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]

NCT07341867

/ Not yet recruiting临床1期IIT

A Pilot Study of Duffy Null-Specific Dose Modifications for Individuals With Duffy Null Phenotype Receiving Standard of Care Systemic Anti-Cancer Therapies

This study is comprised of a main study, an observational study, and optional survey studies. The main study is being done to see whether using Duffy null specific treatment dosing guidelines can reduce or delay dose modifications and avoid neutropenic fever (fever in the setting of low neutrophils) for people with Duffy null phenotype receiving treatment for multiple myeloma or triple negative breast cancer. The observational study is to collect dose modification and neutropenic fever information on patients who do not have the Duffy null phenotype and receive the same standard of care regimens to see if there are differences in dose modifications and neutropenic fever between the two groups. The survey studies seek to understand general health experiences and preferences and experiences specific to people with Duffy null phenotype.
Study Drugs Include:
* Daratumumab
* lenalidomide
* bortezomib
* dexamethasone
* carboplatin
* paclitaxel
* pembrolizumab
* cyclophosphamide
* doxorubicin

开始日期2026-08-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

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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7,918

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: He, Jianming ; Nair, Sandhya ; Einsele, Hermann ; Facon, Thierry ; 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.

3,567

项与来那度胺相关的新闻（医药）

2026-07-21

·医药观澜

诺诚健华CD19单抗3期临床研究于《柳叶刀》主刊发表丨产业新闻

7月21日，诺诚健华宣布，国际医学期刊《柳叶刀》主刊近期刊登坦昔妥单抗联合疗法治疗初治弥漫性大B细胞淋巴瘤（DLBCL）全球3期frontMIND研究结果。结果显示，相较于标准疗法R-CHOP方案，坦昔妥单抗联合来那度胺和R-CHOP的方案（tafa-Len-R-CHOP ）可使疾病进展或死亡风险降低25%，显著改善患者无进展生存期，在经中心病理复核确诊为DLBCL患者事后分析中，疗效获益更加突出。坦昔妥单抗是一款靶向CD19的人源化单克隆抗体。frontMIND研究是一项随机、双盲、安慰剂对照的国际多中心试验，旨在确定疗效和安全性比R-CHOP方案更优的一线治疗方案。中位随访35.2个月后，相较于 R-CHOP 方案，tafa-len-R-CHOP 方案可使疾病进展或死亡风险降低 25%（风险比HR=0.75，P=0.0194），2年无进展生存（PFS）率提高8.2%，3年PFS率提升6.6%。在预设各亚组人群中，tafa-Len-R-CHOP方案均展现出一致的无进展生存期获益趋势，涵盖中心实验室确诊的各淋巴瘤亚型，以及细胞起源（COO）分子亚型，即活化B细胞型（ABC）与生发中心B细胞型（GCB）。在ABC型患者中，tafa-Len-R-CHOP方案组中的PFS获益尤为突出（HR=0.59）。经中心病理复核后分析，tafa-Len-R-CHOP组和R-CHOP 组的24个月PFS率分别为 72.7%和62.2%，显示更好的疗效获益。从地域分布上看，tafa-len-R-CHOP方案在亚洲患者中展现出了更为突出的疗效优势。安全性方面，Tafa-Len-R-CHOP方案不良反应特征符合预期，联合坦昔妥单抗、来那度胺后并未影响 R-CHOP方案的给药剂量与周期安排。在此前结束的2026欧洲血液学协会（EHA）年会上，frontMIND研究结果在最高级别的全体大会上以口头报告形式重磅发布。 DLBCL是全球常见的淋巴瘤，占非霍奇金淋巴瘤 25%~45%。该病异质性极强，中高危、高危DLBCL/高级别B细胞淋巴瘤（HGBL）患者预后差。R-CHOP是DLBCL根治性一线标准方案，但约40%高危患者原发耐药或治疗后复发，高危患者群体的总生存率始终偏低。tafa-len-R-CHOP方案有望成为高危弥漫大B细胞淋巴瘤、高级别B细胞淋巴瘤全新的一线治疗选择。参考资料：[1]《柳叶刀》刊登坦昔妥单抗联合疗法治疗初治DLBCL的Ⅲ期研究结果.From https://mp.weixin.qq.com/s/NN3mSq5ONaCdXNwMyLSpVg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。

2026-07-21

·精准药物

年销40亿美金的激酶抑制剂，专利要到期了

在制药领域，Incyte（纳斯达克代码：INCY）是一个极具辨识度的存在。作为一家全球性生物制药企业，该公司目前拥有超2800名员工、手握10款已获批药物。2011年，其自主研发的JAK1/JAK2抑制剂芦可替尼获FDA批准上市，并迅速成长为治疗骨髓纤维化等血液癌症的重磅炸弹。这款药物不仅为Incyte带来了每年超40亿美元的现金流，更确立了其在激酶生物学和靶向治疗领域的领导者地位。来源：摩熵医药数据然而，随着芦可替尼将于2028年面临专利到期的压力，这座由单一药物构筑的商业底盘，将迎来严峻考验。Incyte，已然站在了“后芦可替尼时代”的十字路口。面对这场关乎未来的周期性大考，Incyte没有选择保守防御，而是开启了一场以并购扩张与技术重塑为核心的深度转型…… 药融圈监测显示，2026年6月8日，Incyte宣布以最高20亿美元的总对价（含12.5亿美元预付款及7.5亿美元里程碑付款）收购Star Therapeutics旗下全资子公司Vega Therapeutics。此次收购的核心资产是一款潜在First-in-class的靶向蛋白S（Protein S）的单克隆抗体VGA039，该药物通过促进血小板附着和增强纤维蛋白沉积的双重机制来恢复止血功能，有望成为全球首款每月一次皮下给药的血管性血友病（VWD）预防性疗法，彻底颠覆现有每周2至3次静脉输注的治疗格局。 VGA039目前正在开展针对VWD的全球3期VIVID-6研究，并已获得美国FDA授予的突破性疗法、快速通道、孤儿药及罕见儿科疾病认定。此次交易不仅是Incyte新任CEO Bill Meury上任后的首笔重磅交易，更是公司为应对核心产品专利到期、拓展血液学新增长引擎的关键战略布局。创新研发布局：前沿靶点突破与AI赋能驱动目前，Incyte的战略重心高度聚焦于三大核心治疗领域：血液学（Hematology）、肿瘤学（Oncology）以及炎症与自身免疫（IAI），其获批药物的适应症及在研临床候选药物的疾病指向，均围绕这三大支柱领域展开。在创新研发领域，Incyte正通过高度精准的生物标志物驱动策略与前沿技术合作，加速下一代创新疗法开发。在骨髓增殖性肿瘤（MPNs）领域，INCA033989是一种抗突变型钙网蛋白（mutCALR）单克隆抗体，针对原发性血小板增多症（ET），INCA033989的I期研究证实其能快速且持久地使血小板计数正常化，并显著降低外周血mutCALR变异等位基因频率（VAF）。凭借这一优异表现，该药于2025年12月获FDA突破性疗法认定，III期注册性临床试验预计于2026年中期启动。针对骨髓纤维化（MF），I期数据显示其单药或联合芦可替尼均能快速缩小脾脏体积、改善症状与贫血，并展现出清除致癌细胞、恢复正常造血的疾病修饰潜力，III期试验计划于2026年下半年启动。此外，Incyte于2025年10月与Enable Injections达成合作，引入enFuse体表给药系统以开发INCA033989的皮下给药制剂，健康受试者的I期药代动力学研究已在2026年第一季度顺利完成。 Incyte还同步推进了另外两款针对骨髓增殖性肿瘤（MPNs）的新一代靶向疗法：INCA035784是一款新型、等效能的T细胞导向mutCALR x CD3双特异性抗体，目前正处于I期临床评估阶段，预计2027年将公布相关；而INCB160058则是一款公司自主研发的新型JAK2V617F突变特异性抑制剂，其无定形固体分散体（ASD）制剂的I期临床试验已于2026年第一季度启动，有望在2026年下半年迎来初步结果。这三款创新疗法的并行推进，将进一步拓宽Incyte在骨髓增殖性肿瘤领域的精准治疗版图。在实体瘤领域，针对铂耐药卵巢癌（PROC），公司自主研发了口服CDK2抑制剂INCB123667，该药物于2025年第四季度启动了针对Cyclin E1过表达铂耐药卵巢癌患者的II期单臂研究（MAESTRA-1）和随机开放标签III期研究（MAESTRA-2），公司还计划于2026年下半年启动一线维持治疗的III期研究。针对胰腺癌，口服强效选择性KRAS G12D抑制剂INCB161734在2025年ESMO大会上公布的I期数据显示出良好的安全性与临床疗效；基于此，公司已于2026年第一季度启动了名为DAWN-303的关键性III期研究，评估其联合标准化疗作为转移性胰腺导管腺癌（PDAC）一线治疗的潜力，初步数据预计于2026年下半年公布。此外，Incyte早在2016年就与Merus达成全球战略研究合作，凭借Merus授权的双抗平台，Incyte开发了TGFβR2xPD-1双特异性抗体INCA33890，该药物通过特异性阻断共表达PD-1细胞上的TGF-β信号传导，有效规避了广泛阻断TGF-β通路带来的已知毒性。在2025年ESMO大会上，Incyte公布了INCA33890在微卫星稳定型结直肠癌（MSS CRC）患者中展现出了良好的耐受性与临床疗效。基于积极的I期数据，Incyte已于2025年第四季度启动了评估INCA33890联合标准化疗及贝伐珠单抗一线治疗MSS CRC的III期研究。在炎症与自身免疫领域，Incyte开发了口服选择性JAK1抑制剂Povorcitinib。该药物治疗化脓性汗腺炎（HS）的两项III期研究均达成主要终点，公司已在2025年底向EMA递交了该药物的MAA申请，预计2026年底有望欧洲获批，NDA申请已于2026年第一季度获美国FDA受理，预计2027年第一季度有望在美国获批；针对白癜风，Povorcitinib的两项III期研究（STOP-V1和STOP-V2）于2026年4月公布积极顶线结果，证实其在面部及全身复色方面具有显著疗效，相关注册申请计划于2027年第一季度提交。此外，Povorcitinib针对结节性痒疹（PN）的III期研究数据也将于2026年第四季度揭晓，其针对中重度哮喘的II期概念验证数据预计将在2026年下半年公布。（2024年，康哲药业从Incyte获得了Povorcitinib在中国大陆、香港、澳门、台湾及东南亚十一国的开发及商业化的独家许可权利。）值得一提的是，Incyte近期还对其研发管线进行了战略性优化。在2026年4月，公司将口服小分子ALK2抑制剂Zilurgisertib（INCB00928）的全球商业化权利授予Mirum Pharmaceuticals。在技术赋能方面，Incyte正通过引入前沿AI技术打造数据驱动的下一代研发引擎，并于2026年5月宣布了两项战略合作：公司扩大了与Genesis Molecular AI的合作，将GEMS平台部署于更多高难度靶点，并开放专有实验数据用于训练其下一代GEMS AI平台；同时，Incyte还与Edison Scientific达成合作，将Edison的“Kosmos”AI科学家嵌入研发全生命周期，初期聚焦靶点发现与验证等高影响力场景，旨在通过持续学习转化与临床数据，将企业数据转化为可复利的核心资产，从而系统性地提升研发决策质量与长期管线产出。成熟商业化产品矩阵：三大核心治疗领域稳健发展在成熟商业化产品矩阵方面，Incyte在血液学、肿瘤学及炎症与自身免疫（IAI）三大核心治疗领域的获批药物不仅构筑了坚实的业务基础，更通过持续的适应症拓展与管线生命周期管理不断释放商业潜力。血液学板块由基石产品JAK1/JAK2抑制剂JAKAFI（芦可替尼）领衔，该药自2011年成为全球首个获批治疗中高危骨髓纤维化（MF）的疗法以来，适应症版图已进一步拓展至真性红细胞增多症（PV）及急、慢性移植物抗宿主病（GVHD）；为进一步提升用药便利性，Incyte开发了每日一次（QD）缓释制剂（JAKAFI XR），该剂型于2026年5月1日官宣获批，并已启动商业化。同时，酪氨酸激酶抑制剂ICLUSIG（泊那替尼）为耐药或携带T315I突变的慢性髓系白血病（CML）及费城染色体阳性急性淋巴细胞白血病（Ph+ ALL）患者提供了关键靶向方案。抗CD19抗体MONJUVI/MINJUVI（坦昔妥单抗）（收购自MorphoSys）已获批用于复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）及滤泡性淋巴瘤（FL）的治疗，并正在拓展联合来那度胺及R-CHOP方案作为新诊断弥漫性大B细胞淋巴瘤（DLBCL）的一线疗法，预计将于2026年上半年向FDA提交sBLA申请。抗CSF-1R单抗NIKTIMVO（Axatilimab）（与Syndax Pharmaceuticals合作）是全球首款获批的靶向慢性GVHD（移植物抗宿主病）炎症和纤维化驱动因素的抗CSF-1R抗体，同时公司开展了该药联合芦可替尼治疗新诊断慢性GVHD，以及联合皮质类固醇作为慢性GVHD初始治疗的研究。肿瘤学领域，PEMAZYRE（佩米替尼）作为全球首款获批上市的FGFR激酶抑制剂（2020年美国），不仅在治疗伴有FGFR2融合或重排的胆管癌领域确立了标杆地位，更于2022年拓展至伴有FGFR1重排的髓系/淋系肿瘤（MLNs），成为全球首个获批用于该罕见血液癌症的靶向疗法。抗PD-1单抗ZYNYZ（Retifanlimab-dlwr）（从MacroGenics引进）的适应症版图同样持续扩大，继2023年获FDA批准治疗默克尔细胞癌（MCC）后，又于2025年获批治疗晚期肛管鳞状细胞癌（SCAC），并在2025年底至2026年相继获得日本和欧盟批准，成为该适应症的一线联合治疗方案。在炎症与自身免疫（IAI）领域，OPZELURA（芦可替尼乳膏）已获批准用于轻至中度特应性皮炎（AD）患者，并且是首个获批用于非节段型白癜风复色的疗法，公司正开展研究将其适应症拓展至成人中度AD、化脓性汗腺炎（HS）。同时，基于FDA的反馈，公司决定暂停OPZELURA在结节性痒疹领域的进一步开发，从而将资源更加聚焦于具备高潜力和明确注册路径的核心项目。此外，Incyte通过与礼来（JAK1/JAK2抑制剂巴瑞替尼）及诺华（MET抑制剂卡马替尼、海外版芦可替尼JAKAVI）的深度战略合作，获取可观的里程碑付款及销售分成。财务表现与未来展望 2025年全年，Incyte实现总营收51.4亿美元，同比增长21%，其中42.29亿美元来自芦可替尼的销售额及销售分成；全年产品净销售额达43.5亿美元，同比增长20%。这一强劲表现主要得益于基石产品JAKAFI（芦可替尼）在全适应症范围内的需求增长、OPZELURA（芦可替尼乳膏）在白癜风及特应性皮炎领域的快速放量、NIKTIMVO（Axatilimab）的强势上市，以及MONJUVI（坦昔妥单抗）和ZYNYZ（Retifanlimab-dlwr）在适应症拓展后的持续增长。在营收大幅攀升的同时，公司2025年全年GAAP及Non-GAAP研发费用同比分别下降21%和22%。进入2026年，Incyte第一季度总营收达12.7亿美元，同比增长21%，其中芦可替尼贡献10.07亿美元；产品净销售额达11亿美元，同比增长20%。随着公司持续推进中后期管线开发及潜在新药的上市准备，2026年第一季度的研发费用同比有所回升。截至2026年3月31日，公司现金、现金等价物和可流通证券总额达40亿美元。展望未来，Incyte对2026财年的总产品净销售额给出了47.7亿至49.4亿美元的指引。其中，JAKAFI（芦可替尼）预计贡献32.2亿至32.7亿美元，该指引已包含每日一次缓释制剂（JAKAFI XR）获批后的初期上市贡献；OPZELURA（芦可替尼乳膏）预计实现7.5亿至7.9亿美元销售额，涵盖了2026年下半年在欧洲等海外市场针对中度特应性皮炎的预期上市；血液学与肿瘤学板块预计贡献8亿至8.8亿美元。总体而言，Incyte正通过成熟产品的持续造血与前沿管线的稳步推进，在巩固现有市场份额的同时，积极向多元化生物制药巨头转型。截至2026年7月2日收盘，Incyte总市值233.47亿美元。参考资料：摩熵医药数据pharma.bcpmdata.com（原药融云数据）； https://investor.incyte.com/news-releases/news-release-details/incyte-acquire-vega-therapeutics-wholly-owned-subsidiary-star； https://investor.incyte.com/news-releases/news-release-details/incyte-reports-first-quarter-2026-financial-results-and-provides； https://web.cms.net.cn/zh/home/；其他相关公开信息（正文图片来自企业官方，除非另有标注）。声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

2026-07-21

·BioSpace

Enterome Phase 2 data show EO2463-induced CD8 T-cell expansion correlates with progression-free survival in patients with indolent non-Hodgkin lymphoma in the watch-and-wait setting

PRESS RELEASE Magnitude of EO2463-induced CD8 T-cell expansion during monotherapy statistically significantly associated with longer progression-free survival (PFS) in patients with indolent non-Hodgkin lymphoma (iNHL) managed in the watch-and-wait setting EO2463-induced CD8 T-cell expansion also statistically significantly associated with complete response rate in patients with relapsed/refractory iNHL treated with EO2463 in combination with lenalidomide and rituximab (R²) Findings support EO2463-induced CD8 T-cell expansion as a potential predictive biomarker for clinical benefit Data presented at Pan Pacific Lymphoma Conference (PPLC) Enterome will also present data on its solid-tumor OncoMimics™ candidate EO4010 at the European Society for Medical Oncology (ESMO) Congress 2026 Paris, France – 21 July 2026 Enterome SA , a clinical-stage company pioneering OncoMimics™, a new class of off-the-shelf, multi-targeted in vivo immune therapies , today announced new positive interim data from the ongoing open-label Phase 1/2 SIDNEY trial of OncoMimics™ EO2463 to treat indolent Non-Hodgkin Lymphoma (iNHL). The data show EO2463 continues to have an effect, now showing a statistically significant correlation with progression-free survival (PFS) as a monotherapy in the watch-and-wait setting, and an additive effect, associated with complete response rates, when used in a triple combination, together with the standard of care, lenalidomide and rituximab (R 2 ). These new findings confirm previous data suggesting specific CD8 T cell expansion caused by EO2463 could be developed as a predictive biomarker and represent a compelling rationale for further study to confirm that EO2463 increases PFS in patients with iNHL. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Enterome presented the data today at the Pan Pacific Lymphoma Conference (PPLC) at the Fairmont Orchid, Kohala Coast (Big Island) in Hawaii. Copy of the poster is available here . “The correlation between the robust CD8 T cell expansion induced by EO2463 and PFS is a landmark finding that creates an imperative for further study and offers new hope for patients suffering from iNHL. It suggests that EO2463, which has been well-tolerated to date, may effectively extend PFS as a standalone therapy without hurting quality of life in this generally older and fragile patient population. We want to prioritize patients classified for watch-and-wait, an observational protocol, because they currently receive no active treatment, despite having to live with the grave psychological impact of their cancer diagnosis,” said Pierre Belichard, Chief Executive Officer of Enterome. “Based on these and other data, we believe EO2463 is ready to start the final stage of registrational clinical development as a first-in-class therapeutic for patients with iNHL in a watch-and-wait setting. We are in active discussions with potential investors and partners to find the best way to bring this product to patients.” SIDNEY (NCT04669171) is an ongoing open-label Phase 1/2 study evaluating the safety, tolerability, immunogenicity and preliminary efficacy of EO2463 as monotherapy and in combination regimens patients with follicular lymphoma and marginal zone lymphoma. The trial includes a dedicated watch-and-wait monotherapy cohort, a first-line low-tumor-burden combination cohort with rituximab, and relapsed/refractory cohorts treated with EO2463+R 2 . Interim data continue to support further evaluation of EO2463 both as a standalone treatment and in combination with established anti-lymphoma therapies. More recently, as SIDNEY progresses, data have begun to show the impact of EO2463 on clinical efficacy. Enterome reported at ASH in late 2025 that EO2463 caused a higher-than-expected complete recovery (CR) rate with the triple combination therapy, EO2463 and R2, compared to the combination of only lenalidomide and rituximab (or “R2”). Data reported at ASH in late 2024 showed that EO2463 monotherapy generated a 46% objective response rate in watch-and-wait patients. Last month, at EHA 2026 , Enterome presented data showing that EO2463-induced CD8 T cell expansions were significantly associated with clinical outcomes in each of the monotherapy, rituximab (“R1”), and R2 cohorts, suggesting that EO2463-induced CD8 T-cell expansion can be used as a predictive biomarker. Today, Enterome announced that new analyses extend this finding to progression-free survival in the monotherapy cohort. Key data presented at PPLC: In the EO2463 monotherapy cohort (Cohort 2, watch-and-wait), higher CD8 T cell expansion was significantly associated with longer progression-free survival (HR=0.18, 95% CI 0.03–0.82; log-rank p=0.020). In the EO2463 plus lenalidomide/rituximab combination cohort (Cohort 1+4, relapsed/refractory disease), higher CD8 T cell expansion was significantly associated with complete response (p=0.0073) EO2463 is an off-the-shelf OncoMimics™ active immunotherapy composed of four synthetic microbial-derived peptides designed to mimic the B-cell lineage markers CD20, CD22, CD37 and CD268 (BAFF receptor), plus the helper peptide UCP2. This multi-target approach is intended to expand pre-existing memory CD8 T cells, selectively target malignant B cells, broaden target coverage and obviate antigen escape. In May 2026, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to EO2463 for treatment of patients with follicular lymphoma . Upcoming presentation at ESMO Congress 2026 Enterome will also present data on its solid-tumor OncoMimics™ candidate EO4010 at the European Society for Medical Oncology (ESMO) Congress 2026 , taking place 23–27 October 2026 in Madrid, Spain. Title : EO4010 (EO) multi-target peptide immunotherapy: tumor directed CD8 T cell expansion kinetics and association to survival in patients (pts) with treated mismatch repair proficient (pMMR) metastatic colorectal carcinoma (mCRC) Presentation number : 859P Presentation time : Sun, October 25, 2026 – Time: 12:00 - 12:45 OncoMimics™  consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs) of solid tumors, or lineage markers (e.g. as observed in B cell lymphomas). These peptides induce a fast and potent  in vivo  expansion of effector-memory CD8 T-cells, naturally primed by gut bacteria, and cross-reactive with TAAs/B cell markers, thereby eliciting cytotoxic responses against tumor cells. Because they are recognized as foreign entities by the immune system, OncoMimics™ help overcome the self-tolerance that limits the ability of many cancer immunotherapies to trigger rapid, potent, and durable endogenous immune responses. The synthetically produced OncoMimics™ peptides are selected and designed  in silico  by mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple highly immunogenic peptides specifically designed to broaden target coverage, mitigate tumor heterogeneity and obviate the cancer’s ability to escape the therapeutic intervention. Enterome SA ( ) is a privately held clinical-stage biopharmaceutical company developing breakthrough OncoMimics™ immunotherapeutics for cancer. The three most advanced product candidates have shown positive early data in Phase 2 clinical development, supporting the novel OncoMimics™ modality. The company’s pioneering approach to drug discovery is based on the unique and powerful bacterial Mimicry drug discovery platform, which allows it to discover OncoMimics™ with high similarity to tumor associated antigens (TAA) based on the big-data insights from millions of gut bacterial proteins that live in humans. For more information, please contact: ENTEROME Pierre Belichard Chief Executive Officer communication@enterome.com INVESTOR & MEDIA RELATIONS Chris Maggos / Giovanni Ca’ Zorzi +41 (0)79 367 6254 / +33 (0)7 84 67 07 27 enterome@cohesionbureau.com Attachment 20260721 Enterome PR PPLC_FINAL

免疫疗法临床结果孤儿药临床2期细胞疗法

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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临床结果

适应症

分期

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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


NCT00403169 (CTgov)	临床2期	晚期肾细胞癌	28	Lenalidomide	淵遞網鏇鹽觸鬱構衊顧 = 齋齋鑰淵繭簾願夢選觸艱夢網襯齋淵淵構襯遞 (壓膚廠構觸選遞窪簾鑰, 憲壓鹹衊艱網選鏇憲醖 ~ 鑰選醖遞膚餘夢選遞構) 更多	-	2026-07-02
NCT02516423 (CTgov)	临床3期	浆细胞瘤	11	Lenalidomide+ixazomib+zoledronic acid+dexamethasone (Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid)	願衊網齋廠淵構餘獵衊 = 窪膚鏇衊窪積簾廠鹹鏇淵鏇鬱鏇獵齋壓顧願構 (簾衊鬱願襯淵製襯積築, 網鏇壓獵築鏇廠窪壓網 ~ 餘繭夢糧選壓構觸製構) 更多	-	2026-06-30
NCT02516423 (CTgov)	临床3期	浆细胞瘤	11	zoledronic acid (Zoledronic Acid)	願衊網齋廠淵構餘獵衊 = 積繭獵憲窪鏇鹽遞網鹽淵鏇鬱鏇獵齋壓顧願構 (簾衊鬱願襯淵製襯積築, 鑰廠選網壓獵鬱簾鑰餘 ~ 憲蓋衊齋膚願簾鏇鹹積) 更多	-	2026-06-30
EULAR2026	N/A	-	27	Lenalidomide 5-10 mg/day	衊衊獵網鬱積簾網蓋淵(膚齋積鏇觸製網糧繭齋) = 憲襯築顧鏇繭製築衊淵憲鹹獵繭艱鹽觸範壓淵 (鹽遞壓蓋構築製醖範繭 ) 更多	积极	2026-06-11
NCT04436107 (BGB-3111-110, Pubmed \| Blood Adv)	临床1期	复发性弥漫性大B细胞淋巴瘤	66	LenalidomideZanubrutinib 160 mg twice daily + LenalidomideZanubrutinib 160 mg twice daily	糧築鑰窪積築襯淵選廠(構蓋觸廠齋夢膚餘觸窪) = 築鑰夢範鹽築鬱鏇廠遞憲觸鹹觸齋衊糧鏇鑰醖 (餘糧簾顧壓網獵選蓋艱 ) 更多	积极	2026-06-09
ASCO2026	N/A	-	3,328	Lenalidomide	襯鑰艱獵製選衊淵壓鹽(廠獵築襯廠糧膚壓齋淵) = 繭構簾衊夢衊構鑰膚衊齋糧膚簾壓鏇憲夢壓夢 (積壓繭齋窪糧糧選艱築 ) 更多	积极	2026-05-29
LEN-EOS (ASCO2026)	N/A	多发性骨髓瘤	127	Bortezomib+Lenalidomide+Dexamethasone (Lenalidomide-induced eosinophilia)	觸齋築糧蓋壓窪夢觸廠(積製選夢顧艱鏇遞範觸) = 繭衊繭醖夢鏇獵構製鹹製遞網鏇簾鏇築夢齋築 (構壓遞鬱顧夢衊蓋範鑰 ) 更多	积极	2026-05-29
LEN-EOS (ASCO2026)	N/A	多发性骨髓瘤	127	Bortezomib+Lenalidomide+Dexamethasone (No Lenalidomide-induced eosinophilia)	觸齋築糧蓋壓窪夢觸廠(積製選夢顧艱鏇遞範觸) = 選簾糧簾觸構積積廠顧製遞網鏇簾鏇築夢齋築 (構壓遞鬱顧夢衊蓋範鑰 ) 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	觸遞繭窪願襯鏇鑰構鏇(壓蓋簾顧膚鏇衊構築憲) = 顧壓蓋繭膚繭遞壓蓋繭鹽壓壓壓蓋獵鏇獵膚糧 (簾遞簾襯願糧憲壓蓋選 ) 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)	淵蓋蓋觸鹽築餘襯齋膚 = 淵範夢願鹹膚夢衊淵鬱廠糧鏇窪壓築鏇選艱齋 (網餘膚鬱淵範窪鹹壓鹽, 願選積夢淵衊齋鏇顧醖 ~ 鏇艱選餘廠鬱醖繭遞願) 更多	-	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 2)	淵蓋蓋觸鹽築餘襯齋膚 = 網範獵網願觸範構夢壓廠糧鏇窪壓築鏇選艱齋 (網餘膚鬱淵範窪鹹壓鹽, 網壓願觸夢壓鏇衊餘選 ~ 齋艱範構鬱選衊憲衊壓) 更多	-	2026-05-29
NCT06549335 (EHA2026)	临床2期	滤泡性淋巴瘤一线	60	Lenalidomide+Zanubrutinib+Obinutuzumab	鬱築築衊淵鏇遞膚簾鬱(齋簾襯製築蓋淵蓋構糧) = 顧廠積構範壓選齋顧願醖築觸鹹壓膚觸鹽簾糧 (艱鑰築築積廠願範願襯 ) 更多	积极	2026-05-12
EHA2026	N/A	弥漫性大B细胞淋巴瘤一线	19	Polatuzumab vedotin+Rituximab+Acalabrutinib+Lenalidomide	鏇獵繭鏇構夢構鏇鬱顧(壓築簾製蓋繭簾選選醖) = No significant adverse events, such as febrile neutropenia, severe vomiting, prolonged neutropenia, or organ dysfunction, were observed in any patient. 膚觸蓋餘製網遞範製醖 (鬱襯襯鏇襯廠構鹹獵憲 )	积极	2026-05-12