A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus

The purpose of this study is to assess the safety and tolerability of JNJ-56022473 following multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus Erythematosus (SLE) and to determine whether premedication with corticosteroids is required to improve the tolerability of SC JNJ-56022473.

开始日期2017-06-30

申办/合作机构

Janssen Research & Development LLC

NCT03011034

/ Completed临床2期

A Phase 2 Proof-of-Concept Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

The main purpose of the study is to evaluate the efficacy (transfusion independence [TI]) of talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) whose disease has relapsed during treatment with or is refractory to Erythropoiesis-Stimulating Agent (ESAs).

开始日期2017-02-14

申办/合作机构

Janssen Research & Development LLC

NCT02992860

/ Terminated临床2期IIT

Single Agent JNJ-56022473 in MDS and AML Patients Failing Hypomethylating Agent Based Therapy

The outcome of HMA-refractory patients with MDS or AML is dismal with a median survival of 5 months after failure, representing a significant unmet medical need due to the very limited treatment options. In this context, a specific targeting of the leukemic stem cell (LSC) seems a promising option to selectively combat the leukemic progenitor cells. In fact, CD123 is overexpressed in AML and MDS progenitors making it an attractive target for immunotherapy-based approaches. JNJ-56022473 is a promising compound that has been engineered with regard to this strategy and the current phase II trial has the aim to evaluate the overall hematological response rate at 3 months in HMA refractory/relapsed AML and MDS patients.

开始日期2016-07-01

申办/合作机构-

100 项与 Talacotuzumab 相关的临床结果

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100 项与 Talacotuzumab 相关的转化医学

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100 项与 Talacotuzumab 相关的专利（医药）

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130

项与 Talacotuzumab 相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Costs per responder for patients with relapsed or refractory multiple myeloma treated with Talquetamab compared with usual care

Article

作者: Mu, Fan ; Patel, Neel ; Yang, Chelsey ; Jiao, Tianze ; Liu, Yi-Hsuan ; Wang, Jiamin ; Grajales-Cruz, Ariel F. ; Zhang, Xinke ; Lee, Hans C. ; Goble, Joseph

AIMS:

To evaluate costs per responder for patients with triple-class exposed (TCE) relapsed or refractory multiple myeloma (RRMM) receiving talquetamab (Tal) on weekly (QW) and biweekly (Q2W) dosing schedules, compared with usual care from a United States commercial payer's perspective.

METHODS:

A cost per responder model was developed over a 6-month time horizon, incorporating pre-progression and post-progression costs. For Tal QW and Tal Q2W, pre-progression costs included costs of drug acquisition, inpatient step-up doses (hospitalization, pre-medication, and tocilizumab), outpatient visits, and monitoring. Pre-progression costs for usual care were estimated based on a weighted average of the 10 most used regimens in a real-world LocoMMotion/MoMMent study, including costs of acquisition, administration, co-medication, and monitoring. Post-progression costs included subsequent treatment for a subset of patients and terminal care costs prior to death. All costs were reported in 2025 United States Dollars. Clinical data of overall response rate (ORR), progression-free survival, and overall survival were obtained from an indirect treatment comparison using MonumenTAL-1 (September 2024 data cut) and LocoMMotion/MoMMent (October 2022 and August 2023 data cuts) as data sources. Deterministic sensitivity analyses and scenario analyses were conducted to assess the robustness of model results.

RESULTS:

Over the 6-month period, the total cost of care was $179,556 for usual care, $295,993 for Tal QW, and $315,135 for Tal Q2W. Despite higher costs, Tal demonstrated superior ORR, resulting in lower cost per responder: $575,962 for usual care, $405,470 for Tal QW, and $443,165 for Tal Q2W, representing a 23-30% reduction in cost per responder with Tal. Sensitivity and scenario analyses showed consistent findings.

CONCLUSION:

Although Tal QW and Q2W are associated with higher total per-patient costs compared with usual care, they offer improved clinical effectiveness, resulting in lower cost per responder. These findings suggest greater economic value for Tal in the treatment of TCE RRMM.

2025-12-01·Cancer Medicine

Talquetamab‐Related Dysgeusia in Multiple Myeloma Compared to BCMA ‐Targeted Bispecifics and High‐Dose Melphalan

Article

作者: Götz Gelbrich ; Julia Mersi ; Hermann Einsele ; Jan H. Frenking ; Magdalena Roll ; Martin Kortüm ; Imad Maatouk ; Jessica Peter ; Leo Rasche ; Johannes Waldschmidt ; Christine Riedhammer ; Franziska Panther ; Anna Fleischer ; Patrick-Pascal Strunz ; Marc-S. Raab

ABSTRACT:

Background:

Dysgeusia is a side effect of the anti‐GPRC5DxCD3 bispecific antibody talquetamab (TAL), but other myeloma treatments, such as high‐dose melphalan (MEL) with autologous stem cell transplantation (ASCT), are also known to alter taste perception in patients with multiple myeloma (MM). This study investigates the spectrum, prevalence and severity of dysgeusia in patients receiving TAL and MEL and compares the results with anti‐BCMA bispecifics as a control for T‐cell‐engaging therapies.

Methods:

Gustatory and olfactory performance was assessed in 87 MM patients divided into three treatment groups: TAL ( n = 26), MEL/ASCT ( n = 35), and BCMA bispecifics ( n = 26). Evaluations included Taste Strips, Sniffin' Sticks Identification Test 16, and comprehensive questionnaires on taste perception, dietary issues, quality of life (QoL), mood, and treatment compliance.

Results:

TAL‐treated patients exhibited severe taste impairment, with 96.2% reporting marked declines. Taste alterations were also observed in patients receiving MEL/ASCT and BCMA bispecifics, though these were less pronounced, affecting 62.9% and 30.8% of cases, respectively. Xerostomia incidence was highest in the TAL group. Patients considering discontinuation of TAL (30%) cited taste alterations as the primary reason. MEL was associated with higher incidences of nausea, vomiting, and appetite loss.

Conclusion:

TAL‐associated taste disturbances have a major impact on patients and require further investigation and mitigation strategies. Enhanced patient support, proactive monitoring, and targeted interventions are critical to improving the well‐being and adherence of MM patients.

2025-06-01·CANCER SCIENCE

The Combination of PARP and Topoisomerase 1 Inhibitors Improves Radiation Therapy for Ewing Sarcoma

Article

作者: Ganguly, Debolina ; Sheppard, Heather ; Shelat, Anang A. ; Xie, Jia ; Gartrell, Jessica ; Kieffer, Matthew ; Cler, Samuel ; Federico, Sara M. ; Twarog, Nathaniel R. ; Atkinson, Stefan ; Bianski, Brandon ; Stewart, Elizabeth A. ; Blankenship, Kaley ; Tinkle, Christopher L. ; Mellado‐Lagarde, Marcia M.

ABSTRACT:

Although primary tumor control rates after surgery and/or radiation therapy (RT) are generally high in patients with Ewing sarcoma (EWS), those with unresectable tumors have failure rates approaching 30% and experience poorer outcomes. Additionally, although metastatic site irradiation is associated with improved survival, dose, and volume effects influence the long‐term toxicity risk. Consequently, it is important to identify novel systemic agents to enhance the therapeutic ratio of RT. Given the reported DNA damage response deficits in EWS, we hypothesized that PARP inhibitors (PARPis) would preferentially potentiate radiation relative to standard‐of‐care (SOC) chemotherapeutics. We investigated primary and recurrent SOC drugs and PARPis with varied trapping potential in combination with radiation in EWS cell lines. At physiologically relevant concentrations, the strong PARP trapper talazoparib (TAL) potentiated radiation to a greater extent than did SOC or other PARPis, although the magnitude of the effect was modest. The radiosensitizing effect of TAL was mediated through the induction of DNA double‐strand breaks, rather than through the catalytic inhibition of PARP1. Drug + RT combinations were further tested in vivo by using orthotopic xenograft models of EWS treated with image‐guided fractionated radiation. The addition of RT to the combination of TAL plus irinotecan (IRN), a recently evaluated clinical regimen for relapsed pediatric solid tumors, significantly prolonged survival and reduced tumor burden in all EWS‐treated mice. This triplet therapy (TAL + IRN + RT) was feasible and yielded responses in several patients with EWS and may represent a useful salvage strategy in recurrent or progressive disease.

项与 Talacotuzumab 相关的新闻（医药）

2024-03-12

·CPHI制药在线

阿斯利康入局！让众多MNC折戟的CD123到底有何魅力？

关注并星标CPHI制药在线近日，中国国家药监局药品审评中心（CDE）官网公示，阿斯利康（AstraZeneca）1类新药AZD9829获得临床试验默示许可，拟开发治疗CD123阳性恶性血液疾病。公开资料显示，AZD9829是一款靶向CD123的拓扑异构酶1抑制剂（TOP1i）-抗体偶联药物（ADC）。AZD9829是一种靶向CD123的抗体与阿斯利康专有的拓扑异构酶1抑制剂（TOP1i）有效载荷连接而成的ADC。该药的主要作用机制是将TOP1i载荷递送到表达CD123的癌细胞中，导致DNA损伤和细胞凋亡。研究表明，AZD9829在体外显示出对CD123阳性的AML细胞系的强大杀伤能力。此外，AZD9829在第一次给药后第28天表现出持久的白血病母细胞减少，包括血液和骨髓中白血病母细胞的减少。据ClinicalTrials官网显示，阿斯利康在美国刚开展一项1/2期临床研究，评估AZD9829单独或联合疗法治疗CD123阳性血液恶性肿瘤患者的安全性、耐受性、药代动力学和初步抗肿瘤活性。预计招募79人，2026年2月份公布研究数据。 CD123：血液肿瘤潜力靶点大多数细胞因子受体是由两个或两个以上的亚单位组成的异源二聚体或多聚体，通常包括一个特异性配体结合α链和一个参与信号的β链。α链构成低亲和力受体，β链一般单独不能与细胞因子结合，但参与高亲和力受体的形成和信号转导。IL-3R、IL-5R 和 GM-CSFR都属于这一类，且都作用于造血系统，促进造血干细胞或定向干细胞的增殖。其中IL-3R的α链被命名为CD123，它是一种跨膜糖蛋白，能够以单体的低亲和力与IL-3特异结合，当与IL-3R的β链（CD131）形成异二聚体时，可以形成高亲和力的IL-3受体复合物，并以通过细胞膜激活细胞内受体级联下游信号，进而激活JAK/STAT, RAS-MAPK和磷脂酰肌醇3-激酶通路。图片来源：参考来源3 同时CD123 在各种血液恶性肿瘤中广泛过度表达，包括急性髓性白血病 (AML)、B 细胞急性淋巴细胞白血病、毛细胞白血病、霍奇金淋巴瘤和母细胞性浆细胞样树突状肿瘤（BPDCN）。更为重要的是，CD123 在白血病干细胞 (LSC) 和分化程度更高的白血病母细胞均表达。虽然CD123也在正常的造血干细胞上表达，但其表达水平低于LSC，这使得 CD123 成为非常有吸引力的治疗靶点。靶向CD123药物开发接连受挫，诸多Big Pharma折戟沉沙 CD123在许多血液系统恶性肿瘤中过表达，主要在CD34+/CD38- AML细胞中过表达，且CD123过表达意味着患者预后不良。因为CD123本身作为肿瘤细胞表面的一个特异性标记物所存在的潜在开发价值，诸多Big Pharma围绕该靶点也做了很多新药开发尝试，但无一例外，这些新的靶向疗法初步尝试都遭受了临床挫折。强生就曾在CD123靶点上摔了两跤。Talacotuzumab是强生旗下公司杨森研发的一款CD123单克隆抗体药物。2021年，一项评估Talacotuzumab联合地西他滨在不适合强化化疗的老年急性髓系白血病（AML）患者中疗效的多中心2/3期临床研究结果显示：联合治疗的完全缓解率和总生存率并不高于单独使用地西他滨。此外，与单独使用地西他滨相比，talacotuzumab联合使用地西他滨的严重治疗相关不良事件更高因此，由于缺乏疗效和高毒性率，强生最终决定停止整个talacotuzumab研究计划。另外，强生和Genmab合作开发的CD123/CD3双特异抗体JNJ63709178也因发生一例严重毒副反应，临床试验被FDA全面叫停。 CD123/CD3双抗方面，诺华也曾高调入局，低调退出。2016年，诺华与Xencor签订高达26亿美元的合作协议，获得用于治疗急性髓系白血病 (AML)的CD123/CD3候选药物XmAb14045（vibecotamab）及用于治疗B细胞恶性肿瘤CD123/CD3候选药物XmAb13676的开发权利。但合作时间不足三年，诺华（2019 年1月）在战略管线重排后放弃了其中一种候选药物XmAb13676，并把该药的商业化和开发权交还给Xencor（2019年6月生效）。彼时，诺华并未完全退出这场交易，双方继续合作开发XmAb14045。但在2019年12月，由于在临床试验中出现的安全性问题（一例患者在首次给药后出现了细胞因子释放综合征（CRS），另一例患者在数次给药后出现了急性肺水肿），FDA暂停了XmAb14045的临床试验。随后一年，诺华还是选择终止了对该药物的临床开发。Xencor似乎也对该候选药物丧失开发信心，Xencor在公告中表示，将完全放弃该药物的开发，公司内部没有未来的研究计划。 CD123在研药物一览 Elzonris（tagraxofusp）是全球首个针对母细胞性浆细胞样树突细胞肿瘤（BPDCN）的治疗药物，也是首个获批的靶向CD123的药物。该药由人IL-3与截短的白喉毒素（DT）进行重组融合而成，其中IL-3结构域能够将细胞毒性DT片段引导至表达CD123的肿瘤细胞，在被肿瘤细胞内化后，不可逆地抑制蛋白质合成并诱导靶细胞凋亡。除了治疗BPDCN，Elzonris还将开发用于治疗其他CD123阳性适应症，包括：慢性骨髓单核细胞性白血病（CMML）、骨髓纤维化（MF）及其他适应症。在tagraxofusp被成功开发并上市的影响下，在过去十多年的时间里，将靶向 CD123 作为治疗 CD123 过度表达的血液系统恶性肿瘤（特别是AML）作为潜在策略的药物开发如火如荼。尽管多款药物在临床中遭遇了重创，但CD123靶点在血液瘤领域的热度却依然不低，尤其对于该靶点在双抗、ADC、CAR-T细胞疗法中的开发，近几年吸引不少药企和研发机构投入。部分在研靶向CD123 药物 APVO436是Aptevo Therapeutics研发的一种创新双特异性重组蛋白，它像两个单克隆抗体连接在一起，可以同时靶向肿瘤细胞表面的CD123和T淋巴细胞表面的CD3，从而将宿主免疫系统的T细胞重定向到患者的肿瘤细胞上，以快速和完全摧毁表面表达CD123的肿瘤细胞。APVO436经改造后可在血液循环中停留足够长的时间，以发现、结合并破坏白血病细胞。 APVO436与维奈托克（venetoclax）和阿扎胞苷联用，在针对急性髓系白血病（AML）患者的1b期剂量递增试验中取得了积极结果。结果显示，患者对该三联疗法的缓解率达82%（9/11），27%（3/11）的患者缓解充分，可继续接受干细胞移植。此外，在有缓解的患者中，有一名患者持续完全缓解达8个周期（方案允许的最长周期），这意味着缓解持续时间（DOR）至少为8个月。目前，中位DOR尚未达到。图片来源：Aptevo Therapeutics官网 IMGN632（Pivekimab sunirine）是ImmunoGen研发的一款靶向CD123的ADC，该药物使用一种新型吲吲哚啉类苯并二氮（IGN）载荷DGN549，它能在不交联的情况下对DNA进行烷基化，导致单链DNA损伤。正在开发用于母细胞性浆样树突细胞肿瘤（BPDCN）和AML，处于临床II期阶段。此前，该药物被FDA授予用于治疗复发/难治性BPDCN的突破性治疗资格。 IMGN632与阿扎胞苷(Vidaza)、维奈克拉 (venetoclax)联合用于新诊断(ND)急性髓性白血病(AML)患者1b/2期也取得了积极结果，并在第 65 届美国血液学会 (ASH) 年会上公布。具体数据显示，在总体人群中，CCR率为68% (34/50)，CR率为54%(27/50)，可评估患者中MRD阴性率为76%(22/29)。图片来源：ImmunoGen官网从上述CD123在研药物表格中不难发现，针对该靶点，目前更多研究机构及企业将目光放在了CAR-T细胞疗法上。鉴于CAR-T疗法近几年在血液肿瘤中的优异表现，该靶点也许能获得新的突破。尽管目前CD123 CAR-T细胞疗法的研发项目颇多，进展也还不错，但临床数据公布的还不多，无法对其进行更多预测。国内有福建医科大学研发的CD123/CLL1 CAR-T，一款双靶点CAR-T细胞疗法，目前处于治疗复发和难治性急性髓细胞白血病的II/III期临床研究阶段。结语总的来说，CD123这个靶点有点邪乎，虽然作为肿瘤细胞表面的一个特异性标记物具有潜在的开发价值，不过临床试验中出现的一系列的不良安全事件说明，CD123在正常组织中存在的些许表达仍可能仍是它的一个致命缺陷。Tagraxofusp药物的成功至少说明CD123是个可成药靶点，但开发相应的靶向药物仍是一个需要长时间待定的验证问题，期待该靶点药物早日取得突破性进展结果。参考来源： 1. 各企业官网 2. Michael J. Slade, Geoffrey Uy，CD123 bi-specific antibodies in development in AML: What do we know so far?Best Practice & Research Clinical Haematology (2020), doi: https://doi.org/10.1016/j.beha.2020.101219. 3. Hanadi El Achi et al，CD123 as a Biomarker in Hematolymphoid Malignancies: Principles of Detection and Targeted Therapies，Cancers 2020, 12, 3087 【智药研习社近期直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

抗体药物偶联物申请上市

2021-01-28

·生物制药小编

赛诺菲、MacroGenics等多家药企布局CD123双特异性抗体

CD123表达于造血干细胞，在血液肿瘤高表达，如母细胞性浆细胞样树突状细胞肿瘤(BPDCN)、急性髓系白血病(AML)、急性淋巴细胞白血病/淋巴瘤(ALL)、毛细胞白血病(HCL)、全身肥大细胞增生症(SM)等。 CD123在多种血液恶性肿瘤表达（文献4） CD123生物学 CD123包含三个胞外结构域（287氨基酸），一个跨膜结构域（30氨基酸），一个短的胞内结构域（53氨基酸）。 CD123是白细胞介素3受体(IL-3R)的α链， IL-3R是β共同受体家族成员。这种膜受体家族调节造血细胞的生长、增殖、存活和分化，以及免疫和炎症反应。白细胞介素3(IL-3)是一种可溶性和多向性细胞因子，调节造血和免疫细胞的功能。IL-3与配体特异性α亚基结合，与β亚基形成异二聚体。激活细胞内受体级联下游信号，进而激活JAK/STAT、Ras-MAPK和磷脂酰肌醇3-激酶通路。 CD123结构及信号通路（文献4）靶向CD123药物相对于非肿瘤造血干细胞，CD123在白血病干细胞中的表达上调，使其成为血液恶性肿瘤中有用的诊断和治疗生物标志物。CD123靶向治疗是一种很有前途的治疗方法。 CD123药物开发（文献4）双特异性抗体 CD123XCD3双抗药物及结构（文献3） Flotuzumab (MGD-006) 靶向CD123XCD3，采用MacroGenics的DART技术。临床研究 NCT02152956，Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)，Phase1/2 SAR440234（Sanofi-Aventis）靶向CD123XCD3，采用Cross-over dual variable (CODV)-Fab-TL技术。临床研究 NCT03594955，First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome，Phase1/2 JNJ-63709178（Jansen）靶向CD123XCD3，采用Hetero H, HL exchange IgG4 bispecific antibody。临床研究 NCT02715011，Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)，Phase1 APVO436（Aptevo）靶向CD123XCD3，采用了(scFv)4-Fc。临床研究 NCT03647800，Study of APVO436 in Patients With AML or MDS，phase1 Vibecotamab/XmAb14045（Xencor）靶向CD123XCD3，采用scFv-Fab。临床研究 NCT02730312，PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies，phase1 融合蛋白 Elzonris（tagraxofusp-erzs）由Stemline Therapeutics研发IL-3和白喉毒素(DT)融合蛋白，2018年12月21日FDA批准用于罕见血液肿瘤母细胞性浆细胞样树突状细胞肿瘤(BPDCN)，2021欧盟也批准了Elzonris用于BPDCNs。2020年意大利制药公司美纳里尼集团(Menarini Group)宣布以最高6.77亿美元的价格收购Stemline Therapeutic。单克隆抗体 Talacotuzumab/JNJ-56022473（Janssen）之前研发代码CSL362（CSL Limited），CD123中和抗体。在患者体内含有较多成熟NK细胞时，可以通过ADCC发挥杀伤作用。临床研究 NCT02472145，An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy，Phase2/3 小编总结单克隆抗体借助ADCC杀灭肿瘤，但是恶性血液病患者体内NK细胞通常数量少，功能弱，所以ADCC效应不强，临床获益不明显。所以赛诺菲，杨森等传统制药巨头和MacroGenics，Xencor等以双抗技术见长的新锐，都开发了CD123XCD3双特异性抗体，通过招募T细胞杀伤肿瘤细胞。参考文献 1.Barry, S.C.; Korpelainen, E.; Sun, Q.; Stomski, F.C.; Moretti, P.A.; Wakao, H.; D’Andrea, R.J.; Vadas, M.A.; Lopez, A.F.; Goodall, G.J. Roles of the N and C terminal domains of the interleukin-3 receptor alpha chain in receptor function. Blood 1997, 89, 842–852. 2.Frankel, A.E.; McCubrey, J.A.; Miller, M.S.; Delatte, S.; Ramage, J.; Kiser, M.; Kucera, G.L.; Alexander, R.L.; Beran, M.; Tagge, E.P.; et al. Diphtheria toxin fused to human interleukin-3 is toxic to blasts from patients with myeloid leukemias. Leukemia 2000, 14, 576–585 3.Michael J. Slade, Geoffrey Uy，CD123 bi-specific antibodies in development in AML: What do we know so far?Best Practice & Research Clinical Haematology (2020), doi: https://doi.org/10.1016/j.beha.2020.101219. 4.Hanadi El Achi et al，CD123 as a Biomarker in Hematolymphoid Malignancies: Principles of Detection and Targeted Therapies，Cancers 2020, 12, 3087 版权声明：本文转自生物制药小编，如不希望被转载的媒体或个人可与我们联系，我们将立即删除【关于药融圈】药融圈围绕我国生物医药产业链，针对生物医药大数据、技术和资本投资、药融园(产业园)等开展系列系统性工作，促进我国生物医药产业健康发展，完善产业链，共同面对全球合作和竞争。点分享点点赞点在看

抗体并购抗体药物偶联物

2017-10-17

·BioSpace

J&J Terminates Two Drugs From Pipeline

J&J Terminates RA and Leukemia Drug From Pipeline Buried in its third-quarter financial announcement, J&J indicated it was dropping two of its pipeline drugs with little or no explanation. Buried in its third-quarter financial announcement , Johnson & Johnson indicated it was dropping two of its pipeline drugs with little or no explanation. The company otherwise had plenty of good news. J&J announced sales of $19.7 billion for the quarter, up 10.3 percent compared to the same period last year. Operational sales increased 9.5 percent and domestic sales increased 9.7 percent. International sales grew 10.9 percent. When you exclude acquisitions and divestures, domestic and international sales each grew 3.8 percent. Deeper into the statement were two sentences: “The Company has made a decision not to pursue global approvals of sirukumab for the treatment of moderately to severely active rheumatoid arthritis. In addition, the clinical trial for talacotuzumab, an investigational compound being studied in patients with acute myeloid leukemia, has been discontinued.” John Carroll, writing for Endpoints News , said , “The writing was already on the wall months ago for sirukumab, once a top prospect for rheumatoid arthritis until its partners at GlaxoSmithKline suddenly walked out. Earlier this year, though, a panel of outside experts voted down the marketing application, fretting over an unexplained imbalance in deaths in the study. The inevitable formal rejection followed.” However, J&J dropping talacotuzumab (JNJ-56022473/CSL362) wasn’t expected. There’s no explanation for why the company gave up on it. Carroll notes that this news is undoubtedly unwelcome, because J&J “has been struggling on the revenue side, leaving some prominent analysts wondering if it can continue to grow pharma sales.” Joaquin Duato , J&J’s global chairman for pharmaceuticals, said in May that the company planned for its branded drug market to continue with a 5 percent annual growth rate through 2020, despite what executives always refer to as “stiff headwinds” on prices. It expected three drugs to be approved this year and four more next year. Carroll writes, “These new drugs were part of one leg of the company’s three-leg strategy for growing revenue, with a promise that it can improve significantly on existing drugs—like Stelara, Invokana and Xarelto—while beefing up on a new core focus on pulmonary arterial hypertension through the Actelion buyout.” J&J also revised its full-year forecast, largely on the basis of strong sales for new cancer drugs. The drugs, specifically Darzalex and Imbruvica, as well as high-margin drugs for rare diseases from its acquisition of Actelion, are expected to be the impetus for future growth. “We are convinced that the pharma pipeline remains robust and more meaningful contributions will kick in beyond 2017,” Joshua Jennings , an analyst with Cowen & Co. wrote in a note to clients. Although those areas are going strong, sales of Remicade for rheumatoid arthritis slowed as biosimilars for the drug hit the market. For its projections for 2017, it increased its profit forecast of $7.12 to $7.22 per share to $7.25 to $7.30 per share. It increased its revenue forecast from $75.8 billion to $76.1 billion to between $76.1 billion and $76.5 billion. HealthBlogger, with Seeking Alpha , writes , “I believe Johnson & Johnson is one of the best positioned companies in the pharmaceuticals space and worthy of long-term investment. However, I think some profit taking on the name would make sense at this time. In fact, after the strong performance in the last two months and a 19 percent move up year-to-date, a valuation check suggests that the risk/reward is much less compelling than a few months ago.”

并购财报临床失败

100 项与 Talacotuzumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14796

研发状态

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
急性髓性白血病	临床3期	美国	Janssen Research & Development LLC	2015-08-04
急性髓性白血病	临床3期	澳大利亚	Janssen Research & Development LLC	2015-08-04
急性髓性白血病	临床3期	比利时	Janssen Research & Development LLC	2015-08-04
急性髓性白血病	临床3期	法国	Janssen Research & Development LLC	2015-08-04
急性髓性白血病	临床3期	德国	Janssen Research & Development LLC	2015-08-04
急性髓性白血病	临床3期	以色列	Janssen Research & Development LLC	2015-08-04
急性髓性白血病	临床3期	波兰	Janssen Research & Development LLC	2015-08-04
急性髓性白血病	临床3期	俄罗斯	Janssen Research & Development LLC	2015-08-04
急性髓性白血病	临床3期	韩国	Janssen Research & Development LLC	2015-08-04
急性髓性白血病	临床3期	西班牙	Janssen Research & Development LLC	2015-08-04

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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


NCT03011034 (CTgov)	临床2期	骨髓增生异常综合征	34	Talacotuzumab (Talacotuzumab)	遞選窪鬱製觸淵衊蓋餘 = 構膚窪憲鬱鑰衊選糧艱夢顧製醖繭淵艱衊積齋 (獵廠鹹醖膚鏇網醖鹹範, 廠遞淵願淵艱鏇遞願夢 ~ 襯鏇鹽觸網鬱壓願積願) 更多	-	2020-03-13
				Daratumumab (Daratumumab)	遞選窪鬱製觸淵衊蓋餘 = 襯膚艱遞簾繭築艱繭鏇夢顧製醖繭淵艱衊積齋 (獵廠鹹醖膚鏇網醖鹹範, 願選鏇繭積蓋積艱膚壓 ~ 艱夢衊網餘鬱範艱願衊) 更多
NCT02472145 (CTgov)	临床2/3期	急性髓性白血病	326	Decitabine (Part B: Decitabine (Alone))	繭餘範觸醖蓋窪積憲膚 = 鹽醖糧觸膚餘築鬱壓齋壓艱夢鏇鹹鏇鬱鑰繭構 (廠蓋構遞鑰餘鏇艱餘鏇, 鬱繭窪鬱艱餘廠膚遞艱 ~ 簾憲艱範夢積憲鏇選構) 更多	-	2019-02-28
				Decitabine+JNJ-56022473 (Part B: Decitabine + JNJ-56022473)	繭餘範觸醖蓋窪積憲膚 = 積廠蓋網築衊糧積襯遞壓艱夢鏇鹹鏇鬱鑰繭構 (廠蓋構遞鑰餘鏇艱餘鏇, 願鑰築廠繭廠網襯製鹽 ~ 鹽壓襯鏇獵願獵獵衊網) 更多