研究结论：外周T细胞淋巴瘤（PTCL）是一类侵袭性强、异质性高的T细胞肿瘤，目前缺乏有效治疗手段。不同基因特征的患者对治疗的反应存在差异。本研究显示，他泽司他联合Amdizalisib在复发/难治性PTCL中表现出良好疗效，尤其在血管免疫母细胞T细胞淋巴瘤（AITL）亚型中缓解率较高。TET2和RHOA共突变的患者可能预示更佳治疗反应。后续需更大样本进一步验证这些发现。专家简介赵维莅教授上海交通大学医学院附属瑞金医院主任医师，教授，博士生导师国家杰出青年科学基金获得者教育部长江学者特聘教授科技部万人计划领军人才百千万人才工程国家级人选上海交通大学医学院附属瑞金医院副院长上海市重中之重临床医学中心主任上海血液学研究所所长中华医学会血液学分会副主任委员，淋巴细胞疾病学组组长中国病理生理学会理事，实验血液学专委会副主任委员中国临床肿瘤协会抗淋巴瘤联盟副主席致力于淋巴细胞恶性疾病的临床和基础研究，以通讯/第一作者在《The New England Journal of Medicine 》《CANCER CELL》、《NATURE GENETICS》、《BLOOD》《LANCET HAEMATOL》、《SIGNAL TRANSDUCT TARGET THER》、《J HEMATOL ONCOL》等国际权威杂志发表文章110余篇，总影响因子超过1500。相关成果以第一完成人获国家科学技术进步奖二等奖1项，省部级一等奖6项，获国家发明专利15项，主持国家科技部重点研发计划、863 重大项目、国家自然科学基金重点项目多项。先后荣获 “全国卫生系统先进工作者”、“全国三八红旗手”、中国青年女科学家奖、EBMT青年领袖奖、吴阶平医药创新奖、谈家桢生命科学奖、上海市科技精英等多项荣誉（来源：《肿瘤瞭望–血液时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果免疫疗法临床3期细胞疗法

2025-05-20

·CPHI制药在线

国产势力崛起：信诺维、恒瑞医药等如何领跑EZH2抑制剂全球竞速？

关注并星标CPHI制药在线5月19日，苏州信诺维医药科技股份有限公司的1类新药XNW5004片被CDE拟纳入突破性治疗品种，拟用于治疗既往接受过至少3线全身系统治疗的复发或难治性滤泡性淋巴瘤（EZH2野生型）。 XNW5004是信诺维医药自主研发的一种底物竞争性、选择性小分子EZH2抑制剂，在临床前体外、体内多个实体瘤模型上展示出良好的抗肿瘤活性，且安全性较好。 XNW5004被开发用于治疗外周T细胞淋巴瘤等淋巴瘤和前列腺癌等晚期或转移性实体瘤，其中复发或难治性外周 T 细胞淋巴瘤（PTCL）适应症于2024年9月被CDE授予突破性疗法认定。目前，XNW5004对照西达本胺治疗复发或难治性PTCL的随机、双盲、多中心III期临床试验正在进行中。针对前列腺癌，临床数据显示XNW5004联合恩扎卢胺可显著延长患者的无进展生存期（PFS）。此次XNW5004的复发或难治性滤泡性淋巴瘤适应症被CDE授予突破性治疗认定，将加速该适应症的开发进程。而已公布的XNW5004治疗复发或难治性非霍奇金淋巴瘤（NHL）的1期临床试验结果显示：XNW5004针对EZH2野生型滤泡性淋巴瘤患者的ORR为40%，DCR为100%，中位PFS和中位DOR均未达到。 EZH2抑制剂进展，SHR2554已报产，系首款国产创新 EZH2是目前非常热门的表观遗传学靶点之一，其是多梳抑制复合物2（PRC2）的催化活性亚单位，主要通过甲基化组蛋白H3第27位赖氨酸（H3K27me3）来抑制靶基因的转录，参与调控细胞周期、细胞衰老、细胞分化及肿瘤发生等病理生理过程。 EZH2最早发现在激素难治性转移性前列腺癌中高表达，后来发现其在乳腺癌、胃癌、结直肠癌、非霍奇金淋巴瘤等多种肿瘤中高表达，且其高表达与这些肿瘤的不良预后和肿瘤侵袭性相关。在血液肿瘤中，研究发现EZH2可通过抑制抑癌基因的表达与转录来对血液肿瘤的增殖和侵袭转移产生影响。而且，EZH2还可影响肿瘤免疫，其一方面可对CD4+、CD8+T及NK细胞的分化产生影响，同时调控调节性T细胞（Tregs）的功能表型；另一方面，研究显示EZH2对肿瘤微环境的抑制和重塑具有多重效应，通过抑制EZH2的表达，可以促进CD8+T细胞的功能并向肿瘤微环境转移，还可减轻Tregs对肿瘤微环境的影响，增加肿瘤微环境中抗原的表达、处理和呈递。据不完全统计，目前全球监管机构已批准2款EZH2抑制剂，即第一三共的伐美妥司他（Valemetostat，Ezharmia）和Epizyme/和黄医药的他泽司他（Tazemetostat，Tazverik）。其中伐美妥司他是全球首款获批的EZH1/2双重抑制剂,在日本获批治疗复发或难治性成人T细胞白血病/淋巴瘤 (ATL)和复发或难治性成人PTCL。他泽司他是全球首款获批的EZH2抑制剂，在美国获批多个适应症：16岁及以上不能完全切除的转移性或局部晚期上皮样肉瘤；至少接受两次全身治疗、EZH2突变阳性的成人复发或难治性FL；没有令人满意的替代治疗方案的成人R/R FL。2025年3月，他泽司他在国内获批，用于治疗复发或难治性FL。此外，目前全球还有多款在研EZH2抑制剂。恒瑞医药开发的EZH2抑制剂SHR2554进展较快，其治疗既往接受过至少1线系统性治疗的复发或难治PTCL的适应症上市申请正在国内接受优先审查。 SHR2554是一款新型、高效、选择性口服EZH2抑制剂，可选择性强效抑制野生型和突变型EZH2酶活性。已公布的首个人体临床试验结果显示，SHR2554每天2次350mg给药安全性可接受，对复发难治FL、PTCL和经典霍奇金淋巴瘤均显示出良好的抗肿瘤活性。而针对复发或难治PTCL，已公布的SHR2554针对复发/难治成熟淋巴瘤的1期临床研究中复发/难治性外周T细胞淋巴瘤（PTCL）部分的分析结果显示：在17例患者中ORR达61%，估计的mDOR为12.3个月，mPFS为11.1个月，12个月总生存率为92%。辉瑞的PF-06821497（mevrometostat）进展也较快，目前正在开展两项3期临床试验MEVPRO-1和MEVPRO-2，其中MEVPRO-1旨在评估PF-06821497联合恩扎卢胺对比恩扎卢胺或多西他赛治疗既往接受过醋酸阿比特龙治疗的转移性去势抵抗性前列腺癌疗效和安全性，MEVPRO-2研究旨在评估PF-06821497联合恩扎卢胺治疗未经阿比特龙治疗的转移性去势抵抗性前列腺癌的疗效和安全性。已公布的1期临床试验结果显示，PF-06821497联合恩扎卢胺对经治转移性去势抵抗性前列腺癌（mCRPC）表现出可喜的抗癌活性，PF-06821497联合恩扎卢胺治疗既往经阿比特龙治疗的mCRPC的中位放射学无进展生存期（rPFS）为17.1个月，相比于历史数据（rPFS为4.8个月）有显著获益。海和药物的HH2853处于1/2期临床。该药是一款强效、高选择性EZH1/2小分子抑制剂。临床前研究显示：HH2853能强效抑制细胞内的整体H3K27me3水平，在PTCL、含有EZH2突变的弥漫性大B细胞淋巴瘤（DLBCL）以及含有SWI/SNF复合物亚基突变的多种实体瘤模型中均显示强效的体内外抗肿瘤活性，且同等剂量下HH2853的抗肿瘤活性与他泽司他相比更优。1期临床试验结果显示：HH2853具有良好的安全性和优异的药代动力学特征，在多瘤种中展示出初步疗效。中科拓苒的TR115、诺华的AXT1003等处于1期临床。其中TR115是一款新一代高活性高选择性EZH2抑制剂，细胞水平的研究结果显示其在表观遗传学靶点间具有良好的选择性，对EZH2野生型及EZH2 Y641F等突变均具有强烈的抑制作用。临床前研究结果显示：TR115能显著的抑制相关肿瘤细胞的增殖及肿瘤的生长，有望成为治疗非霍奇金性淋巴瘤和晚期恶性实体瘤等的新一代的靶向治疗药物。而AXT1003是一款EZH2靶向蛋白降解剂，其治疗晚期恶性肿瘤的1期临床试验正在进行中。总结作为表观遗传关键靶点，EZH2通过甲基化组蛋白H3K27调控基因转录，其异常表达与淋巴瘤、前列腺癌等多种肿瘤的恶性进展密切相关。目前全球已批准2款，恒瑞医药的SHR2554已经报产，辉瑞的PF-06821497和信诺维的XNW5004进展也相对较快，已进入3期临床。然而，目前EZH2抑制剂的发展仍有其局限性，适应症主要集中在淋巴瘤。未来，联合治疗（联合靶向药、化疗药等）、生物标志物开发（预测疗效与耐药）、新型抑制剂研发（克服耐药）以及拓展适应症（非肿瘤疾病领域）将成为EZH2研究的主要方向，有望为相关疾病治疗开辟新局面。END【企业推荐】智药研习社直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

突破性疗法临床1期ASH会议临床2期临床申请

2025-05-12

·ioncology

18-ICML·抢先看丨汇聚中国风采！第18届国际恶性淋巴瘤会议17项口头报告及30项壁报全景呈现

由瑞士肿瘤研究所基金会（IOR）主办的第18届国际恶性淋巴瘤会议（18-ICML）将于2025年6月17日至21日在瑞士卢加诺会议中心（Palazzo dei Congressi）召开。作为全球血液肿瘤学领域最具影响力的两年一度的学术盛会，本届会议预计汇聚来自全球的千余名血液学家、临床肿瘤学家、放射肿瘤学家、儿科医生、病理学家及淋巴瘤研究领域的前沿学者，共同探讨疾病机制、转化医学进展及临床诊疗创新。在本次盛会中，中国学者以丰富的学术成果为会议增光添彩，共呈现17项口头报告及30项壁报展示（截至2025年5月12日）。《肿瘤瞭望-血液时讯》特此系统梳理研究成果，旨在为临床医师及科研工作者提供学术风向标，助力我国淋巴瘤诊疗水平的提升。口头报告（ORAL）*汇报时间均为当地时间1淋巴瘤放射治疗研讨会LYMPHOMA RADIOTHERAPY WORKSHOP中文题目：现今应该采用哪种全身治疗方案？英文题目：Which systemic regimen should be used today?发言人：中山大学附属肿瘤医院蔡清清教授时间：6.17 16:15地点：Cinema Corso中文题目：现代系统性治疗背景下早期阶段的放射剂量与照射体积英文题目：Radiation doses and volumes in early stages with modern systemic therapy发言人：Shunan Qi（北京）时间：6.17 16:30地点：Cinema Corso2聚焦专场-进行中的临床试验“FOCUS ON…” SESSIONS-ONGOING TRIALS中文题目：GUIDANCE-02：一项关于遗传亚型指导的免疫化疗在弥漫大B细胞淋巴瘤中的多中心随机III期研究英文题目：GUIDANCE-02: A multi-center randomized phase 3 study of genetic subtype-guided immunochemotherapy in diffuse large B-cell lymphoma摘要号：OT5发言人：上海交通大学医学院附属瑞金医院赵维莅教授时间：6.18 17:40地点：Cinema Corso3儿童淋巴瘤PEDIATRIC LYMPHOMAS中文题目：中国T细胞淋巴母细胞淋巴瘤儿科患者中融合基因的发生频率及其临床影响英文题目：Frequency of fusion genes and their clinical impacts in Chinese pediatric patients with T cell lymphoblastic lymphoma摘要号：36发言人：高博医学（血液病）北京研究中心北京高博博仁医院医疗张永红教授时间：6.19 15:55地点：Auditorium, West Campus USI中文题目：53例复发或难治性儿童ALK阳性间变性大细胞淋巴瘤的临床分析英文题目：Clinical analysis of 53 cases of relapsed or refractory childhood ALK + anaplastic large cell lymphoma摘要号：38发言人：高博医学（血液病）北京研究中心王凯教授时间：6.19 16:15地点：Auditorium, West Campus USI4套细胞淋巴瘤MANTLE CELL LYMPHOMA中文题目：奥布替尼、来那度胺联合利妥昔单抗作为套细胞淋巴瘤一线治疗的新型三联方案：POLARIS多中心II期研究的最终结果英文题目：Novel Triplet Combination of Orelabrutinib, Lenalidomide, and Rituximab as Frontline Therapy for Mantle Cell Lymphoma: Final Results of POLARIS Multicenter Phase II Study摘要号：48发言人：天津医科大学肿瘤医院宋拯教授时间：6.19 16:15地点：Room A.bradcast in Ginema Corso5早期临床试验EARLY CLINICAL TRIALS中文题目：DZD8586在经共价或非共价BTK抑制剂及BTK降解剂治疗后的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者中的I/II期研究英文题目：Phase 1/2 Studies of DZD8586 in CLL/SLL Patients after Covalent or Non-covalent BTKInhibitors and BTK Degraders摘要号：146发言人：南京医科大学第一附属医院（江苏省人民医院）李建勇教授时间：6.19 17:35地点：Auditorium, West Campus USI7NK/T细胞淋巴瘤NK/T-CELL LYMPHOMA中文题目：SHR2554（一种口服性EZH2抑制剂）在复发或难治性外周T细胞淋巴瘤中的关键性研究英文题目：A Pivotal Study of SHR2554, An Oral Inhibitor Against Enhancer of Zeste Homolog 2 (EZH2), in Relapsed or Refractory (r/r) Peripheral T-cell Lymphoma (PTCL)摘要号：61发言人：北京大学肿瘤医院宋玉琴教授时间：6.20 09 :15地点：Room B,broadcast in Marquee Parco Ciani中文题目：帕博利珠单抗联合放疗治疗新诊断早期自然杀伤/T细胞淋巴瘤虚弱患者的Ⅱ期临床试验（IELSG50）英文题目：A Phase II Trial of Pembrolizumab Concurrent with Radiotherapy for Frail Patients with Newly Diagnosed Early-stage Natural Killer/T-cell Lymphoma (IELSG50)摘要号：62发言人：上海交通大学医学院附属瑞金医院赵维莅教授时间：6.20 09 :30地点：Room B,broadcast in Marquee Parco Ciani中文题目：卡瑞利珠单抗联合低剂量阿帕替尼及培门冬酶后行放疗治疗新诊断Ⅰ/Ⅱ期自然杀伤/T细胞淋巴瘤：一项多中心Ⅱ期研究英文题目：Camrelizumab plus low-dose apatinib and pegaspargase followed by radiotherapy for newly diagnosed stage I/II natural killer/T-cell lymphoma: a multicenter phase II study摘要号：63发言人：Chuanxu Liu（上海）时间：6.20 09 :45地点：Room B,broadcast in Marquee Parco Ciani8淋巴瘤研究：来自中国与欧洲的最新进展LYMPHOMA RESEARCH: NEWS FROM CHINA AND EUROPE中文题目：弥漫性大B细胞淋巴瘤治疗进展：中国视角亮点英文题目：Advances in DLBCL Management: Highlights from China摘要号：UCLI1发言人：哈尔滨血液病肿瘤研究所赵东陆教授时间：6.20 14:35地点：Polivalente room,East Campus USI中文题目：液体活检技术在淋巴瘤领域的最新进展英文题目：State-of-the-art of Liquid Biopsy in Lymphoma摘要号：UCLI3发言人：Meng Wu（北京）时间：6.20 14:55地点：Polivalente room,East Campus USI中文题目：中国新型药物在惰性淋巴瘤治疗中的国际应用概述英文题目：International Overview of Chinese Novel Drugs in Indolent Lymphoma摘要号：UCLI5发言人：吉林大学白求恩第一医院白鸥教授时间：6.20 16:15地点：Polivalente room,East Campus USI9新型药物NEW DRUGS中文题目：一项评估选择性 EZH2 抑制剂-XNW5004 在复发/难治性非霍奇金淋巴瘤受试者中安全性和有效性的 1/2 期研究英文题目：A Phase 1/2 study to evaluate the safety and efficacy of XNW5004, a selective EZH2 inhibitor, in subjects with relapsed/ refractory non-Hodgkin lymphoma摘要号：95发言人：中国医学科学院血液病医院（中国医学科学院血液学研究所）邱录贵教授时间：6:21 10:30地点：Room A10T细胞淋巴瘤的生物学与治疗BIOLOGY AND THERAPY OF T-CELL LYMPHOMAS中文题目：他泽司他联合Amdizalisib 治疗具有不同基因组特征的复发或难治性外周T细胞淋巴瘤患者：一项Ⅱ期研究结果英文题目：Tazemetostat plus Amdizalisib in Relapsed/Refractory Peripheral T-cell Lymphoma Patients with Diverse Genomic Signatures: Results from a Phase 2 Study摘要号：163发言人：上海交通大学医学院附属瑞金医院程澍教授时间：6:21 09:55地点：Room B中文题目：林普利塞联合CHOP方案治疗新诊断外周T细胞淋巴瘤：一项单臂、开放标签、多中心Ⅰb/Ⅱ期研究（LINCH试验）英文题目：Linperlisib Plus CHOP for Newly Diagnosed Peripheral T-Cell Lymphoma: A Single-Arm,Open-Lable, Multi-Center Phase Ib/II Study (LINCH Trial)摘要号：165发言人：中山大学附属肿瘤医院蔡清清教授时间：6.21 10:15地点：Room B中文题目：戈利昔替尼（一种选择性JAK1抑制剂）作为一线全身治疗后外周T细胞淋巴瘤患者维持治疗的疗效更新：Ⅱ期研究（JACKPOT26）进展英文题目：Maintenance Therapy of Golidocitinib, a JAK1 Selective Inhibitor, in Patients with PTCLs after First-line Systemic Therapy: Updates of the Phase 2 Study (JACKPOT26)摘要号：167发言人：浙江大学医学院附属第一医院金洁教授时间：6.21 10:35地点：Room B壁报展示（POSTER）1淋巴瘤生物学Lymphoma biology中文题目：稳定化MYCT58A突变绕过T细胞辅助作用驱动生发中心B细胞淋巴瘤发生英文题目：Stabilized MYCT58A Bypasses T-Cell Help to Fuel Germinal Center B-Cell Lymphomagenesis摘要号：171作者：Baizhi Chen2淋巴瘤遗传学Lymphoma genetics中文题目：EGR2基因突变预示接受布鲁顿酪氨酸激酶抑制剂治疗的慢性淋巴细胞白血病患者预后不良英文题目：EGR2 mutations Confer Poor Prognosis in Chronic Lymphocytic Leukemia Treated with Bruton Tyrosine Kinase Inhibitors摘要号：176作者：Huayuan Zhu中文题目：结外受累滤泡性淋巴瘤的临床特征与分子异质性分析英文题目：Clinical characteristics and molecular heterogeneity in Follicular Lymphoma with extranodal involvement摘要号：178作者：赵维莅3淋巴瘤分类Lymphoma classification中文题目：全基因组测序揭示三种具有不同起源细胞特征和患者预后的滤泡性淋巴瘤亚型英文题目：Whole-genome sequencing reveals three follicular lymphoma subtypes with distinct cell-of-origin and patient outcomes摘要号：193作者：Weicheng Ren中文题目：多组学解析EB病毒驱动的结外NK/T细胞淋巴瘤进展中的异质性、代谢重塑及肿瘤细胞图谱英文题目：Multi-omics dissection of EBV-driven heterogeneity, metabolic remodeling, and tumor cellular landscape in ENKTL progression摘要号：195作者：梁金花4慢性淋巴细胞白血病Chronic lymphocytic leukemia中文题目：癌前生发中心B细胞的免疫监视机制研究英文题目：Immunosurveillance of Precancerous Germinal Center B Cells摘要号：202作者：LINGLING ZHANG中文题目：空间组学与单细胞多组学揭示原发性中枢神经系统淋巴瘤与弥漫大B细胞淋巴瘤的巨噬细胞异质性英文题目：Spatial and Single-Cell Multi-omics Reveal Macrophage Heterogeneity between Primary CNS Lymphoma (PCNSL) and Diffuse Large B-Cell Lymphoma (DLBCL)摘要号：206作者：Liang Hong5边缘区与淋巴浆细胞性淋巴瘤Marginal zone and lymphoplasmacytic lymphoma中文题目：奥布替尼联合奥妥珠单抗（O2方案）一线治疗边缘区淋巴瘤的疗效、安全性及合理性：前瞻性队列研究英文题目：The efficacy, safety and rationality of Orelabrutinib plus Obinutuzumab (O2) in systemic treatment-naïve marginal zone lymphoma: a prospective cohort study摘要号：255作者：Jiadai Xu6套细胞淋巴瘤Mantle Cell Lymphoma中文题目：非结节性套细胞淋巴瘤未必等同于惰性MCL：LEO队列研究的临床观察英文题目：Leukemic non-nodal mantle cell lymphoma (nnMCL) is not necessarily equivalent to indolent MCL: A report from the LEO Cohort Study.摘要号：271作者：Tony Zibo Zhuang7侵袭性B细胞淋巴瘤——一线临床试验Aggressive B-cell lymphomas-first line clinical trials中文题目：新型ZCR方案（泽布替尼、西达本胺、利妥昔单抗）±CHOP方案在双表达弥漫大B细胞淋巴瘤一线治疗中展现显著疗效英文题目：Novel ZCR (Zanubrutinib, Chidamide, Rituximab) ± CHOP Regimen Demonstrates Promising Efficacy in Frontline Treatment of Double-Expressor Diffuse Large B-Cell Lymphoma摘要号：284作者：Zhiming Li中文题目：维泊妥珠单抗、泽布替尼联合利妥昔单抗（Pola-ZR方案）治疗初治老年及虚弱DLBCL患者的疗效与安全性：前瞻性Ⅱ期临床试验英文题目：Efficacy and Safety of Polatuzumab Vedotin, Zanubrutinib and Rituximab (Pola-ZR) in Untreated Elderly and Frail DLBCL Patients: A Prospective Phase 2 Clinical Trial摘要号：285作者：Yuhong Ren8侵袭性B细胞淋巴瘤治疗结果Aggressive B-cell lymphomas outcomes中文题目：POLARIX研究5年亚组分析：亚洲未经治疗的DLBCL患者中Pola-R-CHP方案的疗效获益验证英文题目：Five-Year Analysis of an Asia Subpopulation with Previously Untreated DLBCL Confirms Pola-R-CHP Benefit on Outcomes: The POLARIX Study摘要号：288作者：宋玉琴中文题目：中国大规模真实世界研究：不同基因亚型弥漫大B细胞淋巴瘤的临床实践模式与预后差异英文题目：Clinical practice pattern and outcomes in DLBCL with distinct genetic subtypes: a large-scale real-world study from China摘要号：294作者：许彭鹏9复发/难治性侵袭性B细胞淋巴瘤：临床试验Relapsed/refractory aggressive B-cell lymphomas: clinical trials中文题目：分子亚型指导的R-MINE+X方案治疗复发/难治性弥漫大B细胞淋巴瘤：单臂开放标签多中心Ⅱ期研究英文题目：Molecular Subtype-Guided R-MINE+X Regimen in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Single-arm, Open-label, Multicenter Phase II Study摘要号：317作者：梁金花10中枢神经系统淋巴瘤CNS Lymphomas中文题目：MEDZ-R方案治疗新诊断原发性中枢神经系统淋巴瘤的多中心前瞻性Ⅱ期临床试验英文题目：A multi-center prospective phase II clinical trial of the MEDZ-R regimen for the treatment of newly diagnosed primary central nervous system lymphoma摘要号：332作者：li Zou中文题目：利妥昔单抗联合大剂量甲氨蝶呤及奥布替尼作为新诊断原发性中枢神经系统淋巴瘤的诱导治疗方案英文题目：Rituximab, high-dose methotrexate plus orelabrutinib as induction therapy in newly diagnosed primary central nervous system lymphoma摘要号：333作者：Wenrong Huang中文题目：奥布替尼联合抗PD-1抗体与福莫司汀治疗新诊断原发性中枢神经系统淋巴瘤的Ⅰ/Ⅱ期研究英文题目：A Phase I/II Study of Orelabrutinib Combined with Anti-PD-1 Antibody and Fotemustine for Patients with Newly Diagnosed Primary Central Nervous System Lymphoma (PCNSL)摘要号：334作者：Wanyue Zhao11原发性纵隔淋巴瘤Primary mediastinal lymphoma中文题目：替雷利珠单抗联合R-CHOP方案治疗初治原发性纵隔大B细胞淋巴瘤：前瞻性Ⅱ期临床试验英文题目：Anti-PD-1 antibody (Tislelizumab) combined with R-CHOP for the treatment of previously untreated primary mediastinal B-cell lymphoma: A prospective phase II study摘要号：347作者：Wen Shu juan12霍奇金淋巴瘤Hodgkin Lymphoma中文题目：老年霍奇金淋巴瘤治疗格局演变与预后分析：中国15年多中心回顾性研究揭示新型疗法影响英文题目：Evolving Treatment Landscape and Outcomes in Elderly Hodgkin Lymphoma: A 15-Year Multicenter Retrospective Analysis from China Highlighting the Impact of Novel Therapies摘要号：366作者：赵培起13儿科淋巴瘤Pediatric lymphomas中文题目：中国南方真实世界研究：PD-1抗体单药及联合方案治疗儿童淋巴瘤的疗效与安全性英文题目：real world study of efficacy and safety of PD-1 antibody monotherapy and combination therapy in pediatric lymphoma patients in South China摘要号：375作者：Jia Zhu中文题目：儿童、青少年及青年霍奇金淋巴瘤长期生存者的晚期并发症与生活质评估英文题目：Late Complications and Quality of Life in Long-Term Survivors of Childhood, Adolescent, and Young Adult Hodgkin Lymphoma摘要号：377作者：Linnan Wu14NK/T细胞淋巴瘤NK/T-cell Lymphomas中文题目：EGF-JAK/STAT通路突变对血管免疫母细胞性T细胞淋巴瘤的预后及功能影响研究英文题目：Prognostic and Functional Impact of EGF-JAK/STAT Pathway Mutations in Angioimmunoblastic T-cell Lymphoma (AITL)摘要号：384作者：DACHUAN HUANG中文题目：全血EB病毒DNA载量在血管免疫母细胞性T细胞淋巴瘤中的预后价值分析英文题目：The prognostic role of whole blood Epstein‑Barr virus DNA load in angioimmunoblastic T-cell lymphoma摘要号：385作者：Yi Zhong中文题目：阿扎胞苷联合西达本胺及CHOP方案对比CHOP方案治疗初治外周T细胞淋巴瘤的Ⅱ期研究英文题目：A phase II study of azacitidine and chidamide plus CHOP versus CHOP in previously untreated patients with peripheral T-cell lymphoma摘要号：391作者：Chong Wei中文题目：西达本胺联合阿扎胞苷、米托蒽醌脂质体及泼尼松（CAMP方案）治疗TFH来源的初治外周T细胞淋巴瘤英文题目：Chidamide in combination with azacitidine, mitoxantrone liposomes, and prednisone (CAMP regimen) for treatment-naïve TFH-derived peripheral T-cell lymphoma摘要号：392作者：Huimin Liu中文题目：PD-1抑制剂信迪利单抗联合培门冬酶与安罗替尼治疗Ⅳ期NK/T细胞淋巴瘤的疗效与安全性：多中心前瞻性研究英文题目：A Multi-center, Prospective Study of the Efficacy and Safety of PD-1 Antibody Sintilimab in Combination With Pegaspargase and Anlotinib in Stage IV NKTCL Patients摘要号：400作者：Rong Tao15多发性骨髓瘤Multiple Myeloma中文题目：塞利尼索联合硼替佐米、来那度胺及地塞米松治疗高危初治多发性骨髓瘤的单臂多中心观察性研究英文题目：A single-arm, multi-center, observational study of Selinexor combined bortezomib, lenalidomide, and dexamethasone in high-risk newly diagnosed multiple myeloma(NDMM) 摘要号：403作者：Yuping Zhong16液体活检Liquid Biopsy中文题目：动态ctDNA监测揭示的分子特征：不同基因亚型弥漫大B细胞淋巴瘤的预后价值、临床病程及克隆演化规律英文题目：Molecular features encoded in the dynamic ctDNA monitoring reveal prognostic value, different clinical courses and clone evolution for different genetic subtypes of DLBCL摘要号：422作者：梁金花17新型组合Novel compounds中文题目：泽布替尼联合来那度胺治疗复发/难治性弥漫大B细胞淋巴瘤的Ⅰ期临床研究分析英文题目：Analysis of a Phase 1 Study of Zanubrutinib (Zanu) + Lenalidomide (Len) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)摘要号：439作者：张会来18新型细胞疗法New cellular therapies中文题目：携带OX40信号的CAR-T疗法驱动CD4+T细胞克隆扩增并克服B细胞淋巴瘤免疫抑制微环境：Ⅰ期临床试验英文题目：CAR-T Therapy with OX40 Signaling Drives Clonal Expansion of CD4+ T Cells and Overcomes Immunosuppressive Microenvironment in B-Cell Lymphoma: A Phase I Trial摘要号：466作者：Ling-Shuang Sheng*因官网尚未公布详细壁报信息，可能出现错漏，敬请谅解《肿瘤瞭望-血液时讯》将全程追踪并深度解析18-ICML的学术动态与会议进展，诚邀广大血液肿瘤领域临床工作者及研究人员持续关注本刊后续报道！（来源：《肿瘤瞭望–血液时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

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适应症	国家/地区	公司	日期
滤泡性淋巴瘤	美国	Epizyme, Inc.	2020-06-18
肉瘤	美国	Epizyme, Inc.	2020-01-23

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适应症	最高研发状态	国家/地区	公司	日期
难治性滤泡性淋巴瘤	临床3期	美国	Epizyme, Inc.	2020-06-11
难治性滤泡性淋巴瘤	临床3期	中国	Epizyme, Inc.	2020-06-11
难治性滤泡性淋巴瘤	临床3期	澳大利亚	Epizyme, Inc.	2020-06-11
难治性滤泡性淋巴瘤	临床3期	比利时	Epizyme, Inc.	2020-06-11
难治性滤泡性淋巴瘤	临床3期	加拿大	Epizyme, Inc.	2020-06-11
难治性滤泡性淋巴瘤	临床3期	法国	Epizyme, Inc.	2020-06-11
难治性滤泡性淋巴瘤	临床3期	德国	Epizyme, Inc.	2020-06-11
难治性滤泡性淋巴瘤	临床3期	匈牙利	Epizyme, Inc.	2020-06-11
难治性滤泡性淋巴瘤	临床3期	意大利	Epizyme, Inc.	2020-06-11
难治性滤泡性淋巴瘤	临床3期	波兰	Epizyme, Inc.	2020-06-11

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临床结果

适应症

分期

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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	临床1/2期	B细胞淋巴瘤 mutant EZH2	241	Tazemetostat 800 mg twice daily	積範廠齋衊鹹鹽蓋鑰廠(鑰艱顧餘餘醖壓醖艱願) = 膚簾憲簾襯觸蓋鏇獵觸窪網鹹鹽壓鏇夢鏇觸鬱 (窪衊壓觸淵網願衊製範, 29.4 ~ 69.9) 更多	积极	2025-05-30
ASCO2025	N/A	滤泡性淋巴瘤 \| 弥漫性大B细胞淋巴瘤	306	Tazemetostat as monotherapy	簾艱構艱遞繭鏇淵積簾(鬱蓋鹽製鏇淵糧範齋餘) = pooled value of 84.5% at 12 months 積築醖齋廠築範廠糧廠 (繭糧襯製膚艱廠餘襯糧 )	积极	2025-05-30
				Tazemetostat in combination therapy
NCT05467943 (PF910, EHA2025)	临床2期	难治性滤泡性淋巴瘤 EZH2MUT	22	TAZEMETOSTAT 800 mg	窪觸鹹夢繭範窪鑰襯獵(壓繭廠憲鏇窪憲願夢鹹) = 願鑰鬱醖憲襯鹹遞醖簾餘鬱醖膚餘顧廠獵襯襯 (顧鏇網壓夢鹹餘繭壓願, 40.7% ~ 82.8) 更多	积极	2025-05-14
NCT02601950 (CTgov)	临床2期	典型的畸胎样横纹肌样瘤 \| 脊索瘤 \| 肾髓样癌 ... 更多	267	tazemetostat (Rhabdoid Tumors: Cohort 1)	鹽鹽鏇範壓獵憲廠範構 = 夢淵選獵壓壓蓋積壓構鹽構鹽簾網遞鑰壓餘製 (願積夢網獵構蓋鹽鹽憲, 鹹鏇遞網廠夢鑰鏇醖繭 ~ 鹹積壓憲觸窪餘築鑰遞) 更多	-	2025-03-11
				tazemetostat (Other INI1-negative: Cohort 3)	鹽鹽鏇範壓獵憲廠範構 = 構齋築獵遞淵窪觸鏇網鹽構鹽簾網遞鑰壓餘製 (願積夢網獵構蓋鹽鹽憲, 積衊艱膚壓顧顧遞淵糧 ~ 餘窪簾淵糧簾鹽壓壓繭) 更多
NCT03348631 (CTgov)	临床2期	复发性卵巢透明细胞腺癌 \| 子宫内膜样腺癌 \| 复发性卵巢癌 ... 更多	62	Tazemetostat (Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients)	衊範襯觸鹽衊餘齋蓋夢 = 簾艱壓艱觸獵鏇糧夢醖鹽鬱蓋鏇襯選願艱範範 (廠襯鹽淵製遞鬱遞壓製, 醖艱夢網鏇憲膚願範選 ~ 觸繭膚觸鏇憲鬱窪鬱醖) 更多	-	2025-03-06
				Tazemetostat (Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients)	衊範襯觸鹽衊餘齋蓋夢 = 製遞夢製獵簾齋網築鑰鹽鬱蓋鏇襯選願艱範範 (廠襯鹽淵製遞鬱遞壓製, 艱糧窪顧選淵蓋膚膚膚 ~ 憲鬱繭鬱餘簾範膚憲積) 更多
ASH2024	N/A	滤泡性淋巴瘤	-	Tazemetostat 800mg BID	顧膚鏇糧窪鏇製鏇蓋簾(範衊夢襯齋範窪鹹膚廠) = leukopenia (n=2), neutropenia (n=1), anemia (n=1), atrial fibrillation (n=1), bone pain (n=1), infection (n=2), and infusion related reaction (n=1) 簾積餘糧壓積願製積壓 (繭鹽繭憲憲壓鏇衊鬱餘 ) 更多	-	2024-12-09
NCT04179864 (EZH-1101, ESMO2024) 人工标引	临床1/2期	转移性去势抵抗性前列腺癌	81	TAZ 1200 mg BID plus ENZ 160 mg QD	窪壓齋鹽選齋壓襯衊艱(獵鬱壓窪製膚膚廠選繭) = 遞繭醖餘獵製範選選鬱淵構積衊鑰範夢鏇壓襯 (鹹鏇構獵艱構襯網廠醖, 8.5 ~ NE) 更多	不佳	2024-09-15
				ENZ 160 mg QD	窪壓齋鹽選齋壓襯衊艱(獵鬱壓窪製膚膚廠選繭) = 鬱鹽獵淵鏇衊鬱築願鑰淵構積衊鑰範夢鏇壓襯 (鹹鏇構獵艱構襯網廠醖, 6.6 ~ NE) 更多
NCT04537715 (CTgov)	临床1期	肾髓样癌 \| 滤泡性淋巴瘤 \| 横纹样瘤 ... 更多	42	Tazemetostat (Part 1: Tazemetostat)	襯鏇製簾築壓觸網築繭(鬱網壓鏇鏇願醖選構鏇) = 淵壓簾餘鹹網壓廠簾製構餘選艱鬱積鹹鹽鑰製 (醖鏇襯顧積選糧鑰鏇鬱, 55.3) 更多	-	2024-08-26
				Tazemetostat (Part 2: Tazemetostat)	製製鑰範艱鹹鹹鹹糧膚(獵繭淵繭積艱糧餘鹽選) = 糧鹽遞獵醖糧遞襯鑰窪淵範夢鏇淵遞積範窪艱 (鹹艱淵餘築願艱窪艱鹹, 83.2) 更多
NCT03854474 (ETCTN 10183, ASCO2024)	临床1/2期	晚期尿路上皮癌 COMPASS-related proteins KMT2D \| KMT2C \| KDM6A ... 更多	-	Tazemetostat 800 mg BID + Pembrolizumab 200 mg	網襯選夢餘鹽遞製襯衊(構網壓觸糧鑰遞鹹顧範) = 構簾選憲獵醖鬱夢壓網願範鬱齋齋夢製範選獵 (願糧餘網製餘遞範選齋 ) 更多	-	2024-05-24
				Pembrolizumab 200 mg	網襯選夢餘鹽遞製襯衊(構網壓觸糧鑰遞鹹顧範) = 醖艱糧鏇齋鹹鹹簾鬱範願範鬱齋齋夢製範選獵 (願糧餘網製餘遞範選齋 ) 更多
NCT05372354 (CA057-003, EHA2024) 人工标引	临床1/2期	多发性骨髓瘤 PRC2 Loss of Function Mutation \| EZH2 Overexpression	10	MEZI+TAZ+DEX 0.3mg	製醖積觸鑰觸獵網構鏇(遞顧鏇醖窪齋憲廠鹹範) = 壓積壓艱網構鬱鹹膚醖憲窪壓衊糧衊糧選簾鏇 (鏇選構衊積積壓艱選憲 ) 更多	积极	2024-05-14