利诺泽单抗(Linvoseltamab-gcpt) - 药物靶点：BCMA x CD3_在研适应症：难治性多发性骨髓瘤，复发性多发性骨髓瘤，多发性骨髓瘤_专利_临床

概要

基本信息

药物类型

双特异性T细胞结合器

别名

BCMAxCD3 antibody、BCMAxCD3 bispecific antibody(Regeneron Pharmaceuticals, Inc.)、Linvoseltamab

+ [4]

靶点

BCMA x CD3

作用方式

抑制剂、刺激剂

作用机制

BCMA抑制剂(B细胞成熟蛋白抑制剂)、CD3刺激剂(T细胞表面糖蛋白CD3复合体刺激剂)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [2]

在研适应症

难治性多发性骨髓瘤复发性多发性骨髓瘤多发性骨髓瘤+ [5]

非在研适应症-

原研机构

Regeneron Pharmaceuticals, Inc.

在研机构

Regeneron Pharmaceuticals, Inc.Regeneron Ireland DAC

非在研机构-

权益机构

Springworks Therapeutics, Inc.

Regeneron Pharmaceuticals, Inc.

Sanofi

最高研发阶段批准上市

首次获批日期

欧盟 (2025-04-23),

难治性多发性骨髓瘤复发性多发性骨髓瘤

最高研发阶段(中国)-

特殊审评优先审评 (美国)、快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、附条件批准 (欧盟)

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结构/序列

Sequence Code 17748691L

来源: *****

Sequence Code 616718756H

来源: *****

Sequence Code 1191632834H

来源: *****

关联

13

项与利诺泽单抗相关的临床试验

NCT06932562

/ Not yet recruiting临床3期IIT

A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients

This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).
The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.

开始日期2025-09-01

申办/合作机构

European Myeloma Network

[+1]

NCT06910124

/ Not yet recruiting临床2期IIT

Alpe d'Huez Study: A Parallel Two-Cohort Study of Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse

The purpose of this study is to determine whether giving linvoseltamab with lenalidomide during maintenance treatment to participants with multiple myeloma will:
1. Get rid of any residual multiple myeloma cells in participants' bodies which is known as minimal residual disease negative (MRD-) status. For participants that start the study with residual multiple myeloma cells in participants' bodies: to determine how long you remain MRD-.
2. Increase the length of time that participants' disease is controlled. For participants with relapsed disease, to determine whether participants can re-attain MRD- status.
3. Increase the length of time that participants' disease responds to treatment.
The researchers also want to find out the effects that linvoseltamab has on participants and participants' condition.

开始日期2025-08-01

申办/合作机构

University of Miami

[+1]

NCT06669247

/ Recruiting临床1/2期

A First-in-Human (FIH) Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN7945, an Anti-CD38 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma

This study is researching an experimental drug called REGN7945 in combination with another experimental drug called linvoseltamab, (also known as REGN5458) (each individually called a "study drug" or "study drugs" when combined).
This study is the first time REGN7945 will be tested in humans. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after several other therapies had failed.
The aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab, compared with linvoseltamab alone.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug(s)
* How many people treated with REGN7945 and linvoseltamab compared to linvoseltamab alone have improvement of their multiple myeloma and by how much
* How long people benefit from receiving REGN7945 in combination with linvoseltamab compared with linvoseltamab alone
* How much study drug(s) is in the blood at different times
* Whether the body makes antibodies against the study drugs(s) (which could make the study drug(s) less effective or could lead to side effects)
* If there is any change in pain and cancer-related symptoms, how well people are able to function, and their quality of life when taking the study drug(s)

开始日期2024-12-11

申办/合作机构

Regeneron Pharmaceuticals, Inc.

100 项与利诺泽单抗相关的临床结果

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100 项与利诺泽单抗相关的转化医学

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100 项与利诺泽单抗相关的专利（医药）

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10

项与利诺泽单抗相关的文献（医药）

2025-05-01·Clinical Lymphoma Myeloma & Leukemia

Comprehensive Review of Bispecific Antibody Constructs In Multiple Myeloma: Affinities, Dosing Strategies and Future Perspectives

Review

作者: Rasche, Leo ; Einsele, Hermann ; Waldschmidt, Johannes M ; Kortüm, K Martin

Despite significant advancements, multiple myeloma (MM) remains incurable, and there is still a pressing need for new therapeutic strategies with highly selective mechanisms of action and balanced off-target toxicity. In recent years, the development of "off-the-shelf" bispecific antibodies (bsAbs) has significantly enhanced our ability to treat relapsed or refractory MM. Teclistamab, elranatamab (both BCMA × CD3), and talquetamab (GPRC5D × CD3) are approved for treating MM patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Meanwhile, the range of available bsAbs is rapidly expanding, offering patients and healthcare providers a broad selection of options that vary in target antigens, binding domains, construct designs, dosing regimens, and side effects. As linvoseltamab, alnuctamab, and ABBV-383 (all BCMA × CD3), as well as forimtamig (GPRC5D × CD3) and cevostamab (FcRH5 × CD3) progress through late-stage clinical development, emerging trispecific antibodies are now available that target either 2 different MM-associated antigens or provide additional co-stimulatory signals to prevent T-cell exhaustion. Despite this plethora of therapeutic options, resistance to bsAbs is an inevitability, and the optimal positioning of these drugs within the current MM treatment landscape remains to be determined. In this review, we examine the available data on all clinically accessible bsAbs, evaluating their potential, current limitations, and implications for efficacy and safety, with the aim of achieving deeper responses and longer overall survival for MM patients.

2025-03-04·EXPERT OPINION ON BIOLOGICAL THERAPY

An evaluation of linvoseltamab for treatment of relapsed/refractory multiple myeloma

Review

作者: Rattu, Mohammad A. ; Avigan, Zachary M. ; Richter, Joshua

INTRODUCTION:

Bispecific antibody therapies, primarily targeting B-cell maturation antigen (BCMA), have shown remarkable outcomes in the treatment of heavily pretreated patients with multiple myeloma (MM). However, there are no current head-to-head trials informing practice for selection or sequencing of optimal T cell redirection strategies in later lines of therapy. Linvoseltamab is a novel BCMA-targeted bispecific antibody that was recently evaluated in the phase 1/2 LINKER-MM1 trial and is currently pending formal regulatory approval.

AREAS COVERED:

In this drug evaluation, we review efficacy and toxicity profiles of linvoseltamab in the context of currently approved bispecific antibody therapies for MM. Specifically, we highlight differences in dosing strategy, cytokine release syndrome (CRS) kinetics, and indirect efficacy comparisons between trials of linvoseltamab and other bispecific antibodies.

EXPERT OPINION:

Linvoseltamab has a similar efficacy profile with favorable CRS incidence and time-to-onset compared to other approved bispecific antibodies. Pending final regulatory approval and labeling, further real-world analyses are needed to evaluate its final role in the evolving landscape of T cell redirection therapy for MM.

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

151

项与利诺泽单抗相关的新闻（医药）

2025-07-08

·医药健闻

仿制药专家山德士4.4亿美元投资建厂；基蛋生物拟1.5亿元建设智能化生产研发基地；亚盛医药任命首席财务官 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态仿制药和生物仿制药专家山德士（Sandoz）正在加强其在斯洛文尼亚的足迹，承诺投资4.4亿美元，在距离该国最大机场约24英里的地方建立一个新的生物仿制药工厂，用于无菌产品生产。该项目使该公司在这个中欧国家的计划和持续投资总额超过11亿美元。新工厂的职能将涵盖公司生物仿制药产品组合的制备、灌装、组装和包装，以及现场质量控制。AN Venture Partners（ANV）完成了其第一只基金的募集，这是一个面向全球生物技术公司的2亿美元基金，特别强调支持日本的生物制药生态系统。这家总部位于旧金山和东京的公司于2022年与全球生物技术风险投资公司ARCH Venture Partners合作成立，将投资于任何生物技术相关公司或组织的所有发展阶段。该基金投资将用于产生重大临床影响的科学。DeepMind旗下的药物研发公司Isomorphic Labs正准备开始在人体上测试其人工智能设计的药物。Isomorphic Labs于2021年从DeepMind分拆出来，一直处于将AI融入药物研发的前沿。该公司利用先进的机器学习算法分析海量生物数据，识别潜在的药物靶点，并设计出能够有效治疗多种疾病的新型化合物。亚盛医药任命Veet Misra博士为首席财务官，并任命黄智为全球企业发展&财务高级副总裁。Misra博士和黄智均向公司董事长、CEO杨大俊博士直接汇报。Misra博士拥有20多年的投资银行从业经验。加入亚盛医药之前，他在知名金融公司Cantor Fitzgerald担任医疗健康投行部董事总经理，负责生物制药领域业务。黄智拥有20多年的全球跨国企业管理经验，加入亚盛医药之前担任百济神州大中华区和亚太区首席财务官、全球技术运营和全球商业财务负责人。昆翎集团董事长兼首席执行官甄岭因寻求个人职业发展新机遇，已于6月30日向公司提出辞职申请，其将于7月29日正式离职，离职后不再担任公司任何职务。基蛋生物计划投资1.5亿元建设智能化生产研发基地，包含土地价款、建筑主体工程及配套设施工程费用。项目占地面积约40010.27平方米，总建筑面积约65538.81平方米，主要建设内容为四层综合厂房、高标准仓储中心及配套研发办公设施。项目建成后，将形成化学发光、生化、血球等产品线仪器及试剂的产能，预计2028年建设完成。作为东诚药业的子公司，东诚安迪科始终遵循集团战略指引，完善国内核药网络布局，目前集团投入运营的核药生产中心达到30家。此次奠基的内蒙古安迪科同位素诊疗药物生产中心，将成为串联华北、辐射全国的重要战略支点，助推东诚药业及中国核医疗产业高质量发展。中心将采用先进的生产工艺和设备，致力于研发、生产和销售高品质的同位素诊疗药物，为自治区医疗机构提供优质的同位素诊疗药物产品和服务。劲方医药科技（上海）股份有限公司在港交所递交招股书，拟在香港主板挂牌上市。劲方医药成立于2017年，作为一家处于市场化阶段的生物制药公司，专注于肿瘤、自体免疫和炎症性疾病领域的创新及有效治疗方案。截至2025年6月20日，劲方医药已建立起一条持续更新的产品管线，包括八款候选药品，其中五款处于临床开发阶段。劲方医药的核心产品之一GFH925是一款公司自主发现的创新药物，已在中国获商业化批准。产业动态在第42届全国医药工业信息年会和2025北京·昌平生命科学论坛上，14个医药健康产业重大项目签约落地昌平区。这些重大项目涵盖迈瑞医疗器械、大医集团、优锐生物、佰仁医疗、神基制药、修正药业、汉禾生物、京城里合成生物食品等产业投资类项目，以及安达生物、格来赛、高性能医疗器械国家研究院、汕头大学、春风化雨医疗等创新合作类项目。会上还举行了生命科学重大项目校地共建启动仪式，清华大学、北京大学、中国农业大学、北京化工大学四校合力，将推动生物医药、合成生物、高端仪器装备等前沿领域实现“从0到1”的突破。中国在政府采购活动中对部分自欧盟进口的医疗器械采取对等限制措施。通知规定，对预算金额在4500万元人民币以上的医疗器械采购，确需要采购进口产品的，在履行法定程序后，应当排除欧盟企业(不包括在华欧资企业)参与。对于参与政府采购活动的非欧盟企业，其提供的自欧盟进口的医疗器械占比不得超过项目合同总金额的50%。6月20日欧盟根据《国际采购工具》(IPI)出台措施，限制中国企业和产品参与其医疗器械公共采购，持续在公共采购领域对中国企业设置壁垒。再生元（Regeneron Pharmaceuticals）宣布，美国FDA已加速批准双特异性抗体Lynozyfic（linvoseltamab）用于治疗复发或难治性（R/R）多发性骨髓瘤（MM）成人患者。Linvoseltamab是一款BCMA/CD3靶向双特异性抗体，旨在将多发性骨髓瘤细胞上的BCMA与T细胞表面表达的CD3连接，以促进T细胞活化和癌细胞杀伤。Unnatural Products公司宣布与免疫学公司argenx建立一项多靶点战略合作研究项目，旨在发现和开发针对“不可成药”疾病靶点的口服大环肽药物。根据协议，UNP将获得数千万美元的预付款、近期里程碑付款以及研发资金支持。此外，UNP还有资格获得高达约15亿美元的潜在里程碑付款等款项。全球分子诊断（MDx）解决方案领导者于7月1日宣布推出新一代的传染病分析平台STAgora。该平台是一个实时传染病智能系统，将诊断数据与高级统计建模相结合。STAgora可根据实际诊断检测结果，实现市级、国家级和洲级传染病趋势的实时全球可视化。该平台以清晰、可操作的方式为医疗保健专业人员提供即时、结构化的诊断报告和统计分析。通过可定制的仪表板和实时警报功能对其提供支持。介入肿瘤学解决方案领先制造商Sirtex Medical宣布，美国食品药品监督管理局（FDA）已批准SIR-Spheres Y-90树脂微球在美国用于治疗不可切除性肝细胞癌（HCC）。此次获批后，SIR-Spheres成为美国唯一获批同时治疗肝转移性结直肠癌（mCRC）和肝细胞癌（HCC）的放射性栓塞疗法。远大医药公告，基于钇[90Y]微球注射液DOORwaY90临床试验的突破性中期数据成功达到预设的共同主要终点，FDA提前正式批准了该产品新增适应症，用于治疗不可切除肝细胞癌（HCC），且未限制肿瘤直径大小。这标志着SIR-Spheres钇[90Y]微球注射液成为了全球首个且唯一获FDA批准用于不可切除HCC和结直肠癌肝转移双重适应症的选择性内放射治疗产品。联系美通社+86-10-5953 9500info@prnasia.com

高管变更

2025-07-07

·抗体密码

BCMA TCE双抗：让重症肌无力患者重新站起来！

重症肌无力（MG）是一种抗体介导的自身免疫性疾病（AID），累及神经肌肉接头，导致波动性肌无力和易疲劳。其发病主要与靶向乙酰胆碱受体（AChR）、肌肉特异性激酶（MuSK）或低密度脂蛋白受体相关蛋白4（LRP4）的自身抗体相关。尽管传统免疫抑制疗法和对症治疗可使多数患者症状缓解，但约10%-15%的患者仍属难治性，亟需新型治疗手段。难治性MG（尤其是罕见抗LRP4抗体阳性者）因对标准治疗耐药且疾病负担严重，面临独特挑战。糖皮质激素、血浆置换、静脉注射免疫球蛋白及B细胞清除疗法（如利妥昔单抗）等传统干预措施常难以诱导长期缓解。近期研究进展表明，针对CD19或B细胞成熟抗原（BCMA）的嵌合抗原受体（CAR）-T细胞疗法可通过深度清除B细胞，为包括AChR阳性MG在内的难治性自身免疫病提供潜在治疗选择。最近，来自于德国的研究者报告了一例off-lable使用Teclistamab《第7款双抗!强生BCMA/CD3双抗获批上市》治疗LRP4抗体阳性的难治性MG的患者。治疗前她移动坐在轮椅上，并且说话、吞咽和呼吸困难。而治疗后，其病情持续缓解，单次可以行走1.5公里，说话、吞咽和呼吸无困难，而且免疫抑制类药物可以停止使用。患者概况：该患者于2014年确诊为双抗体阴性重症肌无力（double-seronegative MG），并于2019年检出抗LRP4抗体。尽管接受了多种治疗，包括：B细胞清除单抗（如利妥昔单抗），蛋白酶体抑制剂（如硼替佐米），免疫抑制剂（如硫唑嘌呤、类固醇），静脉注射免疫球蛋白（IVIG），免疫吸附或血浆置换。但2020年7月至2024年10月期间，她仍多次出现肌无力加重（myasthenic exacerbations），并经历一次肌无力危象（myasthenic crisis），病情始终未能持续稳定。2024年8月就诊时，她正接受每周一次的免疫吸附治疗，并每日服用480 mg胆碱酯酶抑制剂。由于严重的肌无力症状，她依赖轮椅行动，并存在言语、吞咽及呼吸困难。根据美国重症肌无力基金会（MGFA）分级标准，她的病情属于IVB级（严重全身型伴延髓肌受累）。Teclistamab给药方案为：Day 1 0.06mg/kg,Day 4 0.3 mg/kg,Day 6 1.5mg/kg，后续5mg/kg维持治疗4周。首次给药后，患者出现细胞因子释放综合征（CRS，第2-3天为1级），但在第2天单次注射托珠单抗（8 mg/kg）后缓解。未观察到急性神经毒性症状，第4个月的脑部MRI检查也未发现异常。在血液毒性方面，患者原本存在2级淋巴细胞减少症，治疗期间虽有一定波动，但未出现显著或持续性恶化（图1B、1C）。关于CD4/CD8比值，我们观察到治疗第7天CD8细胞群显著增加，主要由于循环CD4+ T细胞短暂性降低（仅一次低于200/μL，图1D）。自然杀伤（NK）细胞计数在整个观察期内均处于参考范围内（图1E）。治疗后，循环B细胞被完全清除，抗LRP4抗体转阴。患者在teclistamab治疗前已存在低丙种球蛋白血症，治疗后进一步加重，需从首次给药后第2个月开始定期补充免疫球蛋白（图1F）。此外，麻疹、风疹和破伤风疫苗抗体滴度下降，进一步证实BCMA靶向治疗对体液免疫的影响（图1G）。最关键的是，所有综合评估指标（包括定量重症肌无力评分[QMG]、MG日常生活能力量表[MG-ADL]以及修订版MG生活质量15项量表[MG-QoL15r]）在随访期间均呈现快速且持续的下降。治疗仅4周后，患者即表现出显著改善：可独立步行1公里言语、吞咽及呼吸困难完全消失，仅残留轻微复视症状。至3个月时：胆碱酯酶抑制剂逐步停用，所有免疫抑制剂终止治疗，步行距离延长至1.5公里以上。6个月随访时，患者持续处于无疾病状态（remission），无需任何进一步治疗（图1H、1I）。总结靶向BCMA（B细胞成熟抗原）能够直接清除致病性浆细胞群，从而弥补双特异性抗体（TCEs）在清除深度上的局限性，并且靶向BCMA疗法（如CAR-T细胞疗法和双特异性抗体）在早期研究中已显示出积极疗效，去年研究者在新英格兰杂志发文《TCE自免：热的发烫！》，证明Teclistamab在多种自免疾病中具有较好的疗效，包括皮肤疾病EULAR干燥综合征疾病，类风湿性关节炎等，另外，在今年康诺亚也在新英格兰发文证明BCMA/CD3双抗在自身免疫性溶血性贫血的治疗中展现了优异的疗效。除了自免，再生元布局了BCMA/CD3双抗联合Dupixent（dupilumab，IL-4Rα）治疗严重过敏。Linvoseltamab是一种针对B细胞成熟抗原（BCMA）的双特异性抗体，它通过结合BCMA和CD3来激活T细胞，从而促进T细胞杀死产生免疫球蛋白E（IgE）的浆细胞。IgE是过敏反应的关键驱动因素，由长寿命浆细胞持续产生。因此，Linvoseltamab可能通过消除这些浆细胞来减少IgE水平，从而治疗严重过敏反应。目前，这两种药物的联合使用正在研究中，以探索它们在治疗严重食物过敏方面的潜力。根据一期临床试验的早期数据，Linvoseltamab和Dupixent的组合显示出了积极的效果，可能有助于永久性地消除IgE。我们已经建立ＢiosCMC读者交流群，有兴趣的可以扫描下方二维码添加微信进群，请主动备注姓名-公司-职位（高校-专业），非诚勿扰！声明本公众号所发表文章以宣传知识为目的，因此不构成投资，病人用药等建议。如果文章侵您的权益及时联系小编进行删除！欢迎扫码交流/咨询/合作=参考文献https://doi.org/10.1016/j.ymthe.2025.06.029

细胞疗法免疫疗法临床研究

2025-07-07

·PMLiVE

Regeneron’s Lynozyfic granted FDA accelerated approval to treat multiple myeloma

Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat adults with relapsed or refractory multiple myeloma (MM). Patients eligible for the drug will have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. More than 36,000 new cases of MM, an incurable blood cancer, are expected to be diagnosed in the US this year. Despite advances in treatment, there are around 8,000 MM patients in the US whose disease has progressed after three lines of therapy, and 4,000 whose disease has progressed after four or more therapies. Regeneron’s Lynozyfic is a bispecific antibody that works by bridging B-cell maturation antigen on MM cells with CD3-expressing T cells to drive T-cell activation and cancer-cell killing. The FDA’s decision on the drug was based on results from the phase 1/2 LINKER-MM1 trial, which demonstrated a 70% objective response rate and complete rate of 45%. Median time to first response was 0.95 months, while median duration of response (DoR) was not reached. Estimated DoR was 89% at nine months and 72% at 12 months among responders who had a median follow-up of 13 months. Regeneron’s president and chief scientific officer, George Yancopoulos, said: “With a 70% overall response rate in heavily pre-treated patients, we believe Lynozyfic is poised to potentially become a new standard of care for MM.” In line with the FDA’s accelerated approvals pathway, continued approval for Lynozyfic in this indication may be contingent on the verification of clinical benefit in a confirmatory trial. Beyond R/R MM, Lynozyfic is currently being evaluated across different lines of therapy in the disease, including earlier lines of treatment, as well as MM precursor and other plasma cell disorders. “Given the strength of the data, we are rapidly advancing our broad clinical development programme for Lynozyfic – exploring its use in earlier lines of therapy as monotherapy and in novel combinations – as we aim to meaningfully advance care for patients,” Yancopoulos said.

上市批准加速审批临床结果免疫疗法细胞疗法

100 项与利诺泽单抗相关的药物交易

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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
难治性多发性骨髓瘤	欧盟	Regeneron Ireland DAC	2025-04-23
难治性多发性骨髓瘤	冰岛	Regeneron Ireland DAC	2025-04-23
难治性多发性骨髓瘤	列支敦士登	Regeneron Ireland DAC	2025-04-23
难治性多发性骨髓瘤	挪威	Regeneron Ireland DAC	2025-04-23
复发性多发性骨髓瘤	欧盟	Regeneron Ireland DAC	2025-04-23
复发性多发性骨髓瘤	冰岛	Regeneron Ireland DAC	2025-04-23
复发性多发性骨髓瘤	列支敦士登	Regeneron Ireland DAC	2025-04-23
复发性多发性骨髓瘤	挪威	Regeneron Ireland DAC	2025-04-23

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
多发性骨髓瘤	临床3期	-	Regeneron Pharmaceuticals, Inc.	2025-09-01
残留肿瘤	临床2期	美国	Regeneron Pharmaceuticals, Inc.	2025-08-01
意义不明的单克隆丙种球蛋白病	临床2期	美国	Regeneron Pharmaceuticals, Inc.	2024-09-16
意义不明的单克隆丙种球蛋白病	临床2期	西班牙	Regeneron Pharmaceuticals, Inc.	2024-09-16
免疫球蛋白轻链淀粉样变性	临床2期	美国	Regeneron Pharmaceuticals, Inc.	2024-08-07
免疫球蛋白轻链淀粉样变性	临床2期	韩国	Regeneron Pharmaceuticals, Inc.	2024-08-07
免疫球蛋白轻链淀粉样变性	临床2期	西班牙	Regeneron Pharmaceuticals, Inc.	2024-08-07
免疫球蛋白轻链淀粉样变性	临床2期	英国	Regeneron Pharmaceuticals, Inc.	2024-08-07
阴燃多发性骨髓瘤	临床2期	西班牙	Regeneron Pharmaceuticals, Inc.	2024-01-30
食物过敏	临床1期	美国	Regeneron Pharmaceuticals, Inc.	2024-05-17

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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


NCT03761108 (MM-087 \| phase I/II first-in-human trial \| LINKER-MM1, PipelineReview) 人工标引	临床1/2期	复发性多发性骨髓瘤 \| 难治性多发性骨髓瘤	117	Lynozyfic™ (linvoseltamab-gcpt)	膚憲襯壓蓋醖觸築膚簾(顧廠窪鑰繭顧獵淵遞蓋) = 顧選遞繭構網膚遞糧鏇築鹹願餘壓構餘蓋獵製 (範鹽壓餘壓製夢選糧遞 ) 更多	积极	2025-07-03
NCT05137054 (LINKER-MM2, ASCO2025)	临床1期	复发性多发性骨髓瘤 BCMA \| CD3	18	Linvoseltamab	觸餘顧網簾鹽繭選觸範(艱鏇鹹鹽簾艱醖襯鹹繭) = 網願選觸願遞醖膚鹽網觸壓鏇選糧壓壓鑰齋遞 (鹹襯膚廠襯膚積衊窪製 ) 更多	积极	2025-05-30
NCT05137054 (LINKER-MM2, ASCO2025)	临床1期	复发性多发性骨髓瘤 BCMA \| CD3	18	Carfilzomib	觸餘顧網簾鹽繭選觸範(艱鏇鹹鹽簾艱醖襯鹹繭) = 齋觸選膚淵夢鏇鹽膚廠觸壓鏇選糧壓壓鑰齋遞 (鹹襯膚廠襯膚積衊窪製 )	积极	2025-05-30
NCT05137054 (LINKER-MM2, ASCO2025)	临床1期	复发性多发性骨髓瘤 BCMA \| CD3	22	Linvoseltamab (LINVO)	遞網築餘鑰夢齋遞憲醖(夢鏇鑰蓋願製築窪繭襯) = 壓膚窪顧襯鬱鹹繭遞夢襯顧構網淵壓艱襯觸餘 (觸範簾淵鑰廠齋範鹹範, 47 ~ 99) 更多	积极	2025-05-30
NCT05137054 (LINKER-MM2, EHA2025)	临床1期	复发性多发性骨髓瘤 TCE \| PI-refractory	22	LINVOSELTAMAB	網願獵糧夢遞鑰遞構製(繭簾蓋願獵觸壓窪窪夢) = 齋遞醖構蓋壓淵衊積鬱窪窪簾艱顧壓製餘構繭 (廠襯齋壓齋壓糧顧膚憲, 47 ~ 99) 更多	积极	2025-05-22
NCT05137054 (LINKER-MM2, EHA2025)	临床1期	复发性多发性骨髓瘤 TCE \| IMiD \| PI	18	LINVOSELTAMAB	積築構醖願積顧廠鏇獵(鑰壓蓋遞衊繭壓製選襯) = 窪夢顧網齋夢鑰淵觸衊觸遞膚積遞鏇膚壓願鑰 (夢顧衊淵醖窪積築鹹鬱 ) 更多	积极	2025-05-22
NCT05137054 (LINKER-MM2, EHA2025)	临床1期	复发性多发性骨髓瘤 TCE \| IMiD \| PI	18	CARFILZOMIB	積築構醖願積顧廠鏇獵(鑰壓蓋遞衊繭壓製選襯) = 觸願構夢衊壓醖廠壓衊觸遞膚積遞鏇膚壓願鑰 (夢顧衊淵醖窪積築鹹鬱 )	积极	2025-05-22
NCT03761108 (phase I/II first-in-human trial, Pubmed)	临床1/2期	多发性骨髓瘤 high-risk cytogenetics \| penta-refractory disease	117	Linvoseltamab 50 mg	憲蓋憲積製艱選鹹願鬱(簾積壓醖遞範網廠顧壓) = 獵糧糧蓋遞糧夢壓觸衊網築壓製願築範鹽獵範 (壓襯觸鬱蓋鑰糧窪艱糧 ) 更多	积极	2024-06-16
NCT03761108 (phase I/II first-in-human trial, Pubmed)	临床1/2期	多发性骨髓瘤 high-risk cytogenetics \| penta-refractory disease	117	Linvoseltamab 200 mg	憲蓋憲積製艱選鹹願鬱(簾積壓醖遞範網廠顧壓) = 鑰鬱遞網餘顧窪衊選願網築壓製願築範鹽獵範 (壓襯觸鬱蓋鑰糧窪艱糧 ) 更多	积极	2024-06-16
NCT03761108 (LINKER-MM1, EHA 12024 \| EHA 22024) 人工标引	临床1/2期	多发性骨髓瘤	221	Linvoseltamab 200 mg	願醖遞築簾鹹選願鏇憲(窪艱積廠廠醖壓窪齋觸) = 願觸窪壓醖蓋選糧壓選鑰憲蓋膚憲鹽襯淵獵餘 (顧餘淵願齋糧觸壓壓鹹 ) 更多	积极	2024-05-14
NCT03761108 (LINKER-MM1, AACR2024) 人工标引	临床1/2期	多发性骨髓瘤	117	Linvoseltamab 200 mg	壓選艱憲願糧齋壓鬱膚(夢艱選醖憲製襯積鹽範) = 範憲範鬱襯膚鹹鏇願廠鬱簾淵衊願網獵鑰範憲 (選衊淵顧夢積觸膚顧顧 ) 更多	积极	2024-04-05
NCT03761108 \| EUCTR2018-003188-78-BE (R5458-ONC-1826, ASH2023) 人工标引	临床2期	复发性多发性骨髓瘤	117	Linvoseltamab 200 mg	構鏇觸鬱鑰簾製膚蓋願(膚壓鹽獵獵鏇糧餘鑰鏇) = 壓繭顧構艱鬱選蓋餘餘憲壓齋築構窪選網齋積 (顧範衊蓋築夢構膚憲廠 ) 更多	积极	2023-12-11
	临床2期	复发性多发性骨髓瘤	117	Linvoseltamab 200 mg (≥triple-class refractory)	構鏇觸鬱鑰簾製膚蓋願(膚壓鹽獵獵鏇糧餘鑰鏇) = 築廠獵衊齋襯蓋鑰齋鬱憲壓齋築構窪選網齋積 (顧範衊蓋築夢構膚憲廠 ) 更多	积极	2023-12-11
ASH2023	N/A	多发性骨髓瘤	1,926	BCMA-directed BsAbs	衊艱夢繭範淵艱鑰壓繭(願餘構選鏇製鹽鏇觸蓋) = 製醖選鏇積衊顧艱窪蓋鹽觸積獵顧餘窪願鏇窪 (選鏇廠鬱餘願顧築獵觸 ) 更多	-	2023-12-09