奥妥珠单抗(Obinutuzumab) - 药物靶点：CD20_在研适应症：CD20阳性B细胞慢性淋巴细胞白血病，CD20阳性滤泡性淋巴瘤，滤泡性淋巴瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Afutuzumab、Anti-CD20 monoclonal antibody R7159、Gazyvaro

+ [22]

靶点

CD20

作用方式

抑制剂

作用机制

CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、ADCC(抗体依赖的细胞毒作用)、CD20定向的溶细胞作用

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [6]

在研适应症

CD20阳性B细胞慢性淋巴细胞白血病CD20阳性滤泡性淋巴瘤滤泡性淋巴瘤+ [50]

非在研适应症

CD20阳性弥漫性大B细胞淋巴瘤CD20阳性血液肿瘤肉芽肿伴多血管炎+ [12]

原研机构

Roche Glycart AG

在研机构

Janssen-Cilag Ltd.F. Hoffmann-La Roche Ltd.Hoffmann-La Roche, Inc.

+ [18]

非在研机构

Hoffmann-La Roche Ltd.Janssen-Cilag GmbH

权益机构

Biogen, Inc.

Nippon Shinyaku Co., Ltd.

Genentech, Inc.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (2013-11-01),

慢性淋巴细胞白血病

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、突破性疗法 (美国)

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结构/序列

Sequence Code 68713L

来源: *****

Sequence Code 9699891H

来源: *****

关联

302

项与奥妥珠单抗相关的临床试验

NCT06922604

/ Not yet recruiting临床1期IIT

A Phase 1b Study of Glofitamab in CNS Lymphoma

This phase Ib trial tests the safety and side effects of glofitamab after pre-treatment with obinutuzumab and how well they work in treating patients with central nervous system (CNS) lymphoma. Glofitamab is a bispecific antibody that can bind to two different antigens (substances that cause the body to make a specific immune response) at the same time. Glofitamab binds to CD20 on lymphoma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Obinutuzumab can also be administered as a pre-treatment to make glofitamab safer and more tolerable. Giving glofitamab with obinutuzumab pre-treatment may be safe, tolerable, and/or effective in treating patients with CNS lymphoma.

开始日期2025-09-23

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06849713

/ Not yet recruiting临床2期IIT

A Phase 2 Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The purpose of this study is to determine the proportion of participants who achieve undetectable measurable residual disease (uMRD) in previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

开始日期2025-07-28

申办/合作机构

The Massachusetts General Hospital

[+1]

NCT06940661

/ Not yet recruiting临床2期IIT

Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis (Wegener's). Phase 2 Prospective, Open-label Study

The purpose of this study is to evaluate the efficacy and safety of obinutuzumab to induce clinical and serological remission in patients with relapsing PR3-ANCA granulomatosis with polyangiitis.

开始日期2025-06-01

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

100 项与奥妥珠单抗相关的临床结果

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100 项与奥妥珠单抗相关的转化医学

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100 项与奥妥珠单抗相关的专利（医药）

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1,094

项与奥妥珠单抗相关的文献（医药）

2025-04-28·NEPHROLOGY DIALYSIS TRANSPLANTATION

Obinutuzumab versus rituximab for the treatment of refractory primary membranous nephropathy

Article

作者: Xie, Qionghong ; Zhao, Wenqian ; Hao, Chuan-Ming ; Wang, Yifeng ; Li, Mingxin ; Chen, Ruiying ; Wu, Meihe ; Xu, Mingyue

ABSTRACT:

Background:

Rituximab has been shown effective in patients with primary membranous nephropathy refractory to glucocorticoids plus cyclophosphamide (GC + CTX) or calcineurin inhibitors (CNIs), but the response rates remain limited. Compared with rituximab, obinutuzumab is a humanized anti-CD20 monoclonal antibody with greater B-cell depletion capacity. This study was performed to investigate the effectiveness of obinutuzumab compared with rituximab in treating patients with refractory primary membranous nephropathy.

Methods:

A retrospective study was conducted at Huashan Hospital, Fudan University between 1 January 2015 and 31 July 2024, and included adult patients with primary membranous nephropathy who met the following criteria: (i) resistance to GC + CTX and/or CNI regimens, (ii) dependence on CNIs or (iii) relapse within 1 year after CTX discontinuation. The patients subsequently received either obinutuzumab or rituximab. The primary endpoint was treatment response, which was defined as overall remission of nephrotic syndrome with no need for rescue therapy after obinutuzumab versus rituximab treatment. The secondary measures included immunological remission and safety profiles.

Results:

Among the 51 participants, 20 received obinutuzumab and 31 received rituximab. The response rate was significantly greater in patients receiving obinutuzumab than in those receiving rituximab (90.0% vs 38.7%, P < .001) during a follow-up period of 24 [interquartile range (IQR) 10–34] months. Cox proportional hazards survival regression analysis also revealed the superior effectiveness of obinutuzumab (P < .001). Immunological remission rates were higher in patients receiving obinutuzumab at both 3 months (75.0% vs 20.0%, P < .001) and 6 months (87.5% vs 21.4%, P < .001). The safety profiles of the two treatments were comparable. Among the 19 non-responders treated with rituximab, 10 subsequently received obinutuzumab, and 8 achieved remission during a follow-up period of 20.0 (IQR 18.5–22.3) months.

Conclusion:

This retrospective study suggests that obinutuzumab is an effective treatment option for patients with primary membranous nephropathy refractory to GC + CTX, CNI and rituximab regimens.

2025-04-20·JOURNAL OF CLINICAL ONCOLOGY

Erratum: Phase II Study of Acalabrutinib, Venetoclax, and Obinutuzumab in a Treatment-Naïve Chronic Lymphocytic Leukemia Population Enriched for High-Risk Disease

Article

作者: Lo, Steve ; Ren, Yue ; Weinstock, Matthew ; Ahn, Inhye E. ; Kim, Austin I. ; Davids, Matthew S. ; Walker, Heather A. ; Brown, Jennifer R. ; Crombie, Jennifer L. ; LaCasce, Ann S. ; Lampson, Benjamin L. ; Ryan, Christine E. ; Greenman, Claire ; Tyekucheva, Svitlana ; Fisher, David C. ; Jacobson, Caron A. ; Armand, Philippe ; Montegaard, Josie ; Patterson, Victoria ; Olszewski, Adam J. ; Arnason, Jon E. ; Fernandes, Stacey M.

2025-04-17·NEW ENGLAND JOURNAL OF MEDICINE

Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis

Article

作者: Rovin, Brad H. ; Navarro Sandoval, Cleyber ; Kirchner, Petra ; Santiago, Mittermayer B. ; Zuta Santillán, Adolfina Elizabeth ; Malvar, Ana ; Schindler, Thomas ; Aroca-Martínez, Gustavo ; Yoo, Bongin ; Hassan, Imran ; Irazoque Palazuelos, Fedra ; Garg, Jay P. ; Sehgal, Himanshi ; Tumlin, James A. ; Lila, Alexander M. ; Omachi, Theodore A. ; Ross Terres, Jorge ; Furie, Richard A. ; Alvarez, Damaris ; Saxena, Amit ; Raghu, Harini ; Martins, Elsa ; Pendergraft, William F.

BACKGROUND:

Obinutuzumab, a humanized type II anti-CD20 monoclonal antibody, provided significantly better renal responses than placebo in a phase 2 trial involving patients with lupus nephritis receiving standard therapy.

METHODS:

In a phase 3, randomized, controlled trial, we assigned adults with biopsy-proven active lupus nephritis in a 1:1 ratio to receive obinutuzumab in one of two dose schedules (1000 mg on day 1 and at weeks 2, 24, 26, and 52, with or without a dose at week 50) or placebo. All patients received standard therapy with mycophenolate mofetil, along with oral prednisone at a target dose of 7.5 mg per day by week 12 and 5 mg per day by week 24. The primary end point was a complete renal response at week 76, defined by a urinary protein-to-creatinine ratio of less than 0.5 (with protein and creatinine both measured in milligrams), an estimated glomerular filtration rate of at least 85% of the baseline value, and no intercurrent event (i.e., rescue therapy, treatment failure, death, or early trial withdrawal). Key secondary end points at week 76 included a complete renal response with a prednisone dose of 7.5 mg per day or lower between weeks 64 and 76 and a urinary protein-to-creatinine ratio lower than 0.8 without an intercurrent event.

RESULTS:

A total of 271 patients underwent randomization; 135 were assigned to the obinutuzumab group (combined dose schedules) and 136 to the placebo group. A complete renal response at week 76 was observed in 46.4% of the patients in the obinutuzumab group and 33.1% of those in the placebo group (adjusted difference, 13.4 percentage points; 95% confidence interval [CI], 2.0 to 24.8; P = 0.02). A complete renal response at week 76 with a prednisone dose of 7.5 mg per day or lower between weeks 64 and 76 was observed in more patients in the obinutuzumab group than in the placebo group (42.7% vs. 30.9%; adjusted difference, 11.9 percentage points; 95% CI, 0.6 to 23.2; P = 0.04), and a urinary protein-to-creatinine ratio lower than 0.8 without an intercurrent event was more common with obinutuzumab than with placebo (55.5% vs. 41.9%; adjusted difference, 13.7 percentage points; 95% CI, 2.0 to 25.4; P = 0.02). No unexpected safety signals were identified. More serious adverse events, mainly infections and events related to coronavirus disease 2019, occurred with obinutuzumab than with placebo.

CONCLUSIONS:

Among adults with active lupus nephritis, obinutuzumab plus standard therapy was more efficacious than standard therapy alone in providing a complete renal response. (Funded by F. Hoffmann-La Roche; REGENCY ClinicalTrials.gov number, NCT04221477.).

444

项与奥妥珠单抗相关的新闻（医药）

2025-04-30

·药时代

百济神州索托克拉冲刺上市，引领BCL2抑制剂新纪元！

从泽布替尼到索托克拉，百济神州血液肿瘤管线再突破。2025年4月28日，国家药品监督管理局（NMPA）药品审评中心（CDE）正式受理百济神州在研BCL2抑制剂索托克拉片（英文通用名: sonrotoclax）的新药上市申请（NDA），并已纳入优先审评程序，拟用于治疗既往接受过治疗的慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）成人患者。索托克拉是百济神州自主研发的新一代BCL2抑制剂，也是百济神州继泽布替尼之后有望面市的又一款血液肿瘤的自研产品，或将进一步夯实百济神州在CLL/SLL治疗领域的研发实力。截图来自：CDE官网百济神州高级副总裁、全球研发负责人汪来博士表示：“CLL/SLL是成人常见的血液系统恶性肿瘤，改善患者的长期生存和生活质量至关重要。很高兴看到百济神州在新一代BCL2抑制剂领域取得突破。我们将继续致力于推动创新药物的研发与落地，以期为中国患者带来更多创新治疗选择。”CLL是一种危及生命的B淋巴细胞恶性肿瘤，是成人血液肿瘤最常见的类型之一1、2。CLL源于骨髓的异常白血病B淋巴细胞（白细胞的一种），并可累及外周血和淋巴组织。SLL与CLL是同一种疾病的不同表现，约20％的SLL会进展为CLL3。典型症状包括淋巴结肿大、脾肿大、疲劳、体重减轻和反复感染等4。中国CLL发病率约为三十七万分之一，每年新增患者7000-8000例，患者主要为老年人群，中位发病年龄为65岁5。相较西方国家，中国CLL患者的中位生存期较短，且更容易出现疾病进展和复发，总体预后情况较差6、7。随着中国人口老龄化加速及临床诊断水平提升，中国CLL发病率持续上升。近年来，创新治疗方式不断涌现，以BTK抑制剂、CD20单抗等为代表的靶向治疗药物不断改善CLL患者的预后，开启了CLL治疗的“无化疗”时代。但CLL患者的预后仍存在诸多未被满足的需求，包括缓解深度不够，高危患者生存期有待改善，长期用药依从性不佳等。为此，临床正在开展广泛探索以满足患者的未尽之需。围绕BCL2靶点的临床研究为改善CLL患者预后提供了新的可能。BCL2蛋白是一种调控细胞自然死亡的关键因子，在多种血液恶性肿瘤中有不同程度的表达，是肿瘤细胞逃避凋亡、以及产生耐药的重要因素之一8。BCL2抑制剂能特异性地结合并抑制BCL2蛋白，模拟自然细胞死亡信号，从而诱导癌细胞死亡。BCL2抑制剂的出现，为CLL治疗开辟了全新路径。索托克拉作为百济神州自主研发的新一代BCL2抑制剂，旨在阻断可帮助肿瘤细胞存活的BCL2蛋白。实验室和早期药物开发研究结果已表明，索托克拉半衰期短且无蓄积，已在多种B细胞恶性肿瘤中表现出良好的临床活性9。得益于BCL2抑制剂通过恢复凋亡程序增强其他疗法的杀伤效果，以及同时覆盖多通路以克服耐药性的核心作用机制，其在靶向联合、免疫联合等领域应用前景广阔。目前，临床上已有BCL2抑制剂与BTK抑制剂、化疗、免疫治疗等药物联合使用的临床研究，或可进一步提升临床获益。除了索托克拉单药治疗的探索，百济神州已开展了四项索托克拉联用泽布替尼的联合治疗相关临床研究，包括两项分别用于治疗华氏巨球蛋白血症（WM）、未经治疗的慢性淋巴细胞白血病（TN CLL）的2期临床试验和两项分别用于治疗TN CLL、复发/难治性套细胞淋巴瘤（R/R MCL）的3期临床试验。其中，索托克拉联合泽布替尼作为固定周期治疗方案，在3期CELESTIAL试验中用于CLL患者的一线治疗10，有望进一步推动CLL从长期治疗转变为有限周期治疗。根据百济神州公开披露信息，截至目前，百济神州围绕索托克拉已针对不同适应症和不同联合治疗入组了1800多例患者，且现有临床研究所获得的有效性信号和安全性数据持续印证了该药物在临床前试验中表现出的潜力。1.National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)–Patient Version. Accessed November 2023. https://www.cancer.gov/types/leukemia/hp/cll-treatment-pdq.2.American Cancer Society. What is Chronic Lymphocytic Leukemia? Updated May 10, 2018. Accessed November 2023. https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/what-is-cll.html.3.中国抗癌协会血液肿瘤专业委员会，中华医学会血液学分会.中国慢性淋巴细胞白血病/小淋巴细胞淋巴瘤的诊断与治疗指南（2022年版）4.仝佳音,侯韶英,杨学文,赵小强,刘静静.慢性淋巴细胞白血病患者PD-1免疫抑制剂治疗的疗效及预后[J].实用癌症杂志,2024,39(6):953-956.5.朱水清,杜立哲,陶立波,肖敦明,张玥,徐映锐,宣建伟.中国慢性淋巴细胞白血病患者的年均经济负担分析[J].中国医疗保险,2018,(11):56-62.6.马兰,李艳,王继军,景红梅.慢性淋巴细胞白血病患者临床特征及长期生存分析[J].中国实验血液学杂志,2023,31(5):1345-13517.丁艳玲,李杰,袁军,李燕.慢性淋巴细胞白血病靶向治疗的研究进展[J].上海交通大学学报（医学版）,2024,44(2):264-270.8.曾文,田俊波,肖建华,董自强.Bcl-2抑制剂研究进展[J].实用医学杂志,2013,29(4):665-666.9.Pau Montesinos, et al. "Preliminary Safety and Antileukemic Activity of Sonrotoclax (BGB-11417), a Potent and Selective BCL2 Inhibitor, in Patients with Relapsed/Refractory Acute Myeloid Leukemia." Montesinos BGB-11417-103 RR EHA Abstract 2024. EHA 2024.10.Mazyar Shadman et al. CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naïve (TN) CLL.. JCO 42, TPS7087-TPS7087(2024).DOI:10.1200/JCO.2024.42.16_suppl.TPS7087百济神州PD-1在美国开出首张处方！自有国际实体瘤商业化团队开启新篇章2024-10-28今晚8点！百济PD-1面临FDA大考2024-09-25百济神州持续深耕血液肿瘤领域引领全新时代2024-07-16点击这里，更多了解百济神州!

优先审批申请上市临床研究

2025-04-30

·研发客

百济神州血液肿瘤管线又一重磅！BCL2抑制剂索托克拉申报上市并获CDE受理 | 新闻稿

2025年4月28日，国家药品监督管理局（NMPA）药品审评中心（CDE）正式受理百济神州在研BCL2抑制剂索托克拉片（英文通用名: sonrotoclax）的新药上市申请（NDA），并已纳入优先审评程序，拟用于治疗既往接受过治疗的慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）成人患者。索托克拉是百济神州自主研发的新一代BCL2抑制剂，也是百济神州继泽布替尼之后有望面市的又一款血液肿瘤的自研产品，或将进一步夯实百济神州在CLL/SLL治疗领域的研发实力。来源|CDE官网百济神州高级副总裁、全球研发负责人汪来博士表示：“CLL/SLL是成人常见的血液系统恶性肿瘤，改善患者的长期生存和生活质量至关重要。很高兴看到百济神州在新一代BCL2抑制剂领域取得突破。我们将继续致力于推动创新药物的研发与落地，以期为中国患者带来更多创新治疗选择。”CLL是一种危及生命的B淋巴细胞恶性肿瘤，是成人血液肿瘤最常见的类型之一1,2。CLL源于骨髓的异常白血病B淋巴细胞（白细胞的一种），并可累及外周血和淋巴组织。SLL与CLL是同一种疾病的不同表现，约20％的SLL会进展为CLL3。典型症状包括淋巴结肿大、脾肿大、疲劳、体重减轻和反复感染等4。中国CLL 发病率约为三十七万分之一，每年新增患者 7000~8000 例，患者主要为老年人群，中位发病年龄为65岁5。相较西方国家，中国CLL患者的中位生存期较短，且更容易出现疾病进展和复发，总体预后情况较差6,7。随着中国人口老龄化加速及临床诊断水平提升，中国CLL发病率持续上升。近年来，创新治疗方式不断涌现，以BTK抑制剂、CD20单抗等为代表的靶向治疗药物不断改善CLL患者的预后，开启了CLL治疗的“无化疗”时代。但CLL患者的预后仍存在诸多未被满足的需求，包括缓解深度不够，高危患者生存期有待改善，长期用药依从性不佳等。为此，临床正在开展广泛探索以满足患者的未尽之需。围绕BCL2靶点的临床研究为改善CLL患者预后提供了新的可能。BCL2蛋白是一种调控细胞自然死亡的关键因子，在多种血液恶性肿瘤中有不同程度的表达，是肿瘤细胞逃避凋亡、以及产生耐药的重要因素之一8。BCL2抑制剂能特异性地结合并抑制BCL2蛋白，模拟自然细胞死亡信号，从而诱导癌细胞死亡。BCL2抑制剂的出现，为CLL治疗开辟了全新路径。索托克拉作为百济神州自主研发的新一代 BCL2 抑制剂，旨在阻断可帮助肿瘤细胞存活的BCL2蛋白。实验室和早期药物开发研究结果已表明，索托克拉半衰期短且无蓄积，已在多种B细胞恶性肿瘤中表现出良好的临床活性9。得益于BCL2抑制剂通过恢复凋亡程序增强其他疗法的杀伤效果，以及同时覆盖多通路以克服耐药性的核心作用机制，其在靶向联合、免疫联合等领域应用前景广阔。目前，临床上已有BCL2抑制剂与BTK抑制剂、化疗、免疫治疗等药物联合使用的临床研究，或可进一步提升临床获益。除了索托克拉单药治疗的探索，百济神州已开展了四项索托克拉联用泽布替尼的联合治疗相关临床研究，包括两项分别用于治疗华氏巨球蛋白血症（WM）、未经治疗的慢性淋巴细胞白血病（TN CLL）的2期临床试验和两项分别用于治疗TN CLL、复发/难治性套细胞淋巴瘤（R/R MCL）的3期临床试验。其中，索托克拉联合泽布替尼作为固定周期治疗方案，在3期CELESTIAL试验中用于CLL患者的一线治疗10，有望进一步推动CLL从长期治疗转变为有限周期治疗。根据百济神州公开披露信息，截至目前，百济神州围绕索托克拉已针对不同适应症和不同联合治疗入组了1800多例患者，且现有临床研究所获得的有效性信号和安全性数据持续印证了该药物在临床前试验中表现出的潜力。参考来源：（滑动查看）1.National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)–Patient Version. Accessed November 2023. https://www.cancer.gov/types/leukemia/hp/cll-treatment-pdq.2.American Cancer Society. What is Chronic Lymphocytic Leukemia? Updated May 10, 2018. Accessed November 2023. https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/what-is-cll.html.3.中国抗癌协会血液肿瘤专业委员会，中华医学会血液学分会.中国慢性淋巴细胞白血病/小淋巴细胞淋巴瘤的诊断与治疗指南（2022年版）4.仝佳音,侯韶英,杨学文,赵小强,刘静静.慢性淋巴细胞白血病患者PD-1免疫抑制剂治疗的疗效及预后[J].实用癌症杂志,2024,39(6):953-956.5.朱水清,杜立哲,陶立波,肖敦明,张玥,徐映锐,宣建伟.中国慢性淋巴细胞白血病患者的年均经济负担分析[J].中国医疗保险,2018,(11):56-62.6.马兰,李艳,王继军,景红梅.慢性淋巴细胞白血病患者临床特征及长期生存分析[J].中国实验血液学杂志,2023,31(5):1345-13517.丁艳玲,李杰,袁军,李燕.慢性淋巴细胞白血病靶向治疗的研究进展[J].上海交通大学学报（医学版）,2024,44(2):264-270.8.曾文,田俊波,肖建华,董自强.Bcl-2抑制剂研究进展[J].实用医学杂志,2013,29(4):665-666.9.Pau Montesinos, et al. "Preliminary Safety and Antileukemic Activity of Sonrotoclax (BGB-11417), a Potent and Selective BCL2 Inhibitor, in Patients with Relapsed/Refractory Acute Myeloid Leukemia." Montesinos BGB-11417-103 RR EHA Abstract 2024. EHA 2024.10.Mazyar Shadman et al. CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naïve (TN) CLL.. JCO 42, TPS7087-TPS7087(2024).DOI:10.1200/JCO.2024.42.16_suppl.TPS7087

优先审批申请上市

2025-04-30

·PMLiVE

AstraZeneca’s Calquence regimens recommended by CHMP for chronic lymphocytic leukaemia

AstraZeneca (AZ) has announced that its Calquence (acalabrutinib) regimens have been recommended by the European Medicines Agency’s human medicines committee to treat chronic lymphocytic leukaemia (CLL). The Committee for Medicinal Products for Human Use (CHMP) has recommended that a fixed-duration regimen of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, be approved for use in adults with previously untreated CLL. The CHMP’s positive opinion was based on results from the phase 3 AMPLIFY trial, in which Calquence plus venetoclax and Calquence plus venetoclax with obinutuzumab reduced the risk of disease progression or death by 35% and 58%, respectively, compared to standard-of-care chemoimmunotherapy. After three years, 77% of patients receiving Calquence plus venetoclax and 83% of those being treated with Calquence plus venetoclax and obinutuzumab were progression free, compared to 67% in the chemoimmunotherapy cohort. Additionally, median progression-free survival was not reached for either Calquence arm and was 47.6 months for chemoimmunotherapy. An estimated 27,000 cases of CLL were diagnosed in the UK, France, Germany, Spain and Italy in 2024, making the disease the most common type of leukaemia in adults. Despite being considered an incurable cancer, patients often live with CLL for many years and may remain on continuous treatment, which can have long-term effects. AZ’s Calquence is designed to inhibit the activity of the Bruton’s tyrosine kinase (BTK) protein that leads to the growth of abnormal cancerous B cells. The drug is already approved in Europe to treat certain cases of CLL, and it is hoped that the fixed-duration regimens will minimise the risk of adverse events and drug resistance by allowing patients to take breaks from treatment. Susan Galbraith, executive vice president, oncology haematology research and development, AZ, said: “With this recommendation, Calquence plus venetoclax can potentially be the only all-oral second-generation BTK inhibitor option approved in Europe for patients with previously untreated CLL. “Calquence has demonstrated efficacy and safety in fixed-duration and treat-to-progression regimens providing patients and their doctors more treatment flexibility.” The European Commission will now review the CHMP’s recommendation as it makes a decision on Calquence in this indication.

临床结果上市批准临床3期免疫疗法

100 项与奥妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09321	奥妥珠单抗	L01XC15	DB08935

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
CD20阳性B细胞慢性淋巴细胞白血病	日本	Chugai Pharmaceutical Co., Ltd.	2022-12-23
CD20阳性滤泡性淋巴瘤	日本	Nippon Shinyaku Co., Ltd.	2018-07-02
CD20阳性滤泡性淋巴瘤	日本	Chugai Pharmaceutical Co., Ltd.	2018-07-02
滤泡性淋巴瘤	澳大利亚	F. Hoffmann-La Roche Ltd.	2014-05-15
慢性淋巴细胞白血病	美国	Genentech, Inc.	2013-11-01

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
狼疮性肾炎	申请上市	美国	Roche Holding AG	2025-03-05
边缘区B细胞淋巴瘤	申请上市	中国	F. Hoffmann-La Roche Ltd.	2019-09-28
肿瘤溶解综合征	临床3期	美国	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	澳大利亚	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	法国	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	希腊	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	波多黎各	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	塞尔维亚	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	西班牙	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	中国台湾	AbbVie, Inc.	2024-08-05

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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


NCT04285567 (CRISTALLO, CTgov)	临床3期	慢性淋巴细胞白血病	166	VEN (Arm A: VEN+G)	構遞窪選築糧遞遞鹹艱 = 遞淵窪廠窪願衊鹹選製餘醖鑰製鹹獵願衊製蓋 (齋獵鹹鹽鏇艱築膚鏇鏇, 糧顧憲鑰願鏇醖願簾鏇 ~ 積鬱顧鏇繭構範遞獵鏇) 更多	-	2025-04-17
				bendamustine+fludarabine+cyclophosphamide+rituximab (Arm B: FCR/BR)	構遞窪選築糧遞遞鹹艱 = 衊選鹽願鬱範衊夢壓齋餘醖鑰製鹹獵願衊製蓋 (齋獵鹹鹽鏇艱築膚鏇鏇, 積壓鑰醖觸鹹憲觸膚窪 ~ 餘鏇願築網鹹糧觸憲範) 更多
NCT03836261 (NEWS \| Pubmed) 人工标引	临床3期	慢性淋巴细胞白血病一线	867	Acalabrutinib-Venetoclax	顧鬱築醖遞選醖鬱蓋鏇(糧憲網窪淵膚網襯築製) = 範網鬱夢觸觸糧夢壓衊鹽構壓廠顧觸蓋夢艱製 (積鏇願願膚淵淵蓋遞醖 ) 更多	积极	2025-02-21
				Acalabrutinib-Venetoclax-Obinutuzumab	顧鬱築醖遞選醖鬱蓋鏇(糧憲網窪淵膚網襯築製) = 簾構餘鑰壓簾衊淵構製鹽構壓廠顧觸蓋夢艱製 (積鏇願願膚淵淵蓋遞醖 ) 更多
NCT04221477 (REGENCY, Literature \| BusinessWire) 人工标引	临床3期	狼疮性肾炎	271	obinutuzumab + standard therapy	構醖窪鬱蓋鏇糧鹽繭壓(繭繭積鏇製製壓獵構鹽) = 淵簾蓋憲繭顧鹹齋醖築壓鬱襯膚繭衊顧壓廠齋 (顧鏇鹽衊壓遞製齋鑰壓 ) 更多	积极	2025-02-07
				placebo + standard therapy	構醖窪鬱蓋鏇糧鹽繭壓(繭繭積鏇製製壓獵構鹽) = 衊醖蓋餘積鏇餘鏇齋願壓鬱襯膚繭衊顧壓廠齋 (顧鏇鹽衊壓遞製齋鑰壓 ) 更多
NCT03836261 (AMPLIFY, ASH2024) 人工标引	临床3期	慢性淋巴细胞白血病一线	867	Acalabrutinib + Venetoclax	遞齋選壓壓醖顧觸鏇製(簾繭襯鏇襯艱襯願願範) = 獵齋願鬱繭糧築醖醖範鏇積廠膚範夢鹽範積鏇 (膚齋醖齋製顧窪簾鹽構 ) 更多	积极	2024-12-09
				Acalabrutinib + Venetoclax + Obinutuzumab	遞齋選壓壓醖顧觸鏇製(簾繭襯鏇襯艱襯願願範) = 糧築糧顧顧醖鬱鹽願範鏇積廠膚範夢鹽範積鏇 (膚齋醖齋製顧窪簾鹽構 ) 更多
ASH2024 人工标引	N/A	慢性淋巴细胞白血病一线	-	Venetoclax + obinutuzumab (VO)	襯膚鬱夢鏇鏇鏇糧製壓(網憲艱夢積選範鬱夢鏇) = 顧膚繭襯壓遞憲選夢顧糧糧積網製願網壓選齋 (壓網積鑰蓋鬱鬱齋淵鏇 ) 更多	积极	2024-12-09
				Bruton tyrosine kinase inhibitor (BTKi)	襯膚鬱夢鏇鏇鏇糧製壓(網憲艱夢積選範鬱夢鏇) = 顧選衊夢鑰壓艱淵衊鹽糧糧積網製願網壓選齋 (壓網積鑰蓋鬱鬱齋淵鏇 ) 更多
NCT03223610 (ASH2024) 人工标引	临床1/2期	套细胞淋巴瘤	36	Venetoclax 2IbrutinibPrednisoneObinutuzumabLenalidomide	糧繭蓋膚襯糧鹽簾網顧(壓觸獵構範顧壓壓簾製) = thrombocytopenia (14%), neutropenia (13%), and anemia (10%) 壓構齋製衊壓獵鑰憲窪 (艱糧艱選遞簾艱鹹鏇網 ) 更多	积极	2024-12-09
				Venetoclax 4IbrutinibPrednisoneObinutuzumabLenalidomide
NCT04285567 (CRISTALLO, ASH2024)	临床3期	慢性淋巴细胞白血病 del(17p)	166	Venetoclax-Obinutuzumab	選觸憲獵獵鑰衊艱鏇製(簾蓋製遞糧鹽網鹹憲廠) = 窪廠網遞鹽蓋鹽構醖網製願襯遞遞鏇夢範製鹽 (鹹顧範鹹鹹蓋齋夢鹽糧, 12.3 ~ 40.9) 更多	积极	2024-12-08
				Fludarabine-Cyclophosphamide-Rituximab	選觸憲獵獵鑰衊艱鏇製(簾蓋製遞糧鹽網鹹憲廠) = 蓋廠廠築廠觸醖艱遞繭製願襯遞遞鏇夢範製鹽 (鹹顧範鹹鹹蓋齋夢鹽糧 ) 更多
ASH2024	N/A	慢性淋巴细胞白血病	-	Zanubrutinib	鏇淵範餘齋糧艱廠淵積(襯廠鏇網簾窪鑰積築餘) = No laboratory/clinical TLS occurred on study (Howard criteria) 簾觸遞築鑰製構獵窪鏇 (觸壓餘艱餘製鏇簾鹽窪 ) 更多	-	2024-12-07
ASH2024	N/A	肿瘤溶解综合征	-	Venetoclax-Obinutuzumab	醖獵淵築鹽願膚網願鬱(壓遞鹹製鹽遞醖糧艱鹽) = All TLS events occurred within the first week of O and none during Ven ramp-up. Of the 8 pts with TLS in the VenO arm, 6 were medium-risk and 2 were high-risk at baseline. Five pts in the VenO arm received tx for TLS, 2 pts had dose modification/interruption, and no pts withdrew from tx due to TLS. No events were fatal and all resolved (median time to resolution: 2 days [range: 1-4]) 簾衊築選積鏇齋繭製範 (鹹餘選鬱憲夢廠鏇齋鑰 )	-	2024-12-07
NCT03890289 (GAUDEALIS, CTgov)	临床2期	难治性滤泡性淋巴瘤	5	Idelalisib+Obinutuzumab	窪窪製鬱窪醖餘餘鹹蓋 = 鏇簾憲窪構網糧夢鏇餘鹽網壓鑰餘鹽餘窪鏇範 (鹽壓觸醖鹹繭觸範襯壓, 鹹遞選蓋積齋淵淵構蓋 ~ 鏇艱鬱選觸構築繭網憲) 更多	-	2024-11-21