A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma

This study aims to evaluate the efficacy and safety of an induction regimen combining Bendamustine, Rituximab, Cytarabine (AraC), and Zanubrutinib (BRAZAN), followed by maintenance therapy with Zanubrutinib and Rituximab with or without Sonrotoclax in participants with Mantle Cell Lymphoma (MCL).
The names of the study drugs involved in this study are:
* bendamustine (a type of alkylating agent)
* rituximab (a type of monoclonal antibody)
* cytarabine (a type of antineoplastic)
* zanubrutinib (a type of kinase inhibitor)
* sonrotoclax (a type of BCL2 inhibitor)

开始日期2025-08-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06557330

/ Not yet recruiting临床2期IIT

HM-225: Measurable Residual Disease (MRD) Guided De-intensification of Bendamustine/Rituximab (BR) for Indolent Non-Hodgkin Lymphoma

This is a phase II pilot, single arm, open label study designed to assess the efficacy, safety, and feasibility of MRD adapted duration of BR for untreated or R/R iNHL.

开始日期2025-06-01

申办/合作机构

The Fox Chase Cancer Center

[+1]

NCT06961500

/ Not yet recruiting临床2期IIT

A Multicenter, Phase 2, Randomized Trial of Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A (FL)

This is a multicenter, phase 2, randomized trial to evaluate the efficacy and safety of obinutuzumab with CHOP versus obinutuzumab with bendamustine in treatment-naïve follicular lymphoma (Grade 3A) patients.

开始日期2025-05-01

申办/合作机构

中山大学

100 项与盐酸苯达莫司汀相关的临床结果

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100 项与盐酸苯达莫司汀相关的转化医学

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100 项与盐酸苯达莫司汀相关的专利（医药）

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3,022

项与盐酸苯达莫司汀相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Budget impact of introducing glofitamab for treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy in the United States

Article

作者: Li, Jia ; Mahmoudjafari, Zahra ; Masaquel, Anthony ; Parisé, Hélène ; Bercaw, Eric ; Bognar, Katalin ; Wang, Si-Tien

BACKGROUND:

Glofitamab is a T-cell engaging bispecific monoclonal antibody that was granted accelerated approval from the United States Food and Drug Administration for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy (3L+).

METHODS:

A budget impact model was developed for a hypothetical blended commercial/Medicare health plan with 1,000,000 members. Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine, polatuzumab vedotin + bendamustine + rituximab, rituximab + gemcitabine + oxaliplatin, tafasitamab + lenalidomide, and epcoritamab (Epcor). Total costs included those for drugs, wastage, administration, grade ≥3 adverse reactions, and all-grade cytokine release syndrome) and routine care. Market shares were based on internal projections and expert opinions. Total and per-member per-month (PMPM) net budget impacts over 3 years were calculated.

RESULTS:

Approximately nine patients were projected to be eligible for 3L + DLBCL treatment in a health plan of 1,000,000 members. The introduction of glofitamab as a treatment option resulted in estimated total and PMPM cost savings of $728,697 and -$0.0202, respectively, over 3 years. Costs were reduced across all cost categories but particularly in drug costs. Among the newer therapies, total 3-year cost per treated patient was lowest for glofitamab: $226,658 versus Tisa-cel = $564,113; Axi-cel = $540,002; Liso-cel = $516,272; and Epcor = $335,293. Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108.

CONCLUSIONS:

With the lowest 3-year total cost per treated patient among the newer therapies, glofitamab being an available option in the 3L + DLBCL market is estimated to save a hypothetical 1,000,000-member health plan $728,697 in cumulative total costs and $0.0202 in PMPM costs over 3 years.

2025-07-01·JOURNAL OF INFECTION AND CHEMOTHERAPY

Efficacy of initial combination therapy with anti-SARS-CoV-2 antivirals targeting viral clearance in COVID-19 patients with B-cell lymphoma treated with anti-CD20 antibodies: A retrospective single-centre study in Japan

Article

作者: Wada, Daiki ; Inoue, Akira ; Maruyama, Shuhei ; Saito, Fukuki ; Kuwagata, Yasuyuki ; Ishii, Kazuyoshi ; Shimazaki, Junya ; Nakamori, Yasushi ; Kashihara, Masami

OBJECTIVES:

There is no clear treatment strategy for persistent COVID-19 infection that enables clinicians to effectively achieve viral clearance, determine the optimal time to discontinue treatment, and prevent virus reactivation. This retrospective, single-centre study aimed to analyse the effectiveness of antiviral therapies in COVID-19 patients with B-cell lymphoma receiving anti-CD20 therapy.

METHODS:

Conducted at Kansai Medical University Medical Center between January 2022 and October 2024, the study examined the impact of various antiviral regimens and factors on time to viral clearance, defined as SARS-CoV-2 viral load <1 copy/μL by nasopharyngeal swab.

RESULTS:

Sixty-seven cases met the inclusion criteria, with 40 having a history of bendamustine use, and 33 with combination antiviral therapy as the initial treatment. A multivariable Cox proportional hazards model revealed combination antiviral therapy as the initial regimen (HR 0.36, 95 % CI 0.20-0.65, p < 0.001) significantly shortened time to viral clearance, while bendamustine use (HR 2.74, 95 % CI 1.53-4.89, p < 0.001) significantly prolonged time to viral clearance.

CONCLUSION:

This study showed the potential of early combination antiviral therapy to shorten the time to viral clearance in this high-risk patient population.

2025-06-01·AMERICAN JOURNAL OF HEMATOLOGY

Waldenström Macroglobulinemia: 2025 Update on Diagnosis, Risk Stratification, and Management

Review

作者: Gertz, Morie A.

ABSTRACT:

Disease Overview:

Waldenström macroglobulinemia (WM) is a lymphoplasmacytic lymphoma with immunoglobulin M (IgM) monoclonal protein. Clinical features include anemia, thrombocytopenia, hepatosplenomegaly, lymphadenopathy, and rarely hyperviscosity.

Diagnosis:

The presence of IgM monoclonal protein associated with ≥ 10% clonal lymphoplasmacytic cells in bone marrow confirms the diagnosis. The L265P mutation in MYD88 is detectable in more than 90% of patients and is found in most IgM MGUS patients. MYD88 is not required for the diagnosis.

Risk Stratification:

Age, albumin, hemoglobin level, platelet count, β2 microglobulin, Lactate dehydrogenase (LDH), and monoclonal IgM concentrations are characteristics that are predictive of outcomes.

Risk‐Adapted Therapy:

Not all patients who fulfill WM criteria require therapy; these patients can be observed until symptoms develop. Rituximab‐monotherapy is inferior to combination regimens. Recommended first‐line therapy can be chemoimmunotherapy or a covalent Bruton tyrosine kinase inhibitor. The preferred Mayo Clinic induction is either rituximab and bendamustine (without rituximab maintenance) or zanubrutinib.

Management of Refractory Disease:

Bortezomib, cyclophosphamide, fludarabine, thalidomide, everolimus, pirtobrutinib, carfilzomib, lenalidomide, bendamustine, and venetoclax have all been shown to have activity in relapsed WM. Given WM's natural history, the reduction of therapy toxicity is an important part of treatment selection. Most patients succumb to causes unrelated to macroglobulinemia.

514

项与盐酸苯达莫司汀相关的新闻（医药）

2025-05-31

·CPHI制药在线

1类新药扎堆获批上市；GLP-1新锐派格生物港股上市 | 制药在线一周药物复盘

点击蓝字关注我们本周，热点较多。首先看审评审批方面，至少8个1类新药获批上市，分别来自于恒瑞、百济神州、信立泰等；其次是研发方面，多个要取得重要进展，比如，全球第二款眼科双抗启动Ⅲ期临床；再次是交易及投融资方面，本周有多个交易，其中值得关注的是，石药集团三笔交易在即，涉资50亿美元；最后是上市方面，派格生物港股上市，被称为GLP-1新锐。本周盘点包括审评审批、研发、交易及投融资以及上市四大板块，统计时间为2025.5.26-5.30，包含36条信息。审评审批NMPA上市批准1、5月27日，NMPA官网显示，君实生物重组人源化抗PCSK9单克隆抗体注射液昂戈瑞西单抗注射液新适应症获批。本次获批的适应症为用于治疗：1）杂合子型家族性高胆固醇血症；2）他汀类药物不耐受或禁忌使用的原发性高胆固醇血症和混合型血脂异常。2、5月27日，NMPA官网显示，卫材的莱博雷生片（lemborexant、商品名：达卫可）获批上市，用于治疗失眠症。这是国内首款获批上市的OX1R/OX2R拮抗剂。2019年12月，莱博雷生（商品名：Dayvigo）在美国率先批准上市，用于治疗成人失眠症。目前，莱博雷生已在全球20多个国家及地区获批上市。3、5月27日，NMPA官网显示，荣昌生物的注射用泰它西普获批新适应症，用于治疗全身型重症肌无力（gMG）。此前，泰它西普已有系统性红斑狼疮（SLE）、类风湿关节炎（RA）两项适应症在国内获批上市。泰它西普是一个双靶抗体融合蛋白，可同时靶向BLyS和APRIL。4、5月27日，NMPA官网显示，信立泰1类新药沙库巴曲阿利沙坦钙片（S086）获批上市，用于治疗轻、中度原发性高血压。S086是一种血管紧张素Ⅱ受体-脑啡肽酶双重抑制剂（ARNi），由信立泰自主研发，是全球第二个进入临床的ARNi类小分子化学药物。5、5月27日，NMPA官网显示，康缘药业的舒马普坦萘普生钠片仿制药获批上市，用于急性治疗有或无先兆的偏头痛发作。这是首个上市的舒马普坦萘普生钠片仿制药。原研复方由Pozen和GSK合作研发，包含舒马普坦和环氧合酶（COX）抑制剂萘普生，于2008年在美国获批上市，商品名为Treximet。原研药未在国内获批上市。6、5月28日，NMPA官网显示，诺华的布西珠单抗获批上市，用于治疗糖尿病黄斑水肿（DME）。布西珠单抗是一种靶向血管内皮生长因子A（VEGF-A）的单链抗体，于2019年10月首次在美国获批上市，商品名为Beovu，用于治疗湿性年龄相关性黄斑变性（wAMD）。此外，该产品已于2024年10月、2024年12月向CDE递交布西珠单抗治疗新生血管性（湿性）年龄相关性黄斑变性（AMD）、增殖性糖尿病视网膜病变（PDR）适应症的上市申请。7、5月29日，NMPA官网显示，恒瑞医药1类新药注射用瑞康曲妥珠单抗（SHR-A1811）获批上市，单药适用于治疗存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。瑞康曲妥珠单抗是靶向HER2的抗体偶联药物（ADC）。8、5月29日，NMPA官网显示，泽璟制药的JAK抑制剂杰克替尼片获批上市，用于治疗中、高危骨髓纤维化，包括原发性骨髓纤维化（PMF）、真性红细胞增多症后骨髓纤维化（Post-PV-MF）和原发性血小板增多症后骨髓纤维化（Post-ET-MF）。9、5月29日，NMPA官网显示，恒瑞医药的法米替尼胶囊获批上市，联合PD-1单抗注射用卡瑞利珠单抗用于既往接受含铂化疗治疗失败但未接受过贝伐珠单抗治疗的复发或转移性宫颈癌患者。苹果酸法米替尼胶囊是恒瑞自主研发的小分子多靶点酪氨酸激酶抑制剂，对c-Kit、VEGFR、PDGFR、FGFR、Flt1、Flt3、Ret、c-Src等激酶均有明显的抑制作用。10、5月29日，NMPA官网显示，海创药业1类新药氘恩扎鲁胺软胶囊（商品名：海纳安）获批上市，用于治疗接受醋酸阿比特龙及化疗后出现疾病进展，且既往未接受新型雄激素受体抑制剂的转移性去势抵抗性前列腺癌（mCRPC）成人患者。氘恩扎鲁胺软胶囊是第二代雄激素受体（AR）抑制剂恩扎卢胺的氘代药物。11、5月29日，NMPA官网显示，恒瑞子公司盛迪医药1类新药注射用磷罗拉匹坦帕洛诺司琼（商品名：瑞坦宁）获批上市，用于预防成人高度致吐性化疗（HEC）引起的急性和迟发性恶心和呕吐。化疗相关性恶心呕吐（CINV）是化疗过程中最常见的不良反应之一，不仅使患者对化疗产生恐惧，还会降低治疗依从性，从而影响生存获益。12、5月29日，NMPA官网显示，复星医药1类新药芦沃美替尼片获批上市，用于治疗朗格汉斯细胞组织细胞增生症（LCH）和组织细胞肿瘤成人患者；2岁及2岁以上伴有症状、无法手术的丛状神经纤维瘤（PN）的Ⅰ型神经纤维瘤病（NF1）儿童及青少年患者。芦沃美替尼属于小分子MEK1/2选择性抑制剂，目前正在开展治疗NF1成人患者的Ⅲ期临床试验。13、5月29日，NMPA官网显示，特宝生物1类新药怡培生长激素注射液获批上市，适用于治疗3岁及以上儿童的生长激素缺乏症所致的生长缓慢。这是特宝生物自主研发的每周一次给药长效人生长激素，采用40kDY型分支聚乙二醇（YPEG）分子对人生长激素（rhGH）进行单分子修饰。14、5月29日，NMPA官网显示，迈威生物全资子公司泰康生物1类新药注射用阿格司亭α（注射用重组[酵母分泌型]人血清白蛋白-人粒细胞集落刺激因子（I）融合蛋白，研发代号：8MW0511）获批上市，适用于成年非髓性恶性肿瘤患者在接受容易引起发热性中性粒细胞减少症的骨髓抑制性抗癌药物治疗时，降低以发热性中性粒细胞减少症为表现的感染发生率。15、5月29日，NMPA官网显示，百济神州1类新药注射用泽尼达妥单抗获批上市，适用于既往接受过全身治疗的HER2高表达（IHC3+）的不可切除局部晚期或转移性胆道癌患者。泽尼达妥单抗（zanidatamab，ZW25）是一种HER2靶向双特异性抗体。16、5月29日，NMPA官网显示，诺华的盐酸伊普可泮胶囊新适应症获批，用于治疗阵发性睡眠性血红蛋白尿症（PNH）成人患者。作为特异性补体B因子口服抑制剂，伊普可泮在中国获批的适应症增至三项，包括既往未接受过补体抑制剂治疗的PNH成人患者和成人C3肾小球病（C3G）。申请17、5月26日，CDE官网显示，天广实第三代CD20抗体MIL62申报上市，用于治疗视神经脊髓炎谱系疾病（NMOSD），有望成为首个获批该适应症的国产药物。2025年3月，MIL62治疗NMOSD的临床Ⅲ期试验达到预设终点并完成揭盲。18、5月27日，CDE官网显示，优时比的比奇珠单抗注射液新适应症申报上市，适用于中度至重度斑块状银屑病（PSO）及中度至重度化脓性汗腺炎（HS）成人患者。比奇珠单抗是全球首个且目前唯一获批的IL-17A/F双靶点生物制剂，已在中国获批用于治疗强直性脊柱炎和放射学阴性中轴型脊柱关节炎。19、5月28日，CDE官网显示，麓鹏制药的洛布替尼片（Rocbrutinib）申报上市。此前，该药已被纳入优先审评，适用于既往接受过BTK抑制剂治疗的成人套细胞淋巴瘤（MCL）患者。洛布替尼是麓鹏制药自主研发的一款共价兼非共价BTK抑制剂，不仅能克服第1/2/3代BTKi的耐药。20、5月28日，CDE官网显示，罗氏的注射用维泊妥珠单抗（商品名：优罗华）新适应症申报上市。维泊妥珠单抗是罗氏开发的一款靶向CD79B的ADC，于2023年1月获批两项适应症：1）联合利妥昔单抗、环磷酰胺、多柔比星和泼尼松适用于治疗既往未经治疗的DLBCL成人患者；2）联合苯达莫司汀和利妥昔单抗用于不适合接受造血干细胞移植的R/RDLBCL成人患者。21、5月30日，CDE官网显示，VielaBio的伊奈利珠单抗注射液申报上市，用于治疗重症肌无力。伊奈利珠单抗是一款人源化CD19单抗，于2022年3月首次国内获批上市，2019年5月，翰森以2.2亿美元总额和VielaBio达成合作，获得在中国开发和商业化伊奈利珠单抗，用于治疗NMOSD以及其他潜在的炎症/自免和血液系统恶性肿瘤适应症。22、5月30日，CDE官网显示，盐野义的甲苯磺酸纳地美定片申报上市，用于治疗阿片类药物引起的便秘。纳地美是由盐野义制药株式会社开发的外周μ-阿片受体拮抗剂，已在美国、欧盟、日本、中国台湾及中国香港地区获批上市。2025年1月，正大天晴与盐野义签订独家市场推广协议，正大天晴获得该产品在中国大陆地区的独家市场推广权，初步为期十一年。优先审评23、5月26日，CDE官网显示，舒泰神的凝血因子X（FX）激活剂注射用STSP-0601拟纳入优先审评，用于伴抑制物的血友病A或B成人患者出血按需治疗。STSP-0601治疗伴抑制物的血友病A或B患者的Ⅱb期研究达到预设的主要有效性终点。结果显示，疗效显著，12h有效止血率为81.94%，优于单组目标值（OPC），差异具有统计学意义（P＜0.0001）。24、5月28日，CDE官网显示，科济药业的舒瑞基奥仑赛注射液（CT041）纳入优先审评，用于治疗Claudin18.2表达阳性、至少二线治疗失败的晚期胃/食管胃结合部腺癌的患者。舒瑞基奥仑赛注射液是一款靶向Claudin18.2蛋白的自体CAR-T细胞治疗候选产品，用于治疗Claudin18.2阳性实体瘤，主要治疗胃/食管胃结合部腺癌及胰腺癌。FDA上市批准25、5月28日，FDA官网显示，爱尔康的acoltremon滴眼液（Tryptyr）0.003%获批上市，用于治疗干眼症（DED）的体征和症状。Tryptyr中的活性成分acoltremon是TRPM8热敏感受体的激动剂，通过刺激角膜感觉神经，快速增加自然泪液产生。26、5月29日，默沙东与第一三共共同宣布，已自愿撤回HER3ADC药物patritumabderuxtecan（HER3-DXd）在美国寻求加速批准的生物制品许可申请（BLA），用于治疗既往接受过两种或两种以上全身治疗的局部晚期或转移性EGFR突变非小细胞肺癌（NSCLC）成年患者。研发临床状态27、5月25日，Clinicaltrials官网显示，Kodiak Sciences启动了IL-6/VEGF双抗药物KSI-101（5mg或10mg，玻璃体内注射，每4周1次）治疗炎症继发黄斑水肿（MESI）首个Ⅲ期（PEAK），主要终点是治疗第24周最佳矫正视力（BCVA）评分的平均变化。目前，全球首款获批上市的眼科双抗药物是罗氏的法瑞西单抗（商品名：罗视佳、商品名：Vabysmo）。临床数据28、5月26日，百济神州公布了与安进联合开展的CD3/DLL3双抗药物塔拉妥单抗（tarlatamab）治疗既往接受过至少二线治疗（包括含铂化疗）失败的广泛期小细胞肺癌（ES-SCLC）中国患者的Ⅱ期DeLLphi-307研究结果，主要研究终点为客观缓解率（ORR）。结果显示：与标准化疗方案（SOC）相比，塔拉妥单抗在总生存期（OS）方面具有统计学和临床意义的显著改善，安全性表现与既往试验一致。29、5月30日，赛诺菲和再生元宣布，一项依特吉单抗（Itepekimab，IL33单抗）的Ⅲ期临床AERIFY-1达到主要终点，一项Ⅲ期临床AERIFY-2未达到相同的主要终点。AERIFY-1（主要人群为已戒烟患者）和AERIFY-2（主要人群为吸烟和已戒烟患者）是随机、双盲、安慰剂对照、平行组、Ⅲ期研究，旨在评估依特吉单抗治疗中度至重度COPD患者的疗效、安全性和耐受性。交易及投融资30、5月27日，国为医药宣布，与信立泰签署协议，国为医药将AGT-siRNA小干扰核酸药物GW906原料药及制剂在中国市场的相关权利独家授予信立泰。国为医药将获得最高1.8亿元的首付款及研发里程碑款总金额。未来产品获批上市后，销售里程碑累计最高达3.7亿元。同时，在协议约定期限内，国为医药将获得年度净销售额的一定比例的销售提成。31、5月27日，药物牧场宣布，与厦门特宝生物达成选择权协议。双方将就药物牧场DF-006在大中华区（中国大陆、中国台湾、中国香港及中国澳门）开展乙肝和肝癌领域临床合作。DF-006是一种口服ALPK1激动免疫调节剂，能有效激活肝脏的先天免疫。32、5月27日，礼来宣布，和SiteOneTherapeutics达成确定性协议，礼来将收购SiteOne。根据协议，SiteOne股东将获得高达10亿美元的现金，包括前期付款以及在实现某些监管和商业里程碑后支付的后续款项。交易包括STC-004，这是一款已准备进入Ⅱ期临床研究的Nav1.8抑制剂，正在被研究用于治疗疼痛。33、5月27日，岸迈生物宣布，与TCGLabsSoleil投资组合公司JuriBiosciences签署全球许可协议。该协议授予JuriBiosciences用于治疗转移性前列腺癌的靶向激肽释放肽相关肽酶2（KLK2）和CD3开发的T细胞接合分子的全球独家权利。根据协议，岸迈生物有权收取高达2.1亿美元的资金，包括首付款，和开发、注册和商业化相关的里程碑付款，以及特许权使用费。34、5月30日，信诺维宣布，和安斯泰来就一款靶向CLDN18.2的ADC药物XNW27011达成协议，安斯泰来独家拥有XNW27011在全球（除中国大陆、中国香港、中国澳门和中国台湾地区外）开发商业化权利。信诺维将获得1.3亿美元首付款，并有资格收取最高7000万美元近期付款，以及最高可达13.4亿美元里程碑付款。XNW27011目前正在中国开展Ⅰ/Ⅱ期，针对表达CLDN18.2的实体瘤（包括胃癌、胃食管癌和胰腺癌）患者。35、5月30日，石药集团宣布，正与若干独立第三方就三项潜在交易进行磋商，涉及有关石药集团的若干产品（包括EGFR-ADC及由石药集团技术平台开发的其他药品）在开发、生产及商业化方面的授权及合作。每项潜在交易项下，可能应付予石药集团的潜在首付款、潜在开发里程碑付款及潜在商业化里程碑付款，合计可能达到约50亿美元。三项潜在交易中的其中一项目前已处于后期阶段，预计将于2025年6月完成。上市36、5月27日，派格生物正式登陆港交所，中金公司担任独家保荐人。根据招股书，派格生物计划将募集所得款项的50.2%用于长效GLP-1受体激动剂PB-119的商业化和适应症拓展，34.5%用于GLP-1/GCG双重受体激动剂PB-718的进一步开发，5.3%用于其他管线候选产品的研发，1%用于业务开发活动及加强海外业务，剩下9%用作营运资金。END领取CPHI 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上市批准优先审批临床3期

2025-05-31

·精准药物

PROTAC 降解剂的临床进展（2025 年更新)

蛋白水解靶向嵌合体 (PROTAC,Proteolysis Targeting Chimeras) 是一类新型双功能分子，旨在选择性降解致病蛋白。PROTAC 通常由三个部分组成：结合目标蛋白 (POI) 的配体、募集 E3 泛素连接酶的配体以及连接两者的连接体。这种结构能够利用人体自身的泛素-蛋白酶体系统 (UPS) 来标记和降解目标蛋白，从而为药物研发提供了一种极具前景的新方法。目前，虽然尚未有基于 PROTAC 的疗法上市，但超过５0 种 PROTAC 候选药物正在临床试验中评估。这些在研疗法靶向多种蛋白质，包括雄激素受体(AR)、雌激素受体(ER)、Bruton酪氨酸激酶(BTK)和白细胞介素-1 受体相关激酶 4(IRAK4)。其潜在应用涵盖多种疾病，例如血液系统恶性肿瘤、实体瘤和自身免疫性疾病。表 1. PROTAC 在疾病临床试验中的应用3 款代表性III 期临床的 PROTACs三种 PROTAC 已进入 3 期临床试验： Arvinas/Pfizer 的 ARV-471（ER）、百时美施贵宝的 BMS-986365（AR）和百济神州的 BGB-16673（BTK）。1，Vepdegestrant（ARV-471）Vepdegestrant (ARV-471) 是全球首个进入 III 期临床试验的口服 PROTAC 分子。Vepdegestrant 被开发为一种潜在的首创口服 PROTAC 降解剂，旨在利用人体天然的蛋白质处理系统，特异性降解雌激素受体 (ER)。2024 年 2 月，美国 FDA授予 Vepdegestrant 快速通道资格，用于单药治疗 ER+/HER2- 晚期或转移性乳腺癌成人患者，且该患者此前已接受过内分泌治疗。2025 年 3 月，Arvinas 和辉瑞最近分享了 III 期 VERITAC-2 临床试验 (NCT05654623) 的结果，该试验比较了Vepdegestrant单药治疗与氟维司群在 ER 阳性、HER2 阴性晚期或转移性乳腺癌成人患者中的疗效，这些患者在接受 CDK4/6 抑制剂和内分泌治疗后病情出现进展。该试验在携带 ESR1 突变的患者中达到了其主要终点，与氟维司群相比，其无进展生存期 (PFS) 显著改善，且具有临床意义。该组结果超过了 0.60 的目标风险比。然而，该试验在总体意向治疗 (ITT) 人群中未达到统计学意义。在分析时，总生存期 (OS) 数据尚不成熟，记录的事件数不足所需事件数的 25%。将继续追踪 OS，将其作为关键的次要终点。鉴于 VERITAC-2 III 期临床试验结果好坏参半，Arvinas 在其第一季度业绩中更新了vepdegestrant 项目。作为战略转变的一部分，Arvinas 和辉瑞已决定取消两项计划中的 III 期临床试验——一项是评估Vepdegestrant与辉瑞在研 CDK4 抑制剂阿替莫西利 (atirmociclib) 作为一线治疗的疗效，另一项是探索Vepdegestrant与 CDK4/6 抑制剂作为二线治疗的疗效。尽管存在这些变化，合作伙伴仍在推进计划，在今年下半年提交 vepdegestrant 作为二线单一疗法的审批。Arvinas 天塌了，首款 PROTAC (ARV-471) 三期临床不及预期，股价腰斩2，BMS-986365（CC-94676）近日，美国临床试验注册平台 ClinicalTrials.gov 宣布，百时美施贵宝（BMS）旗下子公司 Celgene 正式启动其在研药物 BMS-986365（又名 CC-94676）的 III 期临床试验。这标志着全球第二个进入 III 期临床试验的 PROTAC 药物，也是首个进入该阶段的靶向 AR 的 PROTAC 药物。BMS-986365 是一种强效的配体导向降解剂 (LDD，ligand-directed degrader)，可促进 CRL4-CRBN E3 泛素连接酶依赖的雄激素受体 (AR) 泛素化和降解。它能有效诱导细胞质和细胞核中野生型和突变型 AR 的快速深度降解。与 AR 拮抗剂恩杂鲁胺相比，BMS-986365 在抑制 AR 驱动的基因转录方面的效力高出约 100 倍，在抑制各种前列腺癌细胞系中的 AR 依赖性增殖方面的效力高出 10 至 120 倍。2024 年 1 月，BMS 在 ASCO 泌尿生殖系统癌症研讨会（ASCO GU 2024）上公布了 BMS-986365 用于治疗转移性去势抵抗性前列腺癌（mCRPC）的 I 期临床数据。结果显示，在每日两次 400-900 mg 剂量下，达到 PSA 水平下降≥30%（PSA30，PSA 是测量血液中前列腺特异性抗原（PSA）的含量）的患者比例呈剂量依赖性增加。在全剂量组中，34%（23/68）的患者达到 PSA30。在接受每日两次 900 mg剂量的患者中，55%（11/20）的患者达到 PSA30，35%（7/20）的患者达到 PSA50，10%（2/20）的患者达到 PSA90。此外，该组中 45%（9/20）的患者在 6 个月时未出现疾病进展。2025 年 1 月，BMS 发布了同一项研究的更新分析。在 60 例接受 400-900 mg 每日两次治疗的患者中，32%（19/60）达到 PSA50，其中包括 10 例来自 900 mg组的患者。总体中位放射学无进展生存期（rPFS）为 6.3 个月，900 mg组为 8.3 个月。值得注意的是，初治患者的中位 rPFS 比既往接受过治疗的患者更长（16.5 个月 vs 5.5 个月）。图 1. 接受每日两次剂量治疗的患者的 rPFS。3，BGB-16673（百济神州）2025 年 4 月，ClinicalTrials.gov 网站列出了百济神州开发的靶向 BTK 的 PROTAC BGB-16673 的首个 III 期临床试验的启动。这标志着首个进入 III 期的 BTK PROTAC，也是全球第三个进入该阶段的 PROTAC 分子。这项正在进行的随机、开放标签 III 期临床试验（n=250）旨在评估 BGB-16673 对比研究者选择的疗法（Idelalisib联合利妥昔单抗、Bendamustine 联合利妥昔单抗或venetoclax联合利妥昔单抗再治疗）在既往接受过 BTK 和 BCL-2 抑制剂治疗的慢性淋巴细胞白血病 (CLL) 患者中的疗效和安全性。主要终点是评估的 36 个月无进展生存期 (PFS)。在 2024 年美国血液学与血液学学会（ASH）年会上，百济神州分享了 CaDAnCe-101 治疗复发/难治性慢性淋巴细胞白血病（CLL）的 I 期研究数据。在 49 例接受治疗的患者中，总体缓解率（ORR）达到 78%（38/49），其中 200 毫克剂量组的 ORR 达到 94%。BGB-16673 在其他血液系统恶性肿瘤治疗中也显示出良好的前景。在 I 期试验中：•华氏巨球蛋白血症：21名患者ORR 为90%;• 滤泡性淋巴瘤：8 名患者ORR为 50%;• 边缘区淋巴瘤：8名患者ORR为 67%;这些结果突显了 BGB-16673 是一种潜在的FIC BTK 降解剂，对 B 细胞恶性肿瘤具有广泛的活性。PROTAC 的概念提出至今已有 20 多年。作为一种新兴的药物研发技术，PROTAC 因其能够靶向此前“不可成药”的蛋白质并克服耐药性的潜力，受到了学术界和制药行业的广泛关注。然而，尽管 PROTAC 药物前景光明，其开发也面临着巨大的挑战。许多 PROTAC 分子分子量较大，难以结晶、溶解性差、渗透性差。此外，一些候选药物的口服生物利用度仍然较低，这给临床转化和商业成功带来了进一步的障碍。声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

蛋白降解靶向嵌合体临床3期临床2期

2025-05-30

·GlobeNewswire-Health Care

Adaptive Biotechnologies Highlights New Data at 2025 ASCO Annual Meeting and EHA 2025 Congress Demonstrating How clonoSEQ® MRD Assessment is Optimizing Patient Care and Drug Development in Lymphoid Cancers

30 scientific abstracts will be presented using clonoSEQ for MRD assessment across multiple types of blood cancersSEATTLE, May 30, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in 30 presentations, including a total of 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago and the European Hematology Association (EHA) Congress taking place June 12-15 in Milan. These presentations include notable new data supporting the clinical actionability of clonoSEQ in both multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). "The breadth of new MRD evidence being shared across various blood cancer types at ASCO and EHA this year highlights the transformative impact MRD is having on clinical care and drug development," said Susan Bobulsky, Chief Commercial Officer, MRD, Adaptive Biotechnologies. "These data presentations are a testament to the central role that clonoSEQ MRD testing now plays in clinical management and drug development across lymphoid cancers, particularly when combined with several clonoSEQ data presentations in diffuse large B-cell lymphoma (DLBCL) anticipated at the 18th International Conference on Malignant Lymphoma (iCML) on June 17-21, 2025 in Lugano, Switzerland." Selected presentations include: Data advancing the clinical actionability of clonoSEQ MRD testing Results from MIDAS, a phase 3 randomized study of 718 transplant-eligible, newly diagnosed multiple myeloma (NDMM) patients, demonstrate the use of MRD status to guide therapy post-induction. (ASCO Abstract 7500, June 3, 9:45-9:57 a.m. CDT, S100bc, McCormick Place Convention Center)Interim data from ADVANCE, a phase 2 randomized study of 306 transplant-eligible patients with NDMM shows the impact of MRD-guided assessments post-induction (ASCO Abstract 7503, June 3, 10:21-10:33 a.m. CDT, S100bc, McCormick Place Convention Center)Interim results from VENETOSTOP, a phase 2 study of 66 CLL patients, report the use of MRD status to shorten duration of venetoclax-based therapy. (EHA Abstract PS1568, June 14, 6:30 p.m. CEST, Poster Hall, Milano Convention Centre) Studies utilizing clonoSEQ MRD assessment as a critical indicator of quadruplet regimen efficacy in multiple myeloma Results from the phase 3 IsKia study of 151 transplant-eligible NDMM patients demonstrates increased rates of sustained MRD negativity at 10-6 with isatuximab plus carfilzomib, lenalidomide, and dexamethasone. (ASCO Abstract 7502, June 3, 10:09-10:21 a.m. CDT, S100bc, McCormick Place Convention Center) Follow-up data from PERSEUS, a phase 3 trial of 709 transplant-eligible patients with NDMM reports the impact of sustained MRD negativity status on progression free survival (PFS) with subcutaneous daratumumab plus bortezomib, lenalidomide and dexamethasone (D-VRd) induction and DR maintenance. (ASCO Abstract 7501, June 3, 9:57-10:09 a.m. CDT, S100bc, McCormick Place Convention Center) Results from DREAMM-8, a Phase 3 study in 302 patients with relapsed or refractory multiple myeloma, found superior PFS and higher MRD negativity rates in patients treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) as compared to standard-of-care pomalidomide, bortezomib, and dexamethasone (PVd). (ASCO Abstract 7515, June 2, 9:00-9:06 a.m. CDT E450b, McCormick Place Convention Center) Data to be presented at ASCO: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaPoster Presentation6540Initial results from a phase II study of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) ± rituximab (R) + tafasitamab (tafa) for adults with newly-diagnosed (ND) Philadelphia chromosome negative (Ph-) B lymphoblastic leukemia (B-ALL)Sunday, June 19 a.m.-12 p.m. CDTPoster Presentation6543Brexucabtagene autoleucel (Brexu-cel) as consolidation treatment in adults with B-cell acute lymphoblastic leukemiaSunday, June 19 a.m.-12 p.m. CDTMultiple MyelomaOral Presentation7500*MRD-driven strategy following IsaKRD induction in transplant-eligible NDMM: Primary endpoints of the phase 3 MIDAS trialTuesday, June 39:45-9:57 a.m. CDTOral Presentation7501Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trialTuesday, June 39:57-10:09 a.m. CDTOral Presentation7502Sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial)Tuesday, June 310:09-10:21 a.m. CDTOral Presentation7503*Randomized, multi-center study of carfilzomib, lenalidomide, and dexamethasone (KRd) with or without daratumumab (D) in patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trialTuesday, June 310:21-10:33 a.m. CDTOral Presentation7507*Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM)Tuesday, June 311:57 a.m.-12:09 p.m. CDTOral Presentation7515Minimal residual disease (MRD) negativity (neg) in patients (pts) with relapsed or refractory multiple myeloma (RRMM) treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) vs pomalidomide, bortezomib, and dexamethasone (PVd): Analysis from the DREAMM-8 trialMonday, June 29-9:06 a.m. CDTOral Presentation7516Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS studyMonday, June 29:06-9:12 a.m. CDTASCO Oral Presentation7517*Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): Outcomes in patients with 1q21+ status in the phase 3 IMROZ studyMonday, June 29:12-9:18 a.m. CDTPoster Presentation7529Daratumumab + bortezomib, lenalidomide, and dexamethasone (DVRd) vs VRd in transplant-ineligible (TIE)/transplant-deferred (TD) newly diagnosed multiple myeloma (NDMM): Phase 3 CEPHEUS trial cytogenetic subgroup analysisSunday, June 19 a.m.-12 p.m. CDTPoster Presentation7535Carfilzomib, lenalidomide, and dexamethasone (KRd) as maintenance therapy after autologous stem-cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma (NDMM)Sunday, June 19 a.m.-12 p.m. CDTASCO Poster Presentation7551*Positron emission tomography with computed tomography (PET/CT) and minimal residual disease (MRD) for efficacy assessment in transplant-ineligible newly diagnosed myeloma (Ti NDMM) patients (pts): IMROZ analysisSunday, June 19 a.m.-12 p.m. CDT Data to be presented at EHA: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaOral PresentationS112Safety and efficacy of single-agent subcutaneous blinatumomab in adults with relapsed/refractory (R/R) b-cell acute lymphoblastic leukemia (B-ALL): results from a phase 1/2 dose expansion studySunday, June 1511:30-11:45 a.m. CESTOral PresentationS117Safety and efficacy of AZD0486 in adolescent and adult patients with relapsed or refractory b-cell acute lymphoblastic leukemia: early results from the phase 1/2 SYRUS studyFriday, June 135:30-5:45 p.m. CESTPoster PresentationPF372Donor-derived, allogeneic CD19/CD22-CAR T cells with myeloablative graft-engineered Allo-HCT for high-risk B-ALLFriday, June 136:30 p.m. CESTChronic Lymphocytic LeukemiaPoster PresentationPF575Preliminary results of the ongoing multicenter, phase 2 study of retreatment with venetoclax plus obinutuzumab (ReVenG) in patients with recurrent chronic lymphocytic leukemia (CLL)Friday, June 136:30 p.m. CESTPoster PresentationPS1568Using minimal residual disease status to guide venetoclax treatment duration in patients with chronic lymphocytic leukemia: interim results from the phase II VENETOSTOP studySaturday, June 146:30 p.m. CESTFollicular LymphomaPoster PresentationPF881Epcoritamab monotherapy demonstrates deep and durable responses at 3-year follow-up in patients with relapsed/refractory follicular lymphomaFriday, June 136:30 p.m. CESTPoster PresentationPS21504-year update of phase 2 ELARA trial: clinical outcomes of tisagenlecleucel in patients (pts) with high-risk relapsed/refractory follicular lymphoma (R/R FL)Saturday, June 146:30 p.m. CESTMantle Cell Lymphoma Poster PresentationPF882Minimal residual disease with bendamustine-rituximab with or without acalabrutinib in patients with previously untreated mantle cell lymphoma: results from the phase 3 ECHO trialFriday, June 136:30 p.m. CESTMultiple MyelomaOral PresentationS201Phase 2 registrational study of anitocabtagene autoleucel for relapsed and/or refractory multiple myeloma (RRMM): updated results from IMMAGINE-1Saturday, June 145:15-5:30 p.m. CESTOral PresentationS205*Minimal residual disease-driven strategy following isatuximab-carfilzomib-lenalidomide-dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma: Primary endpoints of the phase 3 MIDAS trialSunday, June 1511:00-11:15 a.m. CESTOral Presentation S207*A randomized, multi-center study of carfilzomib, lenalidomide and dexamethasone (KRd) with or without daratumumab (D) for the treatment of patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trialSunday, June 1511:30-11:45 a.m. CESTOral PresentationS208*Analysis of sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial)Sunday, June 1511:45 a.m.-12 p.m. CESTPoster PresentationPF727Isa-vrd improves outcomes in high-risk (HR) newly diagnosed transplant-ineligible multiple myeloma (NDMM TI) using the IMS/IMWG consensus HR definition: results from the BENEFIT phase 3 trial (IFM 2020-05)Friday, June 136:30 p.m. CESTPoster Presentation PF729*Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): outcomes in patients with 1q21+ status in the phase 3 IMROZ studyFriday, June 136:30 p.m. CESTPoster PresentationPF750Isatuximab, bortezomib, lenalidomide, dexamethasone (Isa-VRd) in patients with transplant-ineligible (TI) newly diagnosed myeloma (NDMM) and plasmacytomas: IMROZ subgroup analysisFriday, June 136:30 p.m. CESTPoster PresentationPF754Interim analysis of MRD-guided maintenance therapy with belantamab mafodotin and lenalidomide after Auto-HCT in newly diagnosed multiple myelomaFriday, June 136:30 p.m. CESTPoster Presentation PS1722*Positron emission tomography with computed tomography and minimal residual disease for efficacy assessment in transplant-ineligible newly diagnosed myeloma patients: IMROZ analysisSaturday, June 146:30 p.m. CEST *Indicates data to be presented at both ASCO and EHA. About clonoSEQ clonoSEQ® is the first and only FDA-cleared in vitro diagnostic (IVD) test for detecting and tracking minimal (or measurable) residual disease (MRD) in patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) using bone marrow, and in patients with chronic lymphocytic leukemia (CLL) using blood or bone marrow. clonoSEQ is also available in diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). clonoSEQ is covered by Medicare for MM, CLL, ALL, DLBCL and MCL. clonoSEQ identifies and quantifies DNA sequences in malignant cells—detecting one cancer cell in one million healthy cells—to help clinicians and researchers assess and monitor MRD with precision over time. It delivers standardized, sensitive results that inform treatment decisions, predict outcomes, and detect relapses earlier. clonoSEQ is CE-marked under the EU In Vitro Diagnostic Regulation (IVDR). For intended use details in the EU, see the instructions for use, available on request. To review the FDA-cleared uses of clonoSEQ, visit clonoSEQ.com/technical-summary. About Adaptive Biotechnologies Adaptive Biotechnologies ("we" or "our") is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature's most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. Forward Looking Statements This press release contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections regarding the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. ADAPTIVE INVESTORS Karina Calzadilla, Vice President, Investor Relations and FP&A 201-396-1687 investors@adaptivebiotech.com ADAPTIVE MEDIAErica Jones, Associate Corporate Communications Director206-279-2423media@adaptivebiotech.com

临床2期临床3期临床结果ASCO会议

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适应症	国家/地区	公司	日期
弥漫性大B细胞淋巴瘤	日本	SymBio Pharmaceuticals Ltd.	2021-04-28
淋巴细胞白血病	日本	SymBio Pharmaceuticals Ltd.	2016-08-26
惰性B细胞非霍奇金淋巴瘤	美国	Eagle Pharmaceuticals, Inc.	2015-12-07
套细胞淋巴瘤	日本	SymBio Pharmaceuticals Ltd.	2010-10-27
惰性非霍奇金淋巴瘤	奥地利	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	比利时	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	保加利亚	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	德国	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	意大利	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	卢森堡	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	荷兰	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	葡萄牙	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	斯洛伐克	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	西班牙	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	奥地利	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	比利时	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	保加利亚	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	德国	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	意大利	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	卢森堡	Pharma& Schweiz GmbH	2010-07-15

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适应症	最高研发状态	国家/地区	公司	日期
难治性B细胞淋巴瘤	临床3期	中国	-	2010-04-01
复发性慢性淋巴细胞白血病	临床3期	德国	Mundipharma Research GmbH & Co. KG	2001-09-01
难治性经典霍奇金淋巴瘤	临床2期	美国	Bristol Myers Squibb Co.	2018-11-26
CD30阳性T细胞淋巴瘤	临床2期	瑞士	Mundipharma Medical Co.	2018-09-01
复发性经典霍奇金淋巴瘤	临床2期	美国	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	加拿大	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	捷克	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	法国	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	德国	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	爱尔兰	Bristol Myers Squibb Co.	2017-03-28

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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


Pubmed \| Blood Cancer J	临床2期	滤泡性淋巴瘤 BCL-2 \| BCL-xL \| MCL-1	56	Venetoclax	艱餘衊構構鏇觸淵醖餘(壓觸淵窪範簾顧簾夢廠) = 觸範襯醖構築鏇憲鹹餘壓網繭簾觸獵網顧衊鏇 (膚餘積構願襯壓遞製艱 ) 更多	不佳	2025-05-12
				Bendamustine	餘醖鏇醖網衊構襯鬱積(願觸糧簾鹽衊鏇觸願艱) = 醖顧繭醖製糧築窪艱餘製選網壓鑰餘壓醖鹽選 (膚鬱選糧鹽遞廠醖襯顧 )
Pubmed \| Blood Adv 人工标引	N/A	滤泡性淋巴瘤	220	initially treated with bendamustine-rituximab, rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) second-line	獵範獵廠觸獵糧壓糧淵(積遞蓋鬱簾憲糧網獵觸) = 鹹選繭築餘觸餘範遞衊願艱壓齋夢廠鹹繭繭淵 (壓鏇夢餘鏇憲築鹽餘淵, 56 ~ 70) 更多	积极	2025-03-11
NCT02927769 (CheckMate 744, CTgov)	临床2期	复发性经典霍奇金淋巴瘤	72	Bv+nivolumab+bendamustine+brentuximab+brentuximab vedotin (Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse)	築醖顧艱築選願憲網醖 = 衊壓衊淵構網築簾憲鬱膚蓋餘製艱築鹹鏇製廠 (憲鑰鏇繭願醖繭遞夢網, 製願選鏇觸獵簾淵網範 ~ 窪壓襯範鑰網餘遞製齋) 更多	-	2025-02-10
				Bv+nivolumab+bendamustine+brentuximab+brentuximab vedotin (Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse)	齋憲網願鏇餘製簾鬱鏇 = 築憲膚顧壓遞衊築築窪夢鹹築廠選夢鑰蓋鬱夢 (壓壓鑰糧醖鹹繭鏇顧齋, 艱構願獵淵構糧構構鏇 ~ 構艱選鹽壓襯鹽艱鹹壓) 更多
NCT03187223 (BEB-2, CTgov)	临床2期	多发性骨髓瘤 \| 难治性多发性骨髓瘤	120	Melphalan (Arm A (Mel))	簾廠憲鹽鏇觸築選願觸 = 築糧壓網廠餘繭鹹鑰獵醖憲醖願齋蓋鏇壓遞構 (壓襯壓積鏇夢鹹鹹鏇齋, 鏇淵襯鹹鬱網糧網鹽蓋 ~ 網鑰衊繭鑰製夢鹹醖選) 更多	-	2025-01-30
				bendamustine+Melphalan (Arm B (BenMel))	簾廠憲鹽鏇觸築選願觸 = 壓遞鏇膚鬱艱築餘構製醖憲醖願齋蓋鏇壓遞構 (壓襯壓積鏇夢鹹鹹鏇齋, 構選範鹹遞願憲鏇壓膚 ~ 淵窪膚齋網鑰衊艱夢繭) 更多
ASH2024	N/A	套细胞淋巴瘤	-	Bendamustine/Rituximab (BR)	願遞簾鏇鹽鑰餘範網顧(製鬱遞範壓顧糧簾鏇鏇) = 廠製鑰簾醖觸構窪餘醖選夢醖蓋憲獵選獵製願 (齋製衊壓糧繭範鏇選鏇, 59.8 ~ 79.7) 更多	-	2024-12-09
ASH2024	N/A	滤泡性淋巴瘤	-	Tazemetostat 800mg BID	醖遞遞蓋蓋淵築獵衊膚(鏇鑰齋網鑰製糧糧艱鑰) = leukopenia (n=2), neutropenia (n=1), anemia (n=1), atrial fibrillation (n=1), bone pain (n=1), infection (n=2), and infusion related reaction (n=1) 蓋構鬱鹹築鹽選遞衊鏇 (鏇範鹹觸選網遞糧觸遞 ) 更多	-	2024-12-09
ASH2024	N/A	惰性B细胞非霍奇金淋巴瘤	-	Bendamustine Rituximab	鏇遞簾顧衊糧齋製築獵(範遞鏇壓齋簾鬱遞鬱積) = 糧鏇淵願願觸製鏇築餘選積齋積鏇鹹選鹹蓋襯 (簾簾膚網製製壓鏇餘鹽, 8.6 ~ 10.4)	-	2024-12-08
				Placebo	鏇遞簾顧衊糧齋製築獵(範遞鏇壓齋簾鬱遞鬱積) = 網壓獵糧窪構繭憲簾鹽選積齋積鏇鹹選鹹蓋襯 (簾簾膚網製製壓鏇餘鹽, 5.9 ~ 9.4)
NCT04663347 (EPCORE NHL-2, ASH2024) 人工标引	临床1/2期	滤泡性淋巴瘤一线	25	Epcoritamab + Bendamustine + Rituximab	鹽鬱鬱餘鹽憲蓋製壓觸(鑰簾製襯鏇鏇願簾築鹽) = 遞願艱獵網衊餘鹹襯願壓築範顧構艱淵繭製襯 (鹽鏇網壓繭觸築醖製壓 ) 更多	积极	2024-12-07
ASH2024	N/A	套细胞淋巴瘤	-	Acalabrutinib plus bendamustine-rituximab (ABR)	積糧淵簾衊鹽網醖顧齋(廠壓壓鹽網獵構艱鹽繭) = 築膚鏇鹽獵蓋鬱膚艱簾積淵窪襯艱範醖製製齋 (願鹹廠糧製齋襯構選齋 ) 更多	-	2024-12-07
				Placebo plus bendamustine-rituximab (PBR)	積糧淵簾衊鹽網醖顧齋(廠壓壓鹽網獵構艱鹽繭) = 廠顧襯選顧觸鑰顧築鏇積淵窪襯艱範醖製製齋 (願鹹廠糧製齋襯構選齋 ) 更多
NCT03311126 (CTgov)	临床2期	套细胞淋巴瘤	21	bendamustine+Obinutuzumab	積鬱遞餘願製壓窪蓋觸 = 襯觸願膚醖醖憲廠醖製蓋淵獵鬱艱鹽鏇築鹹憲 (範壓艱鹹獵選範鏇齋鑰, 鹽鹽淵餘窪網製鏇餘醖 ~ 窪鬱選鬱膚鏇壓選蓋膚) 更多	-	2024-10-24