A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).

开始日期2025-12-26

申办/合作机构

Janssen Research & Development LLC

NCT05700448

/ Not yet recruiting临床3期

A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)

The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.

开始日期2025-06-01

申办/合作机构

基石药业

NCT06124157

/ Not yet recruiting临床3期IIT

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2025-05-29

申办/合作机构

National Cancer Institute

100 项与培门冬酶相关的临床结果

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100 项与培门冬酶相关的转化医学

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100 项与培门冬酶相关的专利（医药）

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500

项与培门冬酶相关的文献（医药）

2025-05-01·PEDIATRIC BLOOD & CANCER

Higher Rates of Hypersensitivity Reactions to Calaspargase Compared With Pegaspargase: A Single Center Retrospective Review

Article

作者: Patel, Bianca ; Gao, Ang ; Winick, Naomi ; Smith, Caroline ; Zhang, Song ; Slone, Tamra ; Cox, Jessica ; McCarty, Kyra

ABSTRACT:

Background:

Asparaginase is a critical component of curative therapy for the treatment of pediatric acute lymphoblastic leukemia (ALL) and acute lymphoblastic lymphoma (LLy). Pegaspargase (PEG) increased the duration of asparagine depletion and lowered the incidence of hypersensitivity reactions (HSRs) compared with native asparaginase. When a second pegylated product, Calasparagase pegol‐mknl (Cal‐PEG) replaced PEG, we observed an increased incidence of HSR, defined as anaphylaxis or silent hypersensitivity. This led to a single center, retrospective review to determine the incidence of HSR in patients with ALL or LLy who received Cal‐PEG or PEG.

Procedure:

Electronic medical records of all patients who received at least two doses of Cal‐PEG (December 2022–December 2023) or PEG (December 2019–December 2022) were reviewed.

Result:

Overall, patients who received Cal‐PEG had a significantly increased rate of asparaginase‐related HSR compared with patients who received PEG. Twenty‐one of 44 (48%) patients receiving Cal‐PEG and 35 out of 154 (23%) of patients receiving PEG experienced Grade 3 or higher anaphylaxis, or silent hypersensitivity (p = 0.001). After 2:1 matching based on propensity scoring for confounding variables, patients who received Cal‐PEG continued to have a statistically significantly higher rates of HSR, with HSR occurring in 21 out of 44 (48%) and 26 out of 88 (30%) patients receiving Cal‐PEG and PEG, respectively (p = 0.04).

Conclusion:

The current administration of Cal‐PEG in large cooperative group trials will allow for a postmarketing exploration of the true risk of HSR and associated patient‐specific risk factors.

2025-04-08·Blood Advances

Desensitization to calaspargase pegol appears to be less successful than pegaspargase

Article

作者: Inaba, Hiroto ; Hopp, Jaclyn ; Swanson, Hope D. ; Panetta, John C. ; Karol, Seth E. ; Matherne, Milre ; Pui, Ching-Hon

2025-04-01·THERAPEUTIC DRUG MONITORING

A Refined Population Pharmacokinetic Model–Based Guideline for Individualized PEGasparaginase Dosing in Pediatric Acute Lymphoblastic Leukemia

Article

作者: Pieters, Rob ; Brigitha, Leiah J. ; Zaky, Karen ; van der Sluis, Inge M.

Background::

In the Dutch Childhood Oncology Group ALL11 protocol, PEGasparaginase dosing was individualized for standard-risk and medium-risk patients with acute lymphoblastic leukemia. After using our pragmatic old guideline, we aimed to improve individualized PEGasparaginase dosing by developing a population pharmacokinetic model–based dosing guideline.

Method::

After the 3 doses of 1500 IU/m2 administered in induction, standard-risk patients received 1 individualized dose and medium-risk patients 14, targeting trough activity levels between 100 and 250 IU/L. The effectiveness, adherence, and toxicity of our new dosing guideline was assessed and compared with the old guideline.

Results::

In total, 92 patients (714 samples) were included in the new dosing group and 509 patients (4539 samples) were included in the old dosing group. Comparing the effectiveness, we found that 32% (22/67) of patients in the new and 13% (47/354) of patients in the old dosing group were within the target range after the first individualized dose (P < 0.001). Among medium-risk patients, a median of 3 dose reductions was needed to reach and maintain levels within the target range in the new dosing group compared with 5 in the old dosing group (P < 0.001). With a continuous PEGasparaginase dosing schedule, target trough activity levels were reached after 2 dose reductions in the new group versus 4 in the old dosing group. The adherence to the new guideline was >99%, with 6/714 recommended doses deviating from the guideline. With exception of a lower proportion of patients with increased (≥grade 3) serum alanine transaminase (34% new vs 64% old, P < 0.05) in the new dosing group, toxicity was comparable between guidelines.

Conclusions::

With the new dosing guideline, fewer dose-reduction steps are necessary to reach and remain within the target. The high adherence rate emphasized its simplicity and practicality, confirming that it can be easily integrated into clinical practice.

项与培门冬酶相关的新闻（医药）

2025-04-14

·生物制品圈

探秘生物制药：大肠杆菌的神奇 “制药” 之旅

摘要：自重组 DNA 技术出现以来，大肠杆菌在生物制药领域发挥了重要作用。它具有诸多优势，如遗传背景清晰、生产成本低、产量高，但也存在一些局限性，比如无法进行某些特定的蛋白质翻译后修饰。本文对大肠杆菌生产且经美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）批准的生物制药进行了综述，涵盖了激素、酶、肽、疫苗、融合蛋白、抗体片段及其他生物制药等类别，介绍了这些药物的治疗用途、生产公司及研发进展等信息。一、大肠杆菌在生物制药中的角色20 世纪 70 年代，随着重组 DNA 技术的出现，大肠杆菌因其能高效且低成本地生产重组蛋白而备受关注。1982 年，由大肠杆菌生产的重组胰岛素获 FDA 批准，这一里程碑事件开启了生物制药的新时代，也为更多重组药物的生产奠定了基础。尽管大肠杆菌在生产复杂蛋白质时存在一定局限，如缺乏某些翻译后修饰能力，但它依然是生物制药中极具吸引力的宿主菌，其遗传特性明确，拥有多种成熟的克隆技术和表达系统（原文 Figure 1，展示在大肠杆菌中生产重组生物制药的一般方法，帮助读者理解生产流程）。二、大肠杆菌生产的各类生物制药1.激素：大肠杆菌在激素生产方面成果丰硕。1982 年，礼来公司生产的重组人胰岛素（Humulin）获 FDA 批准，用于治疗糖尿病。之后，赛诺菲 - 安万特公司生产的长效胰岛素类似物甘精胰岛素（Lantus）、礼来公司的赖脯胰岛素（Lyumjev）等多种胰岛素类似物相继获批。此外，生长激素、干扰素、甲状旁腺激素等多种激素也由大肠杆菌生产并获批用于临床治疗不同疾病。例如，生长激素用于治疗生长激素缺乏症，干扰素用于治疗多种癌症和肝炎，甲状旁腺激素用于治疗骨质疏松症和控制低钙血症等（原文 Table 1，展示经 FDA 和 EMA 批准的大肠杆菌生产的重组激素及其作用机制，使信息更直观）。当下，还有许多新型胰岛素类似物处于临床研究阶段，旨在提升疗效和控制血糖的速度。2.酶：多种治疗用酶也可由大肠杆菌生产。比如，2010 年获批用于治疗慢性痛风的培戈洛酶（Pegloticase），2012 年获批用于降低肾功能受损患者血浆中甲氨蝶呤（MTX）含量的羧肽酶（Voraxaze），2018 年获批用于治疗急性淋巴细胞白血病的培门冬酶（Calaspargase pegol）等（原文 Table 2，呈现经 FDA 和 EMA 批准的大肠杆菌生产的重组酶及其作用机制）。目前，科研人员还在评估大肠杆菌生产的酶在临床应用中的新潜力，期望开发出更有效的治疗药物。3.肽：大肠杆菌生产的肽类生物制药在多种疾病治疗中发挥着重要作用。如用于治疗急性失代偿性心力衰竭的奈西立肽（Natrecor）、治疗生长发育障碍的胰岛素样生长因子 - 1（Increlex）、治疗骨质疏松症的降钙素（Fortical）等（原文 Table 3，展示经 FDA 和 EMA 批准的大肠杆菌生产的重组肽及其作用机制）。这些肽类药物通过与特定受体结合，调节生理过程，从而发挥治疗作用。4.疫苗：在疫苗生产领域，大肠杆菌也有重要贡献。例如，中国研发的重组戊型肝炎疫苗（Hecolin）是全球首个基于病毒样颗粒的戊型肝炎疫苗，由大肠杆菌生产并于 2011 年获批。还有人乳头瘤病毒（HPV）L1 VLPs 疫苗（Cecolin）、针对马链球菌的 Strangvac 疫苗、预防肺炎球菌感染的肺炎球菌结合疫苗等，以及多种脑膜炎球菌疫苗如 Trumenba 和 Bexsero 等，均由大肠杆菌生产并获批用于人类或动物疾病的预防（原文 Table 4，列举经 FDA 和 EMA 批准的大肠杆菌生产的重组疫苗）。此外，还有一些基于大肠杆菌生产的疫苗正处于研发阶段。5.融合蛋白和抗体片段：许多融合蛋白和抗体片段类生物制药由大肠杆菌生产并获批用于治疗多种疾病。例如，用于治疗年龄相关性黄斑变性的雷珠单抗（Ranibizumab）及其生物类似药 Byooviz 和 Susvimo，治疗 HER2 阳性乳腺癌的曲妥珠单抗（虽最初在仓鼠卵巢细胞生产，但也有在大肠杆菌生产的相关研究），治疗克罗恩病和类风湿关节炎的赛妥珠单抗（Certolizumab pegol）等（原文 Table 5，展示经 FDA 和 EMA 批准的大肠杆菌生产的重组抗体和融合蛋白及其作用机制）。近年来，还有多种在研的大肠杆菌生产的抗体和融合蛋白处于不同临床研究阶段，用于治疗癌症等疾病。6.其他生物制药：除上述类别外，大肠杆菌还用于生产其他多种生物制药。如用于治疗中性粒细胞减少症的非格司亭（Filgrastim）及其聚乙二醇化形式（Neulasta），治疗软组织肉瘤的他索纳明（Beromun），治疗类风湿关节炎的阿那白滞素（Anakinra）等。这些药物在各自的治疗领域发挥着重要作用，为患者提供了有效的治疗选择。三、总结与展望大肠杆菌在生物制药领域具有重要地位，凭借其遗传背景清晰、易于操作、生产成本低和产量高等优势，生产出了众多经 FDA 和 EMA 批准的生物制药，广泛应用于多种疾病的治疗。尽管它存在无法进行某些翻译后修饰等局限性，但随着生物技术的不断发展，这些问题有望得到解决，其在生物制药中的应用潜力将进一步提升。未来，大肠杆菌生产的生物制药可能会在疾病治疗中发挥更重要的作用，占据更大的市场份额。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

疫苗微生物疗法

2024-06-03

·恒瑞医药

2024 ASCO口头报告｜恒瑞创新药卡瑞利珠单抗联合治疗NK/T细胞淋巴瘤研究结果公布

2024年美国临床肿瘤学会（ASCO）年会上，由华中科技大学同济医学院附属协和医院张利玲教授团队开展的“卡瑞利珠单抗联合培门冬酶、依托泊苷和大剂量甲氨蝶呤治疗NK/T细胞淋巴瘤患者的II期前瞻性研究(CLAMP研究)”结果入选大会口头报告。北京时间6月2日，张利玲教授报告了该研究的最新数据。研究结果表明 1 ，卡瑞利珠单抗联合培门冬酶、依托泊苷和大剂量甲氨蝶呤治疗NK/T细胞淋巴瘤患者具有良好的疗效和安全性，有望成为此类患者新的治疗选择。 CLAMP研究入选2024 ASCO大会口头报告研究背景 NK/T细胞淋巴瘤(NKTCL)是一种侵袭性非霍奇金淋巴瘤亚型，通常伴有EBV病毒感染 2 。目前尚无标准治疗方案。对于早期NKTCL，推荐采用放疗同时联合或序贯含门冬酰胺酶(Asp)的化疗方案，5年总生存率为55%-90%。对于晚期患者，推荐使用含Asp的化疗，如SMlLE方案(地塞米松+甲氨蝶呤+异环磷酰胺+左旋门冬酰胺酶+依托泊苷)，5年总生存率为30-40% 3,4 。 PD-1抑制剂已在研究中显示出对NKTCL有效。EBV感染与NKTCL密切相关，并导致JAK-STAT信号通路激活以及PD-L1/2表达增加。细胞毒性化疗药物通过多种机制刺激肿瘤特异性免疫反应，SMlLE方案对NKTCL有效但毒性大 3，4 ，因此本研究保留3种成分(甲氨蝶呤、培门冬酶和依托泊苷)，在细胞毒性治疗方案中加入PD-1抑制剂以探讨PD-1单克隆抗体卡瑞利珠单抗联合培门冬酶、依托泊苷、高剂量甲氨蝶呤(CLAMP方案)治疗NKTCL患者的疗效和安全性。研究设计这项单臂2期研究纳入NKTCL患者。患者分为两组：A组为早期(Ann Arbor分期I/II)患者；B组为晚期(Ann Arbor分期III/IV)和复发/难治性(RR)患者。A组患者行受累野放疗联合3-4个周期的CLAMP治疗，B组给予6个周期的CLAMP治疗。CLAMP方案给药如下：培门冬酶(2500U/m2 d1，最大剂量3750U)，依托泊苷(100mg/m2 d1-3)，大剂量甲氨蝶呤(HD-MTX，3g/m2 d4)，卡瑞利珠单抗(200mg d7)。在放疗后或每2个周期化疗后评估疗效，并于基线、C5D1化疗前2-3d、末次化疗后8周进行PET/CT检查。在前2年每3个月进行1次随访，之后每6个月进行1次随访。研究主要终点为客观缓解率(ORR)和完全缓解率(CRR，根据Lugano 2014标准，基于PET/CT和MRI判定)，次要终点为无进展生存期(PFS)、总生存期(OS)以及安全性。图1. 研究设计研究结果 1.患者基线 2020年7月至2022年12月共纳入41例NK/T细胞淋巴瘤患者，36例为新诊断患者，5例为复发患者。其中14例患者为中枢神经系统(CNS)侵犯高风险，伴有2-4个NKPI危险因素(Ann Arbor期III或IV期、B症状、局部淋巴结受累、乳酸脱氢酶升高)，1例合并噬血细胞综合征(HLH)。表1. 患者基线特征 2.临床疗效放疗结束时，A组ORR达到100%(19/19)，CRR为89.5%(17/19)，部分缓解(PR)率为10.5%(2/19)。表2. A组放疗结束时的疗效结果治疗结束时，所有患者CRR为87.8%(36/41)，PR率为7.3%(3/41)，ORR达95.1%(39/41)，A组患者ORR为100%(19/19)，B组患者ORR为90.9%(20/22)；B组仅有2例患者在治疗过程中出现进展。合并HLH的患者获得完全缓解，无病达12个月以上。表3. 治疗结束后的疗效结果在随访期间，没有患者发生HLH或中枢神经系统受累。中位随访时间为21个月。整个队列的2年PFS率为72.8%，A组和B组2年PFS率分别为91.7%和53.8%。2年OS率为88.0%，A组和B组2年OS率分别为91.7%和77.5%。A组和B组均未达到中位缓解持续时间。安全性方面，整体可控。图2. 2年的PFS率图3. 2年的OS率图4. 肿瘤反应与持续时间研究结论研究结果证明，卡瑞利珠单抗联合培门冬酶、依托泊苷和大剂量甲氨蝶呤(CLAMP方案)治疗NKTCL患者具有良好的疗效和安全性，并提示可减少中枢神经系统受累和HLH的发生，有望成为NK/T细胞淋巴瘤患者新的治疗选择。《“健康中国2030”规划纲要》提出“到2030年，要实现总体癌症5年生存率提高15%”的战略目标。抗肿瘤药物是癌症患者控制和治疗疾病的重要希望。作为创新型国际化制药企业，恒瑞医药长期坚持“科技为本，为人类创造健康生活”的使命，针对肿瘤等严重威胁人类生命健康的疾病开展科研攻关，已上市的16款创新药中抗肿瘤创新药占比过半。未来，恒瑞医药将继续坚持“以患者为中心”的理念，重创新，强研发，力争研制出更多的新药、好药，服务“健康中国”，惠及全球患者。参考文献： [1] Tao Liu, Liling Zhang, et al. CLAMP: A phase II prospective study of camrelizumab combined with pegaspargase, etoposide, and high-dose methotrexate in patients with natural killer (NK)/T-cell lymphoma.2024 ASCO Oral 7002. [2] NCCN Guidelines, Version 2.2024. [3] Qi SN, Li YX. First-line immunochemotherapy for extranodal natural killer/T cell lymphoma. Lancet Haematol. 2024;11(5):e311-e313. doi:10.1016/S2352-3026(24)00071-1 [4] Tse E, Zhao WL, Xiong J, Kwong YL. How we treat NK/T-cell lymphomas. J Hematol Oncol. 2022;15(1):74. Published 2022 Jun 3. doi:10.1186/s13045-022-01293-5 声明： 1.本新闻旨在分享学术前沿动态，仅供医疗卫生专业人士基于学术目的参阅，非广告用途。 2. 恒瑞医药不对任何药品和/或适应症作推荐。 3.本新闻中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。

ASCO会议临床结果临床2期临床1期

2024-04-25

·BiG生物创新社

ASCO 2024丨这些中国临床专家，将分享最新重磅研究

2024年美国临床肿瘤学会(ASCO)年会将于5月31日到6月4日在芝加哥举办，是世界上规模最大、学术水平最高、最具权威性的临床肿瘤学会议，会议汇集了全球肿瘤学医生和专业人士、患者倡导者、工业界代表和主要媒体，共同探讨当前国际最前沿的研究发现和临床试验成果。ASCO成立于1964年,是世界上最大、最具影响力的肿瘤专业学术组织,致力于癌症的预防、治疗及改善对患者的护理。ASCO在全球150多个国家和地区拥有超过45,000名成员。4月24日晚，ASCO官网公布了本次大会的研究标题，几十余名中国专家将在世界舞台上展示其研究成果，报告涵盖了多个瘤种的最新治疗策略和技术，展示了中国在全球癌症研究中的重要地位和贡献。世易编辑团队精心整理了中国专家们的研究报告，供您参考。全体大会报告Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: Primary results of the phase 3 LAURA study. Abstract: LBA4 · Suresh S. Ramalingam教授，美国埃默里大学Winship癌症研究所· 陆舜教授，上海交通大学附属胸科医院口头报告Lung Cancer—Non-Small Cell MetastaticSacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. Abstract: 8502 · 方文峰教授，中山大学肿瘤防治中心 Ivonescimab combined with chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor treatment (HARMONi-A): A randomized, double-blind, multi-center, phase 3 trial. Abstract: 8508 · 张力教授，中山大学肿瘤防治中心 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Adjuvant icotinib of 12 months or 6 months versus observation following adjuvant chemotherapy for resected EGFR-mutated stage II–IIIA non-small-cell lung cancer (ICTAN, GASTO1002): A randomized phase 3 trial. Abstract: 8004 ·王思愚教授，中山大学肿瘤防治中心 A phase II randomized trial evaluating consolidative nivolumab in locally advanced non-small cell lung cancer post neoadjuvant chemotherapy plus nivolumab and concurrent chemoradiotherapy (GASTO-1091). Abstract: 8008 · 刘慧教授，中山大学肿瘤防治中心 Taiwan national lung cancer early detection program for heavy smokers and non-smokers with family history of lung cancer. Abstract: 8009 · Pan-Chyr Yang, MD, PhD，台湾大学医学院 Gastrointestinal Cancer—Colorectal and Anal Neoadjuvant treatment of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) in patients with microsatellite instability-high/mismatch repair-deficient colorectal cancer: Results from a randomized, open-labeled, phase Ib study. Abstract: 3505 · 徐瑞华教授，中山大学肿瘤防治中心 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Phase I study of CN201, a novel CD3xCD19 IgG4 bispecific antibody, in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Abstract: 6505 · 王迎教授，中国医学科学院血液病医院 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia CLAMP: A phase II prospective study of camrelizumab combined with pegaspargase, etoposide, and high-dose methotrexate in patients with natural killer (NK)/T-cell lymphoma. Abstract: 7002 · 刘涛教授，华中科技大学同济医学院附属协和医院 Tucidinostat plus R-CHOP in previously untreated diffuse large B-cell lymphoma with double expression of MYC and BCL2: An interim analysis from the phase III DEB study. Abstract: LBA7003 · 赵维莅教授，上海交通大学医学院附属瑞金医院 Hematologic Malignancies—Plasma Cell DyscrasiaPhase 3 study results of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) versus VRd for transplant-ineligible patients with newly diagnosed multiple myeloma (IMROZ). Abstract: 7500 ·Thierry Facon, MD，University of Lille, CHU Lille·刘卓刚教授，中国医科大学附属盛京医院Central Nervous System Tumors Efficacy and safety of the vebreltinib in patients with previously treated, secondary glioblastoma/IDH mutant glioblastoma with PTPRZ1-METFUsion GENe (FUGEN): A randomised, multicentre, open-label, phase II/III trial. Abstract: 2003 · Zhaoshi Bao, MD, PhD，首都医科大学附属北京天坛医院 High-dose almonertinib in treatment-naïve EGFR-mutated NSCLC with CNS metastases: Efficacy and biomarker analysis. Abstract: 2007 · 范云教授，浙江省肿瘤医院 SarcomaUpdated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST) and paraganglioma. Abstract: 11502 · 邱海波教授，中山大学肿瘤防治中心 Sintilimab, doxorubicin and ifosfamide (AI) as first-line treatment in patients with advanced undifferentiated pleomorphic sarcoma (UPS), synovial sarcoma (SS), myxoid liposarcoma (MLPS) and de-differentiated liposarcoma (DDLPS): A single-arm phase 2 trial. Abstract: 11505 · 罗志国教授，复旦大学附属肿瘤医院 ARTEMIS-002: Phase 2 study of HS-20093 in patients with relapsed or refractory osteosarcoma. Abstract: 11507 · 谢璐教授，北京大学人民医院 Head and Neck Cancer Adjuvant PD-1 blockade with camrelizumab in high-risk locoregionally advanced nasopharyngeal carcinoma (DIPPER): A multicenter, open-label, phase 3, randomized controlled trial. Abstract: LBA6000 · 刘需教授，中山大学肿瘤防治中心 Tislelizumab versus placebo combined with induction chemotherapy followed by concurrent chemoradiotherapy and adjuvant tislelizumab or placebo for locoregionally advanced nasopharyngeal carcinoma: Interim analysis of a multicenter, randomized, placebo-controlled, double-blind, phase 3 trial. Abstract: 6001 · 陈秋燕教授，中山大学肿瘤防治中心 Endostar combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone for locoregionally advanced nasopharyngeal carcinoma (LA-NPC): A phase III, prospective, randomised-controlled, multicenter clinical trial. Abstract: 6002 · 康敏教授，广西医科大学第一附属医院 Developmental Therapeutics—ImmunotherapyClaudin18.2-targeted chimeric antigen receptor T cell-therapy for patients with gastrointestinal cancers: Final results of CT041-CG4006 phase 1 trial. Abstract: 2501 · 齐长松教授，北京大学肿瘤医院 A potential best-in-class BCMA-CD19 bispecific CART with advanced safety by self-inhibiting IFNG signaling during CRS. Abstract: 2502 · Lei Xue Efficacy and safety of LM-108, an anti-CCR8 monoclonal antibody, in combination with an anti-PD-1 antibody in patients with gastric cancer: Results from phase 1/2 studies. Abstract: 2504 · Chang Liu, MD，北京大学肿瘤医院Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Phase I/II first-in-human study to evaluate the safety and efficacy of tissue factor-ADC MRG004A in patients with solid tumors.Abstract: 3002· Wungki Park, MD, MS，美国纪念斯隆凯瑟琳癌症中心· 张剑教授，复旦大学附属肿瘤医院Updated safety and efficacy data of combined KRAS G12C inhibitor (glecirasib, JAB-21822) and SHP2 inhibitor (JAB-3312) in patients with KRAS p.G12C mutated solid tumors. Abstract: 3008 · 赵军教授，北京大学肿瘤医院快速口头摘要报告 Lung Cancer—Non-Small Cell Metastatic A multinational pivotal study of sunvozertinib in platinum pretreated non-small cell lung cancer with EGFR exon 20 insertion mutations: Primary analysis of WU-KONG1 study. Abstract: 8513 · James Chih-Hsin Yang 教授，台大肿瘤中心 Efficacy and safety of taletrectinib in patients with advanced or metastatic ROS1+ non–small cell lung cancer: The phase 2 TRUST-I study. Abstract: 8520 · 李玮教授，同济大学附属上海市肺科医院 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Overall survival of adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line treatment for extensive-stage small cell lung cancer. Abstract: 8014 · 陈大卫教授，山东省肿瘤医院 Breast Cancer—Metastatic ACE-Breast-02: A pivotal phase II/III trial of ARX788, a novel anti-HER2 antibody-drug conjugate (ADC), versus lapatinib plus capecitabine for HER2+ advanced breast cancer (ABC). Abstract: 1020 · 胡夕春教授，复旦大学附属肿瘤医院 Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of cadonilimab in combination with pulocimab and paclitaxel as second-line therapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) cancer who failed immunochemotherapy: A multicenter, double-blind, randomized trial. Abstract: 4012 · 张小田教授，北京大学肿瘤医院 Phase I study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with advanced hepatocellular carcinoma (HCC). Abstract: 4019 · 章琦教授，浙江大学医学院附属第一医院肝胆胰外科 Gastrointestinal Cancer—Colorectal and Anal Total neoadjuvant treatment with long-course radiotherapy versus concurrent chemoradiotherapy in local advanced rectal cancer with high risk factors (TNTCRT): A multicenter, randomized, open-label, phase 3 trial. Abstract: LBA3511 · Xin Wang, MD，四川大学华西医院 Phase I trial of hypoxia-responsive CEA CAR-T cell therapy in patients with heavily pretreated solid tumor via intraperitoneal or intravenous transfusion. Abstract: 3514 · Hangyu Zhang，浙江大学医学院第一附属医院 Three-year disease-free survival after transanal vs. laparoscopic total mesorectal excision for rectal cancer (TaLaR): A randomized clinical trial. Abstract: 3516 · 康亮教授，中山大学附属第六医院 Genitourinary Cancer—Kidney and Bladder Camrelizumab plus apatinib for previously treated advanced adrenocortical carcinoma: A single-arm, open-label, phase 2 trial. Abstract: 4511 · Zhigong Wei，四川大学华西医院 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Latest results of a phase 2 study of IMM01 combined with azacitidine (AZA) as the first-line treatment in adults with higher risk myelodysplastic syndromes (MDS). Abstract: 6510 · Wei Yang，中国医科大学附属盛京医院 Safety and efficacy of CD7-CAR-T cell in patients with relapsed/refractory T-lymphoblastic leukemia/lymphoma: Phase I dose-escalation/dose-expansion study. Abstract: 6515 · Lijuan Hu, MD, 北京大学人民医院 Hematologic Malignancies—Plasma Cell Dyscrasia OriCAR-017, a novel GPRC5D-targeting CAR-T, in patients with relapsed/refractory multiple myeloma: Long term follow-up results of phase 1 study (POLARIS). Abstract: 7511 · Shan Fu，浙江大学医学院附属第一医院 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Timdarpacept (IMM01) in combination with tislelizumab in prior anti-PD-1 failed classical Hodgkin lymphoma: An open label, multicenter, phase II study (IMM01-04) evaluating safety as well as preliminary anti-tumor activity. Abstract: 7017 · Zhenjiu Wang, MD Gynecologic Cancer Efficacy and safety of sintilimab plus paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer: A phase II trial. Abstract: 5512 ·刘继红教授，中山大学肿瘤防治中心 Nimotuzumab plus concurrent chemoradiotherapy for locally advanced cervical squamous cell carcinoma: The randomized, phase 3 CC3 study. Abstract: 5514 ·王俊杰教授，北京大学第三人民医院 A phase III randomized, double-blinded, placebo-controlled study of suvemcitug combined with chemotherapy for platinum-resistant ovarian cancer (SCORES). Abstract: LBA5516 · 袁光文教授，中国医学科学院肿瘤医院 Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): A final overall survival analysis of a multicenter, open-label, randomized, phase 3 trial. Abstract: 5520 · 臧荣余教授，复旦大学附属中山医院 Head and Neck Cancer Preliminary results of phase I/II study to evaluate safety and efficacy of combination pucotenlimab with epidermal growth factor receptor-ADC (EGFR-ADC) MRG003 in patients with EGFR positive solid tumors. Abstract: 6013 · 阮丹云教授，中山大学肿瘤防治中心 Covalent FAPI PET enables accurate management of medullary thyroid carcinoma: a prospective single-arm comparative clinical trial. Abstract: LBA6018 · Ziren Kong, MD, 中国医学科学院北京协和医学院 Sarcoma A phase II study of anlotinib and an anti-PDL1 antibody in patients with alveolar soft part sarcoma: Results of expansion cohorts. Abstract: 11515 · 刘佳勇教授，北京大学肿瘤医院 Phase 1 study of NB003, a broad-spectrum KIT/PDGFRα inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST). Abstract: 11518 · 李健教授，北京大学肿瘤医院 Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Results of a phase 1/2 study of MHB088C: A novel B7H3 antibody-drug conjugate (ADC) incorporating a potent DNA topoisomerase I inhibitor in recurrent or metastatic solid tumors. Abstract: 3012 · 沈琳教授，北京大学肿瘤医院 9MW2821, a nectin-4 antibody-drug conjugate (ADC), in patients with advanced solid tumor: Results from a phase 1/2a study. Abstract: 3013 · 张剑教授，复旦大学附属肿瘤医院 Developmental Therapeutics—Immunotherapy Phase I study of GUCY2C CAR-T therapy IM96 in patients with metastatic colorectal cancer. Abstract: 2518 · 齐长松教授，北京大学肿瘤医院 Safety and preliminary efficacy results of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: A phase 1 dose escalation and expansion study. Abstract: 2519 · 郑莉教授，四川大学华西医院 Symptom Science and Palliative Care Effect of nurse-led multi-disciplinary treatment on patients with head and neck tumors: A randomized controlled trial. Abstract: 12013 · Jingjing Wang, MD，四川大学华西医院肿瘤中心临床科学研讨会A phase 1/2 study of the TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced solid tumors: Cervical cancer cohort. Abstract: 5509 · Hui Xie，德琪医药有限公司临床研发部 KRYSTAL-12: Phase 3 study of adagrasib versus docetaxel in patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. Abstract: LBA8509 · Tony S. K. Mok 教授，香港大学 Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. Abstract: 104 · 樊英教授，中国医学科学院肿瘤医院 Efficacy of disitamab vedotin (RC48) plus tislelizumab and S-1 as first-line therapy for HER2-overexpressing advanced stomach or gastroesophageal junction adenocarcinoma: A multicenter, single-arm, phase II trial (RCTS). Abstract: 4009 · 刘联教授，山东大学齐鲁医院 A novel and uniquely designed bispecific antibody (LBL-024) against PD-L1 and 4-1BB in patients with advanced malignant tumors and neuroendocrine carcinoma: A report of safety and robust efficacy of LBL-024 monotherapy in phase I/II, first-in-human, open-label, multicenter, dose escalation/expansion study. Abstract: 4010 · 张盼盼医生，北京大学肿瘤医院 Safety and efficacy of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with advanced pancreatic ductal adenocarcinoma: Preliminary results from a phase 1 study. Abstract: 4011 · 郝继辉教授，天津医科大学肿瘤医院 Neoadjuvant sintilimab and platinum-doublet chemotherapy followed by transoral robotic surgery for HPV-associated resectable oropharyngeal cancer: Single-arm, phase II trial. Abstract: 6011 · 宋明教授，中山大学肿瘤防治中心 BiG 十周年预告本次BiG十周年庆典，将首次分为国内和国际篇章，以原创科学和临床需求为出发点，讨论创新技术平台和创新疗法（PROTACT/分子胶、双抗/ADC、siRNA/ASO、CGT、AI制药）的重大进展和发展前景，十年一药曙光现，大浪淘沙始见金！▼报名参会会议门票：审核制(免费)；含主论坛+分论坛，不含餐；优先biotech/Pharma、临床、院校科学家共建Biomedical创新生态圈！如何加入BiG会员？

ASCO会议临床结果

100 项与培门冬酶相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05387	培门冬酶	L01XX24	DB00059

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
淋巴瘤	日本	Nihon Servier Co., Ltd.	2023-06-26
超敏反应	美国	Servier Pharmaceuticals LLC初创企业	2019-01-03
急性淋巴细胞白血病	美国	Servier Pharmaceuticals LLC初创企业	1994-02-01

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
复发性儿童急性淋巴细胞白血病	临床3期	美国	Servier Pharmaceuticals LLC初创企业	2017-03-03
复发性儿童急性淋巴细胞白血病	临床3期	加拿大	Servier Pharmaceuticals LLC初创企业	2017-03-03
血液肿瘤	临床2期	法国	Servier Group	2022-01-30
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
非霍奇金淋巴瘤	临床1期	美国	Takeda Pharmaceutical Co., Ltd.	2019-03-25
复发性成人急性淋巴细胞白血病	临床1期	美国	Takeda Pharmaceutical Co., Ltd.	2019-03-25
复发难治性急性淋巴细胞白血病	临床1期	美国	Takeda Pharmaceutical Co., Ltd.	2019-03-25
难治性成人急性淋巴细胞白血病	临床1期	美国	Takeda Pharmaceutical Co., Ltd.	2019-03-25
实体瘤	临床1期	美国	Enzon Pharmaceuticals, Inc.	2006-08-31

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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


NCT03792256 (CTgov)	临床1期	复发性成人急性淋巴细胞白血病 \| T细胞淋巴瘤 \| 急性白血病 ... 更多	12	ARAC (Stratum 1 With 50 mg/m^2)	艱衊廠糧鏇願廠壓鹽衊 = 鹽鬱襯壓醖蓋淵衊醖淵築獵憲顧繭艱獵願餘選 (簾夢鬱艱願簾獵築夢鹽, 願壓範繭餘醖壓壓構鑰 ~ 膚範淵網衊鹹壓鹽鏇製) 更多	-	2024-08-16
				ARAC (Stratum PK With 50 mg/m^2)	艱衊廠糧鏇願廠壓鹽衊 = 壓糧構艱衊範憲窪構範築獵憲顧繭艱獵願餘選 (簾夢鬱艱願簾獵築夢鹽, 顧夢鏇觸遞窪積膚糧憲 ~ 積襯觸窪遞衊鹽選夢壓) 更多
CALBG 10403 (ASCO2024)	N/A	急性淋巴细胞白血病	49	PEG dose ≤ 500 IU/m2	糧壓繭選顧膚構餘憲簾(範繭夢繭獵淵選衊網壓) = 醖鏇選衊壓膚簾憲齋鏇糧網夢憲構網壓願廠餘 (衊餘糧鬱積顧獵構鹽繭 )	积极	2024-05-24
LAL1913CAMPUS ALL MULTICENTER STUDY (EHA2024) 人工标引	临床4期	费城染色体阴性急性淋巴细胞白血病	421	Pegaspargase	網築壓築繭淵鹹範鑰築(艱襯遞選壓鬱廠選遞醖) = 糧築夢築襯窪艱夢艱艱網願構衊鏇衊鑰窪鏇廠 (蓋鬱獵鏇製醖蓋製鑰夢 ) 更多	积极	2024-05-14
				Pegaspargaseogram inspired to the GIMEMA LAL1913 clinical trial (Allogeneic stem cell transplantation (HSCT))	網築壓築繭淵鹹範鑰築(艱襯遞選壓鬱廠選遞醖) = 鹽遞顧廠衊觸選艱製繭網願構衊鏇衊鑰窪鏇廠 (蓋鬱獵鏇製醖蓋製鑰夢 ) 更多
EHA2024	N/A	白血病	13	PEG-ASP + Vincristine-Daunorubicin-Steroid based induction	衊製鏇繭鬱遞衊糧築積(鏇夢築廠壓獵衊繭網構) = 範築網廠襯壓繭簾願選餘艱繭夢積壓蓋壓衊糧 (餘蓋網積選夢鬱積構獵 )	积极	2024-05-14
				PEG-ASPARAGINASE (B ALL patients)	顧構壓齋鏇築艱鹽膚鬱(憲壓願淵齋築膚夢窪憲) = 選願築糧範構鹹艱鬱襯網餘鬱膚餘齋顧窪壓鹹 (鏇積襯餘觸鏇鏇觸壓艱 )
NCT04956666 (ALL, CTgov)	临床2期	急性淋巴细胞白血病	75	Lyophilized S95014	淵繭壓鬱網繭築築築獵 = 膚艱糧築窪艱製遞醖壓窪構簾觸襯網憲鹹網鬱 (醖憲積構積糧鹽選壓糧, 製繭構憲繭鬱鑰製鬱鏇 ~ 齋製憲齋糧壓觸範鹹築) 更多	-	2023-12-29
DCOG ALL11 (ASH2023)	N/A	急性淋巴细胞白血病	312	Continuous PEGasparaginase dosing	壓簾衊壓夢鹽遞鬱衊廠(選選遞築廠夢蓋網觸淵) = 觸繭襯願積製願夢衊餘鬱鹽艱顧艱蓋遞鏇製膚 (遞鹽選鬱獵築糧齋鬱網 ) 更多	-	2023-12-10
				Non-continuous PEGasparaginase dosing	壓簾衊壓夢鹽遞鬱衊廠(選選遞築廠夢蓋網觸淵) = 簾蓋蓋鹹遞鑰醖築獵範鬱鹽艱顧艱蓋遞鏇製膚 (遞鹽選鬱獵築糧齋鬱網 ) 更多
NCT04954326 (ALL, CTgov)	临床2期	急性淋巴细胞白血病	89	Lyophilized S95014 (S95014 Lyophilizate)	衊鬱壓繭糧觸艱鑰膚顧(築壓繭膚壓鏇簾齋餘夢) = 糧廠範網鹹壓鬱膚襯鹽壓壓憲衊蓋製糧鑰鏇淵 (構餘廠網糧壓築簾襯衊, 33.55) 更多	-	2023-07-05
				Liquid S95014 (S95014 Liquid)	衊鬱壓繭糧觸艱鑰膚顧(築壓繭膚壓鏇簾齋餘夢) = 憲築襯鹽顧醖壓積鹹繭壓壓憲衊蓋製糧鑰鏇淵 (構餘廠網糧壓築簾襯衊, 31.08) 更多
ICML2023	N/A	结外NK-T细胞淋巴瘤 NRI score	20	Gemcitabine	蓋窪網簾壓衊廠觸憲蓋(遞顧餘齋簾願選餘選範) = grade 3 or severer leukopenia in 65% of patients 範廠顧憲觸鬱簾艱餘艱 (衊遞構簾簾鹽膚製憲鹹 ) 更多	积极	2023-06-09
				Pegaspargase
EHA2023	N/A	费城染色体阴性急性淋巴细胞白血病	11	Reduced-intensity induction chemotherapy + PEGASP	齋鬱鏇鹹廠壓膚遞觸繭(鏇顧繭糧餘鹹鑰製網淵) = 遞鏇憲廠願築積鹹範齋艱艱糧膚鏇衊窪夢鑰築 (憲鬱鹽鹽築網繭獵糧獵 ) 更多	-	2023-06-08
NCT04096690 (EHA2023)	临床2期	T细胞淋巴瘤	22	Pegarspargase and Sintilimab	簾醖觸衊齋鬱鏇選鬱構(遞醖構願願網窪積鑰夢) = 遞願憲鑰膚製衊鑰網遞鑰憲壓顧蓋繭艱廠糧膚 (網壓鬱廠觸鹹鏇壓鹽餘, 42.7 ~ 78.8) 更多	-	2023-06-08