A Phase 2/3 Randomized Trial Investigating Daratumumab on a Modified Augmented BFM (aBFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LL)

This phase II/III trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with daratumumab may kill more cancer cells.

开始日期2026-03-30

申办/合作机构

The Children's Oncology Group Foundation, Inc.

NCT07082270

/ Not yet recruiting临床1期IIT

Phase I Trial of GB1211 (Selvigaltin), an Oral Galectin-3 (Gal-3) Inhibitor, Combined With Standard of Care Treatment in Relapsed/Refractory Multiple Myeloma (RRMM)

This phase I trial studies the side effects and best dose of selvigaltin when given together with standard of care treatment (daratumumab-hyaluronidase, carfilzomib, dexamethasone) in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Selvigaltin works by blocking the activity of a protein called galectin-3. Galectin-3 is involved in various cellular processes, including inflammation and tissue scarring, which is associated with worse outcomes in several forms of cancer. By blocking the activity of galectin-3, selvigaltin may help reduce inflammation and tissue scarring. Daratumumab-hyaluronidase is a drug composed of daratumumab and hyaluronidase. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Hyaluronidase helps deliver the daratumumab to CD38-expressing cancer cells. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone 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. Giving selvigaltin with standard of care treatment may be safe, tolerable, and/or effective in treating patients with relapsed or refractory multiple myeloma.

开始日期2026-02-01

申办/合作机构

Roswell Park Comprehensive Cancer Center

NCT07191379

/ Not yet recruiting临床4期IIT

Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma. An Open Label, Phase Four, Prospective, Non-randomized, Sponsor-initiated Multicenter Feasibility Study

The main goal in this open label, phase four, prospective, non-randomized, sponsor-initiated multicenter feasibility study is to evaluate the feasibility and safety of self-administration of subcutaneously (SC) daratumumab in the patients with multiple myeloma in their own home. The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. To reduce potential bias, patients will function as their own controls by receiving alternating treatments at home and in the outpatient clinic. To participate, patients must be scheduled for SC daratumumab alone or in combination with other drugs not necessitating outpatient visits on days of planned SC daratumumab self-administration. Patients can be included and trained during cycle 1 and 2, but only treatments administered in cycle 3-6 are considered protocol treatments. Here, patients will receive SC daratumumab once every second week with treatments at day 1 administered in the outpatient clinic and treatments at day 15 administered at home. From cycle 7 onwards, patients continues SC daratumumab outside protocol according to local standards.
At inclusion, baseline demographic and clinical data should be registered for included patients. For each SC daratumumab administration in the protocol, planned treatment location (home/hospital) should be registered together with information on whether the dose was administered as planned. For each protocol treatment, regardless of treatment location, patients, caregivers, and healthcare professionals should register their time spent. In addition, patients should complete the Health Literacy Questionnaire (HLQ) and caregivers are to complete the Caregiver Roles and Responsibilities Scale (CRRS). Throughout the study, patient will also register all unplanned contacts to the healthcare system. Patient will also be asked to complete an evaluation form. Lastly, qualitative evaluations of the experience of self-administration will be conducted through semi-structured interviews with patients and caregivers, as well as focus group interviews with involved healthcare professionals.

开始日期2026-01-01

申办/合作机构

Odense University Hospital

100 项与达雷妥尤单抗相关的临床结果

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100 项与达雷妥尤单抗相关的转化医学

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100 项与达雷妥尤单抗相关的专利（医药）

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2,151

项与达雷妥尤单抗相关的文献（医药）

2026-01-01·BIOMATERIALS

CD38-targeted antibody-polymer drug conjugates for enhanced treatment of multiple myeloma

Article

作者: Li, Shannuo ; Al Faruque, Hasan ; Yang, Jiyuan ; Li, Jiahui ; Kopeček, Jindřich ; Sborov, Douglas W

Multiple myeloma (MM) remains a formidable disease, especially in relapsed or refractory cases when there are limited treatment options. In this study, we introduce two polymer-antibody drug conjugates (pADCs), ISA-P-EPI (U6244-021) and DARA-P-EPI (U6244-031), which contain semitelechelic N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer-epirubicin (EPI) conjugate attached to CD38-targeting antibodies Isatuximab (ISA) and Daratumumab (DARA). These pADCs enhance therapeutic efficacy by combining the specificity of ISA and DARA with the cytotoxic potency of EPI while preserving antibody function. The EPI is linked to the HPMA polymer backbone via a tetrapeptide spacer cleavable by lysosomal enzymes, enabling drug release upon endocytosis within tumor cells. This design achieves a higher drug-to-antibody ratio than conventional ADCs for safer delivery of drug payload. In vitro studies demonstrate efficient binding, internalization, and cytotoxic efficacy of these pADCs in MM cell lines. Mechanistic investigations revealed significant therapeutic effects, including cell cycle arrest, immunogenic cell death, and preserved antibody-dependent cellular cytotoxicity (ADCC). In addition, pADCs were effective in 5 out of 8 primary samples, with their efficacy closely correlating with CD38 surface expression levels. To enhance therapeutic outcomes, we employed panobinostat to upregulate CD38 expression, which further improved pADC efficacy. In a preclinical NRG mouse model inoculated with MM.1S-luc cells, pADC treatment significantly delayed tumor progression and prolonged survival, with all treated mice remaining alive at the 100-day endpoint. These findings underscore the potential of CD38-targeted pADCs as a novel approach to combining chemotherapy with immunotherapy for MM treatment, warranting further investigation into their optimization and clinical application.

2025-12-31·ANNALS OF MEDICINE

Serum free light chain level-based and non-fixed cycle daratumumab treatment strategy for patients with light chain amyloidosis

Article

作者: Huang, Xianghua ; Guo, Jinzhou ; Chen, Wencui ; Li, Zhen ; Zhao, Liang ; Ren, Guisheng

BACKGROUND:

In recent years, daratumumab (DARA) has gained widespread use in the treatment of systemic light chain (AL) amyloidosis. In this study, we assessed the efficacy and safety of a DARA treatment strategy based on serum free light chain (sFLC) levels and non-fixed cycles.

METHODS:

The study included 123 patients with Al amyloidosis who received DARA at our center between July 2020 and September 2023. All patients received the standard DARA treatment (16 mg/kg weekly for four weeks) during the first course. Subsequent treatments were adjusted based on sFLC levels and the physician's judgment.

RESULTS:

The results demonstrated an impressive overall hematologic response rate (ORR) of 94.3%, with a hematologic very good partial response (VGPR) and complete response (CR) rate of 84.5%. Median time to best hematologic response was 1 months. Cardiac and renal response rates were 39.3% and 60.3%, respectively. Thirty patients experienced grade 1/2 infusion-related reactions after the first infusion. The rate of grade 3/4 adverse events was 21%. The most common adverse events of grade 3 or 4 were pulmonary infection (6.5%), neutropenia and lymphocytopenia (5.7%), elevated transaminases (1.6%), acute kidney injury (1.6%). After a median follow-up of 13 months (range 1-38), The 1-year OS and PFS estimates were 96.5% and 84.4%, respectively.

CONCLUSION:

These findings indicate that the sFLC levels based and non-fixed cycle DARA strategy is an efficacious and safe treatment strategy in both newly diagnosed and relapsed/refractory AL amyloidosis.

2025-12-31·ANNALS OF MEDICINE

Clinical outcome of ≥2% circulating tumor cells in newly diagnosed multiple myeloma: insights from a multicenter study

Article

作者: Liang, Dong ; Wang, Hua ; Xia, Zhongjun ; Feng, Yuan ; Yan, Yurong ; Jin, Fengyan ; Chen, Xiaoqin ; Zeng, Min ; Nie, Xiaomiao ; Bu, Yuying ; Bai, Shenrui ; Liang, Yang ; Wang, Qiaoli ; Xu, Weiling ; Feng, Demei

PURPOSE:

Previous studies have shown that ≥2% circulating tumor cells (CTCs) in multiple myeloma are associated with a prognosis similar to primary plasma cell leukemia. This study aims to examine this ultra-high-risk patient subset and evaluate their clinical outcomes in a real-world clinical setting.

METHODS:

We included 1,056 newly diagnosed multiple myeloma patients treated with novel agents. CTCs levels were determined via morphological assessment on peripheral blood smears, using a 2% cutoff to stratify patients into <2% and ≥2% CTCs groups. We then evaluated clinical outcomes across these groups.

RESULTS:

Patients with ≥2% CTCs constitute an ultra-high-risk subgroup, with outcomes resembling those of primary plasma cell leukemia. Survival outcomes improved for patients receiving daratumumab-based quadruplet therapy. Single autologous stem cell transplantation (ASCT) partially improved outcomes for patients with ≥2% CTCs. Achieving complete remission (CR) after induction treatment did not confer a better prognosis for this population. Furthermore, one high-risk cytogenetic abnormality (HRA) worsened outcomes in the <2% CTC group, while ≥2 HRA were associated with poorer outcomes in the ≥2% CTC group. Concurrent 1q21+ and other HRA further conferred a worse prognosis. In de novo extramedullary extraosseous (EME) multiple myeloma, defined as patients presenting with soft tissue or visceral plasmacytomas not connected to bone at initial diagnosis, ≥2% CTCs remained a strong predictor of poor prognosis.

CONCLUSION:

Our study suggests that patients with ≥2% CTCs represent a distinct ultra-high-risk subgroup in multiple myeloma and warrant separate consideration. VRD, IRD, DVRD, and DRD were reliable choices as frontline therapies for patients with <2% CTCs. Daratumumab-based quadruplet therapy may be a promising option for patients with ≥2% CTCs. Further research should continue to explore this specific aspect in greater depth.

1,119

项与达雷妥尤单抗相关的新闻（医药）

2025-10-16

·药明康德

95%脱发患者发量改善！小分子获1.5亿美元助力推进上市；首个！显著延长癌症患者生命，Keytruda联合疗法3期结果公布……

95%脱发患者发量改善！小分子获1.5亿美元助力推进上市 Veradermics今日宣布完成超额认购的1.5亿美元C轮融资。此次融资将用于推进其核心在研产品VDPHL01的注册性试验及预定的新药申请（NDA）提交。VDPHL01是一款专为男女脱发患者设计、潜在首款缓释口服minoxidil候选药物，目前正在进行3期试验。本轮融资由SR One领投，新加入投资方包括Viking Global Investors、Marshall Wace、Invus、abrdn管理的基金、Columbia Threadneedle Investments、Infinitium与LifeSci Venture Partners，现有投资方Longitude Capital、Suvretta Capital Management、Surveyor Capital等继续加持，另有未披露投资者参与。公司同时公布了进行中2期临床研究的初步结果，该研究评估VDPHL01用于治疗男女模式性脱发（pattern hair loss）的疗效与安全性。在2期研究的男性队列中，21名受试者接受每日两次（BID）8.5 mg VDPHL01达两个月后，主要终点非毳毛靶区毛发计数较基线平均增加37.5根/平方厘米；至第4个月，同一批受试者的该指标平均增至较基线增加47.3根/平方厘米。主观评价方面，两个月时55%的受试者报告头发覆盖度“改善”或“显著改善”，至第4个月这一比例升至90.5%；在4个月结束时，95%的受试者表示对头发覆盖度的满意度提高。安全性上，VDPHL01迄今总体耐受性良好，未观察到任何严重不良事件，包括心血管相关不良事件。首个！显著延长癌症患者总生存期，Keytruda联合疗法3期结果公布默沙东（MSD）今日公布3期KEYNOTE-B96研究的积极结果。该研究评估其PD-1抑制剂Keytruda（pembrolizumab）联合化疗（紫杉醇），可合并或不合并贝伐珠单抗，用于治疗铂耐药复发性卵巢癌的疗效与安全性。此前的期中分析已显示，KEYNOTE-B96在PD-L1阳性人群及全体入组人群中均达到主要终点无进展生存期（PFS），并在PD-L1阳性人群中达到总生存期（OS）这一关键次要终点。在最终分析中，与安慰剂联合化疗（可合并或不合并贝伐珠单抗）相比，基于Keytruda的治疗方案在所有入组患者中带来具有统计学和临床意义的OS改善。该研究中Keytruda的安全性与既往研究一致，未发现新的安全性信号。根据新闻稿，KEYNOTE-B96是首个在铂耐药复发性卵巢癌中，基于免疫检查点抑制剂的治疗方案相较安慰剂联合化疗（可合并或不合并贝伐珠单抗）在PD-L1阳性人群及全体入组人群均显示出OS显著获益的研究。显著延长癌症患者总生存期！强生双抗组合3期结果公布强生（Johnson & Johnson）今日宣布，其3期MajesTEC-3研究取得期中结果。该研究评估Tecvayli（teclistamab）联合Darzalex Faspro（daratumumab & hyaluronidase）用于既往接受过1–3线治疗的复发/难治性多发性骨髓瘤（RRMM）患者，与研究者选择的两种标准治疗方案相比的疗效与安全性。经过近三年的随访，Tecvayli联合Darzalex Faspro达到了主要终点，其PFS显著优于标准治疗，且差异具有统计学意义；同时，在首次期中分析中，OS这一关键次要终点也达到了统计学显著性。根据新闻稿，MajesTEC-3是首个在二线治疗阶段即显示PFS与OS获益的在研联合方案3期研究。基于上述具有统计学显著性的结果，独立数据监查委员会（IDMC）已建议对研究进行揭盲。 Tecvayli是一款完全人源化、同时靶向BCMA与T细胞表面CD3受体的双特异性抗体；它既是首款获批用于治疗多发性骨髓瘤的双特异性疗法，也是首款获批靶向BCMA的双特异性抗体。Darzalex Faspro则为皮下注射的CD38靶向单克隆抗体。参考资料： [1] Veradermics Announces Oversubscribed $150 Million Series C Financing to Advance VDPHL01 Through Multiple Phase 3 Trials as Potentially the First Non-Hormonal Oral Therapeutic for Hair Regrowth in Women and Men. Retrieved October 16, 2025 from https://www.veradermics.com/veradermics-announces-150million-seriesc-financing [2] TECVAYLI® plus DARZALEX FASPRO® combination regimen significantly improves progression-free survival and overall survival versus standard of care. Retrieved October 16, 2025 from https://www.jnj.com/media-center/press-releases/tecvayli-plus-darzalex-faspro-combination-regimen-significantly-improves-progression-free-survival-and-overall-survival-versus-standard-of-care [3] Merck Announces Phase 3 KEYNOTE-B96 Trial Met Secondary Endpoint of Overall Survival (OS) in All Comers Population of Patients With Platinum-Resistant Recurrent Ovarian Cancer. Retrieved October 16, 2025 from https://www.merck.com/news/merck-announces-phase-3-keynote-b96-trial-met-secondary-endpoint-of-overall-survival-os-in-all-comers-population-of-patients-with-platinum-resistant-recurrent-ovarian-cancer/ 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3期临床成功临床2期临床结果

2025-10-16

·药明康德

致敬时代丨中位总生存期翻倍！20余年来，创新药如何改变了第二大血癌的治疗格局

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。从识别到治疗，人类认识多发性骨髓瘤的百余年历史 1844年，英国医生Samuel Solly报道了一例奇特的病例。一位39岁的女性在4年前开始出现严重的背部疼痛，此后剧烈的疼痛向四肢骨骼蔓延，让她失去行走能力、全身多处骨折。患者在医院离世后，Solly在尸检中发现，一种质地柔软的红色物质取代了她胸骨和股骨的松质部分。Solly将这种前所未见的症状命名为“mollities ossium”，意为骨质异常松软。这也成为人类对多发性骨髓瘤（multiple myeloma，MM）最早的详细记录。此后，越来越多的医生和科学家开始关注具有类似临床特征的疾病。1873年，俄罗斯医生J. von Rusitzky在尸检中发现，一位患者全身的骨髓中有8处独立的肿瘤病灶。由于病灶多发，Rusitzky将这种病症首次命名为多发性骨髓瘤。如今我们认识到，MM是一种常见的恶性浆细胞肿瘤，在多个国家和地区位居血液系统常见恶性肿瘤的第二位。MM患者的浆细胞在骨髓中增殖并累积，挤压健康血细胞，导致骨损伤、骨密度下降和骨折。这些异常浆细胞还会产生大量异常免疫球蛋白片段，引发肾损伤并削弱患者的免疫功能。 ▲美法仑化学结构（图片来源：PubChem）在很长一段时间内，针对MM的治疗方案都没有出现。20世纪50年代，MM患者的中位总生存期仅约6个月。直到20世纪60年代，化疗药物美法仑（melphalan）的诞生以及后续联合疗法的应用，掀开了MM的现代治疗史。进入80年代，大剂量美法仑化疗联合自体干细胞移植（ASCT）方案的应用，将患者的中位无进展生存期延长至4–5年，成为一线治疗方案。然而在当时，几乎所有患者在接受治疗后最终都会复发，MM的治疗仍然面临着巨大挑战。老药新用：分子胶为MM治疗破局进入21世纪，沙利度胺出现在MM的治疗舞台，成为继美法仑之后首个具有单药活性的MM新药。而这一临床成果的出现，还要从1970年代开始说起。哈佛医学院Judah Folkman教授于1971年提出“通过抑制血管生成抗击癌症”的假说，激发了大量后续研究。1994年，同实验室的Robert D'Amato博士偶然发现沙利度胺具有显著抑制血管生成的作用，并在动物模型中证实其可抑制肿瘤生长。随着研究的深入，沙利度胺在癌症领域的临床试验逐步展开，部分试验还联合使用了抗炎药地塞米松，后者能增强沙利度胺的抗血管生成作用和抗肿瘤活性。基于亮眼的临床试验结果，沙利度胺联合地塞米松方案于21世纪初获FDA批准用于MM治疗。后续研究确认，这类被命名为免疫调节剂（IMiDs）的药物能同时作用于MM细胞和骨髓微环境，发挥免疫调节与抗血管生成的双重作用。基于对作用机制的深入理解，研究人员通过精准药物设计开发出结构优化的新一代IMiDs。沙利度胺的衍生物——来那度胺（lenalidomide）和泊马度胺（pomalidomide）相继问世，并获批用于MM治疗。其中来那度胺与地塞米松联用可使90%的新确诊患者出现缓解。而第三代IMiDs泊马度胺正是来自Robert D'Amato博士的实验室，其于2013年获FDA批准用于治疗复发难治性多发性骨髓瘤（以下简称RRMM）。同样在2013年，《科学》杂志同期发表的两篇论文首次阐明了沙利度胺清除癌细胞的具体分子机制。人们才意识到，这类“老药”实际上早就不经意间运用了蛋白降解技术。具有类似作用机制的小分子后被命名为“分子胶”。一个关于蛋白降解的新探索时代由此开启，不过这已是另一段科学传奇的序幕。一波三折：蛋白酶体抑制剂硼替佐米的意外转型 21世纪初，当以沙利度胺为代表的小分子药物在MM治疗中显现成效之际，另一类小分子药物，以硼替佐米为代表的蛋白酶体抑制剂也成功应用于临床，极大地改善了MM患者的预后。 20世纪80年代，哈佛医学院的Alfred Goldberg教授团队与其他研究人员共同发现了细胞的“废物处理中心”蛋白酶体，并阐明了这类大型蛋白酶如何降解被泛素标记的蛋白质。基于这一基础科学发现，1993年，Goldberg教授作为共同创始人创立了MyoGenics公司（后续更名为ProScript），最初旨在开发用于治疗肌肉萎缩疾病的蛋白酶体抑制剂。PS-341（即后来获FDA批准的硼替佐米）便是在这一阶段被发现。后续研究意外发现，PS-341具有抗癌活性，尤其在MM治疗中效果显著。然而，事情并未就此一帆风顺。ProScript公司在随后经历了一系列并购，PS-341项目也一度被搁置。好在，2002年的一项临床试验结果证实了PS-341治疗难治性血液恶性肿瘤的价值，不仅使PS-341最终“起死回生”，也为MM患者带来了延续生命的希望。2003年，该产品以Velcade（硼替佐米，bortezomib）之名获得FDA批准，用于治疗RRMM，成为首个用于肿瘤治疗的蛋白酶体抑制剂。 ▲硼替佐米化学结构（图片来源：PubChem）蛋白酶体抑制剂是MM治疗领域具有里程碑意义的靶向药物。这是由于，MM细胞高度依赖泛素-蛋白酶体系统来降解细胞内错误折叠的蛋白质，维持细胞内环境稳态。因此，它们会大幅提升蛋白酶体“工厂”的活性，以清除体内异常蛋白。此时若抑制蛋白酶体功能，将使癌细胞因无法承受蛋白代谢负荷而最终崩溃死亡。目前，以硼替佐米为代表的联合方案目前仍是临床指南推荐的一线治疗方案。随着研发进展，新型蛋白酶体抑制剂通过结构优化，进一步提高了对蛋白酶体的抑制效率，有效克服了硼替佐米的耐药问题，同时降低了不良反应发生率。目前，包括Kyprolis（卡非佐米，carfilzomib）及首款口服蛋白酶体抑制剂Ninlaro（伊沙佐米，ixazomib）在内的多种蛋白酶体抑制剂均已获得监管机构批准，用于MM的治疗。免疫疗法时代：为复发难治MM患者带来希望近十多年来，更多治疗MM的新型药物不断出现，MM领域免疫治疗的新纪元已经来临。包括单克隆抗体、双特异性T细胞衔接器、抗体偶联药物（ADC）、CAR-T疗法等在内的新药进一步改善了MM患者的治疗，尤其是针对复发难治及高危MM患者的治疗策略不断涌现。例如，作为一种在MM细胞上表达的跨膜糖蛋白，CD38靶点备受关注。2015年，靶向CD38的Darzalex（达雷妥尤单抗，daratumumab）获FDA批准，成为首个获批治疗MM的单克隆抗体。2020年，另一款靶向CD38上不同的表位的单抗Sarclisa（艾沙妥昔单抗，isatuximab）也获FDA批准治疗MM。此外，靶向SLAMF7糖蛋白的创新免疫刺激抗体Empliciti（elotuzumab）也于2015年获FDA批准治疗MM。双特异性T细胞衔接蛋白是近几年广受关注的一类双特异性抗体类型。这类药物可以将CD3阳性T细胞募集到骨髓瘤细胞附近，并且激活T细胞对肿瘤细胞进行攻击。在MM治疗领域，至少4款双抗新药已获批上市，包括靶向BCMA的Tecvayli（特立妥单抗，teclistamab）、Elrexfio（埃纳妥单抗，elranatamab）、Lynozyfic（linvoseltamab），以及靶向GPRC5D的Talvey（塔奎妥单抗，talquetamab）。这些药物在此前接受过多种治疗方案的RRMM中取得较好的疗效。以今年7月获FDA加速批准的Lynozyfic为例，该产品治疗此前接受过至少4种治疗方案的RRMM患者，客观缓解率达70%，其中45%的患者达到完全缓解或更佳的应答。 BCMA靶点也正在MM治疗中发挥着重要价值。2020年，首款靶向BCMA的ADC疗法Blenrep（玛贝兰妥单抗，belantamab mafodotin）获FDA加速批准，用于既往接受过至少4种疗法的RRMM成人患者。一年后，首款靶向BCMA的CAR-T疗法Abecma（ide-cel）也获FDA批准相同的适应症。此外，目前还有其它3款BCMA靶向CAR-T疗法已经获批监管机构批准治疗MM，包括Carvykti（西达基奥仑赛，cilta-cel）、福可苏（伊基奥仑赛，equ-cel）、赛恺泽（泽沃基奥仑赛，zevor-cel），这些新药进一步提升了患者的治疗效果。以最新获批上市的泽沃基奥仑赛为例，今年9月公布的一项长期随访更新结果显示，中位随访时间为53.3个月时，14例RRMM患者的总缓解率达到100%，其中11例（78.6%）患者达到完全缓解或严格意义的完全缓解。从早期的化疗、造血干细胞移植，到免疫调节剂、蛋白酶体抑制剂以及免疫疗法的涌现，在与MM数十年的斗争中，治疗手段的迭代如同代步工具的升级，让患者在与病魔的赛跑中赢得优势、跑得更远。2016年发表于Clinical Cancer Research的数据表明，由于上述疗法的引入，MM患者的中位总生存期已经延长到8-10年，实现了翻倍增长。近几年来，更多创新疗法在提高复发难治性患者的生存期方面取得显著进展。根据当前部分新药公布的长期随访数据，即使是对于经过多线治疗的复发或难治性MM患者，中位总生存期也已经达到5年以上。一体化平台赋能MM新药研发如今，MM的治疗仍然面临着挑战，例如部分患者会对现有疗法产生抗性，且大多数药物仅能使少数患者受益。研究人员仍然在进一步开发新兴疗法，同时识别哪些患者亚型能够从现有治疗方案中获得更多益处。通过公开渠道梳理，目前还有数百款新药管线正在临床阶段探索治疗MM的潜力，包括了小分子靶向药、蛋白降解剂、抗体、细胞疗法等多种药物类型，更多创新靶点和机制新药正不断涌现。作为全球医药创新的赋能者，药明康德很高兴能助力合作伙伴，加速多款治疗包括MM在内的血液肿瘤的创新疗法问世，造福病患。长期以来，药明康德都在支持全球合作伙伴从药物研究（R）、开发（D）到商业化生产（M）各个阶段的需求，通过独特的一体化、端到端CRDMO模式，助力更多药物加速从实验室来到患者身边。在征伐MM的漫长征途上，这些令人振奋的突破，既源于科学家们敢于突破陈规的远见卓识，也倚赖转化医学领域中学术界与产业界的精诚协作。在此，我们谨向所有在肿瘤治疗领域锲而不舍、默默耕耘的科研与产业界工作者，表达最诚挚的敬意。药明康德愿继续与全球伙伴并肩前行，全力助推创新疗法的研发与临床应用，为更多患者点亮生命的新希望。参考资料： [1] Kamali et al.（2024） Multiple myeloma and the potential of new checkpoint inhibitors for immunotherapy. Ther Adv Vaccines Immunother. doi: 10.1177/25151355241288453. [2]Alfred L. Goldberg (1942–2023).From https://fa.hms.harvard.edu/sites/g/files/omnuum4521/files/hmsofa/files/mm_goldberg_alfred_l.pdf [3] Teicher et al. (2015)CCR 20th Anniversary Commentary: In the Beginning, There Was PS-341.Clinical Cancer Research.doi:https://doi.org/10.1158/1078-0432.CCR-14-2549 [4]Swan et al.(2024) CAR-T cell therapy in Multiple Myeloma: current status and future challenges. Blood Cancer J. doi: 10.1038/s41408-024-01191-8. [5] Anderson KC.(2016)Progress and Paradigms in Multiple Myeloma. Clin Cancer Res.doi: 10.1158/1078-0432.CCR-16-0625. [6]Domenico Ribatti（2017）A historical perspective on milestones in multiple myeloma research. European Juornal of Heamatology. doi:https://doi.org/10.1111/ejh.13003 [7]Robert D'Amato.From https://research.childrenshospital.org/researchers/robert-damato [8]科济药业赛恺泽®长期随访更新结果亮相2025年IMS年会. Retrieved Sep 18,2025.From https://mp.weixin.qq.com/s/uXqSRsSSE5XLzoyYhUSIOw 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

2025-10-16

·FiercePharma

J&J heads to regulators with Tecvayli-Darzalex combo's phase 3 win as earlier myeloma treatment

An eventual approval in the second-line setting would significantly advance Tecvayli in the multiple myeloma treatment sequence. Following a strong early showing of Tecvayli and Darzalex Faspro in newly diagnosed multiple myeloma patients last month, Johnson & Johnson is making the case for its oncology cocktail as a potential second-line therapy for the blood cancer.In the late-stage MajesTEC-3 trial, Tecvayli plus the subcutaneous formulation of J&J’s antibody drug Darzalex beat standard-of-care therapy at helping multiple myeloma patients live longer without their cancer progressing, satisfying the study’s primary endpoint.The trial enrolled patients with relapsed/refractory multiple myeloma who previously tried one to three prior lines of therapy.In addition, the results seen with the Tecvayli-Darzalex Faspro combo allowed the trial to meet its secondary endpoint of overall survival (OS), J&J said in an Oct. 16 press release.“These results demonstrate the clinical benefits of Tecvayli in earlier lines when used in combination, as evidenced by meaningful progression-free survival and overall survival outcomes,” Maria-Victoria Mateos, M.D., Ph.D., a consultant physician in hematology from the University Hospital of Salamanca, said in J&J’s release. An eventual approval in the second-line setting would significantly advance Tecvayli in the multiple myeloma treatment sequence. As it stands, the drug—a BCMA-targeted bispecific T-cell engager—is only cleared by the FDA for solo use in relapsed or refractory multiple myeloma patients who’ve tried at least four prior lines of therapy.The drug’s FDA nod is slightly more restrictive than in the EU, where Tecvayli was first cleared by regulators in August 2022 in myeloma patients after at least three prior therapies.J&J did not disclose comprehensive results from the MajesTEC-3 trial on Thursday, instead noting that the statistical significance of the data inspired an independent data monitoring committee to recommend unblinding the study. The company said it plans to present the results to health authorities and provide detailed data on the Tecvayli combo’s performance at a future medical meeting.J&J’s phase 3 trial pitted the Tecvayli-Darzalex cocktail against an investigator’s choice of Darzalex Faspro with the immunomodulator pomalidomide and the steroid dexamethasone, or Darzalex Faspro in combination with the proteasome inhibitor bortezomib and dexamethasone.The Tecvayli-based regimen won out over the control treatments on both progression-free survival and OS, with statistically significant results at almost three years of follow-up, J&J said. The safety of both drugs in the J&J cocktail was on par with their known profiles as monotherapies, the company added.The positive showing comes shortly after J&J unveiled promising—albeit earlier-stage—signals on Tecvayli and Darzalex Faspro’s potential in the first-line treatment of multiple myeloma.Last month, J&J said an investigational regimen of Tecvayli and Darzalex Faspro showed “meaningful clinical efficacy” in transplant-eligible patients who were newly diagnosed with multiple myeloma, citing a 100% overall response rate among those who received the combo therapy as their first treatment.In that midstage study, dubbed MajesTEC-5, 49 patients were treated across three cohorts that included regimens of Tecvayli and Darzalex Faspro with lenalidomide, both with and without bortezomib, J&J said at the time. Aside from the overall response signal, J&J noted that all minimal residual disease (MRD)-evaluable patients were MRD-negative at the end of the trial’s induction period. Around the time of Tecvayli’s initial FDA nod in October 2022, analysts at SVB Securities estimated that the drug’s sales could eventually eclipse $2 billion at peak. While Tecvayli still has some growing to do to meet those expectations, it’s been no slouch during earnings season, either.For all of 2024, Tecvayli brought home $549 million, growing sales some 39% over the sum it generated over the course of 2023. And, in 2025’s third quarter, which J&J reported on earlier this week, Tecvayli charted a roughly 60% sales increase to $177 million versus the same period last year.

临床结果临床3期上市批准

100 项与达雷妥尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10777	达雷妥尤单抗	L01XC24	DB09331

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
阴燃多发性骨髓瘤	欧盟	Janssen-Cilag International NV	2025-07-24
阴燃多发性骨髓瘤	冰岛	Janssen-Cilag International NV	2025-07-24
阴燃多发性骨髓瘤	列支敦士登	Janssen-Cilag International NV	2025-07-24
阴燃多发性骨髓瘤	挪威	Janssen-Cilag International NV	2025-07-24
免疫球蛋白轻链淀粉样变性	欧盟	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	冰岛	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	列支敦士登	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	挪威	Janssen-Cilag International NV	2016-05-20
多发性骨髓瘤	美国	Janssen Biotech, Inc.	2015-11-16

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
复发性多发性骨髓瘤	临床3期	美国	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	日本	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	澳大利亚	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	比利时	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	丹麦	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	法国	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	德国	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	希腊	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	以色列	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	意大利	Janssen Research & Development LLC	2020-06-12

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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


NCT03792620 (Pubmed)	临床2期	多发性骨髓瘤 CD38	24	Daratumumab, Cyclophosphamide, Thalidomide, Dexamethasone	糧艱獵艱淵鏇鬱齋簾獵(簾築鬱膚夢壓構窪簾範) = 積鹽鏇鏇廠淵願積餘鏇鹽衊夢鏇網製衊選選築 (鏇鑰積簾衊願淵鬱廠積, 68.3 ~ 98.7)	积极	2025-08-01
NCT04230304 (CTgov)	临床2期	复发性慢性淋巴细胞白血病 \| 难治性慢性淋巴细胞白血病 \| 难治性小淋巴细胞淋巴瘤	8	Ibrutinib+Daratumumab	壓鹹簾艱襯壓鏇廠襯獵 = 夢鏇範網壓廠蓋選蓋餘艱醖淵廠衊鬱築夢廠壓 (顧壓鬱窪衊積糧顧淵鑰, 積觸廠齋願顧艱繭簾鑰 ~ 網壓範糧簾鹽襯艱衊鹹) 更多	-	2025-07-01
NCT03012880 (CTgov)	临床2期	多发性骨髓瘤	80	lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort A)	壓衊艱願餘憲壓顧範顧 = 壓鏇糧築淵選獵鹹簾網壓獵糧顧築壓鏇衊鹽顧 (糧願鹽憲製蓋鏇夢鏇淵, 簾膚觸鬱膚淵夢襯艱觸 ~ 憲繭艱艱鏇憲構衊顧構) 更多	-	2025-06-04
				lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort B)	壓衊艱願餘憲壓顧範顧 = 鑰積顧鑰顧餘網壓鹹餘壓獵糧顧築壓鏇衊鹽顧 (糧願鹽憲製蓋鏇夢鏇淵, 鑰築鏇艱膚蓋顧夢範醖 ~ 壓構繭獵壓鑰膚襯繭餘) 更多
NCT04268498 (ADVANCE, ASCO2025)	临床2期	多发性骨髓瘤 minimal residual disease (MRD) positive	306	DKRd (Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone)	網夢觸鏇顧淵夢鑰窪範(選鹽糧鹹衊餘顧夢遞網): adjusted OR = 2.5 (95% CI, 1.5 ~ 4.2) 更多	积极	2025-05-30
				KRd (Carfilzomib, Lenalidomide, Dexamethasone)
ASCO2025	N/A	多发性骨髓瘤	804	Daratumumab	齋夢築積夢築蓋蓋餘窪(鏇襯網鹽襯壓繭淵蓋襯) = 網膚願鬱鬱衊齋餘獵簾網構鹹鹽糧製鑰鑰衊製 (積膚艱齋獵製憲齋網鏇 ) 更多	积极	2025-05-30
				Lenalidomide	齋夢築積夢築蓋蓋餘窪(鏇襯網鹽襯壓繭淵蓋襯) = 蓋糧窪遞齋膚鬱淵糧網網構鹹鹽糧製鑰鑰衊製 (積膚艱齋獵製憲齋網鏇 ) 更多
NCT04661137 (phase 2b study of selinexor, ASCO2025)	临床2期	多发性骨髓瘤	28	Selinexor 80 mg + Carfilzomib 20 mg/m2 + Dexamethasone	鏇製膚鹹憲繭觸蓋齋繭(淵艱遞鬱網觸遞壓遞簾) = 膚齋糧製鬱糧壓醖廠網鏇膚鹹淵範簾鏇顧糧鹹 (夢齋蓋襯鹽鹽鹽願選艱 ) 更多	积极	2025-05-30
				Selinexor 60 mg + Pomalidomide 4 mg + Dexamethasone	鏇製膚鹹憲繭觸蓋齋繭(淵艱遞鬱網觸遞壓遞簾) = 願鹽廠衊繭鹽鬱糧製艱鏇膚鹹淵範簾鏇顧糧鹹 (夢齋蓋襯鹽鹽鹽願選艱 )
CEPHEUS (EHA2025)	临床3期	多发性骨髓瘤 del(17p) \| t(4;14) \| t(14;16) ... 更多	395	DARATUMUMAB, BORTEZOMIB, LENALIDOMIDE AND DEXAMETHASONE (DVRd)	壓顧窪衊鏇簾鏇製繭鹽(觸簾艱齋願鏇獵醖簾積) = 餘蓋醖廠壓鏇膚範醖艱襯積鹽廠夢製願簾壓糧 (鹹遞醖願餘網遞願淵夢 ) 更多	积极	2025-05-22
NCT04181827 (CARTITUDE-4, CTgov)	临床3期	复发性多发性骨髓瘤 \| 多发性骨髓瘤	419	daratumumab+pomalidomide+bortezomib+dexamethasone (DPd) (Arm A: Standard Therapy: PVd or DPd)	積顧襯鑰鏇鹹餘醖餘網(蓋遞餘糧築範廠願淵構) = 廠廠範壓糧選鬱願膚蓋夢蓋鏇鏇餘獵衊襯餘餘 (憲獵壓壓鏇積齋選衊醖, 選廠膚糧範獵築艱鹽積 ~ 齋繭構淵觸鹹鹽餘餘餘) 更多	-	2025-05-20
				Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))	積顧襯鑰鏇鹹餘醖餘網(蓋遞餘糧築範廠願淵構) = 艱壓繭醖窪艱製獵繭積夢蓋鏇鏇餘獵衊襯餘餘 (憲獵壓壓鏇積齋選衊醖, 襯鹽窪襯鬱構積襯獵壓 ~ 選顧鹽壓淵鬱網範積壓) 更多
NCT04703621 (THE DART STUDY, EHA2025)	临床2期	免疫性血小板减少症二线	21	Daratumumab	鹹憲齋鹹憲築鬱襯壓壓(鏇窪遞憲衊積遞衊構鏇) = Infections were the most common treatment-emergent adverse events (38%) 鹽膚構積繭簾選窪鹽襯 (構膚鏇憲夢簾膚獵齋衊 ) 更多	积极	2025-05-14
PB3012 (EHA2025)	N/A	多发性骨髓瘤一线 \| 二线 \| 三线 CD38	133	Daratumumab (1L group)	遞選醖憲鹽製膚鏇糧襯(鹹範餘襯窪構憲艱範願) = 窪淵淵選淵膚鹹簾構餘艱窪餘願願廠鏇鏇鏇蓋 (憲顧淵鹽膚憲願夢膚淵 ) 更多	积极	2025-05-14
				Daratumumab (2L group)	遞選醖憲鹽製膚鏇糧襯(鹹範餘襯窪構憲艱範願) = 範壓鏇繭築鬱顧夢鑰醖艱窪餘願願廠鏇鏇鏇蓋 (憲顧淵鹽膚憲願夢膚淵 ) 更多