A Randomized International Phase 3 Trial of Imatinib and Chemotherapy With or Without Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or Philadelphia Chromosome-Like ABL-Class B-Cell Acute Lymphoblastic Leukemia

This phase III trial compares the effect of the combination of blinatumomab with dasatinib and standard chemotherapy versus dasatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (PH+) or Philadelphia chromosome-like (Ph-Like) ABL-class B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib in combination with standard chemotherapy may work better in treating patients with PH+ or Ph-Like ABL-class B-ALL compared to dasatinib and chemotherapy alone.

开始日期2025-02-28

申办/合作机构

National Cancer Institute

NCT06317662 / Not yet 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2025-01-26

申办/合作机构

National Cancer Institute

NCT06570798 / Not yet recruiting临床2期

A Phase 2a, Open Label, Multi Center, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

The main objective is to assess the safety and tolerability of inebilizumab (Subprotocol A) and subcutaneous (SC) blinatumomab (Subprotocol B) in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis.

开始日期2024-12-31

申办/合作机构

Amgen, Inc.

100 项与贝林妥欧单抗相关的临床结果

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100 项与贝林妥欧单抗相关的转化医学

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100 项与贝林妥欧单抗相关的专利（医药）

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项与贝林妥欧单抗相关的文献（医药）

2024-12-31·Hematology (Amsterdam, Netherlands)

A review of immunotargeted therapy for Philadelphia chromosome positive acute lymphoblastic leukaemia: making progress in chemotherapy-free regimens

Review

作者: Zhang, Shi-Zhong ; Xiong, Zhen-Yu ; Zhu, Hong-Hu ; Shen, Yao-Jia

Philadelphia chromosome-positive acute lymphoblastic leukemia (PH + ALL) is the most common cytogenetic abnormality of B-ALL in adults and is associated with poor prognosis. Previously, the only curative treatment option in PH + ALL was allogeneic hematopoietic stem cell transplantation (Allo-HSCT). Since 2000, targeted therapy combined with chemotherapy, represented by the tyrosine kinase inhibitor Imatinib, has become the first-line treatment for PH + ALL. Currently, the remission rate and survival rate of Imatinib are superior to those of simple chemotherapy, and it can also improve the efficacy of transplantation. More recently, some innovative immune-targeted therapy greatly improved the prognosis of PH + ALL, such as Blinatumomab and Inotuzumab Ozogamicin. For patients with ABL1 mutations and those who have relapsed or are refractory to other treatments, targeted oral small molecule drugs, monoclonal antibodies, Bispecific T cell Engagers (BiTE), and chimeric antigen receptor (CAR) T cells immunotherapy are emerging as potential treatment options. These new therapeutic interventions are changing the treatment landscape for PH + ALL. In summary, this review discusses the current advancements in targeted therapeutic agents shift in the treatment strategy of PH + ALL towards using more tolerable chemotherapy-free induction and consolidation regimens confers better disease outcomes and might obviate the need for HSCT.

2024-12-31·Hematology

Successful treatment of two cases with Philadelphia-chromosome positive acute lymphoblastic leukemia who relapsed after allogeneic stem cell transplantation and the treatments with novel immunotherapies and ponatinib

Article

作者: Noguchi, Yuma ; Sadato, Daichi ; Tanaka, Masatsugu ; Doki, Noriko ; Harada, Yuka ; Nakajima, Hideaki ; Tamai, Yotaro ; Najima, Yuho ; Tachibana, Takayoshi

The outcomes of relapsed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) resistant to new drugs such as tyrosine kinase inhibitors, inotuzumab ozogamicin (InO) and blinatumomab are dismal. We treated two cases of Ph+ALL resistant to these drugs that achieved long-term survival after treatment with chimeric antigen receptor (CAR)-T cell therapy or a second allogeneic hematopoietic stem cell transplantation (HCT) with a sequential conditioning regimen. Case 1: A 15-year-old boy was diagnosed with Ph+ALL. Despite the second HCT after the treatment of ponatinib and blinatumomab, hematological relapse occurred. InO was ineffective and he was transferred to a CAR-T center. After the CAR-T cell therapy, negative measurable residual disease (MRD) was achieved and maintained for 38 months without maintenance therapy. Case 2: A 21-year-old man was diagnosed with Ph+ALL. Hematological relapse occurred after the first HCT. Despite of the treatment with InO, ponatinib, and blinatumomab, hematological remission was not achieved. The second HCT was performed using a sequential conditioning regimen with clofarabine. Negative MRD was subsequently achieved and maintained for 42 months without maintenance therapy. These strategies are suggestive and helpful to treat Ph+ALL resistant to multiple immunotherapies.

2024-12-31·Hematology

Efficacy and safety of blinatumomab for the treatment of patients relapsing after allogeneic hematopoietic cell transplantation: a systemic review and meta-analysis

Review

作者: Liu, Ying ; Guo, Huai-Peng ; Kang, Lei ; Qin, Wei-Wei ; Liu, Cong

OBJECTIVE:

We aim to evaluate the efficacy and safety of blinatumomab for the treatment of post-transplant relapse patients with acute lymphoblastic leukemia (ALL).

METHODS:

The search was conducted using several databases including the PubMed, Cochrane Library, Embase, Chinese National Knowledge Infrastructure (CNKI) and Wanfang Data Knowledge Service Platform to collect clinical studies related to blinatumomab. The primary outcome measures were complete remission (CR), 1-year overall survival (OS), 2-year OS, median OS and adverse events (AEs). Grade ≥3 AEs were mainly analyzed for safety, including anemia, thrombocytopenia, neutropenia, encephalopathy, peripheral paresthesia, tremor and cytokine release syndrome (CRS).

RESULTS:

A total of 7 studies, involving a total of 292 patients were included in the analysis. The analysis results showed CR rate of 48%, 1-year OS rate of 40% 2-year OS rate of 21%, median OS 7.47. For safety analysis, the incidence of grade ≥3 AEs, including the incidence of grade ≥3 anemic toxicity was 13% , the incidence of grade ≥3 thrombocytopenia toxicity was 7% , the incidence of grade ≥3 neutropenia toxicity 24%, the incidence of grade ≥3 encephalopathic toxicity was 4% , the incidence of grade ≥3 peripheral paresthesia toxicity 4%, the incidence of grade ≥3 tremor toxicity 8% , the incidence of grade ≥3 CRS toxicity was 4%.

CONCLUSION:

Blinatumomab may be a safe and an effective treatment approach for post-transplant relapse patients with ALL, but its long-term efficacy is still a big challenge. In regard to Regarding AEs, serious CRS and neurological events were infrequent and manageable.

406

项与贝林妥欧单抗相关的新闻（医药）

2024-12-18

·深蓝观

当越来越多人涌入newco避风港

李昀 | 撰文王晨 | 编辑经过了一整年的加温，“newco”（制药公司将部分资产、技术平台或药物候选产品分离出来，成立一家独立的新公司）这个曾经对行业还很陌生的词汇，一跃成为最热词条。一个最重要的“热”的标志是，开始有更多的冒险者涌入。一个国内的基金，打算在国内先和企业谈判，成立一个newco，然后再去找大的MNC加入。谁都想在这块炙手可热的市场里切一块蛋糕，而不怕冒着切到手的风险。从旁观议论到跃跃欲试，人们对于newco的态度，几乎成了今年生物医药板块的晴雨表。大环境加速催生了这种现象：从去年下半年开始，A股科创板对未盈利生物医药企业就开始冷起面孔；港股的流动性一降再降，投资人变得不好拉；做海外上市的红筹备案也比过去卡得更紧了。三方围堵之下，newco也就成为了恶劣环境下的一小方避风港。在很多人看来，newco只能算是一种权宜之计。它阶段性地利用市场对于管线价值和未来被并购可能的预期，以便快速换取资金。 “第一，在现在这个阶段，大多数优质管线早就通过BD的方式交易出去了；第二，你能不能摸准MNC的脉？第三，对于一个早期管线，在未来临床数据不确定的情况下，你的机制有没有说服力，有没有差异化？要闯过这几关很不容易。所以我觉得Newco这个东西，概念意义大于现象意义，能成的始终是少数。”一名BD工作者对这种模式不置可否。但位置决定看法。毕竟市场已经太久没有能调动想象力的新词汇了，newco的出现让很多苦于退出的投资人和创始人们看到了生机。恒瑞，康诺亚、嘉和生物、岸迈生物等一众药企，也纷纷在今年完成了newco动作。尽管目前只是完成了大致框架，但有了试水者，行业似乎也多了些底气。 “在资本运作方面，中国biotech相较于美国还是小学生。如果能通过newco拿到一些知情权，对于美国临床的运作、市场的运作增进一定的了解，是很有好处的。如果能再进一步，拿到一个董事会席位，深入地介入到项目当中，参与联合指导委员等机制中，就是一个更好的学习机会。” 君合律师事务所资深合伙人、医药医疗业务部主管陶旭东在第九届医药创投大会上说到。从这个意义上来说，newco的意义不只在于管线的价值升值。自从国内biotech的license out达成小高潮后，其交易管线被扫货的海外药企“赚差价”的消息就不断传来。比如海思科以6000万美元的首付加上1.2亿美元的里程碑交付的TYK2抑制剂，被Alumi转换成了5.29亿美元融资加上2.1亿美元的IPO规模；比如恒瑞以2500美万元卖掉的单克隆抗体，成就了被以总价值14亿美元被GSK宣布收购Aiolos Bio。对于newco这种模式，“阶段性”的评价也许并没有错——它不仅是中国biotech应对资本寒冬和监管收紧的周期性对策；同时也是必将走向海外市场的中国药企走出“舒适区”的一步：其中就包括了如何洞悉MNC心理、如何与资本共同管理合作、如何提升管线认可度与海外话语权等。 -01- 什么样的企业适合newco 由于A股通道受阻，今年寻求上市的企业尝试了几种路径，但需要满足很多前提条件。一种是递表港交所。为了解决市场流动性问题，今年港交所调低了市值门槛，有意吸引企业上市。然而，隐形门槛依然存在：由于投资回报的不成正比，想拿到融资较为困难。“必须先把基石投资大致落实之后才能启动香港上市，否则依靠市场化融资，发行成功概率是不高的。” 陶旭东说到。第二种是做双重主要上市。在前几年行业处于资本上升期的时候，“A+H”曾是很多公司的扩容手段；而如今，为了融资，部分企业也传出了双重主要上市的消息，但依然需要满足条件：即公司近期达成了重磅交易，市场认可度和现金储备都很充分。比如百利天恒就在去年12月达成了84亿美元的license out，3月份刚拿到首付款。可以看到，在如今的环境下是否还有路可走，基本上取决于企业的创收能力。“在上市企业没有拿到受理的情况下，最主要的是能够在一级市场拿到私募投资，这取决于有比较好的BD交易。如果你没有，现在是比较难了。” 这一批还有路可走的企业，可以把newco作为自己的备选项。比如恒瑞，一面准备着“A+H”的上市计划，一面以newco的模式打包了3款GLP-1产品组合。毕竟企业估值摆在那里，业绩稳定，管线多，现金充裕，不管是上市还是newco都不是为了燃眉之急，而是为了未来3-5年的发展和可能性。而还有一批企业，管线和业绩都不错但估值低，同样适合走newco路线。“有些在港上市的公司估值不好看。但其实它某一两个特定的管线很受投资人追捧。那么它可以把不同的管线布局到不同的子公司下，做一个分层的私募融资，自己作为控股股东也是一条路。” 陶旭东说到。在他接触的案例中，已经出现了新公司估值超过甚至二倍于老公司的情况。 -02- 国内并购的缺失各大药企之所以要绕到美国去做newco，在一定程度上也反映了国内并购环境并不成熟。 9月24日，证监会发布《关于深化上市公司并购重组市场改革的意见》，行业内将其称为“并购六条”。意见中提出，要进一步强化并购重组资源配置功能。加上4月发布的“国九条”，监管方明显表达了这一周期对并购行为的放松态度。但这一政策目前在生物医药行业激起的水花较为有限。除了一些破产重整和跨界收购以外，和政策最为贴合的、也最受到关注的案例当属中国生物制药全资孙公司以55%的股份占比收购IVD企业浩欧博。但在业内人士看来，这并不是一起典型的创新药交易。“它还有一个传统A股上市的业绩补偿要求，也就是说并购标的必须要盈利，而且这个并购标的控股股东要对这个并购做出承诺，这是传统的A股打法，并不是创新药微盈利的打法，所以我们认为这个标的不是特别具有典型性。” 用传统的A股标准衡量创新药标的，必然无法体现它的很多特性：比如高风险高回报、较长的投入周期、较高的研发比例等。 “在中国，越是优质、有潜力的资产，越不好估值。”一名医药投资人如是说到。这是由于在国外，优质资产存在于各大MNC同类同期/历史产品的评估坐标系中，根据市场的充分竞争原则，溢价标准较为稳定；而在国内，pharma们自身进入创新药领域、搭建转型后框架还没有几年，再加上中国的支付市场和国外不同，大药企对引进资产这件事并没有那么热衷。换句话说，正是因为就目前阶段来说，创新药资产拿在MNC手里比起国内大药企能发挥出更大的市场价值，同时对MNC的战略发展有着更明显的优先级，因此才会出现newco的风口。一些正在做newco的公司实际上是数条腿并行的。比如嘉和生物在今年迎来管理层大换血，新成立的newco企业Candid获得了首批3.7亿美元的融资，同时还整合了两家生物技术公司Vignette Bio和TRC 2004的主要资产。值得注意的是，Vignette Bio是另一家biotech企业岸迈生物的newco。在经过Candid的整合后，两家biotech共同成为新公司股东。于此同时，11月嘉和生物宣布与亿腾医药合并，打响了港股18A公司反向收购第一枪，成立新公司“亿腾嘉和”。嘉和拿钱，亿腾借壳，看起来是目前亏损严重且管线受阻的嘉和生物借助外界一切力量所选择的利益交换。但newco+并购，双腿并行所必然带来的是初始团队与股东话语权的降低。公司的合作关系变多了，但彼此之间如何协调，在未来也许会预留问题。 “newco交易的关键点之一就是，我要保证我的股权是有价值的，所以最首先要谈的一个条款是反稀释。” 陶旭东说到。Newco模式最有想象力的还是新公司的未来升值空间，如果放弃股权话语权，单纯用现金换管线，其实和BD也就没什么差别了。 -03- 消化风口 2024年以来，国内Biotech已经公布的NewCo交易所涉及的交易标的，均为在研的T细胞衔接器类药物（TCE）。目前市场上已有TCE疗法获批，其中就包括安进用于治疗血液系统恶性肿瘤的贝林妥欧单抗。今年5月，安进的另一款TCE疗法获得FDA批准用于治疗铂类化疗期间或之后疾病进展的广泛期小细胞肺癌成人患者，这也意味着TCE疗法已经可以用于实体瘤的治疗了。同时，最新的研究证实，TCE疗法对于一些自免类疾病也有效果，这也让TCE疗法成为了横跨肿瘤与自免两大超级赛道的种子选手，备受各大MNC追捧。今年下半年，中国也成了集中扫货地：8月，默沙东通过13亿美元收购同润生物TCE药物CN201；10月，GSK宣布以3亿美元的首付款、5.5亿美元的里程碑付款从恩沐生物收购TCE产品CMG1A46。之所以TCE管线适合做成newco，原因之一在于国内同类型管线较多，竞争激烈，商业化的不确定性高，不如早期卖给MNC稳妥。“newco很适合消化多余管线。特别是那种风口里诞生的管线，风口一过就找不到投资了。但它的价值，在MNC那里还保留着。”上述医药投资人说。在这个意义下，newco模式很适合用于在中国有开发优势且格局过“卷”的产品类型，比如adc及细胞与基因治疗类产品。同时，由于某些企业的技术路线有其特殊性，在上市时面临限制，也适合用newco暂时脱困。 “很多基因工程修饰细胞的疗法，是属于外资鼓励类，去香港上市没问题；但如果被归入基因治疗，就属于外资禁止类。但反过来作为CAR-T到底是属于细胞治疗还是基因治疗，其实并没有任何一个地方出过权威的论断。” 陶旭东说。在VIE备案并成功上市的企业中，没有一家是属于基因诊断和治疗领域的，这也说明了目前上市监管方对于biotech产品类型的卡死。在未来，CAR-T作为风口领域，想要有更高的融资自由度，newco也或将成为其考虑的一个重要选项。当不断有冒险者涌入，泡沫的风险必将会到来。即便现在，也会有一些过热的趋势出现。恒瑞前段时间做的非常漂亮的newco（相关阅读：NewCo模式，谁的砒霜，谁的蜜糖），已成为行业标杆。另一家国内头部药企也要求做就要“卖出恒瑞那样的好价钱”。一位业内人士感叹，恒瑞的案例有偶然性，价格有些偏高，把行业的胃口吊高了。“外资一些企业和基金想来扫货，好几家biotech说，也要卖恒瑞那样的价格，结果把人家吓跑了。” 当越来越多的冒险者涌入避风港，避风港还安全吗？ ...... 欢迎添加作者交流：李昀：liyun940820

并购IPOASCO会议

2024-12-18

·靶点圈

中外制药Dual-Ig三抗亲和力设计

Dual-Ig（Dual effectpr/receptor redirecting-Immunoglobulin）是中外制药开发的新一代双特异（或者是三特异抗体）平台，该平台旨在解决T细胞浸润较少的实体瘤治疗效果差的难题。其设计的关键是单独的Fab实现对CD3和4-1BB的结合，也就是Two-in-one策略，基于该平台开发的TCE三抗，在体外不仅具有更好的安全性，而且能够在较少T细胞浸润的模型中展现更好的疗效。关于该平台，之前的文章我们已经多次详细介绍过，但是抗体设计细节，中外制药之前并没有披露。最近中外制药发表了关于CLDN6/CD3/4-1BB三抗的文章，该文章披露了该平台的诸多细节。首先抗体是抗体对各靶点的亲和力，我们都知道，对于抗体，特别是双特异抗体，靶点的亲和力的设计对抗体抗体至关重要，不仅决定了抗体的药效，而且还可能决定抗体的安全性相关特征。对于TCE双抗，目前的设计基本上都是靶向TAA的抗体端的亲和力要高于靶向CD3的抗体端，而且有些设计通过突变降低对CD3的亲和力，从而防止CRS等毒性。但是对于已经获批的血液瘤TCE，不同抗体之前的差异还是比较大，但是对于多数抗体，其CD3的亲和力在nM级别，最低的为Blinatumomab(260nM)。在Dual-Ig的设计中，其对人CD3的亲和力为1.34*10-6，相比于传统已经上市的多数抗体，亲和力低了3个数量级左右，就算是和Amgen的已经上市的DLL3/CD3双抗相比，其亲和力也低接近3个数量级。其实之前已经猜到其亲和力会相对较低，但是没有想到这么低。而对于4-1BB的亲和力，其对人4-1BB的亲和力在2.73*10-8，与目前正在开发的PD-L1/4-1BB双抗相比，其亲和力算是比较高的。在今年的ASCO会议上，多个靶向PD-L1/4-1BB，其中多数为个位数的nM级别，基于Dual-Ig设计的SAIL66对4-1BB的亲和力和ABL503/TJ-L14B及QLF31907在一个水平上。在临床前，这些分子都具有良好的安全性，但是在临床中，多多少少都有一定的肝毒性。这些分子中，LBL-024的亲和力最低，在两位数的uM级别，临床中该分子在EP-NEC患者中具有较好的疗效，也是目前唯一一个疗效较好的分子。对于4-1BB，研究表明其是一个激活表达的靶点，多数表达在激活的T细胞上。对于Dual-Ig的设计，我一直以为是对CD3的亲和力高于4-1BB，这样可以利用靶向CD3激活T细胞，然后再利用4-1BB维持T细胞的活性，但是中外制药为何在亲和力上4-1BB要高于CD3不太理解，后续等其专利发表后可以仔细研究一下。在安全性方面，SAIL66治疗和其它TCE双抗类似，都会在一定程度上引起相关细胞因子的释放，从而有产生CRS的风险，不过有研究表明，对于TCE双抗，细胞因子或者CRS一定程度上和治疗效果正相关。中外制药在解决该问题上探索了地塞米松（DEX）联用，提前使用DEX可以很大程度降低相关细胞因子的释放。使用DEX对治疗疗效几乎没有影响，而且在基因层面的分析发现，使用DEX不会影响SAIL66对肿瘤微环境中相关免疫基因的影响。总结： Dual-Ig作为中外制药开发的新一代双特异抗体平台，已经有相关药物进入临床，本次发表的SAIL66临床前数据也能够让我们了解其中的一些细节，其在结合4-1BB的亲和力相对较高，不知道后续会不有肝毒性问题，期待后续的临床数据。我们已经建立抗体密码读者交流群，有兴趣的可以扫描下方二维码添加微信进群，请主动备注姓名-公司-职位（高校-专业），非诚勿扰！往期精彩回顾抗体密码文章合集双特异抗体平台靶点相关双特异抗体作用机制综述，行业概览抗体筛选技术相关公司技术汇总医药资讯因为你的分享、点赞、在看我足足的精气神儿！声明本公众号所发表文章以宣传知识为目的，因此不构成投资，病人用药等建议。如果文章侵您的权益及时联系小编进行删除！欢迎扫码交流/咨询/合作= 参考文献： doi:10.1136/jitc-2024-009563

ASCO会议临床结果免疫疗法

2024-12-16

·drugs

American Society of Hematology, Dec. 7 to 10

The annual meeting of the American Society of Hematology was held from Dec. 7 to 10 in San Diego and attracted participants from around the world, including hematology specialists as well as clinical practitioners and other health care professionals. The conference featured presentations focusing on the diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems. In one study, Kristin A. Shimano, M.D., of the University of California, San Francisco, Benioff Children's Hospital, and colleagues found that for pediatric patients with newly diagnosed immune thrombocytopenia (ITP) within three months of diagnosis, eltrombopag leads to a more durable platelet response during weeks six 6 to 12 of treatment compared with standard treatments. The authors evaluated the use of eltrombopag (a thrombopoietin receptor agonist approved for persistent or chronic ITP) during the new-diagnosis phase and compared the responses between patients treated with eltrombopag and standard therapies (intravenous immunoglobulin, prednisone, and anti-D globulin). The researchers found that compared with those treated with standard therapies, a greater proportion of patients treated with eltrombopag had a platelet count of more than 50,000 during weeks 6 through 12 of the study without requiring a rescue therapy. "This has a huge potential to change our approach to the management of newly diagnosed pediatric ITP," Shimano said. "For patients with moderate bleeding or significant impact on quality of life due to their ITP, eltrombopag may be a good option to get the platelets to a more hemostatic level during the time that they have active ITP." Several authors disclosed financial ties to pharmaceutical and biotechnology companies, including Novartis, which manufactures eltrombopag and funded the study. Abstract No. 709 In another study, Rushad Patell, M.D., of Harvard Medical School in Boston, and colleagues found that the use of glucagon-like peptide-1 (GLP-1) receptor agonists leads to a significant reduction in the risk for blood clots among patients with type 2 diabetes. The authors compared patients who newly started a GLP-1 receptor agonist for type 2 diabetes to patients being prescribed another antidiabetic medication to assess rates of blood clots at one year. The researchers observed a 20 percent reduction in venous thromboembolism rates at 12 months. This benefit was seen across patients with different body mass index at the time of starting the study and included a breakdown for the two different types of blood clots (pulmonary embolism and deep vein thrombosis) when evaluated individually. "This was the first time this medication has been shown to impact venous thromboembolism to our knowledge," Patell said. "If these results are confirmed, they suggest that the use of these medications can have benefits beyond what has already been shown and can now include a reduction of blood clots." Two authors disclosed financial ties to the pharmaceutical and biotechnology industries. Abstract No. 701 Jenny Paredes, Ph.D., of the City of Hope National Medical Center in Duarte, California, and colleagues found that increasing dietary fiber intake is beneficial for the intestinal microbiome of allogeneic hematopoietic cell transplantation (allo-HCT) patients and could lead to an increase in overall survival and a reduction in acute graft-versus-host disease (GVHD). The authors assessed a preclinical mouse model of GVHD with defined diet fiber concentrations and also analyzed the dietary patterns of allo-HCT patients. The investigators found that dietary fiber intake in allo-HCT patients (days −7 to −30) positively correlated with higher overall survival, lower acute GVHD cumulative incidence, and lower gastrointestinal-GVHD cumulative incidence (landmark analysis to 24 months). In addition, fiber consumption positively correlated with microbial alpha-diversity, relative abundance of butyrate producers, and production of short chain fatty acids (SCFAs). In the murine model of GVHD post allo-HCT, the researchers determined that a diet rich in fiber (12 percent cellulose) increased survival to GVHD, led to a higher relative abundance of butyrate producers, and modulated gene expression associated with higher epithelial homeostasis and lower T-cell mediated inflammation (single cell sequencing). "Although follow-up studies on the strategies that can be used to increase dietary fiber in allo-HCT patients are in course, we would like to recommend reevaluating the nutritional plans and meals for allo-HCT patients and including multiple options of high fiber foods for every meal and beverage," Paredes said. "Increasing fiber consumption by 10 to 20 grams per day, based on our results, would lead to a more diverse microbiome, an increase in SCFA production, and consequently, to better overall survival (the Recommended Dietary Allowance for dietary fiber by the U.S. Department of Agriculture is 25 to 30 grams per day)." One author disclosed financial ties to the pharmaceutical and biotechnology industries. Abstract No. 259 ASH: Blinatumomab + Chemo Aids Survival in B-Cell Acute Lymphoblastic Leukemia THURSDAY, Dec. 12, 2024 -- For patients with newly diagnosed, standard-risk B-cell acute lymphoblastic leukemia with an average or high risk for relapse, adding blinatumomab to combination chemotherapy is associated with improved disease-free survival, according to a study published online Dec. 7 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego. Read Full Text ASH: Reduced-Dose Anticoagulants Not Noninferior for Recurrent VTE FRIDAY, Dec. 6, 2024 -- Noninferiority of reduced- versus full-dose anticoagulants cannot be proven in patients with venous thromboembolism who need extended anticoagulation, according to a study to be presented at the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego. Read Full Text ASH: Auto-HCT Not Beneficial for Mantle Cell Lymphoma With Undetectable Residual Disease FRIDAY, Dec. 6, 2024 -- Autologous hematopoietic cell transplant is not beneficial for patients with mantle cell lymphoma in first complete remission with undetectable minimal residual disease, according to a study to be presented at the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego. Read Full Text ASH: Complications Common With Controlled Ovarian Hyperstimulation in Sickle Cell Anemia THURSDAY, Nov. 14, 2024 -- Many individuals with sickle cell anemia undergoing controlled ovarian hyperstimulation with oocyte cryopreservation have complications, according to a study scheduled for presentation at the annual meeting of the American Society of Hematology, to be held from Dec. 9 to 12 in San Diego. Read Full Text ASH: GLP-1 RA Use Tied to Lower Rate of Venous Thromboembolism in Diabetes THURSDAY, Nov. 14, 2024 -- For patients with type 2 diabetes mellitus, glucagon-like peptide 1 receptor agonist use is associated with a lower risk for venous thromboembolism, according to a study scheduled for presentation at the annual meeting of the American Society of Hematology, to be held from Dec. 9 to 12 in San Diego. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果上市批准ASH会议

100 项与贝林妥欧单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09325	贝林妥欧单抗	L01XC19	DB09052

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
伯基特淋巴瘤	日本	Amgen, Inc.	2018-09-21
急性淋巴细胞白血病	加拿大	Amgen Canada, Inc.	2015-12-22
CD19阳性前体B细胞急性淋巴细胞白血病	欧盟	Amgen Europe BV	2015-11-23
CD19阳性前体B细胞急性淋巴细胞白血病	冰岛	Amgen Europe BV	2015-11-23
CD19阳性前体B细胞急性淋巴细胞白血病	列支敦士登	Amgen Europe BV	2015-11-23
CD19阳性前体B细胞急性淋巴细胞白血病	挪威	Amgen Europe BV	2015-11-23
费城染色体阳性成人前体急性淋巴细胞白血病	欧盟	Amgen Europe BV	2015-11-23
费城染色体阳性成人前体急性淋巴细胞白血病	冰岛	Amgen Europe BV	2015-11-23
费城染色体阳性成人前体急性淋巴细胞白血病	列支敦士登	Amgen Europe BV	2015-11-23
费城染色体阳性成人前体急性淋巴细胞白血病	挪威	Amgen Europe BV	2015-11-23
前体B细胞急性淋巴细胞白血病	美国	Amgen, Inc.	2014-12-03

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
Ph样急性淋巴细胞白血病	临床3期	-	National Cancer Institute	2025-02-28
费城染色体阳性白血病	临床3期	-	National Cancer Institute	2025-02-28
费城染色体阳性急性淋巴细胞白血病	临床3期	-	National Cancer Institute	2025-02-28
BCR-ABL1阳性急性淋巴细胞白血病	临床3期	美国	National Cancer Institute	2021-01-25
BCR-ABL1阳性急性淋巴细胞白血病	临床3期	以色列	National Cancer Institute	2021-01-25
BCR-ABL1阳性急性淋巴细胞白血病	临床3期	波多黎各	National Cancer Institute	2021-01-25
B淋巴细胞白血病淋巴瘤	临床3期	美国	National Cancer Institute	2019-07-03
B淋巴细胞白血病淋巴瘤	临床3期	澳大利亚	National Cancer Institute	2019-07-03
B淋巴细胞白血病淋巴瘤	临床3期	加拿大	National Cancer Institute	2019-07-03
B淋巴细胞白血病淋巴瘤	临床3期	新西兰	National Cancer Institute	2019-07-03

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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


NCT04521231 (ASH2024) 人工标引	临床1期	前体B细胞急性淋巴细胞白血病	27	Subcutaneous Blinatumomab 250μg/500μgBlinatumomab 250μg/500μg	願鹹餘鑰餘蓋壓願廠積(鑰齋築觸淵鬱淵觸廠願) = 艱簾顧餘鏇簾襯醖願餘築築壓淵窪齋鏇鏇鬱廠 (構鏇艱鹹艱鑰憲膚鏇憲 ) 更多	积极	2024-12-07
NCT04521231 (ASH2024) 人工标引	临床1期	前体B细胞急性淋巴细胞白血病	27	Subcutaneous Blinatumomab 500μg/1000μgBlinatumomab 500μg/1000μg	願鹹餘鑰餘蓋壓願廠積(鑰齋築觸淵鬱淵觸廠願) = 醖選壓夢遞蓋範壓顧網築築壓淵窪齋鏇鏇鬱廠 (構鏇艱鹹艱鑰憲膚鏇憲 ) 更多	积极	2024-12-07
NCT03263572 (Pubmed) 人工标引	临床2期	费城染色体阳性急性淋巴细胞白血病	60	Ponatinib and Blinatumomab	積衊鏇積觸選簾積窪鏇(築衊網壓鏇願淵壓襯膚) = 襯鑰齋膚醖選鹽壓憲鹽繭製網範鬱鹽獵憲範築 (窪願選鹹選壓憲齋憲顧 ) 更多	积极	2024-07-19
ALLTogether1 DS (EHA2024) 人工标引	临床2期	前体B细胞急性淋巴细胞白血病一线 CD19 Positive	33	Blinatumomab	繭襯遞選鹽構積鬱襯餘(醖壓積鹹鏇壓鹽餘廠餘) = 顧網顧簾築顧鑰糧憲築衊壓願積觸窪淵齋製鏇 (淵艱繭壓遞鬱廠繭遞鏇 ) 更多	积极	2024-05-14
ALLTogether1 DS (EHA2024) 人工标引	临床2期	前体B细胞急性淋巴细胞白血病一线 CD19 Positive	33	Chemotherapy regimens	繭襯遞選鹽構積鬱襯餘(醖壓積鹹鏇壓鹽餘廠餘) = 襯鑰醖衊糧鑰壓膚觸窪衊壓願積觸窪淵齋製鏇 (淵艱繭壓遞鬱廠繭遞鏇 ) 更多	积极	2024-05-14
NCT06237192 (RALL-2016m, EHA2024) 人工标引	N/A	费城染色体阴性急性淋巴细胞白血病 MRD-negative	44	blinatumomab00 mg/dayvenetoclax	艱鏇鑰簾繭窪窪餘襯壓(構範顧蓋築獵鑰遞鏇餘) = 顧範構網構淵淵鑰襯獵遞膚製鑰壓夢窪選獵選 (蓋齋鹽齋鏇獵鹽淵積鑰 ) 更多	积极	2024-05-14
NCT04994717 (Golden Gate, EHA2024) 人工标引	临床3期	前体B细胞急性淋巴细胞白血病一线 Ph-neg	14	Blinatumomab + LIC	廠築範鏇築醖構醖遞鏇(鹽鏇構醖鹹餘遞築鑰糧) = 鏇窪窪淵鏇遞顧製網壓糧鑰餘顧選獵糧積製獵 (糧積餘蓋築壓壓顧顧糧 ) 更多	积极	2024-05-14
PDT-ALL-2016 (EHA2024)	N/A	-	31	Olverembatinib + chemotherapy	膚淵願選衊製範鏇醖遞(網齋鏇衊齋繭鑰廠觸糧) = Two patients (6.4%) experienced grade 2 cytokine release syndrome (CRS) 願淵觸繭醖積窪選餘憲 (製艱簾鑰窪遞蓋觸範鹹 ) 更多	积极	2024-05-14
PDT-ALL-2016 (EHA2024)	N/A	-	31	Olverembatinib + blinatumomab		积极	2024-05-14
EHA2024	N/A	前体B细胞急性淋巴细胞白血病 minimal residual disease (MRD)	5	Blinatumomab	網構襯積觸鏇夢簾獵範(鹽壓廠艱獵膚範鹹獵衊) = 遞廠積鑰願鬱選簾窪鑰選膚憲憲窪衊鹽鹹膚壓 (製繭衊糧鏇築夢淵淵積 )	积极	2024-05-14
AYA-15 (EHA2024)	N/A	费城染色体阴性急性淋巴细胞白血病巩固 CD19 \| CD3	22	Blinatumomab	網築築夢齋齋鏇膚網選(顧構顧製淵選簾範膚積) = 59% with only 9% having grade 2 or more 蓋襯鹹積廠觸憲蓋顧餘 (範製廠網築窪鏇繭齋顧 ) 更多	积极	2024-05-14
EHA2024	N/A	CD19阳性B细胞急性淋巴细胞白血病 BCR-ABL1 fusion gene	8	Blinatumomab + Traditional Conditioning Regimen	築鑰鹹餘願顧衊鬱齋窪(獵繭積獵積鹹艱鑰顧網) = occurred in five patients, with three cases of grade I skin aGVHD, one case of grade III skin aGVHD, and one case of grade III gastrointestinal aGVHD 遞範醖繭鏇鹽顧觸顧鏇 (鑰顧醖網網築鏇艱醖壓 ) 更多	积极	2024-05-14
EHA2024	N/A	费城染色体阳性急性淋巴细胞白血病 t(9;22)	10	HyperCVAD-Blinatumomab-TKI combination	壓築艱蓋醖網憲憲鹹鏇(顧簾繭憲衊構衊糧鏇衊) = One patient died from grade 3+ vascular toxicity of Ponatinib (acute limb ischemia) 構選鹽積鏇鬱繭蓋遞壓 (範獵蓋範顧鑰糧窪糧齋 ) 更多	积极	2024-05-14