A Clinical Phase I/II, Multicenter, Open-label, National Study Evaluating Quintuplet Treat-ment With ISaTuximab, Bortezomib, Lenalidomide and Dexamethasone Plus Etentamig (Etenta-Isa-VRd) in Primary DiagnOsed High-Risk Multiple Myeloma Patients

This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.

开始日期2026-12-01

申办/合作机构

Universitätsklinikum Hamburg-Eppendorf

[+2]

NCT07247097

/ Not yet recruiting临床2期IIT

ELDORADO: a Randomized Phase II Trial of Elranatamab or Daratumumab in Combination With Lenalidomide, Bortezomib, and Dexamethasone (RVd Lite) in Newly Diagnosed, Transplant Ineligible/Deferred Multiple Myeloma

This research study is being done to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the combination of daratumumab, lenalidomide, bortezomib, dexamethasone for patients with newly diagnosed, transplant ineligible/deferred multiple myeloma.

开始日期2026-08-01

申办/合作机构

The Massachusetts General Hospital

[+1]

NCT07029776

/ Not yet recruiting临床2期

A Phase 2 Study Exploring the Use of Bispecific Antibodies to Improve Progression Free Survival in Patients With High-Risk Newly Diagnosed Multiple Myeloma (MMulti-Immune HR)

The purpose of this research is to learn whether using teclistamab and talquetamab at different time points will improve survival in participants with high-risk Multiple Myeloma (MM).
The treatment on this study will consist of Induction chemotherapy and stem cell collection, Immunotherapy 1 chemotherapy and Immunotherapy 2 chemotherapy. For participants whose testing show they are Minimal Residual Disease (MRD) positive (still have myeloma cells present in the bone marrow testing), a Melphalan-based stem cell transplant will be performed. For participants whose testing show they are MRD negative, the stem cell transplant will not be performed. All participants will go on to receive Immunotherapy 3 chemotherapy, Immunotherapy 4 chemotherapy, and Maintenance therapy.

开始日期2026-07-01

申办/合作机构

Janssen Research & Development LLC

100 项与来那度胺相关的临床结果

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100 项与来那度胺相关的转化医学

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100 项与来那度胺相关的专利（医药）

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7,806

项与来那度胺相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Indirect treatment comparison of DVRd plus DR maintenance (PERSEUS study) versus DVTd or VTd with or without lenalidomide maintenance in transplant-eligible patients with previously untreated multiple myeloma

Article

作者: Nair, Sandhya ; Einsele, Hermann ; Facon, Thierry ; He, Jianming ; Dimopoulos, Meletios A. ; Caillot, Denis ; Sonneveld, Pieter ; Zweegman, Sonja ; Ammann, Eric ; Nobrega, Marjorie ; Broijl, Annemiek ; Spencer, Andrew ; Perrot, Aurore ; Schjesvold, Fredrik ; Gay, Francesca ; Hajek, Roman ; Boccadoro, Mario ; Rodriguez-Otero, Paula ; Hulin, Cyrille ; Sitthi-Amorn, Anna ; Rowe, Melissa ; Leleu, Xavier ; Mina, Roberto

AIMS:

To compare the effectiveness of induction and consolidation with daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd) plus maintenance therapy with daratumumab and lenalidomide (DR) with 2 treatment regimens that are widely used for transplant-eligible newly diagnosed multiple myeloma (TE NDMM): bortezomib, thalidomide, and dexamethasone (VTd) or daratumumab-VTd (DVTd) followed by observation (Obs) or lenalidomide maintenance.

MATERIALS AND METHODS:

Individual patient-level data from the PERSEUS (NCT03710603) and CASSIOPEIA (NCT02541383) trials were used to compare DVRd + DR with VTd + Obs and with DVTd + Obs. Inverse probability of treatment weighting was used to adjust for differences in baseline patient characteristics between the two trials; inverse probability of censoring weighting was used to adjust for the second randomization of CASSIOPEIA. Data from the CASSIOPEIA and Myeloma XI (EudraCT 2009-010956-93) trials were combined to model outcomes associated with lenalidomide (R) maintenance following induction with DVTd or VTd.

RESULTS:

DVRd + DR showed superior progression-free survival compared with DVTd + Obs (hazard ratio, 0.39 [95% CI = 0.26-0.59]), VTd + Obs (0.17 [95% CI = 0.12-0.25]), DVTd + R (0.62 [95% CI = 0.41-0.92]), and VTd + R (0.29 [95% CI = 0.18-0.43]). Sensitivity analyses showed results were consistent with the base case.

LIMITATIONS:

The indirect treatment comparison was unanchored due to a lack of common comparators and relied on external data from the Myeloma XI trial to model outcomes associated with DVTd or VTd followed by R maintenance. Despite best efforts to identify and adjust for important treatment effect modifiers, there is a potential for residual confounding.

CONCLUSIONS:

Findings from this study suggest that DVRd followed by DR maintenance offers superior survival outcomes compared with current standards of care in TE patients with NDMM.

2026-12-31·Hematology

Neutrophil extracellular trap-related genes in PTCL: identification, prognosis and drug interaction prediction via bioinformatics-machine learning

Article

作者: Chen, Jing ; Cheng, Fanjun ; Fang, Jun

OBJECTIVE:

This study aimed to identify neutrophil extracellular trap-related genes (NET-RGs), explore their prognostic significance, and predict drug interactions in peripheral T-cell lymphoma (PTCL).

METHODS:

Differentially expressed NET-RGs (DE-NRGs) between PTCL and normal tissues were screened. Functional enrichment analysis was conducted. Bioinformatics and machine learning were used to identify hub genes and assess their diagnostic value. Univariate and multivariate analyses were used to evaluate prognostic roles. Correlation and immune infiltration analyses were performed to explore relationships with the tumor microenvironment (TME). Clinical data were collected from PTCL patients who received potential agents (lenalidomide) as first-line treatment.

RESULTS:

A total of 31 DE-NRGs were identified (18 upregulated and 13 downregulated), enriched in inflammatory response, extracellular matrix organization, and infection involvement. Four hub genes (AKT2, MAPK14, IRF1, and TNF) were identified as effective PTCL diagnostic markers. Higher AKT2/MAPK14 expression correlated with poorer overall survival (OS), while elevated TNF expression associated with better OS; AKT2 and TNF independently predicted OS. These genes were implicated in modulating TME remodeling. Potential therapeutic agents (e.g. capivasertib, lenalidomide) were predicted, and lenalidomide may represent a feasible initial treatment option for PTCL, with an objective response rate (ORR) of 40.0% and a maximum survival duration exceeding 50 months.

CONCLUSION:

NET-RGs play crucial roles in diagnosis, prognosis, and TME regulation, and lenalidomide, a putative TNF-targeting agent, may represent a feasible initial treatment option in PTCL.

2026-12-01·JOURNAL OF MOLECULAR MEDICINE-JMM

Anti-myeloma activity of the CXCR4 antagonist WZ811

Article

作者: Suroviakova, Katarina ; Sedlak, Jan ; Jakubikova, Jana ; Valuskova, Zuzana ; Strizova, Anna ; Marinkovicova, Maria Elisabeth ; Csicsatkova, Nikoleta ; Cholujova, Danka

Abstract:

The CXCR4-CXCL12 axis is crucial for the interaction between malignant plasma cells (PC) and their microenvironment in multiple myeloma (MM). Here, we show that CXCR4 expression is upregulated in MM cell lines and PCs during both premalignant and active stages of MM, compared to normal PCs from healthy donors. The CXCR4 antagonist WZ811 reduced the viability of MM PCs and cell lines, while tumor microenvironment cells from both MM patients and healthy donors exhibited significant resistance. In vivo, WZ811 significantly reduced tumor burden and improved survival. WZ811-mediated MM cell death involved disruption of mitochondrial transmembrane potential, externalization of transmembrane phosphatidylserine, activation of caspases, increased levels of autophagic proteins, and an increase in G 0 /G 1 phase of the cell cycle. WZ811 also eliminated the MM stem cell-like side population, though slight resistance was observed with stromal cells. Additionally, WZ811 increased levels of CXCL12 and extracellular matrix molecules collagen IV and laminin in MM cells. Combining WZ811 with anti-MM agents showed synergism with doxorubicin, dexamethasone, bortezomib, lenalidomide, and pomalidomide, while antagonism was observed with carfilzomib, supporting the clinical assessment of WZ811 in MM.

Key messages:

WZ811 reduced the viability of myeloma primary cells and cell lines.WZ811 reduced tumor burden and improved survival in vivo xenograft model.WZ811 mechanisms involved apoptotic and autophagic cell death.WZ811 eliminated the MM stem cell-like side population.WZ811 synergized with DOX, DEX, BTZ, LEN, and POM.

3,412

项与来那度胺相关的新闻（医药）

2026-06-23

·医药速览

Nature子刊|阿斯利康优化戊二酰亚胺合成路径，加速CRBN药物发现

靶向蛋白质降解（TPD）正在改写药物发现的规则，但其核心药效团——戊二酰亚胺（glutarimide）骨架的合成却始终是制约研发速度的“拦路虎”。近日，Nature Communications在线发表了一项来自阿斯利康（AstraZeneca）等机构的重磅研究成果，报道了一种集有机膦催化、光氧化还原催化与串联环化于一体的全新合成平台。该平台能够从廉价易得的含氮杂环出发，在极短时间内快速组装出结构多样且具有良好Cereblon（CRBN）结合活性的戊二酰亚胺类化合物，其克级制备能力与高通量适应性有望从根本上提升蛋白降解剂药物的发现效率。戊二酰亚胺的合成瓶颈在当下如火如荼的靶向蛋白质降解（TPD）领域，Cereblon（CRBN）E3泛素连接酶配体堪称“兵家必争之地”。无论是PROTAC（蛋白降解靶向嵌合体）还是分子胶降解剂，其分子结构中都频繁出现一个关键的药效团——戊二酰亚胺骨架，这一六元环状酰亚胺结构能够精准嵌入CRBN蛋白表面的疏水口袋，从而启动泛素-蛋白酶体系统的降解级联反应，是决定整个降解剂分子是否有效的“分子锚点”。然而，正是这样一个看似简单的环状结构，却在很长一段时间内成为该领域快速发展的制约因素，传统的合成策略往往需要针对不同母核结构“量体裁衣”，对于异吲哚啉酮类结构，研究人员往往需要从多取代的苯环出发经历多步官能团转化和关环反应；对于苯并咪唑酮等杂环类结构则常依赖于SN2亲核取代反应，但底物如3-溴戊二酰亚胺的制备本身就步骤冗长且产率低下；更有甚者，一些工艺依赖高危试剂如氢化钠或四氧化锇，不仅操作安全性差，也给大规模生产带来巨大隐患。该论文的作者团队敏锐地指出，由于缺乏一种“通用型”的合成平台，药物化学家们在探索新型CRBN配体的结构-活性关系（SAR）时往往举步维艰，极大地限制了对化学空间的探索。膦催化、光催化与串联环化构建的“三步流水线” 针对上述痛点，阿斯利康的研究团队巧妙设计了一条集三种化学转化于一身的“流水线”式合成策略，该策略的核心逻辑在于将戊二酰亚胺骨架的构建拆解为三个逻辑清晰且可串联的模块化步骤，从而实现了从简单含氮杂环到复杂CRBN配体的快速跃迁。整个技术平台的起始原料是种类繁多且商业可得的含氮杂环，其反应路径的设计极具巧思：第一板斧是膦催化的区域选择性C-N键构建，研究团队发现通过使用特定结构的Buchwald类膦配体（如SPhos或CyJohnPhos），能够高区域选择性地催化含氮杂环对丙炔酸叔丁酯的α-加成反应，该反应不仅在温和条件（60°C）下进行，膦催化剂用量更可低至1 mol%，反应时间缩短至1小时以内，且溶剂的介电常数对反应区域选择性具有决定性影响，在低极性溶剂如甲苯中反应定向生成所需的α-加成产物；第二板斧是无金属光催化Giese自由基加成，团队利用光氧化还原催化技术，在可见光（450 nm）照射下实现了前述α,β-不饱和酯与2-卤代乙酰胺的自由基共轭加成，根据卤代底物的不同开发了两套并行的催化体系，对于溴代底物采用4CzIPN作为光催化剂结合三丁胺作为还原剂，对于碘代底物则采用曙红Y结合DIPEA作为还原剂，这两种体系均能在1-2小时内高效完成转化且完全无需使用重金属催化剂；第三板斧是酸介导的串联脱保护/环化，在苯磺酸作用下，前一步得到的光反应中间体发生叔丁基脱除，随后原位发生分子内脱水环化，一锅法高效构建出最终的戊二酰亚胺骨架，该步骤甚至可以实现连续操作无需中间体分离，极大简化了实验操作流程。底物范围广泛且兼容克级放大与高通量筛选为了验证该平台的通用性，研究团队对一系列结构迥异的含氮亲核试剂进行了系统评估，结果表明该方法不仅能够高效合成经典CRBN配体，还能轻松驾驭此前文献中报道较少且合成颇具挑战性的新型骨架。例如，利用该策略团队成功合成了(±)-沙利度胺以及来那度胺，后者通过该路径仅需三步即可完成纯化，有效规避了传统硝基还原路线的安全隐患；该方法同时成功应用于苯并吲哚酮、酞嗪酮等前沿靶向基团的构建，这些产物可以作为“多功能把手”进行后期多样化衍生，为构建庞大的PROTAC库提供了理想的前体。值得一提的是，该方法还展示了令人印象深刻的化学选择性，在含有线性酰胺、氨基甲酸酯或游离苯胺等竞争性亲核位点的复杂底物中，反应能够精准识别并优先与内酰胺或酰亚胺氮原子发生偶联，作用于神经系统的药物氟班色林和匹莫齐特均被成功转化为相应的戊二酰亚胺衍生物，直接证明了该方法的后期官能团化能力。在规模化应用方面，团队以6-甲氧基-3,4-二氢异喹啉-1-酮为起始原料，成功验证了该路线在5克规模上的可行性，通过使用可持续性溶剂并在Lucent360™光反应器中进行反应，研究人员在3小时内即可获得数克级的中间体，最终以34%的总收率得到目标产物，相比之下已报道的专利路线需要4步且总收率仅为19%，新方法在步骤经济性和总收率上实现了全面超越。更为亮眼的是，团队将该三步转化无缝衔接至一个标准的高通量筛选平台，在一个24孔板中一次性平行合成了12种不同的CRBN配体及其相应的N-甲基化阴性对照，借助自动化粉末分配和光反应器，最终22个化合物（成功率高达92%）具有满意的纯度并可直接用于后续的CRBN结合亲和力和理化性质测定，这种“即合成即测试”的能力为快速迭代寻找新一代分子胶和PROTAC分子提供了强有力的工具。总结综上所述，这项由阿斯利康团队主导的研究工作为长期困扰靶向蛋白质降解领域的戊二酰亚胺合成难题提供了一套近乎“全能型”的解决方案，该平台通过膦催化、光催化和酸催化三种有机合成方法的精妙组合，将结构多样化的含氮杂环高效快捷地转化为具有生物活性的CRBN配体，其核心优势体现在普适性强、操作友好以及结果导向三个层面，不仅覆盖了从经典骨架到新型三维环状结构的广泛底物空间，更以克级放大与高通量并行能力极大地缩短了药物化学的“设计-合成-测试”循环周期。参考文献： Whalley, D. M., Lorthioir, O., Anderson, N. A., Braybrooke, E., Coote, S. C., Demanze, S., Douglas, H. L., Putra, O. D., Proctor, K., Si, Y., Staniland, S., Stokes, S., & Woodhouse, A. (2026). A unified platform for the rapid assembly of glutarimides for Cereblon E3 ligase modulatory drugs. Nature Communications. Whalley, D. M., Lorthioir, O., Anderson, N. A., et al. (2026). A unified platform for the rapid assembly of glutarimides for Cereblon E3 ligase modulatory drugs. ChemRxiv. Nileswki, C., Villemure, E., Wang, Y., Zhou, Y., & Wong, A. R. (2024). Tactics and Strategies for the Synthesis of Cereblon Ligands. Synthesis, 56(23), 3543–3554. Recent advances in glutarimide chemistry for cereblon-mediated targeted protein degradation: developments in synthesis and diversification. (2025). RSC Medicinal Chemistry. Renner, A. C., & Kargbo, R. B. (2026). Acyclic Glutarimide PROTAC Precursors Enable Controlled Protein Degradation and Expand Cereblon Ligand Space. ACS Medicinal Chemistry Letters. Kabir, F., Sonobe, T., Zhu, Q., Vallavoju, N., Amako, Y., & Woo, C. M. (2025). Investigation of Glutarimide N-Alkylated Derivatives of Lenalidomide. ACS Chemical Biology. Chamberlain, P. P., & Hamann, L. G. (2019). Development of targeted protein degradation therapeutics. Nature Chemical Biology, 15, 937–944. 推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。 ©2021 医药速览保留所有权利往期链接 “小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记 PROTAC技术| 抗体药物| 抗体药物偶联-ADC 核酸疫苗 | CAR技术| 化学生物学

2026-06-23

·今日头条

患淋巴瘤25年反复复发，瑞金医院原创双抗PSB202，12周肿瘤全消

> 一位与B细胞淋巴瘤抗争25年、历经6套治疗方案仍反复复发的58岁女性，在几乎放弃希望时，一项来自上海交通大学医学院附属瑞金医院的最新研究让她的肿瘤在12周内完全消失，并维持完全缓解超过一年。这项研究聚焦于全球首个进入人体临床试验的CD20/CD37双功能抗体PSB202，为中国自主研发，其成果已发表于国际知名肿瘤学期刊《Journal of Hematology & Oncology》。这不仅是单个患者的胜利，更标志着复发难治淋巴瘤治疗领域的一次关键突破。 ## 事件回放：从25年抗争到PSB202突破这名58岁女性患者于1999年首次确诊边缘区淋巴瘤，经CHOP化疗缓解后，在2016年复发并再次通过RCHOP方案控制病情。然而，后续治疗之路越走越窄，她相继尝试了来那度胺、PI3K抑制剂联合美罗华、R2ICE、BR等方案，但疾病仍一次次复发。到2024年再次复发时，她已历经**6个治疗方案**，免疫系统失灵，出现反复发热、夜间盗汗和体重下降，全家几乎不抱希望。入组PSB202临床试验后，第一剂输注仅引起轻微发烧，无寒战或化疗常见反应，但肿瘤开始缩小；第12周影像学检查显示**完全缓解**，肿瘤消失，目前她已维持完全缓解超过一年，恢复正常生活。 ## 机制解析：双靶点协同与微环境改造 PSB202的研发源于对复发难治患者肿瘤样本的深入分析。团队与齐鲁制药合作，花费数月时间研究CD20和CD37表达情况，发现那些对CD20单抗耐药的细胞，有的CD20表达下降，但有的并未明显减少，提示耐药机制复杂。研究共同第一作者、瑞金医院血液内科主任医师王黎解释，耐药细胞周围的微环境中，能杀肿瘤的NK细胞和巨噬细胞“像睡着了一样”，T细胞则无法有效浸润或功能瘫痪。团队因此锁定了一个冷门靶点**CD37**——它与CD20一样，在几乎所有B细胞淋巴瘤上表达，且复发患者癌细胞表面CD37表达量更高。 - **体外实验显示**：同时阻断CD20和CD37，肿瘤杀伤率从单靶点的60%和50%跃升至**85%以上**。 - **双功能设计**：PSB202同时结合CD20和CD37，形成“双锚定”效应，牢牢固定在癌细胞表面，召唤免疫细胞吞噬肿瘤。 - **微环境改造**：动物实验和单细胞测序表明，PSB202将肿瘤微环境中的巨噬细胞从“促肿瘤”模式转变为“杀肿瘤”模式，并增加T细胞和NK细胞浸润，激活全身免疫反应。 ## 安全性优势：无细胞因子风暴的温和疗法与当前热门的CAR-T或CD3双抗疗法相比，PSB202选择了一条更温和的路径。其机制完全独立于CD3，**不强行激活T细胞**，因此避免了细胞因子风暴（CRS）这一常见严重副作用的风险。王黎指出：“不是CD3不好，是我们想要一种更安静、更持久的杀伤。” 患者治疗过程中仅出现轻微发烧，无化疗相关的呕吐、脱发等痛苦，安全性显著提升。这一特点为那些因副作用担忧而却步的患者提供了新选择。 ## 研究意义：中国原创与国际竞争力 PSB202的研发体现了完整的“中国原创”研究链条：从靶点选择、分子设计、体外筛选、动物验证，到人体I期试验及单细胞机制探索，均由赵维莅教授团队闭环完成。值得一提的是，这是一项**国际多中心I期临床试验**，在中国、美国、澳大利亚同步开展，彰显了我国创新药物研发的国际竞争力。作为第一个发表I期人体数据的CD37相关研究，PSB202填补了该靶点临床研究的空白。 ## 未来展望：精准筛选与更大规模验证研究团队发现，B细胞是肿瘤中CD37的主要来源，且治疗反应好的患者治疗前CD37表达量较高，治疗后显著下降。这意味着**CD37表达水平可能成为生物标志物**，用于提前筛选适合PSB202的患者，实现精准打击。王黎解释：“以后我们可以提前筛选病人，CD37高的，可能对PSB202反应更好。” 目前，该研究基于15名患者的样本，虽初步验证了疗效，但仍需更大规模临床试验确认其长期效果和适用范围。对于无数复发难治的B细胞淋巴瘤患者，PSB202不仅是一款新药，更是照亮治疗困境的一束曙光。

2026-06-23

·BioSpace

Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Incyte Biosciences Japan G.K. today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Minjuvi ® (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). “This approval provides a new option for patients in Japan living with relapsed or refractory DLBCL, an aggressive disease with historically limited treatment options,” said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan. “We are committed to helping address critical unmet needs for patients and their families affected by this challenging cancer.” DLBCL is the most common subtype of non-Hodgkin lymphoma and is an aggressive malignancy of B lymphocytes. While many patients respond to initial therapy, outcomes remain poor for those with relapsed or refractory disease, particularly for patients who are not eligible for autologous stem cell transplant.1 The approval is based on results from the MOR208C203 Trial: L-MIND (NCT02399085), an international Phase II trial, and INCMOR 0208-102 Trial Part 4 (Group 6): J-MIND (NCT04661007), a domestic Phase Ib/II trial in Japan, both of which evaluated the safety and efficacy of Minjuvi in combination with lenalidomide in patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). 2,4 In the L-MIND trial, based on an independent review committee assessment (data cutoff date: November 20, 2018), the overall response rate (ORR) was 58.8% (primary endpoint), with a complete response (CR) rate of 41.3% and a partial response (PR) rate of 17.5%.3 The median duration of response (mDOR) had not been reached at a median follow-up of 44 months or more.3 Furthermore, based on the independent review committee’s assessment in the J-MIND trial (data cutoff date: August 31, 2023), the response rate was 71.4%, with a complete response (CR) rate of 45.2% and a partial response (PR) rate of 26.2%.4 The main adverse events included neutropenia and thrombocytopenia.4,5 Overall, Minjuvi in combination with lenalidomide demonstrated a clinically meaningful response, and the side effects were manageable.4,5 This approval represents the second regulatory approval for Minjuvi in Japan. Minjuvi in combination with rituximab and lenalidomide was previously approved by the MHLW for the treatment of adult patients with relapsed or refractory follicular lymphoma (2L+ FL). L-MIND was a single-arm, open-label Phase 2 study evaluating tafasitamab in combination with lenalidomide in adults with relapsed or refractory diffuse large B-cell lymphoma who had received at least one, but no more than three, prior lines of therapy (including an anti-CD20 therapy such as rituximab) and who were not eligible for, or refused, high-dose chemotherapy followed by autologous stem cell transplant.2 The primary endpoint was overall response rate; secondary endpoints included duration of response, progression-free survival, and overall survival.2 J-MIND Trial Part 4 (Group 6) (NCT04661007) is a Japanese Phase Ib/II clinical trial evaluating the efficacy and safety of tafasitamab in combination with lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Patients enrolled in this trial had received one to three prior systemic therapies, including CD20-targeted therapy, and were deemed by the principal investigator to be ineligible for or unresponsive to autologous hematopoietic stem cell transplantation.4 The primary endpoint of this trial was the objective response rate (ORR) as assessed by an independent review committee based on the Lugano criteria; secondary endpoints included complete response (CR), progression-free survival (PFS), and overall survival (OS).4 Minjuvi® (tafasitamab) is a humanized, Fc-modified, cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. In the U.S., Monjuvi® (tafasitamab-cxix) received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).6 Additionally, Monjuvi is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).6 In Europe, Minjuvi (tafasitamab) received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.7 Additionally, Minjuvi is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1–3a) after at least one line of systemic therapy in Europe.7 In Japan, Minjuvi is approved in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in Japan.8 Minjuvi is also approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). XmAb® is a registered trademark of Xencor, Inc.Monjuvi and Minjuvi are registered trademarks of Incyte. Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity. 1 Sehn LH, Salles G. Diffuse large B-cell lymphoma. N Engl J Med. 2021;384:842–858. Link to source (https://www.nejm.org/doi/full/10.1056/NEJMra2027612) 2 ClinicalTrials.gov. Open label study to evaluate the safety and efficacy of lenalidomide with MOR00208 in patients with R-R DLBCL (L-MIND). Link to source (https://clinicaltrials.gov/study/NCT02399085). Accessed June 2026. 3 Duell J, Abrisqueta P, Andre M, Gaidano G, Gonzales-Barca E, Jurczak W, Kalakonda N, Liberati AM, Maddocks KJ, Menne T, Nagy Z, Tournilhac O, Kuffer C, Bakuli A, Amin A, Gurbanov K, Salles G. Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study. Haematologica. 2024;109(2):553–566. 4 Izutsu K, Fukuhara N, Yuda J, Suehiro Y, Kusumoto S, Casadebaig ML, Suzukawa K, Fukushima K. Tafasitamab as Monotherapy or in Combination in Japanese Patients With B-Cell Non-Hodgkin Lymphoma: Results From the Phase 1b J-MIND Study. Cancer Sci. 2026 Apr;117(4):1093–1105. 5 Salles G, Duell J, González-Barca E, et al. Tafasitamab plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, Phase 2 study. Lancet Oncol. 2020;21:978–988. 6 U.S. Food and Drug Administration. Monjuvi® (tafasitamab-cxix) Prescribing Information. Accessed June 2026. 7 European Medicines Agency (EMA). Minjuvi (tafasitamab) European Public Assessment Report (EPAR) and Product Information. Accessed June 2026. 8 Incyte. Minjuvi® (tafasitamab) Product Information (Japan) and Pharmaceuticals and Medical Devices Agency (PMDA) electronic package insert. Accessed June 2026. The content above comes from the network. if any infringement, please contact us to modify.

$Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)$

临床结果上市批准加速审批

100 项与来那度胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04687	来那度胺	L04AX04	DB00480

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
大B细胞淋巴瘤	美国	Seagen, Inc.	2025-02-11
边缘区B细胞淋巴瘤	美国	Bristol Myers Squibb Co.	2019-05-28
成人T细胞白血病/淋巴瘤	日本	Bristol-Myers Squibb KK	2017-03-02
染色体5q缺失综合征	欧盟	Bristol-Myers Squibb Pharma EEIG	2007-06-14
染色体5q缺失综合征	冰岛	Bristol-Myers Squibb Pharma EEIG	2007-06-14
染色体5q缺失综合征	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2007-06-14
染色体5q缺失综合征	挪威	Bristol-Myers Squibb Pharma EEIG	2007-06-14
滤泡性淋巴瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2007-06-14
滤泡性淋巴瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2007-06-14
滤泡性淋巴瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2007-06-14
滤泡性淋巴瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2007-06-14
套细胞淋巴瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2007-06-14
套细胞淋巴瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2007-06-14
套细胞淋巴瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2007-06-14
套细胞淋巴瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2007-06-14
输血依赖性贫血	欧盟	Bristol-Myers Squibb Pharma EEIG	2007-06-14
输血依赖性贫血	冰岛	Bristol-Myers Squibb Pharma EEIG	2007-06-14
输血依赖性贫血	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2007-06-14
输血依赖性贫血	挪威	Bristol-Myers Squibb Pharma EEIG	2007-06-14
多发性骨髓瘤	美国	Bristol Myers Squibb Co.	2006-06-29

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
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	美国	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	日本	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	阿根廷	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	澳大利亚	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	奥地利	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	加拿大	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	哥伦比亚	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	捷克	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	法国	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	德国	Incyte Corp.	2021-05-11

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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


LEN-EOS (ASCO2026)	N/A	多发性骨髓瘤	127	Bortezomib+Lenalidomide+Dexamethasone (Lenalidomide-induced eosinophilia)	壓蓋艱艱遞鏇獵獵築窪(衊構醖構鏇網壓觸鏇膚) = 積壓觸醖遞遞遞蓋範獵壓憲醖鏇齋蓋壓膚觸範 (淵獵膚糧築鹹觸構網膚 ) 更多	积极	2026-05-29
				Bortezomib+Lenalidomide+Dexamethasone (No Lenalidomide-induced eosinophilia)	壓蓋艱艱遞鏇獵獵築窪(衊構醖構鏇網壓觸鏇膚) = 範鑰鏇製遞醖廠選鏇膚壓憲醖鏇齋蓋壓膚觸範 (淵獵膚糧築鹹觸構網膚 ) 更多
ASCO2026	N/A	-	3,328	Lenalidomide	壓衊蓋衊衊觸網願獵夢(醖膚簾製觸顧艱鬱製遞) = 構鑰艱鹹遞顧壓壓選簾網糧繭鑰壓膚憲淵糧鏇 (繭顧淵糧觸範衊願簾餘 ) 更多	积极	2026-05-29
BelaDRd (ASCO2026)	临床1/2期	多发性骨髓瘤一线	36	Belantamab mafodotin+daratumumab+lenalidomide+dexamethasone	壓顧蓋範糧鹽繭遞選鹹(淵糧獵壓夢膚觸積壓願) = 選夢艱襯餘壓餘網衊廠糧餘範鹹積製襯鹽糧網 (顧淵衊壓範製鬱獵壓範 ) 更多	积极	2026-05-29
NCT03290950 (CTgov)	临床2期	多发性骨髓瘤 \| 浆细胞白血病	69	Lenalidomide+Carfilzomib+Daratumumab+dexamethasone (Cohort 1)	鹹憲衊顧構夢艱遞簾蓋 = 齋獵網製網獵鬱構願齋鹹觸築製壓積繭鏇鬱觸 (繭夢網鬱襯窪淵構鏇廠, 憲簾膚積築範鹹膚獵遞 ~ 膚積願壓鬱顧醖鏇蓋遞) 更多	-	2026-05-29
				Lenalidomide+Carfilzomib+Daratumumab+dexamethasone (Cohort 2)	鹹憲衊顧構夢艱遞簾蓋 = 積繭簾簾選蓋醖願窪獵鹹觸築製壓積繭鏇鬱觸 (繭夢網鬱襯窪淵構鏇廠, 艱繭繭顧醖製壓鹹鏇夢 ~ 簾窪醖壓鹽廠築製觸築) 更多
NCT02659293 (ATLAS, Pubmed \| Lancet Haematol)	临床3期	多发性骨髓瘤一线	180	Carfilzomib+Lenalidomide+Dexamethasone	獵齋鬱鬱築齋鏇憲憲製(廠艱範廠艱選選膚觸積) = 積膚願獵糧醖構選壓糧餘積夢艱範網顧積築鏇 (齋繭衊鏇衊簾夢憲憲顧 ) 更多	积极	2026-04-01
				Lenalidomide	廠餘網鑰網選襯網網衊(蓋鬱膚願襯顧膚窪網獵) = 簾網壓鑰網鑰鹽願顧醖鹽窪夢餘築鬱憲襯繭艱 (糧淵廠艱構願窪顧壓廠, 27.6 ~ 48.2) 更多
NCT03477539 (CTgov)	临床2期	多发性骨髓瘤	49	Lenalidomide+Autologous Hematopoietic Stem Cell Transplantation+Daratumumab	壓觸製廠蓋簾淵製糧蓋 = 衊積窪夢艱齋艱襯膚鏇願築顧繭膚窪鹹壓網鏇 (齋壓憲積鬱顧鬱壓窪構, 鬱獵積艱夢網齋顧網壓 ~ 鏇選鏇窪艱繭齋鹹衊膚) 更多	-	2026-03-09
NCT01919086 (CTgov)	临床2期	多发性骨髓瘤	30	Lenalidomide+Bortezomib+Dexamethasone	願鹽餘夢鹹範窪淵夢壓 = 鏇齋獵鹽齋壓憲製網觸觸簾繭糧鏇糧醖築觸鹽 (繭齋齋願選齋願鏇獵艱, 糧鹹構憲淵鏇繭顧窪築 ~ 築鬱艱糧構膚憲選積憲) 更多	-	2026-03-02
Tandem Meetings ASTCT and CIBMTR2026	N/A	多发性骨髓瘤巩固 \| 维持	179	CAR-T consolidation	繭鬱壓鏇艱艱餘築膚鹹(繭簾鏇廠網選顧範壓夢) = 鹹鏇鹹醖醖製齋窪廠鹹淵築襯憲鏇餘齋衊選廠 (鹹積願築餘築鬱築願襯 ) 更多	不佳	2026-02-04
				Lenalidomide maintenance	範製願範繭壓壓餘憲齋(鬱夢艱顧獵憲鹽網積製) = 衊廠艱築鹹範襯構餘襯積顧構衊鹽艱鏇膚積鏇 (網襯製積製積觸窪網網 ) 更多
Tandem Meetings ASTCT and CIBMTR2026	N/A	多发性骨髓瘤	140	Daratumumab+ bortezomib/cafilzomib+ lenalidomide+ dexamethasone (CD34+ cells <5×10^6/kg)	選襯觸淵廠鬱膚夢遞築(積鹽簾餘襯鹽鹹鏇簾醖) = 艱簾艱構範鬱鹽窪構範鏇膚範獵鏇廠鬱糧願夢 (獵獵襯齋淵繭齋鏇遞製 ) 更多	积极	2026-02-04
				Daratumumab+ bortezomib/cafilzomib+ lenalidomide+ dexamethasone (CD34+ cells ≥5×10^6/kg)	選襯觸淵廠鬱膚夢遞築(積鹽簾餘襯鹽鹹鏇簾醖) = 夢積獵範積餘構範淵顧鏇膚範獵鏇廠鬱糧願夢 (獵獵襯齋淵繭齋鏇遞製 ) 更多
Tandem Meetings ASTCT and CIBMTR2026	N/A	多发性骨髓瘤	71	Daratumumab+Bortezomib+Lenalidomide+Dexamethasone	糧憲膚艱窪遞觸憲築艱(憲醖獵顧衊襯觸積鬱鹹) = 蓋鏇製簾製壓衊餘齋齋膚淵憲築憲艱醖願壓窪 (願鏇鏇遞糧淵遞繭製遞 ) 更多	积极	2026-02-04
				Daratumumab+Bortezomib+Lenalidomide+Dexamethasone (2025 IMS/IMWG high-risk criteria)	糧憲膚艱窪遞觸憲築艱(憲醖獵顧衊襯觸積鬱鹹) = 淵選餘獵鏇積鬱網觸壓膚淵憲築憲艱醖願壓窪 (願鏇鏇遞糧淵遞繭製遞 ) 更多