Feasibility of Treating Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic/Racial Minorities

This phase I trial tests zanubrutinib in combination with sonrotoclax for treating underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Many racial and ethnic minorities face additional treatment challenges which may lead to poorer outcomes, however, there are fewer racial and ethnic minorities participating in clinical trials. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood cancer cells to survive and grow. When sonrotoclax blocks Bcl-2, it slows down or stops the growth of cancer cells and causes them to die. Zanubrutinib and sonrotoclax have been shown to be an effective treatment for B-cell cancers. Giving zanubrutinib in combination with sonrotoclax may be effective in treating ethnic and racial minorities with relapsed or refractory B-cell non-Hodgkin lymphoma.

开始日期2026-02-07

申办/合作机构

City of Hope National Medical Center

[+1]

NCT07052695

/ Not yet recruiting临床1/2期IIT

A Pilot Study Evaluating Mosunetuzumab for Clearance of Detectable Minimal Residual Disease in Chronic Lymphocytic Leukemia

The goal of this study is to test mosunetuzumab given alone or in combination with a Bruton tyrosine kinase inhibitor (BTKi, such as ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib) in participants with CLL (chronic lymphocytic leukemia) or small lymphocytic lymphoma (SLL).
The names of the study drugs in this research study are:
* Mosunetuzumab
* BTK inhibitor: Ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib

开始日期2025-09-30

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06665217

/ Not yet recruiting临床2期IIT

Glofitamab, Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma

The goal of this phase 2 trial is to test the safety and efficacy of G-Pola-ZLP as induction therapy in patients with DLBCL.

开始日期2025-09-24

申办/合作机构

海军总医院

100 项与泽布替尼相关的临床结果

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100 项与泽布替尼相关的转化医学

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100 项与泽布替尼相关的专利（医药）

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586

项与泽布替尼相关的文献（医药）

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

A case report: capillary leak syndrome in a patient receiving high-dose methotrexate, Tislelizumab and zanubrutinib for CNS lymphoma

Article

作者: Hou, Yuxi ; Li, Wenpeng

PURPOSE:

The high-dose methotrexate (MTX) regimen is a first-line treatment for primary central nervous system diffuse large B-cell lymphoma (PCNS-DLBCL). However, MTX-related kidney injury is a severe treatment complication. No cases of capillary leak syndrome (CLS) causing delayed MTX metabolism-associated renal failure have been reported.

CASE PRESENTATION:

A 48-year-old female presented to Zibo Central Hospital in April 2024 with headaches. Contrast-enhanced magnetic resonance imaging (MRI) of the brain revealed a space-occupying lesion in the right occipital lobe. A stereotactic biopsy was performed to determine the nature of the lesion. Postoperative pathology confirmed DLBCL. The patient underwent a TZM regimen, which included Tislelizumab, MTX, and Zanubrutinib. On the first day following MTX, the patient developed generalized edema, shortness of breath, and reduced urine output. Laboratory tests revealed hypoxemia, low albumin levels, and acute kidney injury. Based on these findings, the patient was diagnosed with CLS. To quickly lower the blood MTX concentration, pleural effusion drainage and continuous renal replacement therapy (CRRT) were performed. The treatment was successful, and the patient recovered and was discharged.

CONCLUSION:

CLS is a serious complication for DLBCL patients receiving high-dose MTX therapy.

2025-12-01·Blood Research

Relative efficacy of systemic treatments for patients with relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis according to 17p deletion/TP53 mutations

Article

作者: Lim, Joo Han ; Kim, Jinchul ; Lee, Moon Hee ; Cho, Jinhyun

Abstract:

Purpose:

This network meta-analysis aimed to evaluate the relative efficacy of systemic treatments in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), focusing on key genetic mutations, specifically the 17p deletion and TP53 mutations.

Methods:

We conducted a systematic literature review to identify all publicly available randomized controlled trials (RCTs) using PubMed, EMBASE, the Cochrane database, and meeting abstracts published through December 2023. A Bayesian network meta-analysis was performed to estimate the hazard ratios (HRs) for progression-free survival (PFS) with 95% confidence intervals (CIs) and to determine the ranking of the included regimens.

Results:

Twelve trials involving 4,437 patients and 13 treatment options were included in the meta-analysis. Venetoclax plus rituximab and zanubrutinib emerged as the most effective treatments for the overall R/R CLL population, showing the lowest PFS HR (HR 0.62, 95% CI 0.32–1.20 and HR 0.65, 95% CI 0.49–0.86, respectively) versus ibrutinib, and were ranked as the best agent (surface under the cumulative ranking curve [SUCRA] value of both 90%, respectively) among the included drugs. In the 17p deletion/TP53 mutation subgroup, zanubrutinib demonstrated the most favorable efficacy (HR 0.52, 95% CI 0.31–0.88 versus ibrutinib) with the highest SUCRA value (97%). In patients without these mutations, venetoclax plus rituximab was the most effective (HR 0.49, 95% CI 0.26–0.94 versus ibrutinib) with a SUCRA value of 94%.

Conclusion:

Our findings highlight the superior efficacy of venetoclax plus rituximab and zanubrutinib for treating R/R CLL and confirm that the role of each regimen may vary depending on the clinically significant mutations.

2025-09-01·American journal of ophthalmology case reports

Macular retinoschisis in a patient with multiple lymphoproliferative malignancies

Article

作者: Flaxel, Christina ; Cheng, Justine ; Williams, Todd ; Chen, Andy I ; Yang, Paul

Purpose:

To describe a case of macular retinoschisis in a patient with multiple systemic lymphoproliferative disorders and the challenges of accurate diagnosis of uveal lymphoma.

Observations:

A 66-year-old male presented with unilateral macular retinoschisis and choroidal thickening in the right eye had an unrevealing systemic work-up for inflammatory or neoplastic processes. The patient eventually developed mild vitritis and a diagnostic vitrectomy was performed. Flow cytometry of the vitreous showed clonal expansion consistent with a mature B cell lymphoma of the uveal tract. Repeat systemic work-up including bone marrow biopsy, however, revealed two additional systemic conditions: Waldenstrom macroglobulinemia (WM) and monoclonal B cell lymphocytosis. Based on B cell gene rearrangement testing, the choroidal lymphoma was found to be distinct from the systemic lymphoma. In total, the patient had three lymphoproliferative disorders. Soon after the diagnosis, the left eye also developed choroidal thickening. The patient received orbital external beam radiation and zanubrutinib to treat the systemic WM and the choroidal lymphoma with improvement of macular retinoschisis and choroidal thickening.

Conclusions:

We present a case of macular retinoschisis in a patient with choroidal lymphoma and multiple systemic lymphoproliferative disorders. Both the systemic disease and the uveal lymphoma contributed to the unique ocular findings in this patient. Our case highlights the challenges of uveal lymphoma diagnosis and the importance of tissue biopsy, systemic work-up, and close monitoring.

1,631

项与泽布替尼相关的新闻（医药）

2025-08-30

·药明康德

致敬时代 | 近90%患者癌细胞减少或几乎“全消失”！无需再依赖化疗，多款新型抗癌药为这类患者点亮希望

编者按：2025年，药明康德迎来创立25周年的重要里程碑。值此契机，我们向所有与我们共同书写产业变革篇章的科学家、医药人和投资者致以衷心感谢与诚挚敬意，也特别推出“致敬时代”系列，回顾全球同仁如何借助科学与合作的力量，不断拓展治疗边界、改善患者命运。四分之一个世纪的坚守，只为加速每一款新药的诞生。下一个25年，我们将继续心怀感恩与敬畏，依托独特的CRDMO模式，与全球伙伴携手同行，共赴健康未来。白血病是威胁人类生命的常见恶性血液肿瘤之一。但有一种白血病偶尔被人们称为“最轻的白血病”，那就是慢性淋巴细胞白血病（简称慢淋，CLL）。这是一种成熟B淋巴细胞克隆增殖性肿瘤，表现为外周血淋巴细胞增多。慢淋常见于中老年患者，大致可分为两类，有一种生长非常缓慢，患者往往无明显症状，在很长一段时间里不需药物治疗，只需定期找医生随诊；另一种则生长更快、也更严重。尤其是出现耐药和复发的患者，将面临更差的预后。在欧美国家，慢淋是最常见的白血病类型，大约占白血病总体患者的25%～30%。虽然慢淋在亚洲人群里发生率相对较低，但检出率及诊断率也在逐步上升。到目前为止，慢淋唯一可根治的手段就是异基因造血干细胞移植，但不幸的是，很多患者因为年龄、身体状况、供者等各方面原因，没机会接受这样的治疗。因此对大多数慢淋患者来说，治疗的目标是带病生存，能够长期维持在一个比较好的生活状态。图片来源：123RF 直到20世纪中叶，各类白血病依然缺乏有效的治疗手段。20世纪40年代，科学家们发现氮芥对慢性白血病等血液肿瘤有积极作用，白血病自此进入化疗时代。50~70年代，苯丁酸氮芥和环磷酰胺等烷化剂类药物的研发，让慢淋患者获得了30%~40%的缓解率。80~90年代，氟达拉滨等嘌呤类似物成为慢淋的主要治疗手段，让缓解率提升至50%左右。但化疗带来的细胞毒性等问题，依然影响着患者的生活质量。进入21世纪后，慢淋治疗有了非常大的突破，从传统的化疗走向了以靶向治疗为主的时代，还有层出不穷的新型治疗方案正改变着慢淋治疗的版图。作为全球医药及生命科学行业值得信赖的合作伙伴和重要贡献者，药明康德在25年发展历程中，很荣幸见证了多款慢淋新疗法从实验室到临床的突破历程，更通过提供一体化、端到端的新药研发和生产服务，助力全球合作伙伴加速多款慢淋创新疗法的研发进程，造福病患。今天这篇文章将再次回望近25年来慢淋新疗法的攻坚历程，向那些以勇气、坚持与热爱迎难而上的人们致敬。单克隆抗体疗法：开启靶向时代世纪之交，单克隆抗体疗法率先打破了慢淋治疗主要依赖化疗的局面。其中一个重要靶点是CD20。这是一种B细胞分化抗原，在95%以上的B细胞性淋巴瘤中表达，而在造血干细胞、血浆细胞和其他正常组织中不表达。 1997年，基因泰克（现为罗氏旗下子公司）与渤健共同开发的靶向CD20的利妥昔单抗（rituximab，商品名：Rituxan）问世，随后在各类癌症治疗领域都发挥了重要作用，也包括慢淋。科学家发现，利妥昔单抗与氟达拉滨等化疗药物联用比先后单独使用两款药物效果更好。2010年，利妥昔单抗的新适应症获FDA批准，与氟达拉滨和环磷酰胺联合用于治疗初治和既往经治的CD20阳性慢淋患者。利妥昔单抗的成功，也启发产业不断迭代以CD20为目标的单抗药物，例如由Genmab公司与诺华联合开发的第二代CD20单抗代表药物奥法妥木单抗（ofatumumab）。它是一款全人源化单抗，其结合的表位也与利妥昔单抗不同，主要用于对其它治疗或其它单抗不再有应答的患者。2009年，奥法妥木单抗获FDA批准（商品名：Arzerra），用于对氟达拉滨和阿仑珠单抗耐药的慢淋患者。如今，这两款药物均已成为慢淋的主要治疗药物。由GlycArt Biotechnology、罗氏旗下基因泰克与渤健共同开发、2013年获FDA批准用于慢淋的奥妥珠单抗（obinutuzumab，商品名：Gazyva）属于第三代CD20抗体。与前两款药物相比，它杀死慢淋细胞更直接、作用更强，并且早期试验已证实了该药可快速将B细胞从外周血细胞中清除出去。它可与化疗药物或靶向药物伊布替尼一起作为慢淋初治疗法，也可单独治疗复发或对其它治疗无应答的慢淋。除了上述几种单抗，还有针对CD52抗原的单抗药物阿仑珠单抗（alemtuzumab，商品名：Lemtrada）。它由拜耳与赛诺菲共同开发，2001年获美国FDA批准用于治疗对烷化剂和氟达拉滨耐药的进展期慢淋。 BTK抑制剂：伊布替尼惊艳问世，同类靶向药多点开花说到近十多年慢淋靶向疗法的发展，就不得不提到布鲁顿氏酪氨酸激酶（BTK）抑制剂。其中一款重磅新药战绩尤其辉煌，让慢淋化疗成为了历史——它，就是伊布替尼（ibrutinib），一度被称为“慢淋领域的格列卫”。这款新药背后，有着跌宕起伏的研发历程。 20世纪90年代，一种后来被命名为BTK的酪氨酸激酶进入了科学家的视野。BTK被发现在B细胞受体（BCR）信号通路中起着关键作用；而在慢淋的癌细胞里，BTK蛋白水平会出现异常升高。 BTK自然成为了B细胞恶性肿瘤中富有吸引力的一个治疗靶点，很多公司开始针对BTK设计具有激酶选择性的抑制剂，其中也包括Celera Genomics公司。 21世纪初，Celera公司在探索中孕育了一款靶向BTK并与之共价结合的小分子。由于共价药物可与人体内蛋白非选择性、不可逆、永久结合，一旦脱靶结合到正常的人体蛋白上，可能引起严重的毒副作用，这种潜在风险使共价药物一度成为药物研发的禁忌。因此，Celera公司最初并没有把它作为候选药物，而只是当作“工具化合物”协助BTK抑制剂的筛选。 2006年，一家名为Pharmacyclics的公司收购了这款在Celera公司没能得到充分重视的小分子。Pharmacyclics当时的首席执行官、血液肿瘤专家理查德·米勒（Richard Miller）博士敏锐地意识到了它在B细胞癌症中的潜力。尽管他和团队在B细胞淋巴瘤动物模型中证实了这款药物的活性，但很多研发人员对这款共价结合机制的药物仍然持犹疑态度。然而，很多患者正在死亡的边缘。米勒博士不愿意因为对“共价机制”的风险担忧，而让这些患者无止境地等下去。 2009年，这款小分子的1期临床试验启动了。2011年，Pharmacyclics公司报告了它在1b/2期试验中用于一系列B细胞恶性肿瘤的积极数据，不久后，强生旗下杨森制药（现更名为强生创新制药）也宣布与Pharmacyclics进行合作，共同研发这款新药。 2013年11月，以“伊布替尼”之名，这款不负众望的新药获FDA加速批准上市（商品名：Imbruvica）用于套细胞淋巴瘤的治疗。同一时期，它在慢淋中也表现出惊人的疗效，并在2014年2月获得FDA批准用于既往至少接受过一种治疗的慢淋患者。后续发表于2015年的3年随访结果显示，伊布替尼单药治疗就让90%的慢淋既往经治患者和84%的初治患者获得缓解，达到完全缓解的患者分别占7%和23%，总缓解率为88%。也就是说，近90%的患者肿瘤细胞数明显下降或几乎“全消失”。这是一个激动人心的结果，意味着患者可以摆脱对化疗的依赖。图片来源：123RF 更长期的8年随访研究表明，在经治和初治的慢淋患者中，伊布替尼的总缓解率分别高达89%和87%，分别有10%和35%的患者获得完全缓解，中位无进展生存期分别长达52个月和尚未达到，7年总生存率分别达到55%和84%。 2015年，艾伯维以高达210亿美元的金额收购了拥有伊布替尼的Pharmacyclics，与强生共同继续伊布替尼的研究工作。2016年3月，FDA批准了伊布替尼的第5个适应症，单药用于慢淋患者的一线治疗。这是FDA批准的首个“无化疗”慢淋一线治疗方案，意味着伊布替尼可替代化疗作为慢淋的一线治疗选择，是一个重要的里程碑。在推动此次获批的3期临床试验中，与化疗组相比，接受伊布替尼单药治疗的初治慢淋患者总缓解率达到82.4%，是前者（35.3%）的2倍多，无进展生存期显著延长，疾病进展或死亡风险降低84%。如今，伊布替尼已获FDA批准治疗10余项适应症，并成为多种血液肿瘤的一线治疗选择。目前伊布替尼已在全球100多个国家和地区获批，惠及全球超30万患者。此后，更多BTK靶向药物接连问世，让包括慢淋在内的B细胞恶性肿瘤患者的生活迎来了巨大改善。已获FDA批准的BTK抑制剂还包括由百济神州研发的泽布替尼（zanubrutinib），由礼来、Redx Pharma与LOXO Oncology共同开发、可破解共价BTK抑制剂耐药困局的首个非共价（可逆）BTK抑制剂匹妥布替尼（pirtobrutinib），以及由阿斯利康与Acerta Pharma共同开发的阿可替尼（acalabrutinib）。在中国获批用于慢淋的BTK抑制剂还有由诺诚健华与渤健共同研发的奥布替尼。其它靶向抑制剂：瞄准更多靶点随着医药科技的进步，还有更多重要靶点被发现、更多新的重磅药物诞生。与BTK类似，PI3K蛋白在多种B细胞恶性肿瘤中也存在过度表达的现象，而抑制PI3K不仅会影响BCR信号通路，还会对炎症、细胞信号传导和血管生成产生抑制，从而影响与肿瘤增殖有关的微环境。由ICOS与吉利德共同开发的艾代拉利司（idelalisib，商品名：Zydelig）是第一代口服PI3K-delta抑制剂。它于2014年获FDA批准上市治疗复发/难治性慢淋。它临床活性显著，可诱导细胞凋亡、抑制恶性B细胞系/原发肿瘤细胞系增殖，还能阻断多种信号通路，降低肿瘤细胞的生存能力。由Infinity Pharmaceuticals和Verastem共同开发的度恩西布（duvelisib，商品名：Copiktra）则是一款口服PI3K-delta和PI3K-gamma双重抑制剂。它于2018年获FDA批准用于治疗此前至少使用两种其它疗法的成人复发/难治性慢淋。其对PI3K-delta的抑制导致恶性肿瘤细胞凋亡，而对PI3K-gamma的抑制则减少了肿瘤微环境中支持细胞的分化和转移。 B细胞淋巴瘤因子-2（BCL-2）也是一个重要靶点。BCL-2可阻止细胞凋亡，并在某些类型癌症中过度表达，与耐药性的形成相关。比如由艾伯维与罗氏旗下基因泰克共同开发的维奈克拉（venetoclax，商品名：Venclexta），就是一种口服、选择性BCL-2抑制剂，通过选择性抑制BCL-2的功能，恢复细胞的通讯系统，让癌细胞自我毁灭，达到治疗肿瘤的目的。2016~2019年，维奈克拉先后获FDA批准了多项慢淋相关适应症。今年还有一款在中国获批慢淋适应症的BCL-2抑制剂——由亚盛医药研发的利沙托克拉。探索仍在继续过去25年间，美国FDA共批准了至少14款治疗慢淋的新疗法，除上述药物之外，还有2008年获批的化疗药物苯达莫司汀（bendamustine，商品名Treanda），以及2024年获批的靶向CD19的CAR-T细胞疗法lisocabtagene maraleucel（liso-cel，商品名Breyanzi）。药明康德很高兴能为其中多款疗法提供赋能、助力合作伙伴的这些创新疗法来到全球患者身边。为更好地提高慢淋患者的生活质量、解决药物长期使用带来的耐药等问题，产业圈仍在携手努力。当下还有近200款针对慢淋的新疗法正处于积极的临床研究中，有望在未来造福更多患者。其中多款药物已进入3期临床阶段，涵盖小分子靶向药和靶向蛋白降解剂等多种类型。比如由默沙东与ArQule共同研发的nemtabrutinib，近期研究证实其对BTK抑制剂耐药（包括携带BTK C481S突变）的复发或难治性慢淋患者有效，且在TP53异常亚组中仍有疗效，安全性可控。目前科学家正在进行一项3期试验，以评估这款新药对比维奈克拉+利妥昔单抗联合疗法的疗效。在抗击慢淋的漫漫旅途中，这些令人兴奋的成就源于科学家敢于挑战传统的洞见和勇气，也离不开转化医学中来自学术界和产业界的携手努力。最后，让我们再次向那些在慢淋治疗领域不懈探索的英雄们致以崇高的敬意。药明康德也期待与业界同仁继续同行，助力让更多创新疗法来到患者身边。参考资料： [1] Ponader, S., & Burger, J. A. (2014). Bruton's tyrosine kinase: from X-linked agammaglobulinemia toward targeted therapy for B-cell malignancies. Journal of clinical oncology, 32(17), 1830-1839. https://doi.org/10.1200/JCO.2013.53.1046 [2] The Wild Story Behind A Promising Experimental Cancer Drug. Retrieved Aug 27, 2025, from https://www.forbes.com/sites/davidshaywitz/2013/04/05/the-wild-story-behind-a-promising-experimental-cancer-drug/ [3] 打造一“键”封喉的共价抗癌药——专访北大深圳研究生院潘峥婴博士. Retrieved Aug 27, 2025, from https://www.wuximediaglobal.com [4] Pharmacyclics. Retrieved Aug 27, 2025 from https://www.pharmacyclics.com/home/who-we-are/history [5] Byrd, J. C., Furman, R. R., Coutre, S. E., Flinn, I. W., Burger, J. A., Blum, K. A., ... & O'Brien, S. (2013). Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. New England Journal of Medicine, 369(1), 32-42. DOI: 10.1056/NEJMoa1215637 [6] Johnson & Johnson, Pharmacyclics, Inc. Breakthrough Drug Wins FDA Approval. Retrieved Aug 27, 2025, from https://www.biospace.com/article/releases/johnson-and-johnson-pharmacyclics-inc-breakthrough-drug-wins-fda-approval-/ [7] The drug that may make chemo a thing of the past. Retrieved Aug 27, 2025, from https://www.mdanderson.org/publications/conquest/spring-2014/the-drug-that-may-make-chemo-a-thing-of-the-past.html [8] New Drug Application (NDA): 205552. Retrieved Aug 27, 2025 from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205552 [9] 西安杨森. Retrieved Aug 27, 2025 from https://www.xian-janssen.com.cn/ [10]上海合全药业2018年度报告. Retrieved Aug 27, 2025 from http://pdf.dfcfw.com/pdf/H2_AN201903221308711829_1.pdf [11] AbbVie Completes Acquisition of Pharmacyclics. Retrieved Aug 27, 2025 from https://investors.abbvie.com/news-releases/news-release-details/abbvie-completes-acquisition-pharmacyclics [12] Ozcan, M., Lavie, D., Chaudhry, A., Zhou, X., Paydar, I., Farooqui, M. Z., & Ghia, P. (2024). BELLWAVE-010: A phase 3 study of nemtabrutinib plus venetoclax versus venetoclax plus rituximab (VR) in previously treated patients (pts) with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).https://doi.org/10.1200/JCO.2024.42.16_suppl.TPS7089 [13] Thomas, X. (2013). First contributors in the history of leukemia. World Journal of Hematology, 2(3), 62-70. doi: 10.5315 / wjh.v2.i3.62 [14] Mehranfar, S., Zeinali, S., Hosseini, R., Akbarzadeh, A., Mohammadian, M., & Feizi, A. H. P. (2017). History of leukemia: diagnosis and treatment from beginning to now. Galen Medical Journal, 6(1), e702-e702. DOI: https://doi.org/10.31661/gmj.v6i1.702 [15] Innovation of CLL Treatments: Chemotherapy Era - HealthTree for Chronic Lymphocytic Leukemia. Retrieved Aug 27, 2025 from https://healthtree.org/cll/community/articles/innovation-cll-treatment-chemotherapy-era [16] Rai, K. R., & Jain, P. (2016). C hronic lymphocytic leukemia (CLL)—Then and now. American journal of hematology, 91(3), 330-340. https://doi.org/10.1002/ajh.24282 [17] Perez-Carretero, C., Gonzalez-Gascon-y-Marin, I., Rodriguez-Vicente, A. E., Quijada-Alamo, M., Hernandez-Rivas, J. A., Hernandez-Sanchez, M., & Hernandez-Rivas, J. M. (2021). The evolving landscape of chronic lymphocytic leukemia on diagnosis, prognosis and treatment. Diagnostics, 11(5), 853. doi: 10.3390/diagnostics11050853 [18] 慢性淋巴细胞白血病/小淋巴细胞淋巴瘤诊疗指南（2022年版）. Retrieved Aug 27, 2025 from https://www.nhc.gov.cn/yzygj/c100068/202204/0c1f7d3aca0545abbeb02030ce255930/files/1732863055385_61833.pdf [19] Troubled Infinity licenses cancer drug to Verastem | BioPharma Dive）. Retrieved Aug 27, 2025 from https://www.biopharmadive.com/news/Infinity-duvelisib-verastem-license/429724/ [20] 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工作组,(2025). 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（2025年版）. 中华血液学杂志,46(02)：105-112.DOI:10.3760/cma.j.cn121090-20241209-00551 [21]IMBRUVICA® (ibrutinib) Pooled Outcomes Data from Three Phase 3 Studies Suggest Potential Clinical Efficacy in Patients with High-Risk Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) . Retrieved Aug 27, 2025 from https://www.prnewswire.com/news-releases/imbruvica-ibrutinib-pooled-outcomes-data-from-three-phase-3-studies-suggest-potential-clinical-efficacy-in-patients-with-high-risk-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-cllsll-300457242.html [22]de Claro, R. A., McGinn, K. M., Verdun, N., Lee, S. L., Chiu, H. J., Saber, H., ... & Pazdur, R. (2015). FDA approval: ibrutinib for patients with previously treated mantle cell lymphoma and previously treated chronic lymphocytic leukemia. Clinical Cancer Research, 21(16), 3586-3590. [23] Byrd, J. C., Furman, R. R., Coutre, S. E., Burger, J. A., Blum, K. A., Coleman, M., ... & O'Brien, S. (2015). Three-year follow-up of treatment-naive and previously treated patients with CLL and SLL receiving single-agent ibrutinib. Blood, The Journal of the American Society of Hematology, 125(16), 2497-2506. https://doi.org/10.1182/blood-2014-10-606038 [24] Byrd, J. C., Furman, R. R., Coutre, S. E., Flinn, I. W., Burger, J. A., Blum, K., ... & O'Brien, S. (2020). Ibrutinib treatment for first-line and relapsed/refractory chronic lymphocytic leukemia: final analysis of the pivotal phase Ib/II PCYC-1102 study. Clinical Cancer Research, 26(15), 3918-3927. https://doi.org/10.1158/1078-0432.CCR-19-2856 [25] IMBRUVICA® (ibrutinib) Approved by U.S. FDA for the First-line Treatment of Chronic Lymphocytic Leukemia. Retrieved Aug 27, 2025 from https://news.abbvie.com/2016-03-04-IMBRUVICA-ibrutinib-Approved-by-U-S-FDA-for-the-First-line-Treatment-of-Chronic-Lymphocytic-Leukemia [26] The Bruton tyrosine kinase inhibitor PCI-32765 blocks B-cell activation and is efficacious in models of autoimmune disease and B-cell malignancy | PNAS. Retrieved Aug 27, 2025 from https://www.pnas.org/doi/10.1073/pnas.1004594107 [27] Byrd, J. C., Blum, K. A., Burger, J. A., Coutre, S. E., Sharman, J. P., Furman, R. R., ... & O'Brien, S. M. (2011). Activity and tolerability of the Bruton's tyrosine kinase (Btk) inhibitor PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): Interim results of a phase Ib/II study. Journal of Clinical Oncology, 29(15_suppl), 6508-6508. [28] Phase Ib/II Study of the Activity and Tolerability of the Bruton’s Tyrosine Kinase Inhibitor PCI-32765 in CLL/SLL | Research To Practice. Retrieved Aug 27, 2025 from https://www.researchtopractice.com/index.php?q=5MJCASCO2011/CLL/1 [29] Pharmacyclics Forms Pact to Develop and Commercialize PCI-32765 for Hematologic Cancers with Janssen Biotech, Inc. (prnewswire.com) . Retrieved Aug 27, 2025 from https://www.prnewswire.com/news-releases/pharmacyclics-forms-pact-to-develop-and-commercialize-pci-32765-for-hematologic-cancers-with-janssen-biotech-inc-135271818.html [30] Advani, R. H., Buggy, J. J., Sharman, J. P., Smith, S. M., Boyd, T. E., Grant, B., ... & Fowler, N. H. (2012). Bruton tyrosine kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. Journal of Clinical Oncology, 31(1), 88-94. doi: 10.1200/JCO.2012.42.7906 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床研究

2025-08-29

·EndPoints

BeOne plots accelerated approval for rare lymphoma drug after toplining Phase 1/2 data

BeOne Medicines said its candidate for a rare but aggressive form of B cell lymphoma has passed an early-stage test. Its BCL2 inhibitor, known as sonrotoclax, met the primary endpoint of overall response rate in a single-arm Phase 1/2 study of 125 patients with relapsed or refractory mantle cell lymphoma (MCL). The participants received sonrotoclax following treatment with anti-CD20 therapy and a BTK inhibitor, according to a Friday release . Sonrotoclax also demonstrated “promising results” in secondary endpoints, including complete response rate, duration of response, and progression-free survival, but BeOne did not provide data. It plans to present more results at a future medical meeting and share them with agencies, including the FDA. BeOne is planning to file the drug for accelerated approval. Sonrotoclax is already being evaluated in a confirmatory Phase 3 trial called CELESTIAL-RR MCL, which enrolled its first patient earlier this year. The placebo-controlled study is testing the drug in combination with BeOne’s BTK inhibitor Brukinsa in patients who have previously received anti-CD20 treatment or chemoimmunotherapy, according to the clinical trials register. BeOne, formerly BeiGene, successfully carved a market niche in the B cell non-Hodgkin lymphoma space with Brukinsa. The drug won its first FDA approval in 2019 for MCL, later securing label expansions for certain settings of marginal zone lymphoma, chronic lymphocytic leukemia and follicular lymphoma. While Brukinsa targets the BTK enzyme, which is crucial for the growth of B cells, sonrotoclax targets a protein called B cell lymphoma 2, known to help cancer cells survive. Sonrotoclax works by mimicking natural cell death signals, according to BeOne. The drugmaker estimates that MCL affects around 28,000 people globally. The treatment landscape for relapsed or refractory disease is “fragmented,” and outcomes are “unacceptably poor,” BeOne’s head of R&D Lai Wang said in the release.

临床3期免疫疗法临床结果上市批准加速审批

2025-08-29

·Firstwordpharma

BeOne's sonrotoclax heads to regulators after mantle cell lymphoma study win

BeOne Medicines said it will seek regulatory approvals in the US and elsewhere globally for sonrotoclax (BGB-11417), following the release of positive topline data from a Phase I/II trial in relapsed or refractory mantle cell lymphoma (MCL). The 125-patient study met its primary endpoint of overall response rate, positioning the next-generation BCL2 inhibitor for potential approval in the rare and aggressive form of blood cancer.The trial enrolled adult patients whose disease had progressed following treatment with anti-CD20 therapy and a BTK inhibitor. Results showed "clinically meaningful responses in this heavily pretreated population" and "promising results" across secondary endpoints including complete response rate, duration of response and progression-free survival, according to the company. Additionally, the safety profile was generally well-tolerated and "toxicities were manageable." Full data will be shared at an upcoming medical meeting."For people with relapsed or refractory mantle cell lymphoma, the disease is aggressive, the treatment landscape fragmented, and the outcomes unacceptably poor," remarked Lai Wang, BeOne's global head of R&D. Wang said the topline results "underscore [sonrotoclax's] potential to deliver meaningful and durable responses" for patients with relapsed/refractory MCL, which affects an estimated 28,000 people globally and has a five-year survival rate of approximately 50%.BeOne is already familiar with the MCL space through Brukinsa (zanubrutinib), its BTK inhibitor approved by the FDA for multiple B-cell malignancies, including second-line MCL in 2019. The drug, which generated sales of roughly $2.4 billion across the US and Europe in 2024, is also cleared for Waldenström's macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma.BeOne said new drug applications for sonrotoclax are already under review in China for both relapsed/refractory MCL and CLL/SLL. The company also launched earlier this year the Phase III confirmatory CELESTIAL-RR MCL study, which will evaluate sonrotoclax in combination with Brukinsa versus Brukinsa alone in an estimated 300 patients with relapsed/refractory mantle cell lymphoma.

临床3期上市批准临床结果

100 项与泽布替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11422	泽布替尼	L01XE	DB15035

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
浆母细胞淋巴瘤	日本	BeOne Medicines Ltd.	2024-12-27
滤泡性淋巴瘤	泰国	BeOne Medicines Ltd.	2024-02-07
华氏巨球蛋白血症难治	泰国	BeOne Medicines Ltd.	2024-02-07
复发性滤泡性淋巴瘤	欧盟	BeiGene Ireland Ltd.	2023-11-17
复发性滤泡性淋巴瘤	冰岛	BeiGene Ireland Ltd.	2023-11-17
复发性滤泡性淋巴瘤	列支敦士登	BeiGene Ireland Ltd.	2023-11-17
复发性滤泡性淋巴瘤	挪威	BeiGene Ireland Ltd.	2023-11-17
复发性边缘区淋巴瘤	美国	BeOne Medicines Ltd.	2023-01-19
难治性边缘区淋巴瘤	巴西	BeOne Medicines Ltd.	2022-11-10
难治性滤泡性淋巴瘤	英国	BeOne Medicines Ltd.	2021-12-06
边缘区B细胞淋巴瘤	乌拉圭	BeOne Medicines Ltd.	2021-04-28
巨球蛋白血症	加拿大	BeOne Medicines Ltd.	2021-03-30
慢性淋巴细胞白血病	中国	百济神州（苏州）生物科技有限公司	2020-06-03
小淋巴细胞淋巴瘤	中国	百济神州（苏州）生物科技有限公司	2020-06-02
套细胞淋巴瘤	美国	BeOne Medicines Ltd.	2019-11-14

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
特发性膜性肾病	临床3期	美国	BeOne Medicines Ltd.	2023-04-17
特发性膜性肾病	临床3期	中国	BeOne Medicines Ltd.	2023-04-17
特发性膜性肾病	临床3期	阿根廷	BeOne Medicines Ltd.	2023-04-17
特发性膜性肾病	临床3期	巴西	BeOne Medicines Ltd.	2023-04-17
特发性膜性肾病	临床3期	加拿大	BeOne Medicines Ltd.	2023-04-17
特发性膜性肾病	临床3期	捷克	BeOne Medicines Ltd.	2023-04-17
特发性膜性肾病	临床3期	意大利	BeOne Medicines Ltd.	2023-04-17
特发性膜性肾病	临床3期	波兰	BeOne Medicines Ltd.	2023-04-17
特发性膜性肾病	临床3期	俄罗斯	BeOne Medicines Ltd.	2023-04-17
特发性膜性肾病	临床3期	土耳其	BeOne Medicines Ltd.	2023-04-17

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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


NCT03336333 (SEQUOIA, ASCO2025) 人工标引	临床3期	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤一线	111	Zanubrutinib monotherapy	夢襯膚夢選網夢艱襯鹽(繭蓋獵齋淵簾繭鏇選積) = 獵築膚獵鏇醖壓簾鹹願窪憲壓繭夢獵窪築築蓋 (壓淵夢蓋構齋範選觸願 ) 更多	积极	2025-05-30
NCT03336333 (SEQUOIA, ASCO2025) 人工标引	临床3期	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤一线	114	Zanubrutinib 160 mg twice dailyZanubrutinib 160 mg twice daily + Venetoclax ramp-up to 400 mg once daily from cycle 4 to cycle 28, followed by continuous zanu monotherapyVenetoclax ramp-up to 400 mg once daily from cycle 4 to cycle 28, followed by continuous zanu monotherapy	襯夢蓋膚願憲鹹繭顧獵(窪糧鑰鹽壓簾淵壓顧顧) = 壓築蓋襯餘鬱網膚選觸鬱鑰遞遞遞艱廠壓齋鹽 (淵選齋製艱廠鑰遞選膚 ) 更多	积极	2025-05-30
				Zanubrutinib 160 mg twice dailyZanubrutinib 160 mg twice daily + Venetoclax ramp-up to 400 mg once daily from cycle 4 to cycle 28, followed by continuous zanu monotherapyVenetoclax ramp-up to 400 mg once daily from cycle 4 to cycle 28, followed by continuous zanu monotherapy (del(17p)− and TP53 wt)	襯夢蓋膚願憲鹹繭顧獵(窪糧鑰鹽壓簾淵壓顧顧) = 積蓋窪積選鹹膚簾衊積鬱鑰遞遞遞艱廠壓齋鹽 (淵選齋製艱廠鑰遞選膚 ) 更多
NCT03336333 (SEQUOIA, ASCO2025 \| EHA2025)	临床3期	慢性淋巴细胞白血病 del(17p)	-	Zanubrutinib	憲築願觸廠夢衊餘獵願(憲鏇鹽齋糧製繭餘壓構): HR = 0.41 (95% CI, 0.25 ~ 0.67)	积极	2025-05-30
				Acalabrutinib plus Venetoclax
NCT03336333 (SEQUOIA, ASCO2025)	临床3期	慢性淋巴细胞白血病一线 del(17p)	-	Zanubrutinib	窪遞構鹽繭壓鏇簾淵築(窪範餘淵膚製廠憲壓膚) = 齋糧繭鹽繭簾膚襯獵繭艱蓋蓋網憲願襯觸網積 (襯齋築艱蓋醖網積淵鹽 )	积极	2025-05-30
				Acalabrutinib plus Venetoclax	窪遞構鹽繭壓鏇簾淵築(窪範餘淵膚製廠憲壓膚) = 觸窪鏇襯積窪蓋蓋餘壓艱蓋蓋網憲願襯觸網積 (襯齋築艱蓋醖網積淵鹽 )
ASCO2025	N/A	套细胞淋巴瘤 Bruton tyrosine kinase inhibitor (BTKi)	80	Patients previously treated with acalabrutinib	夢範鑰鹽壓壓製積艱鹽(窪願糧願鬱簾繭築顧醖) = 襯夢遞簾齋構鹽糧選繭餘願夢製獵鹽構鹹淵餘 (醖窪夢選衊齋鏇膚淵製 )	-	2025-05-30
				Patients previously treated with ibrutinib	夢範鑰鹽壓壓製積艱鹽(窪願糧願鬱簾繭築顧醖) = 構觸範顧廠鏇鏇顧獵構餘願夢製獵鹽構鹹淵餘 (醖窪夢選衊齋鏇膚淵製 )
NCT03336333 (SEQUOIA, ASCO2025)	临床3期	慢性淋巴细胞白血病	163	Continuous Zanubrutinib	構鏇膚餘夢窪鏇壓艱餘(壓製夢範襯選憲遞壓憲) = a trend for extended OS 淵醖顧蓋膚餘鹹鏇醖築 (鑰窪膚網鹹製醖範膚獵 ) 更多	积极	2025-05-30
				Fixed-Duration Venetoclax + Obinutuzumab
ASCO2025	N/A	小淋巴细胞淋巴瘤	505	Zanubrutinib	窪範鏇顧簾願顧壓餘鹹(壓糧網遞願廠糧選製壓) = 選繭顧製選蓋壓鏇鬱網糧網窪餘鑰鹹餘齋範鑰 (艱艱艱鏇網構鏇築鏇窪 ) 更多	积极	2025-05-30
				Acalabrutinib	窪範鏇顧簾願顧壓餘鹹(壓糧網遞願廠糧選製壓) = 餘餘觸築範壓顧蓋範壓糧網窪餘鑰鹹餘齋範鑰 (艱艱艱鏇網構鏇築鏇窪 ) 更多
NCT03336333 (SEQUOIA, EHA2025) 人工标引	临床3期	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤一线 TP53 Mutation \| del(17p13.1)	114	Zanubrutinib 160 mg twice dailyZanubrutinib 160 mg twice daily + Venetoclax ramp-up to 400 mg once dailyVenetoclax ramp-up to 400 mg once daily	選餘醖鬱壓糧選鹽網獵(廠觸窪艱醖選積積夢簾) = 衊簾衊膚簾製夢衊窪願憲夢鹹顧製廠鏇選範繭 (廠鬱鑰選選簾壓夢艱膚 ) 更多	积极	2025-05-14
				Zanubrutinib 160 mg twice dailyZanubrutinib 160 mg twice daily + Venetoclax ramp-up to 400 mg once dailyVenetoclax ramp-up to 400 mg once daily (del(17p) and/or TP53 mut)	選餘醖鬱壓糧選鹽網獵(廠觸窪艱醖選積積夢簾) = 獵夢遞鏇觸範構淵願鹽憲夢鹹顧製廠鏇選範繭 (廠鬱鑰選選簾壓夢艱膚 ) 更多
NCT04277637 (BGB-11417-101, EHA2025) 人工标引	临床1期	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤	47	Sonrotoclax + Zanubrutinib	鹽壓齋構淵淵鹹選憲醖(醖鹹鬱鏇積餘繭壓廠鹹) = 淵鹹鏇鑰繭繭蓋繭積鬱願鑰鬱艱蓋淵選窪淵齋 (願選糧夢製鏇襯顧網淵 ) 更多	积极	2025-05-14
NCT05896007 (EHA2025) 人工标引	临床2期	原发性中枢神经系统淋巴瘤一线	23	Zanubrutinib (160 mg BID orally), rituximab (375 mg/m² IV on d0),Zanubrutinib (160 mg BID orally), rituximab (375 mg/m² IV on d0), and methotrexatemethotrexate (3.5 g/m² IV on d1). (induction therapy)	糧積顧廠積選願鏇顧膚(範廠鹹簾壓顧夢觸齋鹹) = 廠製獵夢選簾願鬱齋壓醖醖選繭網憲憲齋範鹹 (鏇醖繭廠餘網鹹網鬱壓 ) 更多	积极	2025-05-14
				Zanubrutinib (160 mg BID orally), rituximab (375 mg/m² IV on d0),Zanubrutinib (160 mg BID orally), rituximab (375 mg/m² IV on d0), and methotrexate (3.5 g/m² IV on d1). (second cycle)	糧積顧廠積選願鏇顧膚(範廠鹹簾壓顧夢觸齋鹹) = 顧窪蓋淵醖膚蓋遞膚憲醖醖選繭網憲憲齋範鹹 (鏇醖繭廠餘網鹹網鬱壓 ) 更多