The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease.
BV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer.

开始日期2024-04-17

申办/合作机构

Memorial Sloan Kettering Cancer Center

[+1]

NCT06343948 / Not yet recruiting临床3期

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer After Failure of at Least One Prior Line of Chemotherapy

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+HER2- breast cancer after failure of at least one prior line of chemotherapy.

开始日期2024-04-01

申办/合作机构

四川百利药业有限责任公司

[+1]

NCT06023641 / Recruiting临床1/2期IIT

A Protocol for the Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease

This is a phase I-II study to determine safety and efficacy of combining liposomal irinotecan with vincristine alternating with VAC in intermediate-risk patients, liposomal irinotecan with temozolomide and vincristine alternating with VAC in high-risk patients and the chemotherapy combinations when given with concomitant radiation therapy in intermediate and high risk patients.
Primary Objective
The primary objective of the Phase I part is to estimate the maximum tolerated doses (MTDs) and recommended Phase II doses (RP2Ds) of combining liposomal irinotecan with vincristine alternating with VAC in intermediate-risk patients, liposomal irinotecan with temozolomide and vincristine alternating with VAC in high-risk patients and the chemotherapy combinations when given with concomitant radiation therapy in intermediate and high risk patients.
Estimate event-free survival for intermediate-risk participants treated with VAC and vincristine and liposomal irinotecan (VLI) with the addition of maintenance therapy with vinorelbine and cyclophosphamide.
Estimate the event-free survival for high-risk patients treated with VAC and vincristine, liposomal irinotecan, and temozolomide with the addition of maintenance therapy with vinorelbine and cyclophosphamide.
Estimate the local recurrence rate for unresected intermediate- and high-risk patients with initial tumor size with ≥5 cm randomized to between 59.4 GyRBE and 68 GyRBE total proton radiation dose while receiving VAC/VLI (intermediate-risk) or VAC/VLI plus temozolomide (high-risk) and maintenance therapy.
Secondary Objectives
To assess the relation between pharmacogenetic variation in CEP72 genotype and vinca alkaloid (vincristine; vinorelbine) disposition in children with rhabdomyosarcoma.
To assess the relation between the pharmacogenetic variation in drug metabolizing enzymes and drug transporters, and the pharmacokinetics of vinca alkaloids, liposomal irinotecan, and cyclophosphamide in children with rhabdomyosarcoma.
To assess the extent of inter-patient variability in the pharmacokinetics of vinca alkaloids, liposomal irinotecan, and cyclophosphamide in children with rhabdomyosarcoma, and explore possible associations between drug disposition and patient specific covariates (e.g., age, sex, race, weight).
Estimate the cumulative incidence of local recurrence in patients with low-risk disease treated with either no adjuvant radiation or minimal volume radiation.

开始日期2024-03-01

申办/合作机构

St. Jude Children's Research Hospital, Inc.

100 项与长春瑞滨双酒石酸盐相关的临床结果

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100 项与长春瑞滨双酒石酸盐相关的转化医学

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100 项与长春瑞滨双酒石酸盐相关的专利（医药）

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4,145

项与长春瑞滨双酒石酸盐相关的文献（医药）

2024-04-01·Current Medicinal Chemistry

Construction of RNA Methylation Modification-immune-related lncRNA Molecular Subtypes and Prognostic Scoring System in Lung Adenocarcinoma

Article

作者: Wang, Jiajing ; Shu, Jianfeng

Background::

RNA methylation modification is not only intimately interrelated with cancer development and progression but also actively influences immune cell infiltration in the tumor microenvironment (TME). RNA methylation modification genes influence the therapeutic progression of lung adenocarcinoma (LUAD), and mining RNA methylation modification prognosis-related markers in LUAD is crucial for its precise prognosis.

Methods::

RNA-Seq data and Gene sets were collected from online databases or published literature. Genomic variation analysis was conducted by the Maftools package. RNA methylation-immune-related lncRNAs were obtained by Pearson correlation analysis. Then, Consistent clustering analysis was performed to obtain RNA methylation modification- immune molecular subtypes (RMM-I Molecular subtypes) in LUAD based on selected lncRNAs. COX and random survival forest analysis were carried out to construct the RMM-I Score. The receiver operating characteristic (ROC) curve and Kaplan Meier survival analysis were used to assess survival differences. Tumor immune microenvironment was assessed through related gene signatures and CIBERSORT algorithm. In addition, drug sensitivity analysis was executed by the pRRophetic package.

Results::

Four RNA methylation modified-immune molecular subtypes (RMM-I1, RMM- I2, RMM-I3, RMM-I4) were presented in LUAD. Patients in RMM-I4 exhibited excellent survival advantages and immune activity. HAVCR2, CD274, and CTLA-4 expression were activated in RMM-I4, which might be heat tumors and a potential beneficial group for immunotherapy. OGFRP1, LINC01116, DLGAP1-AS2, CRNDE, LINC01137, MIR210HG, and CYP1B1-AS1 comprised the RMM-I Score. The RMM-I Score exhibited excellent accuracy in the prognostic assessment of LUAD, as patients with a low RMM- I Score exhibited remarkable survival advantage. Patients with a low RMM-I score might be more sensitive to treatment with Docetaxel, Vinorelbine, Paclitaxel, Cisplatin, and immunotherapy.

Conclusion::

The RMM-I molecular subtype constituted the novel molecular characteristic subtype of LUAD, which complemented the existing pathological typing. More refined and accurate molecular subtypes provide help to reveal the mechanism of LUAD development. In addition, the RMM-I score offers a reliable tool for accurate prognosis of LUAD.

Infection

Clinical and immunological outcomes of SARS-CoV-2-infected vaccine responders, vaccine non-responders, and unvaccinated patients evaluated for neutralizing monoclonal antibody treatment at a single German tertiary care center: a retrospective cohort study with prospective follow-up

Article

作者: Wagner, L ; Willmann, A ; Jeske, S D ; Rothe, K ; Pernpeintner, V ; Erber, J ; Vogel, E ; Hoffmann, D ; Iakoubov, R ; Spinner, C D ; Minic, M ; Strauß, E-M ; Protzer, U ; Schneider, J ; Christa, C ; Triebelhorn, J ; Berthele, A ; Voit, F ; Renders, L

Abstract:

Purpose:

This study assessed the clinical and immunological outcomes of SARS-CoV-2-infected patients with risk factors for severe disease depending on their immunological status.

Methods:

In this retrospective study with single follow-up visit, clinical outcome and humoral immunity was monitored in SARS-CoV-2 infected patients at risk. The results were compared based on the patients’ initial immunological status: unvaccinated (UV), patients who did not develop neutralizing antibodies after vaccination (vaccine non-responders, VNR), and patients who expressed neutralizing antibodies after vaccination (vaccine responders, VR). Patients who lacked neutralizing antibodies (VNR and UV) were treated with nMABs.

Results:

In total, 113 patients at risk of severe COVID-19 consented to participate in the study. VR and UV were not admitted to the hospital. During the observation period, UVs had the highest rate of SARS-CoV-2 re-infections. Three of 41 VNRs (7.3%) were hospitalized due to severe COVID-19, with two of them having undergone iatrogenic B-cell depletion. The humoral immune response after infection was significantly lower in the VNR group than in the VR group in terms of anti-N, anti-receptor-binding domain (RBD), anti-S antibody titers, and anti-S antibody avidity. In a sub-analysis of VNR, B cell-deficient non-responders had significantly lower levels of anti-N antibodies and anti-S avidity after infection than other VNRs.

Conclusion:

VNR, particularly B-cell-depleted VNR, remained at risk of hospitalization due to COVID-19. In the VR group, however, no clinical complications or severe disease were observed, despite not receiving nMAbs. Tailoring the administration of nMABs according to patient vaccination and immunological status may be advisable.

Aging

Risk model based on genes regulating the response of tumor cells to T-cell-mediated killing in esophageal squamous cell carcinoma

Article

作者: Zhang, Yanhui ; Yu, Chuting ; Wang, Wei ; Wang, Luo-Wei ; Bian, Yan ; Lin, Han ; Tian, Bo ; Zhou, Siwei ; Zhang, Xun

Immune checkpoint inhibitors (ICIs) represent a promising therapeutic approach for esophageal squamous cell carcinoma (ESCC). However, the subpopulations of ESCC patients expected to benefit from ICIs have not been clearly defined. The anti-tumor cytotoxic activity of T cells is an important pharmacological mechanism of ICIs. In this study, the prognostic value of the genes regulating tumor cells to T cell-mediated killing (referred to as GRTTKs) in ESCC was explored by using a comprehensive bioinformatics approach. Training and validation datasets were obtained from The Cancer Genome Atlas (TCGA) and Gene Expression Omnibus (GEO), respectively. A prognostic risk scoring model was developed by integrating prognostic GRTTKs from TCGA and GEO datasets using a ridge regression algorithm. Patients with ESCC were divided into high- and low-risk groups based on eight GRTTKs (EIF4H, CDK2, TCEA1, SPTLC2, TMEM209, RGP1, EIF3D, and CAPZA3) to predict overall survival in the TCGA cohort. Using Kaplan-Meier curves, receiver operating characteristic curves, and C-index analysis, the high reliability of the prognostic risk-scoring model was certified. The model scores served as independent prognostic factors, and combining clinical staging with risk scoring improved the predictive value. Patients in the high-risk group exhibited abundant immune cell infiltration, including immune checkpoint expression, antigen presentation capability, immune cycle gene expression, and high tumor inflammation signature scores. The high-risk group exhibited a greater response to immunotherapy and neoadjuvant chemotherapy than the low-risk group. Drug sensitivity analysis demonstrated lower IC50 for AZD6244 and PD.0332991 in high-risk groups and lower IC50 for cisplatin, ATRA, QS11, and vinorelbine in the low-risk group. Furthermore, the differential expression of GRTTK-related signatures including CDK2, TCEA1, and TMEM209 were verified in ESCC tissues and paracancerous tissues. Overall, the novel GRTTK-based prognostic model can serve as indicators to predict the survival status and immunotherapy response of patients with ESCC, thereby providing guidance for the development of personalized treatment strategies.

项与长春瑞滨双酒石酸盐相关的新闻（医药）

2024-04-09

·精准药物

南方医科大学发现胃癌治疗新策略

本文为转化医学网原创，转载请注明出处作者：Jerry导读：胃癌(GC)包含癌干细胞(CSCs)亚群，被认为是肿瘤发生和转移的主要因素。有必要阐明CSCs表型的分子机制，并开发新的胃癌生物标志物和治疗靶点。4月4日，南方医科大学研究团队在期刊《Cell Death&Disease》上发表了研究论文，题为“POLQ inhibition attenuates the stemness and ferroptosis resistance in gastric cancer cells via downregulation of dihydroorotate dehydrogenase”。本研究表明，POLQ抑制剂和铁死亡诱导剂的联合作用协同杀死胃癌CSCs，从而为胃癌治疗提供了一种新的策略。https://www.nature.com/articles/s41419-024-06618-5#Sec24研究背景 01 胃癌(GC)是全球第五大恶性肿瘤和第四大致死性癌症，治疗策略包括手术、化疗或免疫治疗。然而，高比例的GC患者最终会复发，导致整体5年生存率仅为20-30%。癌症干细胞(CSCs)是一小群具有干细胞样特性的癌细胞，已被认为是肿瘤复发、转移和耐药的根源。因此，明确CSCs表型的分子机制，并开发新的胃癌生物标志物和治疗靶点非常迫切和必要。铁死亡是一种由过度脂质过氧化引起的细胞死亡形式，最近成为一种重要的肿瘤抑制机制。谷胱甘肽过氧化物酶4(GPX4)、铁死亡抑制蛋白1(FSP1)和二氢乳清酸脱氢酶(DHODH)构成了铁死亡的三个主要防御系统。虽然癌细胞通常具有较高的ROS水平，这对于肿瘤进展至关重要，如迁移、增殖和生存，而CSCs被认为具有较低的ROS水平。最近研究报道，癌干细胞可以通过上调抗氧化反应来逃避铁死亡。研究进展 02 研究人员评估了药理学POLQ抑制在胃癌细胞干性和铁死亡敏感性方面的治疗潜力。证据表明，铁死亡通过限制癌细胞在血液中的生存来抑制转移。为了确定抑制POLQ是否可以通过增加铁死亡来减少转移负担，研究人员采用了尾静脉转移模型。在尾静脉注射后，小鼠被给予生理盐水、NVB或联合利普司他丁-1治疗。经过4周的治疗，NVB减少了MGC-803细胞的肺转移，利普司他丁-1有效地挽救了这一效果。因此，通过药理学抑制POLQ可能是一种潜在的策略，以通过使癌细胞对铁死亡敏感来对抗转移性疾病。由于药物抑制POLQ会减弱胃癌细胞的干性，并使胃癌对铁死亡敏感，因此研究人员进一步研究了在体内联合使用POLQ抑制剂和铁死亡诱导剂治疗胃癌的治疗潜力。研究人员采用皮下异种移植模型和腹腔内成瘤模型进行了动物实验。对于皮下异种移植模型，联合使用POLQ抑制剂和抑制SLC7A11的铁死亡诱导剂柳氮磺吡啶，协同抑制了MGC-803异种移植瘤的生长。在移植瘤组织中，NVB和柳氮磺吡啶联合治疗显著抑制了Ki67和DHODH的表达，并增加了4HNE的表达，但对照组和单独使用柳氮磺吡啶治疗的肿瘤组织中没有这种现象。此外，NVB和柳氮磺吡啶联合治疗增加了PTGS2的mRNA表达。尽管差异没有统计学意义，但可以观察到，在NVB治疗的肿瘤组织中，干性标志物CD24和CD44的mRNA表达降低(P = 0.0687;P = 0.0796)。在所有这些动物研究中，药物治疗对动物体重没有显著影响，这表明该治疗在体内是可耐受的。在腹腔内成瘤模型中，每只小鼠的右下腹腔内注射500万MGC-803细胞，经过两周的治疗后，联合使用POLQ抑制剂和柳氮磺吡啶治疗降低了腹腔侵袭。总之，研究结果表明，POLQ抑制剂和柳氮磺吡啶联合使用是一种潜在的治疗胃癌的药物。柳氮磺吡啶联合抑制POLQ有效促进胃癌的治疗研究结论 03总之，本研究结果确定了一种通过调节E2F4-DHODH轴的POLQ介导的干性和铁死亡防御机制。这项工作表明，POLQ抑制剂和铁死亡诱导剂的联合作用协同杀死胃癌CSCs，从而为胃癌提供了一种新的治疗策略。参考资料：https://www.nature.com/articles/s41419-024-06618-5#Sec24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↓

免疫疗法CSCO会议

2024-04-08

·今日头条

协同抗肿瘤！南方医科大学发文：发现胃癌治疗新策略

本文为转化医学网原创，转载请注明出处作者：Jerry 导读：胃癌(GC)包含癌干细胞(CSCs)亚群，被认为是肿瘤发生和转移的主要因素。有必要阐明CSCs表型的分子机制，并开发新的胃癌生物标志物和治疗靶点。 4月4日，南方医科大学研究团队在期刊《Cell Death&Disease》上发表了研究论文，题为“POLQ inhibition attenuates the stemness and ferroptosis resistance in gastric cancer cells via downregulation of dihydroorotate dehydrogenase”。本研究表明，POLQ抑制剂和铁死亡诱导剂的联合作用协同杀死胃癌CSCs，从而为胃癌治疗提供了一种新的策略。 https://www.nature.com/articles/s41419-024-06618-5#Sec24 研究背景 01 胃癌(GC)是全球第五大恶性肿瘤和第四大致死性癌症，治疗策略包括手术、化疗或免疫治疗。然而，高比例的GC患者最终会复发，导致整体5年生存率仅为20-30%。癌症干细胞(CSCs)是一小群具有干细胞样特性的癌细胞，已被认为是肿瘤复发、转移和耐药的根源。因此，明确CSCs表型的分子机制，并开发新的胃癌生物标志物和治疗靶点非常迫切和必要。铁死亡是一种由过度脂质过氧化引起的细胞死亡形式，最近成为一种重要的肿瘤抑制机制。谷胱甘肽过氧化物酶4(GPX4)、铁死亡抑制蛋白1(FSP1)和二氢乳清酸脱氢酶(DHODH)构成了铁死亡的三个主要防御系统。虽然癌细胞通常具有较高的ROS水平，这对于肿瘤进展至关重要，如迁移、增殖和生存，而CSCs被认为具有较低的ROS水平。最近研究报道，癌干细胞可以通过上调抗氧化反应来逃避铁死亡。研究进展 02 研究人员评估了药理学POLQ抑制在胃癌细胞干性和铁死亡敏感性方面的治疗潜力。证据表明，铁死亡通过限制癌细胞在血液中的生存来抑制转移。为了确定抑制POLQ是否可以通过增加铁死亡来减少转移负担，研究人员采用了尾静脉转移模型。在尾静脉注射后，小鼠被给予生理盐水、NVB或联合利普司他丁-1治疗。经过4周的治疗，NVB减少了MGC-803细胞的肺转移，利普司他丁-1有效地挽救了这一效果。因此，通过药理学抑制POLQ可能是一种潜在的策略，以通过使癌细胞对铁死亡敏感来对抗转移性疾病。由于药物抑制POLQ会减弱胃癌细胞的干性，并使胃癌对铁死亡敏感，因此研究人员进一步研究了在体内联合使用POLQ抑制剂和铁死亡诱导剂治疗胃癌的治疗潜力。研究人员采用皮下异种移植模型和腹腔内成瘤模型进行了动物实验。对于皮下异种移植模型，联合使用POLQ抑制剂和抑制SLC7A11的铁死亡诱导剂柳氮磺吡啶，协同抑制了MGC-803异种移植瘤的生长。在移植瘤组织中，NVB和柳氮磺吡啶联合治疗显著抑制了Ki67和DHODH的表达，并增加了4HNE的表达，但对照组和单独使用柳氮磺吡啶治疗的肿瘤组织中没有这种现象。此外，NVB和柳氮磺吡啶联合治疗增加了PTGS2的mRNA表达。尽管差异没有统计学意义，但可以观察到，在NVB治疗的肿瘤组织中，干性标志物CD24和CD44的mRNA表达降低(P = 0.0687;P = 0.0796)。在所有这些动物研究中，药物治疗对动物体重没有显著影响，这表明该治疗在体内是可耐受的。在腹腔内成瘤模型中，每只小鼠的右下腹腔内注射500万MGC-803细胞，经过两周的治疗后，联合使用POLQ抑制剂和柳氮磺吡啶治疗降低了腹腔侵袭。总之，研究结果表明，POLQ抑制剂和柳氮磺吡啶联合使用是一种潜在的治疗胃癌的药物。柳氮磺吡啶联合抑制POLQ有效促进胃癌的治疗研究结论 03 总之，本研究结果确定了一种通过调节E2F4-DHODH轴的POLQ介导的干性和铁死亡防御机制。这项工作表明，POLQ抑制剂和铁死亡诱导剂的联合作用协同杀死胃癌CSCs，从而为胃癌提供了一种新的治疗策略。参考资料： https://www.nature.com/articles/s41419-024-06618-5#Sec24 注：本文旨在介绍医学研究进展，不能作为治疗方案参考。如需获得健康指导，请至正规医院就诊。热门·直播/活动 🕓 上海｜06月14日-16日 ▶ 第六届上海国际癌症大会将于6月14-16日在上海举办，学科交叉，共同推进肿瘤研究与诊治多模态！ 🕓 北京｜09月20日-21日 ▶ 第五届单细胞技术应用研讨会暨空间组学前沿研讨会欢迎您的参与！点击对应文字查看详情

CSCO会议免疫疗法

2024-04-02

·BioSpace

Datopotamab Deruxtecan Biologics License Application Accepted in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

Application based on results from the TROPION-Breast01 phase 3 trial Additional BLA under review in the U.S. for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan for patients with advanced nonsquamous non-small cell lung cancer TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)-- Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or metastatic disease. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca. The Prescription Drug User Fee Act (PDUFA) date, the U.S. Food and Drug Administration (FDA) action date for its regulatory decision, is January 29, 2025. The BLA is based on results from the pivotal TROPION-Breast01 phase 3 trial, which were presented at a Presidential Symposium at the European Society for Medical Oncology (#ESMO23) 2023 Congress and in an oral presentation at the 2023 San Antonio Breast Cancer Symposium (#SABCS23). In the trial, datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoint of progression-free survival (PFS) compared to investigator’s choice of chemotherapy in patients with unresectable or metastatic HR positive, HER2 negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. For the dual primary endpoint of overall survival (OS), interim results numerically favored datopotamab deruxtecan over chemotherapy but were not mature at the time of data cut-off. The trial is ongoing and OS will be assessed at future analyses. The safety pro datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified. The most common grade 3 or higher treatment-related adverse events in the datopotamab deruxtecan and chemotherapy arms, respectively, were neutropenia (1% vs. 31%), stomatitis (6% vs. 3%), fatigue (2% vs. 2%) and anemia (1% vs. 2%). “The FDA’s acceptance of the BLA brings us closer to providing patients with previously treated HR positive, HER2 negative breast cancer an alternative option to conventional chemotherapy earlier in the metastatic setting,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Following our recently accepted application for advanced nonsquamous non-small cell lung cancer in the U.S., along with additional regulatory reviews underway in China, the EU, Japan and other regions, we are working swiftly to bring datopotamab deruxtecan as a potential new treatment option to patients around the world.” “Despite marked progress in the treatment of HR positive, HER2 negative breast cancer, most patients with advanced disease develop endocrine resistance and face the prospect of one or several lines of chemotherapy,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “If approved, datopotamab deruxtecan has the potential to provide these patients an efficacious and better tolerated alternative to conventional chemotherapy.” An additional BLA for datopotamab deruxtecan based on results from the pivotal TROPION-Lung01 phase 3 trial is under review in the U.S. for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally. About TROPION-Breast01 TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one additional systemic therapy for unresectable or metastatic disease. The dual primary endpoints of TROPION-Breast01 are PFS as assessed by blinded independent central review and OS. Key secondary endpoints include objective response rate, duration of response, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. TROPION-Breast01 enrolled more than 700 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov. About Hormone Receptor Positive, HER2 Negative Breast Cancer More than 275,000 breast cancer cases were diagnosed in the U.S. in 2022.1 HR positive, HER2 negative breast cancer is the most common subtype, accounting for more than 65% of diagnosed cases.2 Breast cancer is considered HR positive, HER2 negative when tumors test positive for estrogen and/or progesterone hormone receptors and negative for HER2 (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2,3 Standard initial treatment for this subtype of breast cancer is endocrine therapy but most patients with advanced disease will develop resistance, underscoring the need for additional options.4,5 TROP2 is a protein broadly expressed in HR positive, HER2 negative breast cancer and is associated with increased tumor progression and poor survival.6,7 About Datopotamab Deruxtecan (Dato-DXd) Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, datopotamab deruxtecan is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple negative breast cancer and HR positive, HER2 negative breast cancer. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan. About the DXd ADC Portfolio of Daiichi Sankyo The DXd ADC portfolio of Daiichi Sankyo currently consists of six ADCs in clinical development across multiple types of cancer. ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan, a TROP2 directed ADC, are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc., Rahway, N.J. USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan and DS-3939 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit . References: 1 World Health Organization. Global Cancer Observatory: United States of America. Accessed April 2024. 2 National Cancer Institute. SEER cancer stat facts: female breast cancer subtypes. Accessed April 2024. 3 Iqbal N, et al. Mol Biol Int. 2014;852748. 4 Lin M, et al. J Cancer. 2020; 10.7150/jca.48944. 5 Lloyd MR, et al. Clin Cancer Res. 2022;28(5):821-30. 6 Goldenberg D, et al. Oncotarget. 2018;9(48): 28989-29006. 7 Vidula N, et al. Breast Cancer Res Treat. 2022 Aug;194(3):569-575. View source version on businesswire.com: Contacts Media: Global/US: Jennifer Brennan Daiichi Sankyo, Inc. jbrennan2@dsi.com +1 908 900 3183 (mobile) Japan: Daiichi Sankyo Co., Ltd. DS-PR@daiichisankyo.co.jp Investor Relations: DaiichiSankyoIR@daiichisankyo.co.jp Source: Daiichi Sankyo, Inc. View this news release online at:

临床3期引进/卖出临床结果抗体药物偶联物

100 项与长春瑞滨双酒石酸盐相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01935	长春瑞滨双酒石酸盐	L01CA04	DB00361

研发状态

适应症	最高研发状态	国家/地区	公司
非小细胞肺癌	批准上市	中国更多	-
转移性乳腺癌	临床2期	意大利更多	Istituto Europeo di Oncologia SRL 更多
难治性霍奇金淋巴瘤	终止	美国更多	University of Miami 更多
小儿横纹肌肉瘤	无进展	澳大利亚更多	National Cancer Institute 更多
小泡型横纹肌肉瘤	无进展	新西兰更多	National Cancer Institute 更多

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临床结果

适应症

分期

评价

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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


NCT03321981 (CTgov)	临床2期	ER阳性乳腺癌 \| HER2阳性乳腺癌 \| 转移性乳腺癌	105	Trastuzumab+Zenocutuzumab (Cohort 1 Doublet)	壓壓積壓鏇壓鹹鹹壓願(鬱簾艱衊遞選獵窪構繭) = 鹹遞網築網構齋繭範醖膚積鬱淵艱衊獵糧窪網 (壓簾糧願蓋鏇願衊廠範, 蓋構淵範餘鏇選鏇鹽選 ~ 繭淵襯遞廠構網顧鏇獵) 更多	-	2024-03-07
				Trastuzumab+Zenocutuzumab+Vinorelbine (Cohort 1 Triplet)	壓壓積壓鏇壓鹹鹹壓願(鬱簾艱衊遞選獵窪構繭) = 餘蓋鬱窪積襯蓋蓋餘觸膚積鬱淵艱衊獵糧窪網 (壓簾糧願蓋鏇願衊廠範, 範築廠繭艱繭願鑰糧壓 ~ 膚蓋簾選選廠範積構積) 更多
NCT02954055 (CTgov)	临床2期	晚期乳腺癌 \| ER阳性/HER2阴性乳腺癌	140	Paclitaxel (Arm A)	蓋艱繭製蓋鑰簾範醖觸(鹽願願醖憲簾衊齋簾願) = 鹹膚願鹽衊選壓鑰簾遞製觸鹹構齋膚襯襯廠餘 (餘鹽夢鑰範獵鬱願積廠, 膚鏇餘醖鏇簾蓋選遞範 ~ 憲齋壓鏇簾願衊構築膚) 更多	-	2024-02-26
				CYCLOPHOSPHAMIDE+Vinorelbine+Capecitabine (Arm B)	蓋艱繭製蓋鑰簾範醖觸(鹽願願醖憲簾衊齋簾願) = 製齋醖積選壓範範簾築製觸鹹構齋膚襯襯廠餘 (餘鹽夢鑰範獵鬱願積廠, 廠夢構憲齋淵糧鏇窪願 ~ 簾選製餘淵製廠網築積) 更多
NCT02709720 (CTgov)	临床2期	非小细胞肺癌 \| 局部晚期肺癌	68	Vinorelbine+Cisplatin	憲憲築顧蓋壓糧艱衊夢(淵積齋觸獵糧築獵糧鏇) = 鏇蓋鑰顧製膚構鏇繭顧獵壓糧窪壓廠襯衊選鏇 (獵襯鹽鹹夢獵簾襯壓鹹, 獵選願廠襯餘顧顧窪製 ~ 夢築鹽構鬱鏇築範夢範) 更多	-	2024-01-11
ESMO2023 人工标引	N/A	HER2阳性转移性乳腺癌二线 HER2 positive	89	Vinorelbine + Inetetamab + Pyrotinib	膚膚簾範壓廠鏇廠願蓋(糧鬱觸衊簾鑰繭蓋齋積) = 餘艱醖糧壓範廠鏇衊鹽鹽鹹願鹹壓夢齋糧鏇齋 (醖襯鬱糧築鏇夢製選糧 )	积极	2023-10-21
				Vinorelbine + Inetetamab + Pyrotinib (second-line treatment)	積顧衊齋獵積願糧鬱憲(醖齋糧衊獵網膚淵構選) = 網廠鹹築範鹽遞製蓋憲繭觸願窪憲膚遞網衊鏇 (遞糧糧鏇繭齋鏇鑰積鬱 ) 更多
NCT00574496 (CTgov)	临床2期	复发性经典霍奇金淋巴瘤	25	allogeneic hematopoietic stem cell transplantation+vinorelbine tartrate+ifosfamide+mycophenolate mofetil+methotrexate+procarbazine hydrochloride+cyclosporine+fludarabine phosphate+Cyclophosphamide+mechlorethamine hydrochloride+prednisone+melphalan+gemcitabine hydrochloride+vincristine sulfate	築鹹範淵鏇壓簾醖構願(憲壓鹹鏇鹹繭選鏇餘築) = 衊鑰範顧鹽衊蓋範憲窪鏇艱廠鑰範淵淵鑰觸網 (蓋遞淵糧顧鹹壓簾鬱獵, 鏇淵廠膚壓鑰鬱鑰願顧 ~ 繭構艱願鬱築構鏇遞觸) 更多	-	2023-09-28
Pubmed	临床2期	转移性乳腺癌二线	29	Dual oral metronomic vinorelbine and capecitabine regimen	窪艱廠遞艱齋襯鏇簾鏇(餘窪鹹顧淵選艱簾構積) = 齋觸襯鹹遞構積鬱製鏇窪糧繭構觸鏇艱構願襯 (範衊醖積廠積構醖鑰窪 ) 更多	-	2023-07-04
ChiCTR2100049487 (ASCO2023) 人工标引	临床2期	晚期非小细胞肺癌一线	12	metronomic oral vinorelbine+Camrelizumab	艱餘艱壓鬱衊廠艱艱襯(觸淵襯觸淵獵鬱構糧顧) = 窪網膚糧願願鹹壓積獵觸艱網積膚糧鬱夢衊襯 (獵願膚壓範壓積醖鏇餘, 3.9 ~ 14.7) 更多	积极	2023-05-31
ESMO_ELCC2023	临床2期	转移性非小细胞肺癌	247	Oral Vinorelbine	襯願願觸廠襯簾餘築構(蓋構鏇衊鹽構製衊選鏇) = 鹽構膚齋夢繭繭壓獵觸鬱糧選餘齋窪襯顧願獵 (鹹衊齋憲鹽糧選鑰夢觸, 51.1; 63.7) 更多	-	2023-03-31
NCT03414658 (AVIATOR/TBCRC045, SABCS2023)	临床2期	HER2阳性转移性乳腺癌 PD-L1 \| TIL	100	NH	鏇衊願夢簾憲廠廠網觸(網壓鑰鬱餘餘壓範鏇餘) = 淵糧衊廠遞鏇鬱糧願鏇鬱網選膚膚襯壓蓋構繭 (築製簾醖廠選壓鏇餘簾, 0.37 ~ 0.86)	积极	2023-03-01
				NHA	鏇衊願夢簾憲廠廠網觸(網壓鑰鬱餘餘壓範鏇餘) = 範壓簾簾觸襯觸簾憲鑰鬱網選膚膚襯壓蓋構繭 (築製簾醖廠選壓鏇餘簾 )
ESMO_ASIA2022	N/A	晚期肺腺癌一线	105	icotinib	艱艱鬱獵襯糧醖網醖選(願夢艱鏇鏇製範構窪艱) = 鹹顧積餘顧網淵壓艱壓顧願鹽簾蓋憲範鬱構壓 (觸遞憲膚壓糧獵鏇願網 )	-	2022-12-03
				icotinib plus vinorelbineicotinib plus vinorelbine	艱艱鬱獵襯糧醖網醖選(願夢艱鏇鏇製範構窪艱) = 簾淵壓繭簾遞顧觸淵齋顧願鹽簾蓋憲範鬱構壓 (觸遞憲膚壓糧獵鏇願網 )