A Phase 2/3 Randomized Trial Investigating Daratumumab on a Modified Augmented BFM (aBFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LL)

This phase II/III trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. 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. Giving chemotherapy with daratumumab may kill more cancer cells.

开始日期2026-08-28

申办/合作机构

The Children's Oncology Group Foundation, Inc.

NCT06561074

/ Recruiting临床2期IIT

A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)

To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed/refractory T-ALL and T-LLy. The safety of this drug combination will also be studied.

开始日期2025-09-25

申办/合作机构

The University of Texas MD Anderson Cancer Center

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2025-06-05

申办/合作机构

National Cancer Institute

100 项与 Calaspargase Pegol-MKNL 相关的临床结果

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100 项与 Calaspargase Pegol-MKNL 相关的转化医学

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100 项与 Calaspargase Pegol-MKNL 相关的专利（医药）

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项与 Calaspargase Pegol-MKNL 相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Economic burden associated with switching from frontline pegaspargase or calaspargase pegol to second-line recombinant Erwinia in pediatrics and adolescents/young adults with acute lymphoblastic leukemia

Article

作者: Papademetriou, Eros ; Prashar, Arun ; Bhagnani, Tarun ; Gu, Tina ; Maese, Luke ; Chatterjee, Indrani ; McCormick, Meghan

AIMS:

This study aims to quantify costs and healthcare resource utilization (HCRU) associated with switching from frontline (1 L) pegaspargase (PEG)/calaspargase pegol (CAL-PEG) to second-line (2 L) recombinant Erwinia in pediatric and adolescent/young adult (AYA) patients aged <40 years with acute lymphoblastic leukemia (ALL), overall and by use of therapeutic drug monitoring (TDM).

MATERIALS AND METHODS:

This was a retrospective study using Optum's deidentified Clinformatics Data Mart database. Pediatric/AYA patients (US) diagnosed with ALL between January 2021 and September 2023 and treated with 1 L asparaginase-containing regimens were identified. Asparaginase switch rates were assessed. HCRU and per-patient per-year (PPPY) costs were compared between patients who completed treatment with PEG/CAL-PEG and those who switched to recombinant Erwinia. Outcomes were compared between patients who received TDM and those who did not.

RESULTS:

A total of 154 pediatric/AYA patients with ALL were identified who initiated 1 L treatment with a PEG/CAL-PEG-containing regimen. Overall, 35/154 (22.7%) patients switched from 1 L asparaginase to recombinant Erwinia. Patients who switched from 1 L asparaginase to recombinant Erwinia had significantly higher mean total healthcare costs ($1,006,262 vs. $429,502; p < 0.0001), primarily driven by higher outpatient visits (82.57 vs. 72.75 PPPY; p = 0.0988) and their associated costs ($754,063 vs. $245,978; p < 0.0001), compared with patients who remained on 1 L asparaginase. When compared by use of TDM (61/154 [39.6%]), 28.0% in the non-TDM group and 14.8% in the TDM group switched from 1 L asparaginase to recombinant Erwinia. Mean outpatient costs were $381,017 and $319,468 (p < 0.0003), respectively.

LIMITATIONS:

Caution is required in the interpretation of the results of this retrospective study as claims data are not designed specifically for research purposes.

CONCLUSIONS:

Switching from 1 L PEG/CAL-PEG to 2 L recombinant Erwinia is associated with higher healthcare costs. Consideration should be given to TDM, which may mitigate unnecessary switches of asparaginase.

2026-09-01·EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS

PKPD-Based Translational Modeling of Calaspargase Pegol Preclinical Activity in Hepatocellular Carcinoma

Article

作者: Okour, Malek ; Fouliard, Sylvain ; Hoeben, Eef ; Tyagi, Ethika ; Barbier Saint Hilaire, Pierre ; Madelain, Vincent ; Acharya, Chayan

BACKGROUND AND OBJECTIVE:

Calaspargase pegol (CalPEG) is a PEGylated conjugate of L-Asparaginase (L-Asp) and an asparagine specific enzyme approved by the Food and Drug Administration (FDA) as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) in children and young adults. Although CalPEG is an established and effective treatment for childhood ALL, its potential in solid tumors is still underexplored. Recent reports illustrated that L-Asp may also have potential for the treatment of certain aggressive solid tumors, including hepatocellular carcinoma (HCC)[1-5]. In order to investigate this potential, clinical and preclinical data were integrated using model-informed drug development (MIDD) approaches, which are among the most adequate tools to facilitate the translation of preclinical into clinical data [6-9]. This work explores the potential of pharmacokinetic/pharmacodynamic tumor growth inhibition (PKPD TGI) modeling to maximize the use of in vivo preclinical data and PK data in patients with ALL for translation of preclinical observed antitumor activity to clinical efficacy.

METHODS:

A PKPD TGI model was developed that described tumor volumes (TVs) versus time in a preclinical hypermethylated xenograft mouse model relevant for HCC. Translation of the PKPD TGI model to human was performed by linking the structural TGI model developed in mice with human PK model of CalPEG. This model was developed on PK data, i.e., plasma Asp activity (PAA), obtained in pediatric and adult patients with ALL and was used to predict TGI profiles of CalPEG in adult patients with HCC.

RESULTS:

The developed PKPD TGI model adequately described the TV versus time profiles in tumor bearing (TB) mice and quantified the PKPD relationship between PAA and TGI in TB mice. The structural mouse TGI model was linked to predicted human PK parameters and this human PKPD TGI model was used to perform simulations and to predict antitumor activity of CalPEG at different doses/schedule in patients with HCC.

CONCLUSIONS:

The results indicate that PKPD TGI modeling can be used to build a preclinical to clinical translational framework to predict the exposure-response relationship in patients with HCC and to inform dosing strategies or trial designs for solid tumors.

2026-07-01·PEDIATRIC BLOOD & CANCER

Variability in Calaspargase Pegol Administration and Monitoring Across U.S. Pediatric Oncology Centers

Article

作者: Chang, Bill H. ; Morgan, Lori E. ; Maxa, Kim L. ; Raybin, Jennifer L. ; Stork, Linda ; Miller, Lane H.

ABSTRACT:

Introduction:

Asparaginase is a foundational medication in the treatment of pediatric acute lymphoblastic leukemia and lymphoma (ALL/LLy), but its safety and efficacy are complicated by antibody‐mediated toxicities. The recent transition to calaspargase pegol (sc‐PEG) in the United States introduces questions regarding optimal administration, reaction classification, and therapeutic drug monitoring (TDM). Existing studies offer conflicting results with limited generalizability, and standardized evidence‐based guidelines remain lacking.

Methods:

We developed a brief electronic survey to assess practices related to sc‐PEG administration, TDM, and reaction classification at U.S. pediatric cancer centers. The survey was distributed in two phases, and responses were reconciled to ensure one representative submission per institution.

Results:

We received completed responses from 46 unique institutions. Most (93.3%) reported routine premedication prior to sc‐PEG infusion; however, eight different premedication regimens were used. Infusion strategies also varied: 47.4% of centers used a flat two‐hour rate, 33.3% an escalating rate, and 11.9% a one‐hour flat rate. Forty‐two centers (91.3%) had a standard TDM approach, but timing and criteria for serum asparaginase activity (SAA) monitoring differed. While 91.3% used both clinical signs and SAA levels to identify hypersensitivity, only 67.4% adhered to COG guidelines outlining SAA adequacy thresholds. Fewer than half (41.3%) systematically tracked hypersensitivity or silent inactivation.

Conclusion:

This survey reveals substantial variability in sc‐PEG administration and monitoring practices across U.S. pediatric cancer centers, underscoring the lack of standardized, evidence‐based guidelines. These findings highlight the need for prospective research to define optimal strategies and improve the accuracy of hypersensitivity recognition with sc‐PEG.

项与 Calaspargase Pegol-MKNL 相关的新闻（医药）

2026-06-24

·生物工艺与技术

生物制药生产中的大肠杆菌

大肠杆菌在重组DNA技术的发现中肩负了巨大的工作量。随着重组蛋白胰岛素在大肠杆菌中生产并用于治疗糖尿病，生物制药行业进入了一个新的时代。继胰岛素之后，许多由大肠杆菌生产的生物制药已获得美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）的批准，用于治疗各种人类疾病。尽管大肠杆菌存在一些缺点，如缺乏翻译后修饰和毒性，但它仍然是一个重要的宿主，具有许多优势，如在重组蛋白生产中是一个广为人知的细菌、生产成本低、生产系统简单且产量高。本研究考察了在大肠杆菌中生产并获得批准的生物制药，涵盖了肽类、激素、酶类、融合蛋白、抗体片段、疫苗和其他药物。这些生物制药的批准主题、生产时间、生产公司及其在该领域的应用和发展也进行了讨论。简介 20世纪70年代，随着重组DNA技术的引入，发现大肠杆菌能够强效且经济地生产重组蛋白。此之前，猪牛的胰腺是治疗糖尿病所需胰岛素的来源。然而，1980年代初，美国食品药品监督管理局（FDA）批准了由大肠杆菌生产的首个重组胰岛素，开启了糖尿病治疗的下一阶段，并为生产更多的重组药物提供了途径。这一成就表明，尽管胰岛素是一个需要氧化蛋白折叠的异二聚体，但它可以在大肠杆菌中合成。从那时起，改进后的重组药物，如单克隆抗体，开始使用包括大肠杆菌、酵母、丝状真菌、昆虫细胞和哺乳动物细胞在内的多种表达宿主进行生产。与其他重组微生物相比，大肠杆菌仍然是其最具吸引力的宿主之一。该细菌的基因学已被充分研究，且多种克隆技术和表达系统使其能够有效生产多种蛋白质。图1展示了一种在大肠杆菌中生产重组生物制药的通用方法。图1. 在大肠杆菌中生产生物药的一般方法。大肠杆菌因其快速生长、低廉的营养需求、易于扩展规模以及能够生产高产、高质量的药物而在大规模生产中受到青睐。然而，大肠杆菌的应用也存在一些限制。例如，某些复杂蛋白的生产可能受限于无法进行特定的翻译后修饰，从而限制了蛋白的成熟和二硫键的形成。人们普遍认为，适当的糖基化和折叠对于复杂蛋白（如单克隆抗体）尤为重要。目前，欧洲药品管理局（EMA）和美国FDA已批准多种由大肠杆菌生产的重组治疗药物用于多种临床用途。本综述讨论了由大肠杆菌生产的关键生物制药，涵盖激素、酶类、肽类、疫苗、融合蛋白、抗体片段和其他生物制药类别。大肠杆菌在生物制药生产中的应用激素激素是生物制药生产中的一个重要类别，大肠杆菌在该领域的发展中发挥了重要作用。人类胰岛素（Humulin）是首个由大肠杆菌生产的重组生物制药，用于治疗糖尿病，由Eli Lilly公司生产，并于1982年获得美国FDA批准。随后，Lantus，一种长效胰岛素甘精分子，由Sanofi-Aventis公司在大肠杆菌中生产，并于2000年在美国和欧盟获得批准。胰岛素甘精是通过重组方式生产的人类胰岛素类似物，能够与胰岛素受体结合。近年来，许多胰岛素类似物通过重组方式在大肠杆菌中生产。其中，Lyumjev（胰岛素Lispro），一种快速起效的胰岛素类似物，由Eli Lilly公司在大肠杆菌中生产，并于2020年获得FDA和EMA批准，用于治疗1岁及以上糖尿病患者。生长激素是可以在大肠杆菌中生产的最早的生物制药之一。生长激素Somatropin（Humatrope）由Eli Lilly公司在大肠杆菌中重组生产，用于治疗儿童生长激素缺乏症（GHD），并于1987年获得FDA批准。Sogroya（Somapacitan-beco），一种长效生长激素，由Novo Nordisk公司使用重组DNA技术在大肠杆菌中生产。通过改造Somapacitan分子，使其能够可逆地与血液中的白蛋白结合，从而减缓Somapacitan的排出，延长其作用时间。它于2020年获得FDA批准，2021年获得EMA批准，用于2.5岁及以上的成人和儿童患者。在一项临床研究中，Somapacitan每周使用一次对成人GHD患者有效且耐受良好。在另一项III期研究中，每周使用Somapacitan与每日生长激素相比，在儿童GHD患者中显示出相似的疗效和安全性。Skytrofa（Lonapegsomatropin-tcgd），一种长效生长激素，由Ascendis Pharma公司使用重组DNA技术在大肠杆菌中生产。2021年，FDA批准其用于治疗1岁及以上患有生长激素分泌不足的儿童患者。重组干扰素α-2b（Intron A）用于治疗生殖器疣、癌症和肝炎，由Merck Sharp & Dohme公司生产，并于1986年获得FDA批准。随后，干扰素分子的改良变体（干扰素α-2a、α-2b、α-1a、α-1b）被开发用于治疗各种疾病（如肾癌、肾细胞癌、非霍奇金淋巴瘤、皮肤T细胞淋巴瘤、慢性髓性白血病、黑色素瘤）。Besremi（ropeginterferon alfa-2b-njft）由PharmaEssentia公司使用重组DNA技术在大肠杆菌中生产，并于2021年获得FDA批准，用于治疗成人多血症（PV）（一种以血细胞增多为特征的罕见血液疾病）。在多血症患者接受3年治疗后，ropeginterferon alfa-2b被证明有效且安全，且对标准治疗反应更好。也有研究评估了ropeginterferon alfa-2b在妊娠期多血症患者中的疗效和安全性，但这些研究强调了需要更多的案例研究。 Forsteo（teriparatide），一种人类副甲状腺激素类似物，由Eli Lilly公司在大肠杆菌中生产，并于2003年获得EMA批准用于治疗骨质疏松症。随后，许多类似Forsteo的生物仿制药（如Movymia、Terrosa和Sondelbay）在大肠杆菌中生产。其中，Sondelbay（teriparatide），一种人类副甲状腺激素片段，由Accord Healthcare公司使用重组DNA技术在大肠杆菌中生产，并于2022年获得EMA批准，用于治疗骨质疏松症。Natpara（副甲状腺激素）由NPS Pharmaceuticals公司在大肠杆菌中重组生产，并于2015年获得FDA批准，用于治疗副甲状腺功能减退症（低钙血症）。重组副甲状腺激素疗法的临床研究持续了5年和12个月，结果表明该疗法能改善副甲状腺功能减退症患者的生化参数，并确认了治疗的疗效和安全性。此外，Natpar，一种重组人类副甲状腺激素，由Takeda Pharmaceuticals公司在大肠杆菌中生产，并于2017年获得EMA批准用于治疗副甲状腺功能减退症。最近的研究旨在调查在大肠杆菌中生产新的激素类似物和改性。超快速起效的胰岛素类似物，如VIAject/Linjeta、Biodel胰岛素（BIOD-531）、BioChaperone Lispro和LY900014，正在进行临床研究。这些制剂在作用速度和血糖控制方面优于传统胰岛素，如Humalog、NovoLog和Fiasp。另一种策略是将胰岛素类似物与重组人透明质酸酶结合。研究发现，胰岛素-透明质酸酶组合能在健康志愿者和1型糖尿病患者中引起更快的起效和更低的餐后高血糖。公司还在进行针对2型糖尿病的新型胰岛素的测试。例如，Eli Lilly正在测试LY3209590，这是一种设计的胰岛素，结合了抗体Fc结构域，具有长效基础型特性，并与甘精胰岛素进行了比较。酶类酶在多种生物过程中发挥重要作用，是另一类可以在大肠杆菌中生产的治疗蛋白。Pegloticase（重组人尿酸氧化酶，Krystexxa）于2010年在美国获得批准，用于治疗成人慢性痛风，由Savient Pharmaceuticals公司在大肠杆菌中重组生产。最近的一项研究表明，在无法控制的痛风患者中，将Pegloticase与甲氨蝶呤（MTX）联合使用可引发更高的治疗反应和更低的免疫原性。 Voraxaze（葡萄糖氨酸酶），一种羧肽酶，由BTG International公司生产，用于减少肾功能受损患者体内的甲氨蝶呤（MTX）。葡萄糖氨酸酶将MTX转化为谷氨酸和2,4-二氨基-N（10）-甲基叶酸。在大肠杆菌中重组生产的葡萄糖氨酸酶于2012年获得FDA批准，2022年获得EMA批准。 Calaspargase pegol（Asparlas），一种天冬氨酸酶，由Servier Pharmaceuticals公司在大肠杆菌中生产，用于治疗1个月至21岁急性淋巴细胞白血病（ALL）患者。使用重组DNA技术生产的Calaspargase pegol于2018年获得FDA批准。在一项ALL患者研究中，Calaspargase pegol的天冬氨酸酶活性比天然来源于大肠杆菌的Pegaspargase更为持久。 Pegvaliase-pqpz（Palynziq）由Biomarin公司在大肠杆菌中生产。这种酶可以减少血液中的苯丙氨酸含量，并于2018年获得FDA批准，用于治疗成人苯丙酮尿症患者。在一项研究中，介绍了使用Pegvaliase治疗苯丙酮尿症患者的病例经验。此外，最近还进行了一项临床试验，研究了使用Pegvaliase治疗过程中的治疗中断和剂量调整。 Revcovi（Elapegademase-lvlr）由Leadiant Biosciences公司在大肠杆菌中重组生产。该酶于2018年获得FDA批准，用于治疗腺苷脱氨酶重症联合免疫缺陷症（ADA-SCID）患者，包括成人和儿童。临床研究显示，Elapegademase治疗ADA-SCID患者的疗效和安全性，且使用Revcovi能够有效治疗ADA-SCID。近年来，使用大肠杆菌生产的酶类在临床前研究中得到了评估，旨在开发新的酶候选药物用于各种临床应用，以增强现有治疗的效果并最小化副作用。肽类肽类是生物制药中的一个基础类别，涵盖了广泛的治疗药物，并在临床应用中具有重要作用。本节重点讨论可以在大肠杆菌中生产的肽类。Natrecor（nesiritide），一种重组人类利尿肽，由Johnson & Johnson/Scios公司在大肠杆菌中生产。2001年，FDA批准其用于治疗急性失代偿性心力衰竭患者。 FDA于2005年批准Increlex（mecasermin），一种由重组DNA技术在大肠杆菌中生产的类胰岛素生长因子-1（IGF-1），用于治疗严重原发性IGF-1缺乏症或生长激素基因缺失的儿童生长失败。临床研究表明，mecasermin有效促进这些患者的线性生长。 Fortical（降钙素），一种用于治疗骨质疏松症和其他骨骼疾病的激素，也是在大肠杆菌中生产的。该肽由Unigene Laboratories公司生产，并于2005年获得FDA批准。研究表明，它能够有效减少骨吸收并增加骨矿物质密度，尤其在骨质疏松症患者中。 Gattex（teduglutide），由NPS Pharmaceuticals公司生产，于2012年获得FDA批准，用于治疗短肠综合症。研究表明，teduglutide治疗能显著改善短肠综合症患者的肠道吸收能力，并减少对外源性营养支持的需求。 Voxzogo（Vosoritide），一种利尿肽，由Biomarin Pharma在大肠杆菌中生产。2021年，FDA和EMA批准其用于治疗儿童患者的软骨发育不全。在一项针对5岁及以上（<18岁）软骨发育不全儿童的III期研究中，发现52周的Vosoritide治疗是一个重要的治疗选择。随后，Vosoritide治疗被报告为安全并能促进软骨发育不全儿童的持续生长。 Oxervate（cenegermin），一种神经生长因子，由Dompé U.S.公司使用重组DNA技术在大肠杆菌中生产。它于2017年获得EMA批准，2018年获得FDA批准，用于治疗神经营养性角膜炎（一种眼部疾病）。一项研究报告称，Cenegermin治疗能有效改善角膜上皮、角膜感觉和视力，但需要更全面的研究。然而，另一项研究报告指出，使用Cenegermin进行局部治疗时，如果与包带型隐形眼镜一起使用，可能会在镜片和眼表面造成药物沉淀。另一种在大肠杆菌中生产的肽类是Idefirix（imlifidase）。该药物用于预防身体排斥移植肾脏，由Hansa Biopharma公司在大肠杆菌中使用重组DNA技术生产，并于2020年获得EMA批准。研究表明，Imlifidase治疗可能是使肾脏移植受者去敏感化的有效且有前景的方法，但仍需要更多的临床数据以了解其使用和应用。近年来，在大肠杆菌中生产的生物制药肽类有助于生产那些可能难以化学合成的长肽或复杂肽。通过在大肠杆菌中生产的肽类生物制药包括了用于靶向各种疾病（如心血管病、代谢病、感染、癌症和自身免疫性疾病）的创新临床前方法。疫苗疫苗的开发和生产是生物制药领域的一个关键前沿，旨在保护公共健康并预防各种传染性疾病。在这一背景下，大肠杆菌被用作生产疫苗的多功能且宝贵的工具。Hecolin（Innovax）是首个基于病毒样颗粒的乙型肝炎病毒疫苗，由大肠杆菌生产，并于2011年获得中国食品药品监督管理局（CFDA）许可。在中国，针对16至65岁成人的III期研究报告显示，Hecolin有效预防了乙型肝炎病毒感染。人乳头瘤病毒（HPV）L1 VLPs疫苗（Cecolin；Innovax）也是由大肠杆菌生产，并在中国批准上市。在一项III期研究中，该HPV疫苗对生殖器损伤和持续性感染有效。 Strangvac疫苗，含有马链球菌CCE、mEq84和IdeE抗原，是由Intervacc公司使用重组DNA技术在大肠杆菌中生产的，用于防治马链球菌引起的马脖腺炎，并于2021年获得EMA批准。一项研究报告称，Strangvac疫苗接种是安全的，且能有效保护马匹免受由马链球菌引起的脖腺炎。 Prevnar 13疫苗用于预防13种肺炎链球菌血清型引起的肺炎，由Wyeth Pharmaceuticals公司使用棒状分枝杆菌生产，并于2010年获得FDA批准。此外，辉瑞公司于2016年宣布，Prevnar 13是唯一获得批准用于所有年龄段人群的肺炎球菌疫苗。随后，肺炎球菌结合疫苗（蛋白质多糖）也在大肠杆菌中重组生产，并显示其在与Prevnar 13疫苗相比时，能够用于预防肺炎球菌感染。此外，还进行了一项研究，旨在提高在大肠杆菌中生产的肺炎球菌生物结合疫苗的产量并减少内毒素的形成。 Trumenba（B组脑膜炎球菌疫苗），也称为MenB-FHbp，由Wyeth Pharmaceuticals（辉瑞子公司）在大肠杆菌中生产。Trumenba包含两种重组的Neisseria meningitidis B群的因子H结合蛋白（FHbp）变体。2014年，FDA批准其用于10至25岁人群预防由B群脑膜炎球菌引起的疾病，2017年EMA批准该疫苗用于预防该病。一项最新的III期研究表明，MenB-FHbp在青少年和年轻成人中应用良好，耐受性好，安全性高，并能增加保护性抗体反应。2018年至2020年间进行的接种研究报告称，Trumenba接种后没有出现死亡或免疫后的不良事件。另一种脑膜炎球菌疫苗，Bexsero（含有B群脑膜炎球菌的片段），也称为4CMenB，由GlaxoSmithKline公司在大肠杆菌中生产。Bexsero于2015年获得FDA批准，适用于10至25岁患者，2013年获得EMA批准，适用于2个月及以上人群。在美国进行的一项研究显示，Bexsero疫苗没有引发新的安全问题，且所有的副作用大多为轻微的。根据9年的数据报告，4CMenB的使用在不同年龄组中并未引起显著的安全问题。然而，接种后婴儿可能会出现短暂的发热。一项最近的研究报告称，使用4CMenB能有效预防5岁以下儿童的侵袭性脑膜炎球菌病。在大肠杆菌中生产的间日疟原虫抗原已被证明能够增强小鼠的细胞免疫和体液免疫反应，并可能成为针对基于间日疟原虫的疟疾的潜在疫苗候选者。此外，首批动物疫苗之一，p45猫白血病病毒包膜抗原（Leucogen；Virbac），是由Hansa Biopharma使用重组DNA技术在大肠杆菌中生产，并于2009年获得EMA批准。Letifend（LETI Pharma），一种来自利什曼原虫的蛋白质Q疫苗，用于治疗犬类利什曼病，也是使用重组DNA技术在大肠杆菌中生产，并于2016年获得EMA批准。大肠杆菌继续被用于生产各种疫苗抗原。例如，1998年，FDA批准了一种包含重组生产的由博莱氏螺旋体产生的外表面脂蛋白OspA的莱姆病疫苗。然而，由于担心严重的副作用，该疫苗在2002年被撤回市场。一个改进版本VLA15，仍然在大肠杆菌中生产，目前正在进行III期临床试验。融合蛋白和抗体片段在大肠杆菌中生产融合蛋白和抗体片段已成为开发生物制药的关键策略，并为各种治疗应用提供了特定的解决方案。Ranibizumab分子（Lucentis）由Genentech/Roche公司在大肠杆菌中生产，用于治疗年龄相关性黄斑变性（AMD），并于2006年在美国获得批准。Ranibizumab是一种单克隆抗体片段，针对所有血管内皮生长因子A（VEGF-A）同种型。该结合物可防止与细胞表面受体如VEGFR1和VEGFR2的二聚化，从而减少血管生成、内皮细胞增生和血管泄漏。Ranibizumab是治疗糖尿病性黄斑水肿的重要选择，并能改善增殖性糖尿病视网膜病变。随后，Byooviz，一种与Lucentis类似的生物相似药，在大肠杆菌中生产，并于2021年获得FDA和EMA批准，用于治疗AMD、视网膜静脉闭塞后黄斑水肿和近视性脉络膜新生血管。Susvimo（ranibizumab），一种VEGF抑制剂，由Genentech公司在大肠杆菌中生产，并于2021年获得FDA批准，用于治疗AMD。曲妥珠单抗（Herceptin）单克隆抗体由Genentech/Roche公司在中国仓鼠卵巢细胞中生产，并于1998年获得FDA批准用于临床治疗。然而，已有研究表明该分子也可以在大肠杆菌中生产。人类表皮生长因子受体2（HER2）蛋白位于细胞表面，在调节细胞生长和通信中起着至关重要的作用。约四分之一的乳腺癌患者发现该受体表达过高。曲妥珠单抗（抗HER2）针对HER2受体，已报告其可以减缓由于HER2信号传导引起的癌症发展。赛妥珠单抗（Cimzia）单克隆抗体片段由UCB Pharma公司在大肠杆菌中生产，用于治疗克罗恩病和类风湿性关节炎（RA）。它也是一种肿瘤坏死因子（TNF）抑制剂。该Fab（抗原结合片段）分子以可溶性形式生产，并于2008年获得FDA批准。罗米普利司汀（Nplate）融合蛋白由Amgen公司在大肠杆菌中生产，用于治疗免疫性血小板减少性紫癜。这种蛋白在细胞质中以包涵体的形式生产，并于2008年获得FDA批准，2009年获得EMA批准。莫昔单抗帕苏多毒素（Lumoxiti）融合蛋白由AstraZeneca公司生产，并于2018年获得FDA批准。该重组蛋白特异性结合B细胞表面的CD22受体，并在大肠杆菌中生产，用于治疗毛细胞白血病。 Caplacizumab（Cablivi）抗体由Ablynx/Sanofi公司生产，用于治疗获得性血栓性血小板减少性紫癜，并于2019年获得FDA批准。该单克隆抗体在大肠杆菌中以可溶性形式生产，靶向冯·维尔兰德因子。EMA也于2018年批准其用于12岁以上儿童和成人。 Brolucizumab（Beovu）是一种由诺华公司生产的单克隆单链可变片段，用于治疗AMD。该分子结合VEGF受体，并通过重组DNA技术在大肠杆菌中生产，于2019年获得FDA批准。另一个单克隆抗体片段是Bentracimab（PB2452）。Bentracimab能逆转抗血栓药物替卡格雷（Brilinta）的作用。在健康志愿者的研究中，Bentracimab显示出有效性和安全性。目前，Bentracimab的III期临床试验——替卡格雷快速持续逆转干预试验正在进行中。此外，2023年达成协议，宣布SFJ Pharmaceuticals将负责Bentracimab的持续临床研究。在大肠杆菌中生产的融合蛋白和抗体片段也用于癌症治疗。Tebentafusp（Kimmtrak）融合蛋白由Immunocore公司在大肠杆菌中生产，用于治疗转移性葡萄膜黑色素瘤，并于2022年获得FDA和EMA批准。Oportuzumab monatox（Vicineum）融合蛋白由Sesen Bio公司在大肠杆菌中生产，用于治疗膀胱癌，并已开发至III期研究。通过重组DNA技术生产的这种可溶性形式的蛋白靶向上皮细胞黏附分子抗原，该抗原在大多数实体肿瘤中高表达。然而，2022年7月18日，公司宣布决定停止在美国进一步开发Vicineum。近年来，Genentech和Sutro Biopharma已在临床研究中探索了大肠杆菌生产的去糖基化抗体。Genentech在II期和III期研究中探索了抗MET抗体onartuzumab（OA-5D5，RG3638），用于治疗多种晚期实体瘤；然而，由于缺乏显著的临床效果，III期试验被停止。此外，Genentech的全长IgG4双特异性抗体BIT7201A（RG7990）也在I期研究中测试，用于哮喘治疗，并显示出良好的耐受性。Sutro Biopharma的三种单克隆抗体药物偶联物和一种双特异性单克隆抗体药物偶联物目前都处于I期临床试验阶段。STRO-001正在评估用于治疗多发性骨髓瘤和B细胞恶性肿瘤；STRO-002用于治疗过度表达FolRα的铂耐药性卵巢癌和其他实体瘤；ispectamab debotansine（CC-99712，BMS-986352）用于治疗多发性骨髓瘤；M1231用于非小细胞肺癌和食道癌。这些都在I期临床试验中。其他生物制药大肠杆菌生产的生物制药的范围不仅限于疫苗、抗体、酶、融合蛋白、抗体片段和激素，还包括具有独特应用的各种治疗药物。本节重点介绍了在大肠杆菌中生产的其他生物制药。Filgrastim分子（Neupogen）是由安进公司在大肠杆菌中生产的重组人粒细胞集落刺激因子，用于治疗中性粒细胞减少症，并于1991年在美国获得批准。2002年，同一公司开发了Filgrastim分子的聚乙二醇化形式（Neulasta），用于治疗癌症相关感染。随后，许多Neulasta（聚filgrastim）生物相似药被生产出来。Stimufend（聚filgrastim-fpgk）是由Fresenius Kabi公司生产的，用于治疗中性粒细胞减少症，并于2022年获得FDA批准。 Beromun（tasonermin）是一种肿瘤坏死因子（TNF-α），由Boehringer Ingelheim公司在大肠杆菌中重组生产，用于治疗软组织肉瘤，并于1999年获得EMA批准。 Anakinra分子（Kineret）是一种白介素-1受体拮抗剂，由瑞典孤儿生物技术公司Biovitrum在大肠杆菌中重组生产，用于治疗类风湿性关节炎，并于2001年在美国获得批准。 Meterleptin（Myalept）是一种类脂素，由Aegerion Pharmaceuticals公司在大肠杆菌中重组生产。2014年，FDA批准其用于治疗获得性或先天性广泛性脂肪营养不良患者的类脂素缺乏症。虽然脂肪营养不良是一种罕见疾病，且治疗选择有限，Meterleptin的研究较少，但一项研究表明，它显著改善了接受Meterleptin治疗者的生活质量。 Tagraxofusp-erzs（Elzonris）是一种细胞因子，由Stemline Therapeutics公司使用重组DNA技术在大肠杆菌中生产。2018年，FDA批准其用于治疗儿童和成人的爆发性浆细胞状树突状细胞肿瘤，并于2021年获得EMA批准。结论大肠杆菌具有诸多优势，如良好的遗传结构知识、克隆技术应用简便、生产快速、对营养培养基要求简单以及易于大规模生产。然而，它在生产复杂蛋白质时存在一些局限性（如缺乏后期翻译修饰和二硫键形成的限制）。尽管如此，大肠杆菌仍然是生产生物制药的一个有吸引力的宿主。本文回顾了FDA和EMA批准的大肠杆菌生产的生物制药，包括激素、酶、疫苗、融合蛋白和抗体片段。本文按时间顺序讨论了从胰岛素开始，到目前为止，在大肠杆菌中生产并获得批准的生物制药，并介绍了这些生物制药用于治疗的疾病。此外，还提到了相关领域中一些正在进行的治疗研究。因此，大肠杆菌仍然是许多已经生产并将来会生产的生物制药的重要宿主，用于治疗各种疾病。未来，随着生物技术的研究和发展，可以消除大肠杆菌重组蛋白生产中的局限性，提高其效果。因此，来自大肠杆菌的生物制药可能在治疗疾病和制药行业中占据重要地位。原文：İ.İncir, Ö.Kaplan, Escherichia coli in the production of biopharmaceuticals. Biotechnology and Applied Biochemistry, 2024.

2022-12-12

·PRNewswire

Real-World Analysis Suggests Pediatric-Inspired Regimens Lead to Higher Overall Survival in Adolescent and Young Adult Patients with Newly-Diagnosed Acute Lymphoblastic Leukemia

Adolescent and young adult patients treated with asparaginase containing pediatric-inspired regimens showed a 69% reduction in risk of death (HR: 0.31; 95% CI, 0.18-0.55) and higher overall survival compared to matched patients treated with non-pediatric-inspired regimens The two-year rate of stem cell transplant was lower in patients treated with pediatric-inspired regimens compared to patients treated with non-pediatric-inspired regimens BOSTON, Dec. 12, 2022 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced findings from a retrospective study observing higher overall survival (OS) in adolescent and young adult (AYA) newly-diagnosed acute lymphoblastic leukemia (ALL) patients treated with asparaginase containing pediatric-inspired regimens (PIR) versus non-pediatric-inspired regimens. Detailed results from the new real-world analysis were presented today in an oral session at the 64th Annual Meeting of the American Society of Hematology (ASH). "Pediatric oncologists have long understood the effectiveness of pediatric-inspired regimens for treating children and teenagers with most types of acute lymphoblastic leukemia, but this analysis indicates those benefits extend to a broader population of older adolescents and young adults," said David R. Freyer, DO, MS, study co-author, Co-Director of the AYA Cancer Program at the USC Norris Comprehensive Care Center, and member of the Leukemia Lymphoma Program at Children's Hospital Los Angeles. "Although the use of pediatric-inspired regimens in young adults is inconsistent across adult centers, we believe this analysis supports their use in this patient population and hope it promotes further investigation to better understand their impact on overall survival and long-term outcomes." Study Background: This real-world analysis initially looked at the administrative health claim records of 11,650 newly-diagnosed ALL patients on separate days between 2007-2020. Of those, 2,312 were aged 15-39, and 1,313 had at least one record of a PIR or HyperCVAD or ALL DRG code or other chemotherapy within six months of diagnosis. Patient records were then examined to ensure no evidence of ALL remission or relapse prior to the index date, no evidence of stem cell transplant prior to the index date and at least six months of continuous health plan enrollment before the index date, leaving a total of 596 patients in the analysis. Among the 596 patient records remaining in the analysis, 303 (51%) were confirmed to have not been treated with a PIR, while 187 (31%) were confirmed to have been treated with a PIR. An additional 15% received unknown therapy (due to limited available data) and 3% lacked sufficient information but received treatment that suggests a PIR (and were included in the sensitivity analysis). Non-PIR patients were matched to PIR patients based on propensity score matching to balance the baseline characteristics. A total of 374 matched patients (187 PIR vs. 187 non-PIR) were used in the primary analyses. This is a retrospective study not powered or adjusted for multiplicity to assess OS. P-values are for descriptive purposes only. Findings of sensitivity analyses were consistent with the primary analyses. Results: Overall, this real-world analysis suggests treatment with a PIR leads to higher OS in AYA patients with newly-diagnosed ALL. Patients treated with a PIR (n=187) had a 69% lower risk of death compared to matched patients who received non-PIR (n=187) (hazard ratio [HR]=0.31; 95% confidence interval [CI], 0.18-0.55; log-rank test p-value<0.0001). In addition, the two-year rate of allogeneic stem-cell transplant (SCT) was lower among AYA patients with newly-diagnosed ALL treated with a PIR (16.5%) versus non-PIR (33.4%). "While additional studies are needed, these real-world findings provide important insights into the benefits of pediatric-inspired regimens containing asparaginase in adolescent and young adult patients with newly-diagnosed acute lymphoblastic leukemia, who have a historically poorer survival rate in comparison to pediatric patients," said Susan Pandya, MD, Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier. "We look forward to continuing our research efforts for ASPARLAS, one of our approved asparaginase products, and exploring the potential application in other indications including solid tumors where there is emerging preclinical rationale." The full abstract is available for viewing on the ASH 2022 website. About Servier Pharmaceuticals Servier Pharmaceuticals LLC is a commercial-stage company with a passion for innovation and improving the lives of patients, their families and caregivers. As a privately held company, Servier has the unique freedom to devote all of its time and energy towards patients who require our treatments, care and innovation in areas of unmet medical need. As a leader in oncology, Servier is committed to finding solutions that will address today's challenges. The company's oncology portfolio includes innovative medicines designed to bring more life-saving treatments to a greater number of patients, across the entire spectrum of disease and in a variety of tumor types. Servier has significantly accelerated its investment in hard-to-treat cancers with more than 50% of its research and development dedicated to delivering significant advances in areas of high unmet need that may truly move the needle for our patients. Servier believes co-creation is fundamental to driving innovation and is actively building alliances, acquisitions, licensing deals and partnerships that bring solutions and accelerate access to therapies. With the company's commercial expertise, global reach, scientific expertise and commitment to clinical excellence, Servier Pharmaceuticals is dedicated to bringing the promise of tomorrow to the patients that we serve. For more information: . About Servier Founded to serve health, Servier is a global group governed by a Foundation that aspires to have a meaningful social impact, both for patients and for a sustainable world. With its unique governance model, it can fully serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs. The 21,800 employees of the Group are committed to this shared vocation, source of inspiration every day. As a world leader in cardiology, Servier's ambition is to become a renowned, focused and innovative player in oncology by targeting hard-to-treat cancers. That is why the Group allocates over 50% of its R&D budget to developing targeted and innovative therapies in oncology. Neuroscience and immuno-inflammatory diseases are the future growth drivers. In these areas, Servier is focused on a limited number of diseases in which accurate patient profiling makes it possible to offer a targeted therapeutic response through precision medicine. To promote access to quality care for all at a lower cost, the Group also offers a range of quality generic drugs covering most pathologies, relying on strong brands in France, Eastern Europe, Brazil and Nigeria. In all these areas, the Group includes the patient voice at each stage of the life cycle of a medicine. Headquartered in France, Servier relies on a strong geographical footprint in over 150 countries and achieved a revenue of €4.7 billion in 2021. For more information on the new Group website: servier.com. Press contacts Servier Pharmaceuticals (U.S.) Julia Ferreira [email protected] Servier Group (France and worldwide) Sonia Marques [email protected] +33 (0)1 55 72 40 21 / + 33 (0)7 84 28 76 13 Disclosures This release contains general information about the Servier Group and its entities (hereinafter "Servier and its Affiliates") and is intended for informational purposes only. The information is thought to be reliable; however, Servier and its Affiliates make no representation as to the accuracy or completeness of the information contained herein or otherwise provided and accept no responsibility or liability, in contract, in tort, in negligence, or otherwise, should the information be found to be inaccurate or incomplete in any respect. Servier and its Affiliates are not acting as an advisor to the recipient of this information, and the ultimate decision to proceed with any transaction rests solely with the recipient of this information. Therefore, prior to entering into any proposed transaction, the recipient of this information should determine, without reliance upon Servier or its Affiliates, the economic risks and merits, as well as the legal, tax, and accounting characterizations and consequences, of the transaction and that it is able to assume these risks. This statement also contains forward-looking statements that are subject to varying levels of uncertainty and risk. Investigational new drugs and indications are subject to further scientific and medical review and regulatory approval. They are not approved for use by the FDA. Any reliance placed on this document is done entirely at the risk of the person placing such reliance. The information contained in this document is neither an offer to sell nor the solicitation of an offer to enter into a transaction. The content of this document is a summary only, is not complete, and does not include all material information about Servier and its Affiliates, including potential conflicts of interest. To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates disclaim all representations, warranties, conditions and guarantees, whether express, implied, statutory or of other kind, nor does it accept any duty to any person, in connection with this document. Without prejudice to the generality of the foregoing, Servier and its Affiliates do not warrant or represent that the information or opinions contained in this document is accurate or complete. To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates shall not be liable for any loss, damage or expense whatsoever, whether direct or indirect, howsoever arising, whether in contract, tort (including negligence), strict liability or otherwise, for direct, indirect, incidental, consequential, punitive or special damages arising out of or in connection with this document, including (without limitation) any course of action taken on the basis of the same. The estimates, strategies, and views expressed in this document are based upon past or current data and information and are subject to change without notice. SOURCE Servier Pharmaceuticals

临床结果ASH会议

2021-10-05

·药事纵横

急性淋巴细胞白血病治疗药物一览：多款TKIs获批，ADC、CAR-T新疗法入局

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）。因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。关键词：ALL；Tecartus；新疗法 10月1日，吉利德旗下的凯特制药宣布FDA批准其Tecartus（brexucabtagene autoleucel）用于治疗成人复发或难治性B细胞前体急性淋巴细胞白血病（ALL）患者。 Tecartus是一种自体抗CD19 CAR-T细胞疗法，2020年7月被FDA加速批准用于治疗先前接受过2种或多种系统疗法（包括一种BTK抑制剂）的复发或难治性套细胞淋巴瘤（R/R MCL）成人患者。此次Tecartus获批治疗ALL是基于1/2期研究ZUMA-3的数据。该研究是一项国际多中心、单臂、开放标签注册研究，在接受标准系统疗法或造血干细胞移植后难治或复发的成人ALL患者中展开，主要终点为由独立审查委员会评估的完全缓解（CR）或血液学不完全恢复的完全缓解。结果显示：中位随访时间12.3个月，在疗效可评估患者中 65%患者达到CR或血液学恢复不完全的 CR，超50%患者的CR持续时间超过12个月，中位缓解持续时间 (DOR) 为 13.6 个月。安全性方面，在接受目标剂量治疗的患者中，3级以上细胞因子释放综合征和神经毒性事件发生率分别为26%和35%，通常可控。急性淋巴细胞白血病（ALL）是一种常见的恶性血液病，以骨髓和淋巴组织中不成熟淋巴细胞的异常增殖和聚集为特点，可累及淋巴结、脾脏、肝脏、中枢神经系统和其他器官。ALL主要分为T细胞ALL、前体B细胞ALL和成熟B细胞白血病三类，其中前体B细胞ALL是ALL的最常见形式，约占75%。目前，ALL治疗除传统的化疗和造血干细胞移植，全球已经批准了多款新疗法，其中Gleevec/Glivec、Sprycel和Iclusig均属于酪氨酸激酶抑制剂 (TKI)，Blincyto是全球获批的首个CD19-CD3双特异性T细胞衔接（BiTE）免疫疗法，Besponsa是一款CD22靶向抗体药物偶联物（ADC），而Kymriah是一种CD19靶向的基因修饰自体T细胞免疫细胞疗法（CAR-T疗法）。而且，近年来FDA还批准另外两款新的ALL药物，即施维雅的Asparlas（calaspargase pegol-mknl，Cal-PEG）和Jazz制药的Rylaze。其中Asparlas是一种长效天冬酰胺特异性酶，2018年12月被FDA批准作为多药化疗方案的一个组成部分，用于1个月至21岁的儿童和青少年ALL患者的治疗。Rylaze 是一种生物制剂重组的菊欧文氏菌天冬酰胺酶，以特殊荧光菌的技术平台研发而来，2021年7月被FDA批准作为化疗方案的一部分，治疗对常见化疗方案中大肠杆菌源性天冬酰胺酶制品过敏的ALL和淋巴母细胞淋巴瘤（LBL）的1个月龄以上的儿童和成人患者。此外，目前还有其他几款药物被开发用于治疗ALL，如亘喜生物的GC027、Autolus Therapeutics的AUTO3。其中GC027利用亘喜生物独有的TruUCAR专利技术以及无需进行HLA匹配的健康供者T细胞开发的一款即用型CAR-T细胞疗法，通过靶向CD7抗原表达的肿瘤细胞治疗T细胞恶性肿瘤。目前，该药治疗R/R急性T淋巴细胞白血病(T-ALL)的一项I期临床试验取得积极结果。AUTO3是一种自体富集T细胞，经单个逆转录病毒载体修饰表达2个独立的嵌合抗原受体（CAR），分别靶向B淋巴细胞抗原CD19和CD22，并且每个CAR都针对单个靶点活性进行了独立优化。通过同时针对2种B细胞抗原，AUTO3旨在减少B细胞恶性肿瘤患者因单一抗原丢失导致的复发。2019年4月，该药被FDA授予治疗ALL的孤儿药资格（ODD）。药事纵横投稿须知：稿费已上调，欢迎投稿各位朋友好，觉得本文对您有帮助，请随手点一下下方的在看，以便让你的朋友也能看到哦。

免疫疗法抗体药物偶联物细胞疗法抗体孤儿药

100 项与 Calaspargase Pegol-MKNL 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10096	Calaspargase Pegol-MKNL	L01XX02 L01XX86	DB14730

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
急性淋巴细胞白血病	美国	Servier Pharmaceuticals LLC	2018-12-20

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
费城染色体阴性急性淋巴细胞白血病	临床3期	美国	Institut de Recherches Intern Servier	2021-07-07
费城染色体阴性急性淋巴细胞白血病	临床3期	美国	Institut Servier de Medecine Translationnelle SARL	2021-07-07
淋巴母细胞淋巴瘤	临床2期	美国	Shire Plc	2012-06-01
淋巴母细胞淋巴瘤	临床2期	加拿大	Shire Plc	2012-06-01
混合表型急性白血病	临床1期	美国	AbbVie, Inc.	2023-03-29
混合表型急性白血病	临床1期	美国	Servier Pharmaceuticals LLC	2023-03-29
难治性 T 急性淋巴细胞白血病	临床1期	美国	Servier Pharmaceuticals LLC	2023-03-29
难治性 T 急性淋巴细胞白血病	临床1期	美国	AbbVie, Inc.	2023-03-29
难治性T淋巴细胞淋巴瘤	临床1期	美国	AbbVie, Inc.	2023-03-29
难治性T淋巴细胞淋巴瘤	临床1期	美国	Servier Pharmaceuticals LLC	2023-03-29

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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


NCT04817761 (SPARK-ALL, ASCO2026)	临床2/3期	费城染色体阴性急性淋巴细胞白血病一线	42	Calaspargase pegol	鑰窪糧夢願鏇顧艱壓簾(廠繭艱願窪膚鑰窪製齋) = At 21 days after the D43 post-consolidation dose, all pts in the PNPAA set had NPAA values above the 0.1 U/mL efficacy threshold. 蓋醖窪艱繭壓餘製衊餘 (網簾廠襯鑰鹽選襯顧衊 ) 更多	积极	2026-05-29
NCT04817761 (EHA2025) 人工标引	临床2/3期	费城染色体阴性急性淋巴细胞白血病一线 Philadelphia Chromosome	295	Calaspargase pegolCalaspargase pegol (S95015)	襯顧衊簾鹽糧積構築鑰(衊鬱壓獵鏇艱鹹糧鏇構) = not been reached 餘鏇襯築顧網鬱簾網願 (衊繭夢獵鏇醖廠網獵壓 ) 更多	积极	2025-05-14
				Calaspargase pegolCalaspargase pegol (S95015) (pts with undetectable MRD)
NCT01574274 (DFCI 11-001, CTgov)	临床2期	急性淋巴细胞白血病 \| 淋巴母细胞淋巴瘤	240	SC-PEG (SC-PEG (Arm A))	蓋構網壓窪憲鹽鑰淵獵 = 糧蓋鬱壓醖襯齋衊積範夢膚廠構鹹糧窪築簾憲 (糧鏇製蓋觸廠積網築餘, 衊醖築觸製遞鑰選衊網 ~ 餘襯蓋壓網糧繭衊窪觸) 更多	-	2022-09-10
				Oncaspar (Oncaspar (Arm B))	蓋構網壓窪憲鹽鑰淵獵 = 憲餘淵鏇夢顧廠簾壓衊夢膚廠構鹹糧窪築簾憲 (糧鏇製蓋觸廠積網築餘, 製淵餘廠鹹廠觸窪襯壓 ~ 積觸鹹壓遞餘簾壓蓋願) 更多
NCT01574274 (DFCI 11-001, ASCO 12019 \| ASCO 22019) 人工标引	临床2期	急性淋巴细胞白血病 \| 淋巴瘤	239	pegaspargase	積憲艱壓膚繭醖衊鬱膚(構齋壓憲鹽糧襯廠襯夢) = 鑰獵蓋壓構顧觸鏇鏇窪醖獵遞鏇鹹繭簾積齋夢 (壓衊築範構窪襯衊糧糧 ) 更多	积极	2019-05-31
				calaspargase pegol	積憲艱壓膚繭醖衊鬱膚(構齋壓憲鹽糧襯廠襯夢) = 廠齋積醖糧構鏇夢繭顧醖獵遞鏇鹹繭簾積齋夢 (壓衊築範構窪襯衊糧糧 ) 更多
NCT00671034 (AALL07P4, CTgov)	临床3期	前体B细胞成淋巴细胞白血病淋巴瘤	166	Calaspargase Pegol 2100 (Arm I (Calaspargase Pegol 2100))	襯範選顧艱願範廠夢構(膚鏇觸襯膚膚餘蓋窪襯) = 選艱蓋範鹹醖窪範壓憲鏇鏇夢築餘構製鏇鑰憲 (觸齋選鏇獵艱糧製鏇餘, 148.51) 更多	-	2018-09-06
				Calaspargase Pegol (Arm II ( Calaspargase Pegol 2500))	襯範選顧艱願範廠夢構(膚鏇觸襯膚膚餘蓋窪襯) = 醖襯衊獵鹽艱糧網網選鏇鏇夢築餘構製鏇鑰憲 (觸齋選鏇獵艱糧製鏇餘, 133.0) 更多