This phase I trial tests the safety, side effects and best dose of epcoritamab alone and epcoritamab with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R- mini-CHP) for the treatment of diffuse large B cell lymphoma (DLBCL) in elderly or unfit patients. Epcoritamab 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). Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell receptors, and delivers monomethyl auristatin E to kill them. Rituximab is a monoclonal antibody. It binds to a protein called cluster of differentiation antigen 20 (CD20), which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Epcoritamab alone and epcoritamab with pola-R-mini-CHP may be safe, tolerable and/or effective in treating DLBCL in elderly or unfit patients.

开始日期2026-12-08

申办/合作机构

Jonsson Comprehensive Cancer Center

[+1]

NCT07638722

/ Not yet recruiting临床2期IIT

MOZART MZL: A Randomized Phase II Study Evaluating Mosunetuzumab Alone and in Combination With Either Zanubrutinib or Polatuzumab Vedotin for the Treatment of Patients With Relapsed/Refractory Marginal Zone Lymphoma

This phase II trial compares the effect of mosunetuzumab alone to mosunetuzumab with zanubrutinib or polatuzumab vedotin in patients with marginal zone lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Mosunetuzumab 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). Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as marginal zone lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD79B receptors, and delivers monomethyl auristatin E to kill them. Giving mosunetuzumab alone or with zanubrutinib or polatuzumab vedotin may work well for treating relapsed or refractory marginal zone lymphoma.

开始日期2026-10-03

申办/合作机构

SWOG

[+1]

NCT07702851

/ Not yet recruiting临床2期IIT

A PROSPECTIVE MULTICENTER PHASE 2 STUDY OF THE CHEMOTHERAPY-FREE COMBINATION OF POLATUZUMAB VEDOTIN AND GLOFITAMAB IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA WITHIN 12 MONTHS OF R-CHOP TREATMENT

Patients with diffuse large B-cell lymphoma (DLBCL) who are primary refractory to first-line R-CHOP therapy or relapse within 12 months after R-CHOP have a poor prognosis and limited treatment options. Conventional salvage chemotherapy has limited efficacy, and CAR-T cell therapy may be limited by manufacturing time, accessibility, and patient condition. Therefore, an immediately available, chemotherapy-free treatment strategy that may reduce the cumulative toxicity of conventional cytotoxic chemotherapy is needed.
Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that delivers a cytotoxic agent to malignant B cells, and glofitamab is a CD20×CD3 bispecific antibody that activates T cells and induces immune-mediated antitumor activity. The combination of these two agents may provide complementary antitumor effects through direct tumor cell killing and T-cell-mediated immune response.
This single-arm, open-label, phase 2 study will evaluate the efficacy and safety of polatuzumab vedotin in combination with glofitamab in patients with DLBCL who are primary refractory to or relapse within 12 months after first-line R-CHOP therapy. Approximately 47 participants will be enrolled. The primary endpoint is the complete response rate at the end of treatment, as assessed by the investigator according to Lugano 2014 criteria.

开始日期2026-09-01

申办/合作机构

Yonsei University

100 项与维泊妥珠单抗相关的临床结果

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100 项与维泊妥珠单抗相关的转化医学

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100 项与维泊妥珠单抗相关的专利（医药）

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790

项与维泊妥珠单抗相关的文献（医药）

2026-07-01·INTERNAL MEDICINE

Hereditary Neuropathy with Liability to Pressure Palsies Unmasked by Polatuzumab Vedotin-containing Chemotherapy

Article

作者: Yoshikawa, Masaaki ; Suzuyama, Kohei ; Hoshino, Yuki ; Goto, Yuta ; Shichijo, Chika ; Kawanami, Takeru ; Ide, Toshihiro ; Hirahara, Rintaro ; Koike, Haruki

We report the case of a 49-year-old man with hereditary neuropathy with liability to pressure palsies unmasked by polatuzumab vedotin-containing chemotherapy. Neuropathic symptoms were predominant in areas surrounding the right and left ulnar nerves after the first course of chemotherapy. However, they progressed in a stepwise manner, involving other limb regions, after the second and third courses. Nerve conduction studies revealed demyelinating neuropathy conspicuous at the compression sites, and fluorescence in situ hybridization showed deletion of the PMP22 gene. This case underscores the importance of considering the development or exacerbation of hereditary neuropathies including hereditary neuropathy with liability to pressure palsies in patients receiving polatuzumab vedotin.

2026-07-01·Physiological Reports

Physiologically relevant media are associated with overlapping metabolic responses in primary human hepatocytes and Huh7 cells

Article

作者: Sanna, Fabio ; Dennis, Kaitlyn M. J. H. ; Smith, Kieran ; Nagarajan, Shilpa R. ; Hodson, Leanne ; Westcott, Felix ; Cross, Eloise

Abstract:

The initiation and progression of metabolic dysfunction‐associated steatotic liver disease (MASLD) is challenging to study in vivo in humans, and robust in vitro high‐fidelity disease models are limited. Although primary human hepatocytes (PHH) are often considered to be the gold standard, immortalized hepatic cell lines are often utilized because of their scalability and experimental tractability. Therefore, the aim of this study was to compare the metabolic responses of PHHs with our characterized Huh7‐based model when exposed to the physiologically relevant fatty acid (FA) mixtures. PHH and Huh7 cells were treated with 2% human serum and a combination of sugar and FAs enriched in either unsaturated (OPLA) or saturated (POLA) FAs for 4 or 7 days, respectively. Stable isotope tracers were utilized to investigate basal changes in hepatocyte metabolism in response to different treatment regimes. Changes in cell viability, media biochemistry, intracellular metabolism, lipid droplet morphology, and gene expression were quantified. Huh7 cells had greater viability than PHH, while NEFA uptake and triglyceride secretion were similar. Both OPLA and POLA increased the proportion of large lipid droplets in Huh7 cells, whereas only OPLA produced comparable effects in PHH. Despite higher baseline TG in PHH, both models showed similar lipid composition, de novo lipogenic responses, and glycogen levels. Compared to Huh7 cells, PHH exhibited higher media 3‐hydroxybutyrate, lower media lactate, reduced glucose uptake, and donor‐dependent transcriptomic variability. Our data demonstrate that Huh7 cells are metabolically adaptable and, when cultured in physiologically relevant media, metabolic readouts are more similar to those observed in PHH cells, thus making Huh7 a potentially useful workhorse model to investigate relevant pathways that may underpin the development of MASLD. Progress in MASLD research is constrained by limited access to human liver tissue and the scarcity of robust in vitro models. Although PHHs are considered the gold standard, they can be limited by poor viability and donor‐to‐donor variability. Huh7 cells are metabolically flexible and can recapitulate key metabolic responses of PHH when exposed to physiologically‐relevant chronic culture conditions, making them an alternative to PHH that is a scalable and reproducible model for investigating intrahepatic triglyceride (IHCTG) accumulation and MASLD progression.

2026-07-01·International Journal of Clinical Oncology

Emerging treatment strategies for newly diagnosed diffuse large B-cell lymphoma

Review

作者: Miyazaki, Kana

Abstract:

Despite recent progress in improving patient survival, the outcomes in approximately 40% of patients with diffuse large B-cell lymphoma (DLBCL) remain poor. For many years, R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) has been the standard first-line treatment for DLBCL; however, pola-R-CHP (polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone) has recently emerged as a new treatment option. In parallel, novel molecularly targeted therapies that target signaling pathways, cellular antigens, and epigenetic regulators associated with high-risk DLBCL are in development. Treatment strategies tailored to the cell of origin or to specific molecular subtypes are also being explored using subtype-specific targeted agents. In addition, agents that have demonstrated efficacy in patients with relapsed or refractory DLBCL—such as the anti-CD19 antibody tafasitamab and immunomodulatory drugs such as golcadomide—are currently under investigation for use in newly diagnosed patients. Immunotherapies, including anti-CD19-chimeric antigen receptor-T therapy and CD20×CD3 bispecific antibodies (BsAbs), have significantly improved outcomes in patients with relapsed or refractory disease and are now under evaluation as early-line therapies. BsAbs can enable more flexible treatment strategies, including combination regimens with cytotoxic or chemotherapy-free approaches. This review summarizes recent advances and ongoing trials that are investigating novel therapeutic strategies for newly diagnosed DLBCL that may soon be incorporated into clinical practice.

936

项与维泊妥珠单抗相关的新闻（医药）

2026-07-29

·生物药大时代

2026年全球ADC CXO竞争格局

▲9月4-5日 CBI生物医药创新博览会扫码报名声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 2025年，全球ADC药物商业化进程显著提速。据弗若斯特沙利文统计，2025年全球ADC药物市场规模已达约172亿美元。行业数据显示，全球已上市的20余款ADC药物合计销售额达165-168亿美元，较2021年（约55亿美元）增长超2倍，增速显著跑赢医药大盘。Enhertu全年销售额49.82亿美元（+32.7%），Padcev、Polivy相继跨过20亿美元门槛，增速均超45%。商业化扩容叠加药企外包生产的趋势加深，持续拉动ADC研发及生产需求向CDMO企业转移，订单储备充沛。外包渗透率跳升，CDMO拐点已至 ADC赛道正从单点放量走向长周期增长。弗若斯特沙利文预测，全球ADC市场规模将从2023年的104亿美元增至2030年的662亿美元，年复合增速30.3%，远超同期生物药9.2%的整体水平。技术迭代推动偶联范式从传统ADC向XDC延伸，载荷与载体的多元组合正在打开更广阔的产业空间。这股景气沿产业链向上传导，直接撬动了CRDMO需求。据弗若斯特沙利文数据显示，全球ADC及广义生物偶联药物CRDMO市场规模从5亿美元扩张至35亿美元，预计2030年达110亿美元，十余年接近20倍增长。ADC涉及抗体、连接子、毒素的协同开发与复杂偶联工艺优化，技术壁垒显著高于单抗等常规生物药，天然决定了其外包渗透率更高。换言之，ADC CDMO已不再是传统生物药外包的延伸赛道，而是凭借更高的技术附加值和外包率，正在成为CXO行业增长最快、盈利弹性最大的细分板块。全球ADC CDMO竞争格局面对这一高速增长的市场，海内外CDMO企业正围绕产能、技术与全球化布局展开激烈竞逐。以下为2026年全球主要ADC CDMO企业的产能布局与项目进展情况。海外：龙沙、三星与富士PK Lonza正借ADC高景气加速端到端产能卡位。2026年上半年集团核心EBITDA利润率进一步抬升至34.8%，公司顺势将全年核心EBITDA利润率指引上调至33%–34%。除此之外，宣布扩建瑞士Visp的payload-linker/HPAPI产能预计2028年投产。并在瑞士Stein新增一条商业化规模多用途ADC无菌灌装线，预计2030年投产，这是由一家大型药企的长期ADC合作承诺背书。 Samsung Biologics与Fujifilm正加速追赶。三星生物仁川松岛设立专用设施，配备500升偶联反应器，计划2027年前补齐制剂产能。Fujifilm则依托日本富山研发中心及701F、704F两大生产基地构建全链条服务能力，其ADC生产线同样预计于2027年下半年投入运行。 Catalent凭借SMARTag®技术平台实现定点、可控的药物-蛋白质偶联，仅利用蛋白质天然修饰位点，对细胞系工程改造要求极低。该平台支持高DAR值偶联物及双载荷ADC的构建。公司在美国加州Emeryville设有配备完整ADC研发与生产能力的专属设施。 Abzena则凭借ThioBridge®技术平台实现定点、稳定的ADC偶联，可提供均一的药物抗体比（DAR）分布与更优的药代动力学特性。公司在美国加州、宾州布里斯托和英国剑桥设有三处基地。工艺开发阶段可处理100ml-50L反应体积，GMP生产阶段可扩展至1-200L，单日偶联物纯化能力超过1公斤。国内：药明领跑国际，各企业蓄力追赶在国内ADC CDMO阵营中，药明合联不仅是国内市场的绝对龙头，更是全球ADC CXO赛道的引领者。 2025年，药明合联实现营收59.44亿元（+46.69%），全球市场份额预计已超24%，较2022年的9.9%实现翻倍跃升，位居全球同行业第一。公司形成无锡马山基地、新加坡基地与江阴基地三大产能支点，并通过战略并购东曜药业快速扩充产能。截至2025年末，药明合联拥有252个进行中的综合项目，累积服务客户643个，与全球制药企业20强中的14家建立合作，未完成订单14.89亿美元（+50.30%），新签订单13.3亿美元（+约41%）。公司预计2026年至2030年将投入80亿元人民币资本开支，持续巩固其全球领先地位。凯莱英是增长最为迅猛的追赶者。2025年其生物药CDMO板块收入2.94亿元（+95.8%），金山与奉贤双基地协同发力，奉贤商业化ADC车间预计2026年第二季度交付。截至2025年末，毒素连接体业务服务临床阶段项目36个（含6个PPQ项目），首个ADC药物已通过PAI核查进入商业化阶段，预计2026年将有4个项目陆续步入商业化。普洛药业依托获必维认证的高活平台切入赛道，配备6个OEB5级高活操作间。截至2025年末，已与713家国内外创新药企业签订保密协议，三年内将交付的商业化在手订单超60亿元。博腾股份2025年新分子业务收入0.68亿元（+224%），增速亮眼。更关键的是海外订单破局，斩获海外双载荷ADC IND整包项目，多肽和Payload-linker业务均实现NDA项目突破。重庆ADC商业化平台预计2026年12月建成。皓元医药深耕ADC领域多年，2025年收入28.77亿元（+26.73%），归母净利润2.40亿元（+19.0%）。截至年末已承接ADC项目超190个，合作客户超1700家，重庆基地已通过欧盟QP审计。已有16个ADC相关小分子产品完成美国FDA sec-DMF备案，参与5个BLA申报。九洲药业2025年度整体营收55.09亿元，净利润7.3亿元，盈利能力明显提升。ADC业务通过小分子+多肽平台能力切入，已建立覆盖获批药品前十连接子的连接子库，并完成部分毒素库与螯合剂库建设，拥有OEB4/OEB5级高活实验室和GMP车间。药石科技聚焦Linker-Payload模块生产。2025年新分子实体板块收入0.84亿元（+50%+），全年累计交付各类创新型Linker、Payload及Linker-Payload复合物超200个，并完成2个全新结构Linker项目的数十公斤级PPQ批次生产交付，在研GMP级别项目已接近10个。 2026年，全球ADC CDMO格局正经历结构性重塑。海外巨头的新增产能多集中于2027年后释放，而国内厂商已凭借差异化技术与交付效率率先卡位。随着行业从“拼产能”转向“拼兑现”，高壁垒的端到端交付能力与商业化订单兑现度将成为穿越周期的核心分水岭。参考资料：各企业官网、公开资料等 END 官方建群啦！生物药大时代组建了抗体药、疫苗、核酸药物等多个相关领域的实名制微信交流群，扫描下方二维码即可入群！

2026-07-27

·大众健康网

45%缓解率、32个月生存期、70%客观缓解――希望之城携硬核数据亮相2026 ASCO

希望之城是全美规模最大、技术最前沿的癌症研究与治疗机构之一，其国家医疗中心亦被《美国新闻与世界报道》评为全国顶级癌症中心。来自该机构的研究人员将在2026年美国临床肿瘤学会（ASCO）年会上公布一系列最新研究成果。届时，希望之城将展示涵盖实体瘤与血液癌症的共计49篇摘要。这些研究成果将于5月29日至6月2日在芝加哥发布，反映出各方正不断加大力度，力求基于肿瘤生物学特征、既往治疗史以及影响疗效的患者个体因素，量身定制更为精准的癌症治疗方案。 Marcel van den BrinkM.D., Ph.D. 希望之城首席医疗官 Marcel van den Brink 医学博士表示：“癌症治疗正步入一个全新阶段——在这一阶段，解读每位患者疾病的生物学本质，已与治疗本身同等重要。我们在ASCO上展示的研究，不仅彰显了精准医疗正如何在多种癌症类型中落地成为现实，更揭示了如何借助这些科学洞见，打造更智能的治疗策略、改善患者预后，并推动整个领域持续前行。” 希望之城重点口头报告一览：摘要 4519：肠道微生物组模式与晚期肾癌免疫治疗应答之间的关联摘要 7007：靶向抗体联合疗法显著改善复发/难治性大B细胞淋巴瘤患者预后（SUNMO研究亚组分析）摘要 4015：针对晚期肝癌关键肿瘤生长通路的实验性疗法摘要 5014：针对晚期前列腺癌的新型靶向疗法的首次人体研究微生物组研究或为肾癌免疫疗法疗效预测提供新线索希望之城的研究人员发现，肠道微生物群的组成可能影响转移性肾细胞癌患者对免疫联合疗法的应答。这一发现提示，肠道微生物群或可成为未来指导治疗选择的潜在生物标志物。微生物组正日益成为希望之城的研究焦点。近期，希望之城召集联邦卫生机构负责人及多家顶级癌症中心举办专题研讨会，旨在加速该领域的研究进展。本研究数据来源于两项随机 I 期临床试验的合并分析。这两项试验评估了在标准免疫检查点抑制剂方案基础上，联合或不联合CBM5881（一种旨在调节肠道微生物群的活体生物制剂）的疗效。入组患者均为既往未接受过治疗的转移性肾细胞癌患者，分别接受纳武利尤单抗（nivolumab）联合伊匹木单抗（ipilimumab），或纳武利尤单抗（nivolumab）联合卡博替尼治疗（cabozantinib），这两类方案均为当前常用的免疫治疗一线选择。合并分析结果显示，在免疫治疗基础上联合CBM588的患者，客观缓解率达到了66.7%，而仅接受标准治疗的患者客观缓解率为20%。联合治疗组的中位无进展生存期延长至32.1个月，而标准治疗组仅为3.7个月。研究人员还采用了一种名为TOPOSCORE的宏基因组学指标来评估肠道菌群失衡程度，结果发现，肠道菌群紊乱越严重的患者，从CBM588联合治疗中的获益越大。在这一亚组中，加用CBM588后，中位无进展生存期从2.8个月显著延长至24.9个月。值得注意的是，肠道微生物群谱与治疗应答之间的关联在接受纳武利尤单抗联合伊匹木单抗治疗的患者中尤为突出，提示不同免疫治疗背景下，微生物群的作用机制可能有所差异。这一新数据为日益增多的“肠道微生物群与免疫应答相关”的研究提供了有力支持。 “这些发现表明，微生物群可能在塑造免疫治疗结局中发挥着直接作用。如果在更大规模的研究中得到验证，这一策略将有望指导临床治疗决策，改善肾癌患者的预后。”希望之城博士后研究员 Rahul Winayak 医学博士介绍道。目前，一项随机III期试验正在开展中，以进一步评估该策略的临床价值。双特异性抗体联合疗法可改善淋巴瘤患者预后，早期治疗同样获益来自III期SUNMO试验的最新数据持续显示，双特异性抗体mosunetuzumab与抗体药物偶联物polatuzumab vedotin的联合治疗方案，能够改善不适合接受自体干细胞移植的复发或难治性大B细胞淋巴瘤患者的预后。该研究将患者随机分配至联合治疗方案组或利妥昔单抗（rituximab）、吉西他滨（gemcitabine）和奥沙利铂（oxaliplatin）标准化疗组。中位随访时间超过两年，结果显示联合治疗组的客观缓解率达到70.3%，而标准治疗组为40.0%，同时联合治疗组患者的疾病进展风险显著降低。本次更新分析的重点在于按治疗线数评估疗效。在接受二线治疗的患者中，联合治疗方案相比三线及以上患者以及接受化疗的患者，均显示出更高的缓解率、更深的缓解程度以及更长的缓解持续时间。多个亚组的中位无进展生存期和完全缓解持续时间尚未达到，充分体现了该疗法疗效的持久性。 Elizabeth Lihua BuddeM.D., Ph.D. 随着随访时间延长，联合治疗方案的安全性保持稳定，高级别细胞因子释放综合征发生率较低，且未观察到神经毒性。这些结果支持将该新型方案用于无法耐受强化化疗的患者。希望之城企业免疫效应细胞项目执行医学主任 Elizabeth Budde（潘莉华）医学博士2表示：“这些结果进一步确立了双特异性抗体联合疗法作为传统化疗替代方案日益重要的地位。我们尤为鼓舞的是，在早期治疗线中也能观察到持久的疗效，因为改善长期治疗结局对每一位患者都至关重要。” 靶向关键肿瘤生长通路的新型疗法在晚期肝癌治疗中前景乐观希望之城的研究人员正在评估一种靶向Wnt/β-catenin信号通路的首创小分子抑制剂——tegavivint。该通路是多种肝癌的重要驱动因素，而这类肝癌历来治疗难度极大。这项正在进行的I/II期研究纳入了晚期肝细胞癌患者，这些患者至少接受过一线全身治疗，且病情已无法通过手术或局部治疗控制。在通过分子检测确认存在Wnt通路突变，并接受推荐剂量范围内治疗的患者中，该疗法展现出明确的临床活性：客观缓解率为22%，疾病控制率为89%。在病程较早阶段接受治疗的患者中，中位无进展生存期达到8个月。 Daneng LiM.D. 值得注意的是，该研究还提供了靶点结合的证据，包括甲胎蛋白水平下降以及Wnt通路循环肿瘤DNA等位基因频率的变化。这些发现表明，药物确实作用于预期的生物学通路，而靶向Wnt信号通路的既往研究正是面临着靶点验证这一关键难题。对此，希望之城胃肠肿瘤内科医生 Daneng Li 医学博士说道：“靶向Wnt通路长期以来都是肿瘤治疗领域的一项重大挑战，但当前数据表明，我们或许终于取得了实质性进展。若能在后续研究中获得进一步验证，这一策略将有望显著拓展晚期肝癌患者的治疗选择，并为他们提供一种潜在的靶向治疗方案，从而切实改善预后。” 首次人体试验显示新型前列腺癌疗法展现出早期疗效希望之城的研究人员公布了ABBV-969首次人体试验的初步结果。ABBV-969是一种双靶点抗体药物偶联物，可同时靶向PSMA和STEAP1——这两种蛋白在晚期前列腺癌中普遍高表达。该疗法的设计理念在于将强效抗癌药物精准递送至表达PSMA和/或STEAP1抗原的肿瘤细胞。这项I期研究入组的患者均为转移性去势抵抗性前列腺癌患者，且已接受过多线既往治疗，包括雄激素受体通路抑制剂以及以紫杉烷类药物为基础的化疗（用于抑制细胞分裂）。研究者为患者设置了多个剂量水平，以评估该药物的安全性、药代动力学特征及初步疗效。在存在可测量病灶的患者中，该疗法达到了45%的客观缓解率，且在多个剂量水平（从3 mg/kg起）均观察到了治疗响应。前列腺特异性抗原（PSA）水平的下降亦十分常见：67%的患者实现了PSA50缓解（PSA下降≥50%），28%的患者实现了更深的PSA下降（PSA下降≥90%）。 Tanya Barauskas DorffM.D., F.A.S.C.O. 本研究评估了多个剂量范围，目前剂量优化工作仍在进行中。该疗法也展现出可控的安全性特征。最常见的高级别不良事件为血液学事件（包括贫血），这些事件通常是可逆的，且与药物的作用机制相符。希望之城泌尿生殖系统肿瘤内科医生、美国临床肿瘤学会会士 Tanya Dorff 医学博士3认为：“我们已经看到初步信号，表明即使对于经过深度治疗的患者，这种靶向策略也能带来显著的临床响应。下一步的关键在于更好地明确这一疗法的最佳定位，以进一步改善患者的治疗结局。” 1. 希望之城已与 Osel 公司就 CBM588 在癌症治疗领域的使用相关知识产权签订了独家许可协议。根据该协议条款，希望之城有权从 Osel 公司获得商业化收益。Peter Lee博士是希望之城授权给 Osel 公司该项技术的发明人之一，因此有权分享希望之城从 Osel 公司获得的商业化收益中的一部分。Lee博士同时担任 Osel 公司的联合创始人兼董事会成员，并持有该公司股权。 2.Elizabeth Budde 博士担任 F. Hoffmann-La Roche 公司的付费顾问。 3.Tanya Dorff 博士担任艾伯维（AbbVie）公司的付费指导委员会成员。

2026-07-27

·动脉网

CytomX Therapeutics宣布任命 Charles Fuchs博士（医学博士、公共卫生硕士）为董事会成员CytomX Therapeutics Announces Appointment of Charles Fuchs, M.D., M.P.H., to the Board of Directors

SOUTH SAN FRANCISCO, Calif., July 27, 2026 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced the appointment of Charles Fuchs, M.D., M.P.H., to its Board of Directors. 加利福尼亚州南旧金山，2026年7月27日（环球电讯社）——掩蔽型条件激活生物制剂领域的领导者CytomX Therapeutics, Inc.（纳斯达克股票代码：CTMX）今日宣布任命Charles Fuchs医学博士、公共卫生硕士为公司董事会成员。“We are pleased to welcome Dr. Fuchs to our Board,” said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics. “Dr. Fuchs is a highly accomplished oncology expert and industry leader with more than three decades of experience across academia and global drug development, including advancing multiple cancer therapies from early research through approval. “我们很高兴欢迎福克斯博士加入我们的董事会，”CytomX Therapeutics 的首席执行官兼董事长肖恩·麦卡锡（Sean McCarthy）博士表示。“福克斯博士是一位成就卓著的肿瘤学专家和业界领袖，在学术界和全球药物开发领域拥有三十多年的经验，包括推动多种癌症疗法从早期研究直至获批上市。”His expertise in oncology product development and specifically in gastrointestinal oncology will be invaluable as we continue to advance Varseta-M and the broader PROBODY therapeutic pipeline to improve patient outcomes.”. “他在肿瘤产品开发，尤其是胃肠道肿瘤领域的专业知识，将在我们持续推进 Varseta-M 及更广泛的 PROBODY 治疗管线以改善患者预后方面发挥不可或缺的作用。”Dr. Fuchs has more than three decades of leadership experience across oncology research and biopharmaceutical drug development. Charles most recently served as Chief Medical Officer of Tubulis, where he oversees clinical strategy and pipeline development. Prior to joining Tubulis, he served as Senior Vice President and Global Head of oncology and hematology drug development at Genentech and Roche, where he led multiple novel therapies to approval, including Lunsumio, Columvi, Polivy, and Tecentriq. 福克斯博士在肿瘤学研究和生物制药药物开发领域拥有三十多年的领导经验。查尔斯最近担任图布利斯公司首席医疗官，负责监督临床战略和管线开发。在加入图布利斯之前，他在基因泰克和罗氏担任高级副总裁兼全球肿瘤学和血液学药物开发负责人，期间领导多种创新疗法获得批准，包括Lunsumio、Columvi、Polivy和Tecentriq。Before joining the pharmaceutical industry, Dr. Fuchs served as Director of the Yale Cancer Center and Physician in Chief at Smilow Cancer Hospital, where he contributed to the launch of several biotech companies and founded EvolveImmune Therapeutics. Earlier, he held several senior roles at Dana Farber Cancer Institute, including Chief of the Gastrointestinal Cancer Division, and Harvard Medical School, where he built leading research programs in gastrointestinal cancers and cancer epidemiology. 在加入制药行业之前，福克斯博士曾担任耶鲁癌症中心主任及斯米洛癌症医院首席医师，期间他助力多家生物技术公司的创立，并创办了EvolveImmune Therapeutics公司。此前，他在丹娜—法伯癌症研究所和哈佛医学院担任多个高级职务，包括胃肠道癌症科主任，并在胃肠道癌症和癌症流行病学领域建立了领先的研究项目。Dr. Fuchs also serves as a Senior Advisor to Frazier Life Sciences. He is a board certified medical oncologist, holding an M.D. from Harvard Medical School and an M.P.H. from the Harvard T.H. Chan School of Public Health.. 福克斯博士还担任弗雷泽生命科学公司的高级顾问。他是一名获得董事会认证的肿瘤内科医生，拥有哈佛医学院的医学博士学位以及哈佛大学陈曾熙公共卫生学院的公共卫生硕士学位。“I am delighted to join CytomX’s Board at this important time for the company,” said Dr. Fuchs. “CytomX has built its highly differentiated PROBODY platform with the potential to meaningfully expand the therapeutic window of cancer therapies and address large patient populations with high unmet need. “在公司发展的这一重要时刻，我很高兴加入CytomX的董事会，”Fuchs博士表示。“CytomX已经建立了其高度差异化的PROBODY平台，该平台有可能显著扩大癌症疗法的治疗窗口，并满足大量未满足需求的患者群体。”I am particularly excited to see the potential of the Varseta-M EpCAM ADC program to make an important impact for colorectal cancer patients and I look forward to working with the Board and management team to help advance this product towards pivotal studies and ultimately to regulatory approval.”. “我特别期待看到Varseta-M EpCAM ADC项目为结直肠癌患者带来重要影响，并期待与董事会和管理团队合作，共同推动该产品进入关键性研究阶段，并最终获得监管批准。”About CytomX Therapeutics, Inc. 关于CytomX Therapeutics公司CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, masked PROBODY CytomX 是一家处于临床阶段、专注于肿瘤学的生物制药公司，致力于开发新型条件性激活的掩蔽型 PROBODY。® ®therapeutics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), cytokines and T-cell engagers. 旨在定位于肿瘤微环境的治疗药物。通过在其PROBODY治疗平台支持下开创局部生物制剂的新型研发管线，CytomX的愿景是为癌症治疗创造更安全、更有效的疗法。CytomX强大且差异化的研发管线包含多种治疗模式的治疗候选药物，包括抗体药物偶联物（“ADC”）、细胞因子和T细胞衔接器。CytomX’s clinical-stage pipeline includes varsetatug masetecan (Varseta-M; CX-2051) and CX-801. Varseta-M is a masked, conditionally activated ADC armed with a topoisomerase-1 inhibitor payload and directed toward epithelial cell adhesion molecule (EpCAM). EpCAM is a highly expressed tumor antigen that has previously been undruggable due to expression on normal tissues. CytomX 的临床阶段管线包括 varsetatug masetecan（Varseta-M；CX-2051）和 CX-801。Varseta-M 是一种掩蔽型、条件性激活的抗体偶联药物（ADC），携带拓扑异构酶 1 抑制剂载荷，靶向上皮细胞黏附分子（EpCAM）。EpCAM 是一种高表达的肿瘤抗原，由于其在正常组织中的表达，此前一直被视为不可成药靶点。Varseta-M is designed to open a therapeutic window for this high potential target and is initially being developed for the treatment of metastatic colorectal cancer. Varseta-M was discovered in collaboration with ImmunoGen, now part of AbbVie. CX-801 is a masked interferon alpha-2b PROBODY. Varseta-M 旨在为这一高潜力靶点开启治疗窗口，并最初被开发用于治疗转移性结直肠癌。Varseta-M 是与 ImmunoGen（现为艾伯维旗下公司）合作发现的。CX-801 是一种掩蔽型干扰素 alpha-2b PROBODY。® ®cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CX-801 is initially being developed for the treatment of metastatic melanoma. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Regeneron and Moderna. 该细胞因子在传统上对免疫肿瘤学治疗敏感以及不敏感（冷）的肿瘤中具有广泛的潜在适用性。CX-801 最初是为治疗转移性黑色素瘤而开发的。CytomX 已与包括安进（Amgen）、再生元（Regeneron）和莫德纳（Moderna）在内的多家肿瘤学领域领导者建立了战略合作关系。For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit . 欲了解更多关于 CytomX 的信息，以及其如何致力于将条件激活疗法打造为抗癌治疗的新标准护理方案，请访问。www.cytomx.com www.cytomx.comand follow us on 并在关注我们LinkedIn 领英and 和X X(formerly Twitter) （前身为 Twitter）. 。Company Contact: 公司联系人：Chris Ogden 克里斯·奥格登SVP, Chief Financial Officer 高级副总裁兼首席财务官cogden@cytomx.com cogden@cytomx.comInvestor Contact: 投资者联系人：Precision AQ 精密空气质量Stephanie Ascher 斯蒂芬妮·阿舍stephanie.ascher@precisionaq.com stephanie.ascher@precisionaq.comMedia Contact: 媒体联系人：Precision AQ 精准AQColleen Ketchum 科琳·凯彻姆colleen.ketchum@precisionaq.com colleen.ketchum@precisionaq.com

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适应症	国家/地区	公司	日期
大B细胞淋巴瘤	日本	Chugai Pharmaceutical Co., Ltd.	2026-03-23
高级别B细胞淋巴瘤	美国	Genentech, Inc.	2026-03-18
难治性弥漫性大 B 细胞淋巴瘤	中国	罗氏（中国）投资有限公司	2026-03-10
难治性淋巴瘤	加拿大	Hoffmann-La Roche Ltd.	2020-07-09
复发性弥漫性大B细胞淋巴瘤	欧盟	Roche Registration GmbH	2020-01-16
复发性弥漫性大B细胞淋巴瘤	冰岛	Roche Registration GmbH	2020-01-16
复发性弥漫性大B细胞淋巴瘤	列支敦士登	Roche Registration GmbH	2020-01-16
复发性弥漫性大B细胞淋巴瘤	挪威	Roche Registration GmbH	2020-01-16
难治性弥漫性大B细胞淋巴瘤活化B细胞型	欧盟	Roche Registration GmbH	2020-01-16
难治性弥漫性大B细胞淋巴瘤活化B细胞型	冰岛	Roche Registration GmbH	2020-01-16
难治性弥漫性大B细胞淋巴瘤活化B细胞型	列支敦士登	Roche Registration GmbH	2020-01-16
难治性弥漫性大B细胞淋巴瘤活化B细胞型	挪威	Roche Registration GmbH	2020-01-16
弥漫性大B细胞淋巴瘤	美国	Genentech, Inc.	2019-06-10

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适应症	最高研发状态	国家/地区	公司	日期
难治性侵袭性非霍奇金淋巴瘤	临床3期	美国	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	中国	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	日本	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	阿根廷	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	巴西	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	加拿大	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	以色列	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	墨西哥	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	新西兰	Hoffmann-La Roche, Inc.	2022-04-25
难治性侵袭性非霍奇金淋巴瘤	临床3期	秘鲁	Hoffmann-La Roche, Inc.	2022-04-25

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适应症

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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


POLARIX (ASCO2026)	N/A	高级别B细胞淋巴瘤	19,327	Pola-R-CHP	廠網膚築淵蓋膚餘觸窪(醖蓋憲積觸糧餘獵製蓋) = 廠遞鏇齋醖鹽鏇襯積襯醖鹽積鏇觸積範醖鑰選 (獵鹹遞膚鹽顧艱淵簾糧 ) 更多	积极	2026-05-29
				R-CHOP	廠網膚築淵蓋膚餘觸窪(醖蓋憲積觸糧餘獵製蓋) = 衊淵窪膚壓糧獵網鏇憲醖鹽積鏇觸積範醖鑰選 (獵鹹遞膚鹽顧艱淵簾糧 ) 更多
NCT05169658 (RESPONSE-ADAPTED TREATMENT WITH MOSUNETUZUMAB, CTgov)	临床2期	滤泡性淋巴瘤 \| 惰性B细胞非霍奇金淋巴瘤 \| 边缘区B细胞淋巴瘤	42	FDG-Positron Emission Tomography+Mosunetuzumab+Polatuzumab Vedotin+Obinutuzumab	鏇廠觸夢網齋製衊蓋壓 = 艱衊衊鹽窪範衊艱齋蓋願襯遞憲鑰鏇窪積蓋艱 (蓋簾顧願廠製鹽襯餘積, 積願窪壓淵醖遞遞廠醖 ~ 膚淵鹹膚簾簾醖鹽簾繭) 更多	-	2026-05-13
EHA2026	N/A	弥漫性大B细胞淋巴瘤一线	103	Polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP)	鬱繭壓鹽築醖膚淵蓋淵(鹽衊糧鬱襯觸餘選壓餘) = 獵獵憲鏇構膚簾繭鹹製網願餘選餘觸糧鏇淵艱 (壓觸鹽構構憲齋製夢鑰 ) 更多	积极	2026-05-12
EHA2026	N/A	大B细胞淋巴瘤	625	Polatuzumab Vedotin + Rituximab + Cyclophosphamide + Doxorubicin + Vincristine Sulfate + Sphingosine-1-Phosphate Lyase Inhibitor + Prednisone	鹹夢憲醖餘顧顧觸觸膚(醖顧觸積廠觸顧淵糧鏇) = 獵齋範餘製選鹽觸餘選廠顧膚餘醖糧鏇製餘鏇 (夢獵網築淵齋糧築觸壓 ) 更多	积极	2026-05-12
				Rituximab + Cyclophosphamide + Doxorubicin + Vincristine Sulfate + Sphingosine-1-Phosphate Lyase Inhibitor + Prednisone	鹹夢憲醖餘顧顧觸觸膚(醖顧觸積廠觸顧淵糧鏇) = 遞襯齋繭憲廠鬱遞範襯廠顧膚餘醖糧鏇製餘鏇 (夢獵網築淵齋糧築觸壓 ) 更多
EHA2026	N/A	弥漫性大B细胞淋巴瘤一线	55	Pola-R-CHP	範廠選簾簾憲顧網艱積(壓鏇獵築鑰範壓鏇顧願) = 鹽夢糧遞餘衊獵網範網鏇遞築襯鏇膚窪獵醖淵 (構糧窪糧顧顧構鑰艱憲 ) 更多	积极	2026-05-12
				R-CHOP/R-miniCHOP	範廠選簾簾憲顧網艱積(壓鏇獵築鑰範壓鏇顧願) = 繭鏇廠憲顧願鑰獵鬱蓋鏇遞築襯鏇膚窪獵醖淵 (構糧窪糧顧顧構鑰艱憲 ) 更多
EHA2026	N/A	弥漫性大B细胞淋巴瘤一线	437	Polatuzumab Vedotin plus R-CHP	襯淵選鏇蓋憲衊艱遞齋(廠鏇艱醖鑰築艱醖願選) = 積艱蓋襯鑰鹹積艱鹽衊膚鑰憲鹽壓齋鏇網餘簾 (衊襯簾壓網艱選憲夢簾 ) 更多	积极	2026-05-12
EHA2026	N/A	弥漫性大B细胞淋巴瘤一线	236	Pola-R-CHP	糧遞鹹繭襯選顧窪鏇獵(積鹹廠衊繭襯繭遞鹽憲) = 壓蓋顧鹽鹽蓋憲繭膚淵構鹽選壓襯鹽範願艱糧 (繭淵艱遞顧憲餘壓鏇積 ) 更多	积极	2026-05-12
				R-CHOP	糧遞鹹繭襯選顧窪鏇獵(積鹹廠衊繭襯繭遞鹽憲) = 鬱繭鹽齋醖餘齋鹽鹽襯構鹽選壓襯鹽範願艱糧 (繭淵艱遞顧憲餘壓鏇積 ) 更多
EHA2026	N/A	EBV 相关的移植后淋巴增殖性疾病	3	Polatuzumab vedotin and rituximab with dose-adjusted chemotherapy	繭選艱製鏇簾醖艱構齋(淵艱觸鏇鏇製鏇蓋齋築) = Grade 3-4 neutropenia occurred in 3/3 patients but was manageable with growth factor support. No grade ≥3 peripheral neuropathy was observed. Importantly, no events of acute graft rejection, treatment-related graft failure, or irreversible hepatotoxicity were recorded. Infections were managed with standard antimicrobials, and no treatment-related mortality occurred. 糧膚壓獵觸醖衊壓齋廠 (壓鑰鬱淵鹹蓋壓遞觸襯 )	积极	2026-05-12
EHA2026	N/A	弥漫性大B细胞淋巴瘤	206	Polatuzumab vedotin with bendamustine and rituximab (Pola-BR)	襯鑰餘顧獵範衊糧構鏇(願衊築艱憲顧築簾繭構) = 鏇願鏇襯鏇襯壓淵憲願遞鹽顧鑰醖簾憲廠廠製 (艱鹹鏇積夢鹽醖衊廠夢 ) 更多	积极	2026-05-12
				Tafasitamab plus lenalidomide (Tafa-Len)	襯鑰餘顧獵範衊糧構鏇(願衊築艱憲顧築簾繭構) = 艱鏇淵糧蓋壓遞齋鬱範遞鹽顧鑰醖簾憲廠廠製 (艱鹹鏇積夢鹽醖衊廠夢 ) 更多
NCT04332822 (POLAR BEAR, EHA2026)	临床3期	弥漫性大B细胞淋巴瘤一线	300	Pola-R-miniCHP	獵齋蓋網憲顧繭夢夢膚(衊製齋鹹淵鏇鹽積顧遞) = 鹹壓顧製鹽製鏇製淵繭糧鬱餘繭餘鹽築願壓醖 (廠襯淵餘鬱遞膚膚獵壓 ) 更多	积极	2026-05-12
				R-miniCHOP	獵齋蓋網憲顧繭夢夢膚(衊製齋鹹淵鏇鹽積顧遞) = 範窪鑰蓋窪衊獵艱鏇觸糧鬱餘繭餘鹽築願壓醖 (廠襯淵餘鬱遞膚膚獵壓 )