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2024-09-02

申办/合作机构

Epizyme, Inc.

[+1]

NCT05983965 / Not yet recruiting临床1期IIT

Phase I Study to Evaluate Safety and Tolerability of Tazemetostat in Relapsed/Refractory Peripheral T-cell Lymphoma

Tazemetostat is an oral EZH2 inhibitor which has been FDA approved for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment option. We propose a study to evaluate the safety of tazemetostat in relapsed / refractory peripheral T-cell lymphoma.

开始日期2024-08-01

申办/合作机构

The University of Alabama at Birmingham

NCT05467748 / Not yet recruiting临床1/2期

Phase Ib/II Study of Safety and Efficacy of EZH2 Inhibitor, Tazemetostat, and PD-1 Blockade for Treatment of Advanced Non-small Cell Lung Cancer

This is an open label, single arm, phase Ib/II clinical trial of checkpoint blockade, pembrolizumab and EZH2 inhibitor, tazemetostat combination therapy for patients with advanced non-small cell lung cancer who have progressed from front or second-line treatment. Patients will be enrolled at multiple Veterans Affairs Medical Centers.

开始日期2024-07-01

申办/合作机构

VA Office of Research and Development

100 项与他泽司他相关的临床结果

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100 项与他泽司他相关的转化医学

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100 项与他泽司他相关的专利（医药）

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209

项与他泽司他相关的文献（医药）

2106-07-05·Oncotarget

EZH2 promotes colorectal cancer stem-like cell expansion by activating p21cip1-Wnt/β-catenin signaling

Article

作者: Xie, Gan-Feng ; Chen, Jian-Fang ; Liang, Hou-Jie ; Xiang, Li-Sha ; He, Jian-Ming ; Xie, Xiong ; Li, Ni ; Zha, Lin ; Li, Hong-Tao ; Luo, Xi

Because colorectal cancer (CRC) stem-like cells (CCS-like cells) contribute to poor patient prognosis, these cells are a potential target for CRC therapy. However, the mechanism underlying the maintenance of CCS-like cell properties remains unclear. Here, we found that patients with advanced stage CRC expressed high levels of polycomb group protein enhancer of zeste homologue 2 (EZH2). High expression of EZH2 in tumor tissues correlated with poor patient prognosis. Conversely, silencing EZH2 reduced CRC cell proliferation. Surprisingly, EZH2 was more highly expressed in the CCS-like cell subpopulation than in the non-CCS-like cell subpopulation. EZH2 knockdown significantly reduced the CD133+/CD44+ subpopulation, suppressed mammosphere formation, and decreased the expression of self-renewal-related genes and strongly impaired tumor-initiating capacity in a re-implantation mouse model. Gene expression data from 433 human CRC specimens from TCGA database and in vitro results revealed that EZH2 helped maintain CCS-like cell properties by activating the Wnt/β-catenin pathway. We further revealed that p21cip1-mediated arrest of the cell cycle at G1/S phase is required for EZH2 activation of the Wnt/β-catenin pathway. Moreover, the specific EZH2 inhibitor EPZ-6438, a clinical trial drug, prevented CRC progression. Collectively, these findings revealed EZH2 maintaining CCS-like cell characteristics by arresting the cell cycle at the G1/S phase. These results indicate a new approach to CRC therapy.

2024-05-01·PharmacoEconomics

Budget Impact of Introducing Fixed-Duration Mosunetuzumab for the Treatment of Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy in the USA

Article

作者: Shapouri, Sheila ; Matasar, Matthew ; Parisé, Hélène ; Wu, Mei ; Bercaw, Eric ; Kim, Eunice ; Lin, Shih-Wen

OBJECTIVE:

This study aimed to assess the budget impact of introducing fixed-duration mosunetuzumab as a treatment option for adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies and to estimate the total cumulative costs per patient in the USA.

METHODS:

A 3-year budget impact model was developed for a hypothetical 1-million-member cohort enrolled in a mixed commercial/Medicare health plan. Comparators were: axicabtagene ciloleucel, tisagenlecleucel, tazemetostat, rituximab plus lenalidomide, copanlisib, and older therapies (rituximab or obinutuzumab ± chemotherapy). Costs per patient comprised treatment-associated costs including the drug, its administration, adverse events, and routine care. Dosing and safety data were ascertained from respective package inserts and clinical trial data. Drug costs (March 2023) were estimated based on the average wholesale acquisition cost reported in AnalySource^®, and all other costs were based on published sources and inflated to 2022 US dollars. Market shares were obtained from Genentech internal projections and expert opinion. Budget impact outcomes were presented on a per-member per-month basis.

RESULTS:

Compared with a scenario without mosunetuzumab, its introduction over 3 years resulted in a budget increase of $69,812 (1% increase) and an average per-member per-month budget impact of $0.0019. Among the newer therapies, mosunetuzumab had the second-lowest cumulative per patient cost (mosunetuzumab = $202,039; axicabtagene ciloleucel = $505,845; tisagenlecleucel = $476,293; rituximab plus lenalidomide = $263,520; tazemetostat = $250,665; copanlisib = $127,293) and drug costs, and its introduction only increased total drug costs by 0.1%. By year 3, the cumulative difference in the per patient cost with mosunetuzumab was -$303,805 versus axicabtagene ciloleucel, -$274,254 versus tisagenlecleucel, -$61,481 versus rituximab plus lenalidomide, -$48,625 versus tazemetostat, and $74,747 versus copanlisib. Older therapies were less costly with 3-year cumulative costs that ranged from $36,512 to $147,885.

CONCLUSIONS:

Over 3 years, the estimated cumulative per patient cost of mosunetuzumab is lower than most available newer therapies, resulting in a small increase in the budget after its formulary adoption for the treatment of relapsed or refractory follicular lymphoma.

2024-02-01·Clinical lymphoma, myeloma & leukemia

Indirect Treatment Comparisons of Mosunetuzumab With Third- and Later-Line Treatments for Relapsed/Refractory Follicular Lymphoma

Review

作者: Wei, Michael C ; Bosch, Francesc ; Vassilakopoulos, Theodoros P ; Zumofen, Marie-Helene Blanchet ; Maio, Danilo Di ; Nastoupil, Loretta J ; Kuruvilla, John

BACKGROUND:

No established standard of care exists for relapsed/refractory (RR) follicular lymphoma (FL) after ≥2 prior therapies. We conducted indirect treatment comparisons (ITCs) to compare the efficacy and tolerability of mosunetuzumab with those of available treatments used in this setting.

METHODS:

A systematic literature review (SLR) and subsequent feasibility assessments were conducted to identify the most suitable comparator studies in terms of design, available endpoints and populations. Imbalances in patient characteristics between NCT02500407 and studies featuring aggregate or patient-level data availability were accounted for using matching-adjusted indirect comparison (MAIC) and propensity score-based methodologies, respectively.

RESULTS:

ZUMA-5, ELARA, DELTA, DYNAMO, UNITY-NHL, AUGMENT and NCT01897571 passed the MAIC feasibility assessment. Patient-level data were available from GADOLIN, CONTRALTO and NCT02257567. MAIC results generally favored mosunetuzumab over tazemetostat in EHZ2wild-type patients for all outcomes and over PI3K inhibitors for complete response (CR), objective response rate (ORR), discontinuations due to adverse events and progression-free survival (PFS) with umbralisib. MAICs favored CART therapies for PFS and, to a lesser extent, ORR and CR. Comparisons with anti-CD20 antibody-based regimens yielded mixed results.

CONCLUSIONS:

ITCs suggest that mosunetuzumab may lead to superior outcomes over tazemetostat (in EHZ2wild-type patients) and PI3K inhibitors and may be a promising alternative to re-challenging with a different anti-CD20 regimen in patients who relapse after ≥2 prior anti-CD20 lines. Although preliminary results somewhat favored CART therapies, limitations and uncertainties remain because of intrinsic differences in study design. Mosunetuzumab could thus be a promising treatment option for patients with RR FL after ≥2 prior therapies.

113

项与他泽司他相关的新闻（医药）

2024-05-20

·GBIHealth

60亿美元！恒瑞医药/Hercules达成GLP-1产品组合和股权协议；春立医疗膝关节置换手术导航系统获NMPA批准上市

药械追踪No.1 /和黄医药公布索乐匹尼布Ⅲ期临床及恶性血液肿瘤数据和黄医药近日发布公告称，将在今年6月的欧洲血液协会（EHA）年会上公布索乐匹尼布ESLIM-01 Ⅲ期研究的顶线及亚组结果，以及创新探索性血液恶性肿瘤疗法HMPL-306、HMPL-760及他泽司他（tazemetostat）的最新及更新后的临床数据。索乐匹尼布是一种用于治疗血液恶性肿瘤和自身免疫性疾病的新型、高选择性口服脾酪氨酸激酶（Syk）抑制剂，该药治疗免疫性血小板减少症的III期ESLIM-01研究已达到所有终点，ITP适应证也因此获国家药监局纳入突破性治疗品种及优先审评。->点击阅读原文，解锁完整双语新闻No.2 /优卡迪生物CAR-T产品进入突破性治疗近日，优卡迪生物医药公司申报的具有沉默白介素6（IL-6）表达功能的靶向CD19基因工程化自体T细胞注射液拟纳入突破性治疗品种，针对难治/复发急性淋巴细胞白血病。该产品是优卡迪生物研发的一款具有IL-6敲减功能的CD19靶向CAR-T细胞（ssCART-19）。2020年，ssCART-19细胞注射液获CDE许可开展注册临床试验，用于中枢神经系统白血病（俗称“脑白”）治疗，并获得了美国FDA孤儿药资格。->点击阅读原文，解锁完整双语新闻No.3 /春立医疗膝关节置换手术导航系统获NMPA批准上市国家药品监督管理局日前批准北京市春立正达医疗器械股份有限公司的膝关节置换手术导航系统上市，型号为黄河INS 1-手持骨科机器人。截至目前，国内已有11家企业的17款国产关节手术机器人获批上市。最近中标的多为一体机，意味着骨科机器人围绕着一体化、智能化的路径发展。->点击阅读原文，解锁完整双语新闻企业动态No.1 /60亿美元！恒瑞医药与美国Hercules达成GLP-1产品组合和股权协议恒瑞医药近日发布公告称，将具有自主知识产权的GLP-1产品组合有偿许可给Hercules CM Newco, Inc.，美国Hercules公司将获得在除大中华区以外的全球范围内开发、生产和商业化GLP-1产品组合的独家权利。根据协议，恒瑞医药将获得首付款和近期里程碑总计1.1亿美元。基于产品实际年净销售额情况，Hercules将向恒瑞支付累计不超过57.25亿美元的销售里程碑款。->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作，GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ sylvia.hua@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

上市批准临床3期优先审批孤儿药免疫疗法

2024-05-17

·GlobeNewswire-Health Care

HUTCHMED Highlights Sovleplenib Phase III ESLIM-01 Study and Hematological Malignancy Programs Data to be Presented at the upcoming EHA2024 Congress

May 17, 2024 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that topline and subgroup results from the ESLIM-01 Phase III study of sovleplenib, as well as new and updated data related to novel investigational hematological malignancy therapies HMPL-306, HMPL-760 and tazemetostat, will be presented at the upcoming European Hematology Association (“EHA”) Hybrid Congress, taking place on June 13-16, 2024 in Madrid, Spain and online. ESLIM-01 is a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in adult patients with primary Immune Thrombocytopenia (“ITP”) who have received at least one prior line of standard therapy (NCT05029635). In 188 patients randomized to receive oral sovleplenib or placebo, sovleplenib demonstrated a clinically meaningful early and sustained durable platelet response in patients with primary ITP with durable response rate of 48.4% compared to zero with placebo (p Most patients were heavily pretreated with a median of four prior lines of ITP therapy and a majority (71.3%) of the patients had received prior TPO/TPO-RA1 treatment. Further post-hoc subgroup analysis of the study demonstrated consistent clinical benefits across ITP patients regardless of prior lines of ITP therapies or prior TPO/TPO-RA exposure, regardless of TPO/TPO-RA treatment types and number of prior regimens. In addition to the promising data in ITP, results from Phase II part of the ongoing ESLIM-02 Phase II/III study (NCT05535933) of sovleplenib for warm antibody autoimmune hemolytic anemia (wAIHA) will also be presented at the congress demonstrating encouraging hemoglobin (Hb) benefit compared with placebo, with overall response rate of 43.8% vs. 0% in the first 8 weeks, and overall response rate of 66.7% during the 24 weeks of sovleplenib treatment (including patients that crossed over from placebo). A favorable safety profile was also demonstrated. Details of the presentations are as follows: HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. The content above comes from the network. if any infringement, please contact us to modify.

临床结果免疫疗法

2024-04-29

·美通社

在增长平台和新药的推动下，益普生2024年第一季度实现销售额强劲增长并确认2024年全年指引

巴黎 2024年4月29日 /美通社/ -- 全球特药领域生物制药公司益普生（Euronext：IPN；ADR：IPSEY）今日公布了2024年第一季度的销售业绩。 2024 年第一季度 2023 年第一季度变化百分比 % 百万欧元百万欧元实际以固定汇率计算 [1] 增长平台 [2] 509.7 452.0 12.8 % 16.2 % 新药 [3] 45.5 14.3 n/a n/a 索马杜林 ® 257.8 263.2 -2.0 % -1.3 % 其他 9.5 12.4 -23.8 % -20.5 % 总销售额 822.4 741.9 10.9 % 13.3 % 重点回顾以固定汇率计算 [1] ，总销售额增长率为13.3%（报告为10.9%），该增长主要归因于以下两方面：增长平台 [2] 销售额增长16.2% [1] 和新药贡献增加。索马杜林销售额仅下降1.3% [1] Onivyde在美国获得监管批准并上市，用于转移性胰腺导管腺癌（mPDAC）的一线治疗确认2024年财务指引益普生首席执行官David Loew表示：“我们在第一季度实现了出色的业绩，为益普生2024年的增长奠定了坚实的基础。在增长平台的成功和新药贡献增加的支持下，我们的销售额继续保持强劲增长，这证明我们战略计划得到了成功实施。此外，研发管线也不断传来喜报，本季度，Onivyde在美国获得监管批准，用于胰腺癌的一线治疗。” "今年是我们增长计划的关键时期，我们将推出四款新药或适应症。我们的重点仍然是产品组合的表现和研发管线的扩张，以及以改善患者生活和医疗结局为中心的明确可持续增长战略。" 2024 年全年指引益普生已确认其2024年财务指引，其中排除了任何潜在的额外后期 [4] 外部创新机会的影响：以固定汇率计算，总销售额增长超过6.0%。基于2024年3月的平均汇率水平，预计汇率将对总销售额产生约1%的不利影响核心营业利润率约为总销售额的30%，包括预期的早期和中期外部创新机会带来的额外研发费用总销售额指引包括对在美国和欧盟进一步推出索马杜林兰瑞肽仿制药的预期。业务发展 2024年2月，益普生宣布美国食品药品监督管理局（FDA）已批准Onivyde联合奥沙利铂、氟尿嘧啶和亚叶酸（NALIRIFOX）作为mPDAC成人患者一线治疗的补充新药申请。这是继2015年FDA批准Onivyde联合氟尿嘧啶和亚叶酸用于治疗接受吉西他滨治疗方案后出现疾病进展的mPDAC患者后，第二次批准将Onivyde方案用于治疗mPDAC。在美国批准Onivyde作为mPDAC成人患者的一线治疗药物的同时，Onivyde还被授予孤儿药独占许可，监管独占期持续至2031年（批准后自动启用7年独占期）。 2024年4月，益普生宣布就靶向ROR1肿瘤抗原的抗体偶联药物（ADC）STRO-003达成全球独家许可协议。STRO-003正处于临床前开发的最后阶段。该协议赋予益普生全球独家开发和商业化STRO-003的权利，这也是益普生不断扩大的研发管线中的第一款ADC候选药物。益普生和Skyhawk Therapeutics于2024年4月宣布签署全球独家合作协议，共同发现和开发调节罕见神经系统疾病RNA的新型小分子药物。该协议包括一项选择权，根据该选择权，益普生将获得在全球范围内开发成功候选药物的独家许可。 Onivyde 诉讼 2024年3月，益普生收到关于Conjupro Biotherapeutics, Inc. （Conjupro）向美国FDA提交505(b)(2)申请的第IV段通知函，请求批准盐酸伊立替康脂质体注射液上市，用于治疗既往接受吉西他滨治疗后出现进展的mPDAC患者。该信函对保护Onivyde及其用途的多项专利提出了质疑。作为回应，益普生于2024年4月向美国新泽西州地方法院对Conjupro和某些相关公司实体提起专利侵权诉讼，并将全力捍卫自身权利，因为其专利组合包括将于2027年到期的脂质体组合物的美国专利保护，以及涵盖该制剂和批准用于治疗吉西他滨治疗后出现进展的mPDAC患者的其他专利（有效期至2033年，一线治疗的额外保护有效期至2036年）。说明所有财务数据均以百万欧元（€m）为单位。本报告的业绩涵盖2024年3月31日之前的3个月期间（2024年第一季度），而进行数据对比的对象为2023年3月31日之前的3个月期间（2023年第一季度）。点击【阅读原文】，至益普生全球官网，查阅详细报告。注 [1] 以固定汇率（ CER ）计算，即通过应用前一时期使用的汇率重新计算相关时期的业绩，排除任何外汇影响 [2] 吉适 ® （ A 型肉毒毒素）、达必佳 ® （曲普瑞林）、 Cabometyx ® （ Cabozantinib ）和 Onivyde ® （伊立替康） [3] Bylvay ® （ Odevixibat ）、 Tazverik ® （ Tazemetostat ）和 Sohonos ® （ Palovarotene ） [4] Ⅲ 期临床开发或之后关于益普生益普生是一家全球性的生物制药公司，专注于在肿瘤、罕见病和神经科学三个治疗领域为患者提供革新型药物。我们的研发管线以外部创新为动力，有近百年的开发经验以及美国、法国、英国的全球中心作为有力的支持。分布于40多个国家的全球团队，共同与我们在世界各地的合作伙伴关系，使我们为100多个国家的患者提供药物。益普生在巴黎（泛欧交易所：IPN）上市并通过赞助的I级美国存托凭证项目（ADR：IPSEY）在美国上市交易。有关益普生的更多信息，请访问 ipsen.com . 关于益普生中国益普生集团于1992年进入中国，2019年在上海设立创新中心，是全球四个研发中心之一。益普生于2021年在上海成立中国区总部，并于2022年根据集团业务变动，同步剥离多元健康业务，专注于特药领域，针对三大疾病领域（肿瘤、罕见病、神经科学）携手上海创新中心持续推出创新治疗方案以满足中国患者亟待解决的治疗需求。益普生 - 有关前瞻性声明的警示说明本文所含前瞻性声明、目的和目标基于集团的管理战略、当前观点和假设。此类声明涉及已知和未知的风险和不确定性，可能导致实际结果、业绩或事件与本文所预期的大不相同。上述所有风险均可能影响集团在未来实现其财务目标的能力，财务目标是基于现今可用信息在合理的宏观经济条件下设定的。"相信"、"期望"和"期待"等词语和类似表述的使用是为了明确前瞻性声明，包括集团对未来事件的期望，此类事件包括监管文件和决定。此外，本文所述目标的制定未考虑外部增长假设和潜在未来收购，而这两者可能会使指标发生变化。目的的依据是集团认为合理的数据和假设。目标取决于将来可能发生的条件或事实，而不仅取决于历史数据。考虑到某些风险和不确定性的发生，实际结果可能与这些指标有很大出入，明显表现为在早期研发阶段或临床试验中有前景的产品可能最终永远不会投放市场或达到其商业目标，尤其是由于注册或竞争原因。集团必须面对或可能面对来自仿制药的竞争，这可能会转化为市场份额的损失。此外，研发过程涉及多个阶段，每个阶段都涉及重大风险，即集团可能无法实现其目的并被迫放弃就自身已投入大量资金的产品所做的努力。因此，集团不能确定在临床前试验中获得的有利结果是否会在随后的临床试验中得到确认，也不能确定临床试验的结果是否足以证明相关产品的安全性和有效性。不能保证产品将获得必要的注册批准或该产品将被证明在商业上是成功的。如果基本假设证明不准确或确实出现风险或不确定性，则实际结果可能与前瞻性声明中的结果有很大不同。其他风险和不确定性包括但不限于一般行业条件和竞争；一般经济因素，包括利率和货币汇率波动；制药行业法规和医疗保健立法的影响；全球医疗成本抑制趋势；竞争对手获得技术进步、新产品和专利；新产品研发中固有的挑战，包括获得监管部门的批准；集团准确预测未来市场状况的能力；生产困难或延误；国际经济的金融不稳定和主权风险；对集团专利的有效性和创新产品的其他保护的依赖；以及可能面临的诉讼，包括专利诉讼和/或监管诉讼。此外，集团依赖第三方来研发和销售某些产品，这些产品可能会产生大额特许权使用费用；这些合作伙伴的行为可能会对集团的活动和财务结果造成损害。集团不能确定其合作伙伴将履行各自的义务。集团可能无法从这些协议中获得任何利益。集团任何合作伙伴违约均会产生低于预期的收益。此类情况可能会对集团的业务、财务状况或业绩产生负面影响。集团明确声明，除非适用法律有所要求，否则其不承担更新或修订本新闻稿中所包含的任何前瞻性声明、目标或假设的任何义务，以反映此类声明所依据的事件、条件、假设或情况的任何变化，也不会就此作出任何承诺。集团的业务受制于其在法国金融市场监管机构备案的注册文件中概述的风险因素。该文件中所列风险和不确定性并非详尽无遗，建议读者参阅集团网站（ www.ipsen.com ）上集团的最新通用注册文件。

孤儿药IPO申请上市医药出海

100 项与他泽司他相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11485	他泽司他	L01	DB12887

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
滤泡性淋巴瘤	美国	Epizyme, Inc.	2020-06-18
肉瘤	美国	Epizyme, Inc.	2020-01-23

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
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

评价

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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


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	網廠齋積窪艱鏇夢簾鏇(夢鬱壓繭獵願鏇膚淵簾) = 糧顧衊鹹膚鑰蓋淵衊獵醖糧窪鑰獵選鑰築艱製 (顧艱範衊鏇鹽醖鬱鹽憲 ) 更多	-	2024-05-24
				Pembrolizumab 200 mg	網廠齋積窪艱鏇夢簾鏇(夢鬱壓繭獵願鏇膚淵簾) = 獵鑰餘廠觸製襯鏇窪製醖糧窪鑰獵選鑰築艱製 (顧艱範衊鏇鹽醖鬱鹽憲 ) 更多
Phase II Study of Tazemetostat Plus Amdizalisib (EHA2024)	临床2期	淋巴瘤	21	Tazemetostat 800mg BID	構獵淵窪衊餘獵憲蓋鏇(糧膚製網憲獵艱鬱淵獵) = 4 pts, 19.0% 膚襯鏇壓齋糧襯鹹簾艱 (淵遞選糧構簾觸淵獵築 ) 更多	积极	2024-05-14
				Amdizalisib 30mg QD
NCT05372354 (CA057-003, EHA2024)	临床1/2期	复发性多发性骨髓瘤	12	MEZI+TAZ+DEX 0.3mg	構蓋夢餘壓築網製繭範(積艱糧觸簾艱蓋構鑰膚) = Overall, 8 (66.7%) pts experienced a grade (Gr) 3/4 treatment-emergent adverse event (TEAE); the most common hematologic TEAEs were neutropenia (33.4%) and anemia (16.7%). Most common (reported in >1 pt) non-hematologic Gr 3/4 TEAEs included infections (16.7%) and dyspnea (16.7%). No dose-limiting toxicities were observed. No TEAEs led to MEZI dose reduction or discontinuation. At data cutoff there were no deaths due to TEAEs. 鬱構鑰壓醖繭鏇製憲憲 (範餘顧膚艱築製壓蓋壓 )	积极	2024-05-14
				MEZI+TAZ+DEX 0.6mg
NCT04224493 (SYMPHONY-1, ASH2023)	临床3期	难治性滤泡性淋巴瘤	815	Tazemetostat plus Lenalidomide and Rituximab	構網範顧顧遞積願鏇積(蓋構膚膚餘壓簾獵鏇壓) = 鬱繭衊艱蓋餘鹹淵簾獵範夢糧鑰鏇壓願鏇鑰範 (醖蓋壓築衊積艱顧遞鏇 )	积极	2023-12-11
				Lenalidomide and Rituximab	構網範顧顧遞積願鏇積(蓋構膚膚餘壓簾獵鏇壓) = 觸鹽衊構觸憲糧淵糧艱範夢糧鑰鏇壓願鏇鑰範 (醖蓋壓築衊積艱顧遞鏇 )
ASH2023	临床2期	滤泡性淋巴瘤	62	Tazemetostat 800mg BID + R-CHOP	廠衊選醖簾繭衊蓋糧遞(鹽鏇壓襯顧繭願糧鏇觸) = 窪繭醖餘鬱網壓願鏇選鹽鹹齋壓顧齋衊築構構 (顧鑰繭鏇觸觸窪蓋觸齋 ) 更多	-	2023-12-09
NCT04762160 (CTgov)	临床2期	滤泡性淋巴瘤	5	Tazemetostat+Rituximab	膚網壓壓範鏇艱淵襯觸(積齋壓鹽願網襯窪範膚) = 築顧壓襯糧構醖範顧衊鑰餘鏇餘蓋鬱顧醖艱願 (鹽窪鹽膚鹹獵顧範窪築, 築艱壓夢觸壓夢衊製製 ~ 鑰構艱鹹鏇積艱鹽壓簾) 更多	-	2023-11-21
NCT05627245 (ETCTN P10500, ICML2023)	临床1期	复发性淋巴瘤 \| 难治性淋巴瘤 EZH2 mutation \| EP300 mutation \| CREBBP mutation	12	Tazemetostat	製鹹淵淵醖鹽鹹襯壓鹹(鹽鏇壓廠範鹽鹹鹹淵製) = 襯積壓憲觸夢膚糧醖鏇構網觸夢願簾壓鹽簾淵 (夢夢製鑰顧膚窪繭淵壓 ) 更多	积极	2023-06-09
				Belinostat	製鹹淵淵醖鹽鹹襯壓鹹(鹽鏇壓廠範鹽鹹鹹淵製) = 壓簾艱餘艱獵襯網夢繭構網觸夢願簾壓鹽簾淵 (夢夢製鑰顧膚窪繭淵壓 )
NCT04705818 (CAIRE, ASCO2023) 人工标引	临床2期	转移性微卫星稳定结直肠癌 Microsatellite Stable	47	Tazemetostat 800 mg+Durvalumab 1120 mg	簾鏇積範顧艱觸構鑰構(衊鑰夢鹽夢遞網選鹽顧) = 簾艱選廠觸壓艱膚網鹽廠膚襯繭簾築願鏇繭簾 (鹽蓋鹽觸廠鬱齋鏇願顧, 19.7 ~ 53.5) 更多	积极	2023-05-31
NCT04624113 (ASCO2023) 人工标引	临床1期	头颈部鳞状细胞癌	12	pembrolizumab+Tazemetostat	選觸壓選衊艱蓋膚觸憲(獵簾壓夢膚製夢襯獵製) = tazemetostat was 800 mg twice daily when given with pembrolizumab 衊醖窪餘糧憲蓋糧遞膚 (窪糧獵齋構顧簾築壓鏇 ) 更多	积极	2023-05-26
NCT03213665 (APEC1621C, CTgov)	临床2期	难治性软组织肉瘤 \| 室管膜瘤 \| 难治性非霍奇金淋巴瘤 ... 更多	20	Tazemetostat	鹹餘壓膚積醖選膚廠餘(選顧壓壓範願構網鏇顧) = 憲鹹獵壓顧鑰醖膚觸糧憲憲網齋鏇憲鏇鑰窪齋 (繭鹹選鬱夢遞築膚淵鹽, 構網鬱簾膚繭餘願製觸 ~ 夢遞簾遞鏇選膚蓋壓鬱) 更多	-	2023-04-27