A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)

This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS <1 gastric or GEJ cancer.

开始日期2025-02-27

申办/合作机构

Daiichi Sankyo Co., Ltd.

[+1]

NCT06686394

/ Recruiting临床1/2期

HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn:
* About the safety and how well people tolerate of patritumab deruxtecan
* How many people have the cancer respond (get smaller or go away) to treatment

开始日期2025-02-26

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

CTR20220458

/ Active, not recruiting临床3期

Trastuzumab Deruxtecan（T-DXd）单药或T-DXd序贯THP对比ddAC-THP用于高危HER2阳性早期乳腺癌受试者新辅助治疗的III期开放性试验（DESTINY-Breast11）

pCR（ypT0/Tis ypN0）：在HER2阳性EBC受试者中通过使用中心评估结果评价pCR（ypT0/Tis ypN0），证明新辅助T-DXd单药或序贯THP相比于ddAC-THP的优效性。

开始日期2022-06-21

申办/合作机构

阿斯利康投资（中国）有限公司

[+2]

100 项与曲妥珠单抗生物类似药(Synthon BV) 相关的临床结果

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100 项与曲妥珠单抗生物类似药(Synthon BV) 相关的转化医学

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项与曲妥珠单抗生物类似药(Synthon BV) 相关的文献（医药）

2025-05-01·LANCET ONCOLOGY

Chemotherapy-free neoadjuvant pembrolizumab combined with trastuzumab and pertuzumab in HER2-enriched early breast cancer (WSG-KEYRICHED-1): a single-arm, phase 2 trial

Article

作者: Ossowski, Stephan ; Gluz, Oleg ; Braun, Michael ; Kentsch, Angela ; Christgen, Matthias ; Depenbusch, Reinhard ; Biehl, Claudia ; Bartels, Stephan ; Reinisch, Mattea ; Armeanu-Ebinger, Sorin ; Harbeck, Nadia ; Schroeder, Christopher ; Ziske, Carsten ; Hilpert, Felix ; Scheffen, Iris ; Volk, Valery ; Blohmer, Jens Uwe ; Feuerhake, Friedrich ; Zu Eulenburg, Christine ; Kuemmel, Sherko ; Hartkopf, Andreas ; Graeser, Monika ; Kostara, Athina ; Pelz, Enrico ; Schmid, Peter ; Wuerstlein, Rachel ; Lüdtke-Heckenkamp, Kerstin ; Kreipe, Hans Heinrich ; Kelemen, Olga ; Schütz, Leon ; Jóźwiak, Katarzyna

BACKGROUND:

Accumulating evidence indicates that about 30-40% of patients with HER2-positive early breast cancer might achieve excellent outcomes without chemotherapy. Therefore, we aimed to test the pathological complete response after the addition of pembrolizumab to dual anti-HER2 blockade and omission of chemotherapy in patients with HER2-enriched breast cancer.

METHODS:

WSG-KEYRICHED-1 was a single-arm, multicentre, open-label, hypothesis-generating phase 2 trial done at 15 breast cancer centres in Germany. Women aged 18 years and older, with previously untreated clinical stage T1c-T3, N0-N2, M0, primary unilateral early invasive breast cancer, and locally confirmed HER2 immunohistochemistry score 2+ or 3+ status, and hormone receptor-positive or receptor-negative status, were enrolled. Women with centrally confirmed HER2-enriched subtype by prediction analysis of microarrays 50 gene set (PAM50) and an Eastern Cooperative Oncology Group performance status of 0-1 were allocated to four cycles of intravenous pembrolizumab (200 mg every 3 weeks for 12 weeks), intravenous trastuzumab biosimilar ABP 980 (8 mg/kg loading dose, then 6 mg/kg every 3 weeks for 12 weeks), and intravenous pertuzumab (840 mg loading dose, then 420 mg every 3 weeks for 12 weeks). The primary outcome was the proportion of patients with a pathological complete response (defined as ypN0 or ypT0/is), assessed in the full analysis set, which included all patients who had at least one dose of trial treatment and had central tumour assessment within 3 weeks after the end of trial treatment. For the primary endpoint to be met, at least 52·2% of patients had to have a pathological complete response to support the hypothesis that the proportion of patients with pathological complete response after trial treatment would be higher than 40% with statistical significance. Safety was analysed in all patients who had at least one dose of trial treatment. The study is registered with ClinicalTrials.gov, NCT03988036, and has been completed.

FINDINGS:

Between Sept 2, 2020, and May 5, 2021, 48 women were enrolled, of whom four did not have surgery, and one had only a local pathological complete response assessment. Therefore, 43 patients with central pathological complete response assessment were included in the full analysis set. Median follow-up was 8·6 months (IQR 8·3-9·0). 20 (47%) of 43 patients had a pathological complete response by central assessment (lower bound of the one-sided 95% CI 33%), thus the null hypothesis (40% pathological complete response) could not be rejected (p=0·22). Four (8%) of 48 patients had grade 3-4 adverse events deemed related to drug treatment. The most common grade 3-4 adverse events were increased alanine aminotransferase (n=1), drug hypersensitivity (n=1), nephritis (n=1), and panic attack (n=1). Serious adverse events occurred in four (8%) of 48 patients, which were drug hypersensitivity (n=1), panic attack (n=1), pyrexia (n=1), and COVID-19 (n=1). Pembrolizumab was discontinued or postponed due to adverse events in three (6%) of 48 patients. No deaths occurred.

INTERPRETATION:

Although the null hypothesis could not be rejected, the WSG-KEYRICHED-1 trial highlights the potential of a short chemotherapy-free combination of pembrolizumab with dual anti-HER2 therapy, warranting the initiation of randomised trials investigating the immunotherapy without chemotherapy in patients with HER2-enriched breast cancer.

FUNDING:

Merck Sharp & Dohme and NanoString Technologies.

2024-04-01·Future oncology (London, England)

Real-world clinical scenarios during introduction of trastuzumab biosimilar for HER2-positive breast cancer in the European Union

Article

作者: Sandschafer, Darcie ; San, Tevy ; Wyrwicz, Lucjan ; Rodríguez Sánchez, César A ; Lewis, Sandra ; Sánchez-Rovira, Pedro

Aim: Trastuzumab-anns is an intravenously administered biosimilar to trastuzumab approved by the EMA and US FDA for treatment of HER2+ early and metastatic breast cancer as well as metastatic gastric cancer. Lack of real-world characterization of biosimilar use has hindered uptake. Methods: This observational chart review characterizes 488 patients who received trastuzumab-anns in EU clinical practice settings. Results: Approximately 2/3rds of patients initiated trastuzumab-anns in adjuvant and neoadjuvant settings and most were naive new starters (70%). 30% were switchers from another trastuzumab, among whom 48% switched from trastuzumab iv. reference product. Common reasons for trastuzumab-anns discontinuation were a switch to another biosimilar product (34.8%, n = 85) or to trastuzumab reference product (15.6%, n = 38). Conclusion: Trastuzumab-anns was widely used in various treatment settings for HER2+ breast cancer.

2023-06-01·Geburtshilfe und Frauenheilkunde

Comparison of Biosimilar Trastuzumab ABP 980 with Reference Trastuzumab in Neoadjuvant Therapy for HER2-positive Breast Cancer – an Analysis of a Large University Breast Cancer Centre

Article

作者: Hahn, Markus ; Volmer, Lea-Louise ; Engler, Tobias ; Matovina, Sabine ; Müller, Heike ; Hartkopf, Andreas Daniel ; Brucker, Sara Yvonne ; Grischke, Eva-Maria ; Staebler, Annette

Abstract:

Background ABP 980 is a biosimilar antibody to reference trastuzumab (RTZ). Aim of the following study is to confirm the similarity of ABP 980 and RTZ in terms of clinical efficacy and safety in patients with HER2-positive early breast cancer (EBC) undergoing neoadjuvant trastuzumab-containing chemotherapy in a clinical real-world situation that also includes patients receiving pertuzumab. Methods Patients with HER2-positive EBC, who were treated from 12/2010 to 03/2020 at the Department of Women’s Health at Tuebingen University Hospital, Germany, with at least four cycles of neoadjuvant chemotherapy (+/− pertuzumab) in combination with ABP 980 or RTZ were included in a retrospective analysis. For efficacy analysis patients achieving a pathologic complete remission (pCR = no invasive tumor in breast and lymph nodes) were compared. Safety was evaluated by comparing the number of patients with a decrease in left ventricular function (LVEF) of > 10%. Results 124 patients were included of whom 46 (37.1%) have received ABP 980 and 77 (62.9%) were treated with RTZ. A pCR was found in 77 patients (62.1%). For patients treated with ABP 980 as compared to RTZ, there was no significant difference regarding efficacy (pCR-rates of 60.9% versus 62.8%, p = 0.829) or cardiac safety (LVEF decline in 6.5% versus 2.6%, p = 0.274). Conclusion Similarity of ABP 980 as compared to RTZ was confirmed in a real-world situation, including a large proportion of patients that have also received pertuzumab treatment.

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项与曲妥珠单抗生物类似药(Synthon BV) 相关的新闻（医药）

2025-11-05

·抗体圈

第8个适应症！第一三共注射用德曲妥珠单抗国内上市申请获受理

2025年11月5日，据国家药品监督管理局药品审评中心（CDE）官网显示，第一三共的注射用德曲妥珠单抗（DS-8201a，T-DXd，优赫得，100mg/瓶）的药品上市申请获受理，拟定适应症为联合帕妥珠单抗用于不可切除或转移性HER2阳性成人乳腺癌患者的一线治疗。据悉，这是优赫得在中国提交的第八个适应症的上市申请，也是其在中国申报的第五个乳腺癌适应症的上市申请。优赫得是一种靶向人表皮生长因子受体2（HER2）的抗体偶联药物（ADC），具有与曲妥珠单抗相同的氨基酸序列的人源化抗-HER2免疫球蛋白G1（IgG1）单克隆抗体（mAb），通过稳定的基于四肽的连接子与膜通透性拓扑异构酶I抑制剂DXd（依沙替康的衍生物）共价连接，可在肿瘤细胞内被选择性裂解。释放的药物载荷进入细胞核并破坏细胞内的脱氧核糖核酸（DNA），导致细胞死亡。本次新增适应症的上市申请主要基于DESTINY-Breast09（以下简称DB-09）研究的中期分析结果。 DESTINY-Breast09研究是一项评估T-DXd联合或不联合帕妥珠单抗（T-DXd组中对帕妥珠单抗设盲）对比SoC THP（紫杉烷、曲妥珠单抗和帕妥珠单抗）作为一线药物治疗用于HER2阳性、晚期或转移性乳腺癌受试者的疗效和安全性的随机化、三组、全球多中心III期研究。患者以1:1:1的比例随机分配至治疗组（T-DXd+安慰剂、T-DXd+帕妥珠单抗或THP）。主要疗效终点为基于RECIST v1.1标准、经盲态独立中心审查（BICR）评估的无进展生存期（PFS）。关键次要疗效终点为总生存期（OS）。其他次要终点包括研究者评估的PFS、确认的客观缓解率（ORR）和缓解持续时间（DOR）。 DB-09研究显示，在预设的PFS中期分析中，与THP组相比，随机分配至T-DXd联合帕妥珠单抗组的患者经BICR评估的PFS显示出统计学显著且具有临床意义的改善。T-DXd联合帕妥珠单抗组中位PFS达40.7个月，对比THP组为26.9个月，疾病进展或死亡风险降低44%（风险比0.56，95%置信区间[0.44, 0.71]；P < 0.00001）。在各预设的亚组（包括PIK3CA突变患者vs非突变患者、初发vs复发转移性疾病以及激素受体阳性vs阴性HER2阳性转移性乳腺癌患者）中，均观察到了类似的PFS改善。总生存期分析尚不成熟，但观察到改善趋势。同时，观察到的联合治疗组安全性特征与其中各单药治疗的已知安全性特征基本一致，未发现新的安全性信号。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床3期抗体药物偶联物临床结果临床成功申请上市

2025-11-05

·丁香园 Insight 数据库

明星 ADC 又一新适应症在国内报上市

11 月 5 日，CDE 官网显示，第一三共注射用德曲妥珠单抗（DS-8201a，T-DXd，100mg/瓶）的新适应症上市申请获受理，联合帕妥珠单抗用于不可切除或转移性 HER2 阳性成人乳腺癌患者的一线治疗。这是德曲妥珠单抗在中国提交的第八个适应症的上市申请，也是其在中国申报的第五个乳腺癌适应症的上市申请。来源：CDE 官网该上市申请主要基于 DESTINY-Breast09（简称 DB-09）研究的中期分析结果。这是一项评估 T-DXd 联合或不联合帕妥珠单抗（T-DXd 组中对帕妥珠单抗设盲）对比 SoC THP（紫杉烷、曲妥珠单抗和帕妥珠单抗）作为一线药物治疗用于 HER2 阳性、晚期或转移性乳腺癌受试者的疗效和安全性的随机化、三组、全球多中心 III 期研究。主要疗效终点为BICR 评估的 PFS，关键次要疗效终点为 OS。结果显示，在预设的 PFS 中期分析中，与 THP 组相比，随机分配至 T-DXd 联合帕妥珠单抗组的患者经 BICR 评估的 PFS 显示出统计学显著且具有临床意义的改善。T-DXd 联合帕妥珠单抗组中位 PFS 达 40.7 个月，对比 THP 组为 26.9 个月，疾病进展或死亡风险降低 44%（风险比 0.56，95% 置信区间 [0.44, 0.71]；P < 0.00001）。在各预设的亚组（包括 PIK3CA 突变患者 vs 非突变患者、初发 vs 复发转移性疾病以及激素受体阳性 vs 阴性 HER2 阳性转移性乳腺癌患者）中，均观察到了类似的 PFS 改善。总生存期分析尚不成熟，但观察到改善趋势。同时，观察到的联合治疗组安全性特征与其中各单药治疗的已知安全性特征基本一致，未发现新的安全性信号。德曲妥珠单抗是一种靶向 HER2 的 ADC，具有与曲妥珠单抗相同的氨基酸序列的人源化抗-HER2 免疫球蛋白 G1（IgG1）单克隆抗体（mAb），通过稳定的基于四肽的连接子与膜通透性拓扑异构酶 I 抑制剂 DXd（依沙替康的衍生物）共价连接，可在肿瘤细胞内被选择性裂解。释放的药物载荷进入细胞核并破坏细胞内的脱氧核糖核酸（DNA），导致细胞死亡。 2019 年 3 月，第一三共与阿斯利康达成了一项 69 亿美元的合作，在全球范围内共同开发和商业化该产品。在国内，德曲妥珠单抗此前已经获批四项适应症（见下图），涵盖乳腺癌、胃癌、非小细胞肺癌。来源：丁香园 Insight 数据库封面来源：企业logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：月牙 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

抗体药物偶联物临床3期

2025-11-05

·第一三共中国

优赫得®（注射用德曲妥珠单抗）联合帕妥珠单抗用于HER2阳性乳腺癌一线治疗的上市申请已获CDE受理

2025年11月4日-中国，第一三共优赫得®（注射用德曲妥珠单抗，DS-8201a，T-DXd，100mg/瓶）的药品上市申请已获国家药品监督管理局药品审评中心（CDE）正式受理，拟定适应症为联合帕妥珠单抗用于不可切除或转移性HER2阳性成人乳腺癌患者的一线治疗。这是优赫得®在中国提交的第八个适应症的上市申请，也是其在中国申报的第五个乳腺癌适应症的上市申请。优赫得®是一种靶向人表皮生长因子受体2（HER2）的抗体偶联药物（ADC），具有与曲妥珠单抗相同的氨基酸序列的人源化抗-HER2免疫球蛋白G1（IgG1）单克隆抗体（mAb），通过稳定的基于四肽的连接子与膜通透性拓扑异构酶I抑制剂DXd（依沙替康的衍生物）共价连接，可在肿瘤细胞内被选择性裂解。释放的药物载荷进入细胞核并破坏细胞内的脱氧核糖核酸（DNA），导致细胞死亡。本次新增适应症的上市申请主要基于DESTINY-Breast09（以下简称DB-09）研究的中期分析结果。　关于DESTINY-Breast09研究 DESTINY-Breast09研究是一项评估T-DXd联合或不联合帕妥珠单抗（T-DXd组中对帕妥珠单抗设盲）对比SoC THP（紫杉烷、曲妥珠单抗和帕妥珠单抗）作为一线药物治疗用于HER2阳性、晚期或转移性乳腺癌受试者的疗效和安全性的随机化、三组、全球多中心III期研究。患者以1:1:1的比例随机分配至治疗组（T-DXd+安慰剂、T-DXd+帕妥珠单抗或THP）。主要疗效终点为基于RECIST v1.1标准、经盲态独立中心审查（BICR）评估的无进展生存期（PFS）。关键次要疗效终点为总生存期（OS）。其他次要终点包括研究者评估的PFS、确认的客观缓解率（ORR）和缓解持续时间（DOR）。 DB-09研究显示，在预设的PFS中期分析中，与THP组相比，随机分配至T-DXd联合帕妥珠单抗组的患者经BICR评估的PFS显示出统计学显著且具有临床意义的改善。T-DXd联合帕妥珠单抗组中位PFS达40.7个月，对比THP组为26.9个月，疾病进展或死亡风险降低44%（风险比0.56，95%置信区间[0.44, 0.71]；P < 0.00001）。在各预设的亚组（包括PIK3CA突变患者vs非突变患者、初发vs复发转移性疾病以及激素受体阳性vs阴性HER2阳性转移性乳腺癌患者）中，均观察到了类似的PFS改善。总生存期分析尚不成熟，但观察到改善趋势。同时，观察到的联合治疗组安全性特征与其中各单药治疗的已知安全性特征基本一致，未发现新的安全性信号。1 关于HER2阳性乳腺癌乳腺癌是严重威胁女性健康的疾病，也是全球导致女性癌症死亡的首要原因（2022年占所有癌症病例的11.6%）2。在中国，2022年约有乳腺癌新发病例357200例，死亡75000例3。尽管近年来在乳腺癌的诊断和治疗方面取得了进展，但仍有约5-10%的患者在首次就诊时患有转移性疾病，而高达20-30%的早期乳腺癌会发展为转移性疾病4。转移性乳腺癌（mBC）目前仍无法根治，估计5年总生存率（OS）仅为38%5。人表皮生长因子受体2（HER2）阳性乳腺癌作为乳腺癌的重要分型之一，约占所有乳腺癌的20%6。在发现HER2靶向疗法前，HER2水平升高是一种不良预后因素，可导致高复发率并增加死亡率7。在HER2阳性转移性乳腺癌的治疗中，在标准化疗的基础上加用曲妥珠单抗可将中位无进展生存期（mPFS）从4.6个月提高至7.4个月，中位总生存期（mOS)从20.3个月提高至25.1个月8。曲妥珠单抗问世后，已开发出多种HER2靶向药物。其中，帕妥珠单抗+曲妥珠单抗+紫杉烷（THP）联合治疗作为一线标准治疗（SoC），已证实的mPFS为18.7个月，mOS为56.5个月9。尽管在过去的二十年中，乳腺癌的治疗取得了重大进展，但仍无法根治HER2阳性转移性乳腺癌。因此，HER2阳性转移性乳腺癌患者仍迫切需要有效性更佳的治疗方案，以延长生存期，甚至实现治愈。　　　　　　关于第一三共　　　　　　　第一三共是一家为社会可持续发展做贡献的创新型全球医疗保健公司，致力于发现、开发和提供新的标准疗法，以提高世界各地患者的生活质量。第一三共专注制药行业120余年，凭借其世界一流的科学和技术，为癌症、心血管疾病和其他医疗需求远未得到满足的疾病患者研发新的治疗方法和创新药物。如欲了解更多信息，请访问www.daiichisankyo.com。参考文献： 1.DESTINY-Breast09 Data Press Release. 2. GLOBOCAN. Global Cancer Observatory.2022. 3.Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. 4.中国晚期乳腺癌规范诊疗指南（2024版）中华肿瘤杂志 2024 年12 月第 46 卷第 12 期 5.Gennari A, André F, Barrios CH, Cortés J, de Azambuja E, DeMichele A, et al. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol.2021;32(12):1475-95. 6.Arteaga CL, Sliwkowski MX, Osborne CK, Perez EA, Puglisi F, Gianni L. Treatment of HER2-positive breast cancer: current status and future perspectives. Nat Rev Clin Oncol 2011;9(1):16-32. 7.Chia S, Norris B, Speers C, Cheang M, Gilks B, Gown AM, et al. Human epidermal growth factor receptor 2 overexpression as a prognostic factor in a large tissue microarray series of node-negative breast cancers. J Clin Oncol 2008;26(35):5697-704. 8.Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344(11):783-92. 9.Swain SM, Baselga J, Kim SB, Ro J, Semiglazov V, Campone M, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med 2015;372(8):724-34. 声明: 1.本材料不用于任何推广目的，相关信息亦不应作为治疗或使用建议。如有相关问题请咨询医疗卫生专业人士。 2.本文涉及未在中国获批的产品或适应症，第一三共不推荐任何未获批药品/适应症的使用。

临床结果临床3期抗体药物偶联物申请上市

100 项与曲妥珠单抗生物类似药(Synthon BV) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC03	DB00072

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
胃食管交界处腺癌	美国	Amgen, Inc.	2019-06-13
HER2阳性乳腺癌	澳大利亚	Amgen Australia Pty Ltd.	2019-05-16
HER2阳性胃食管交界处癌	澳大利亚	Amgen Australia Pty Ltd.	2019-05-16
HER2阳性胃腺癌	澳大利亚	Amgen Australia Pty Ltd.	2019-05-16
HER2阳性胃癌	日本	Daiichi Sankyo Co., Ltd.	2018-09-21
乳腺癌	欧盟	Amgen Europe BV	2018-05-16
乳腺癌	冰岛	Amgen Europe BV	2018-05-16
乳腺癌	列支敦士登	Amgen Europe BV	2018-05-16
乳腺癌	挪威	Amgen Europe BV	2018-05-16
转移性乳腺癌	欧盟	Amgen Europe BV	2018-05-16
转移性乳腺癌	冰岛	Amgen Europe BV	2018-05-16
转移性乳腺癌	列支敦士登	Amgen Europe BV	2018-05-16
转移性乳腺癌	挪威	Amgen Europe BV	2018-05-16
胃癌	欧盟	Amgen Europe BV	2018-05-16
胃癌	冰岛	Amgen Europe BV	2018-05-16
胃癌	列支敦士登	Amgen Europe BV	2018-05-16
胃癌	挪威	Amgen Europe BV	2018-05-16

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胃食管交界处癌	临床3期	美国	Daiichi Sankyo Co., Ltd.	2025-02-27
胃食管交界处癌	临床3期	中国	Daiichi Sankyo Co., Ltd.	2025-02-27
胃食管交界处癌	临床3期	日本	Daiichi Sankyo Co., Ltd.	2025-02-27
胃食管交界处癌	临床3期	阿根廷	Daiichi Sankyo Co., Ltd.	2025-02-27
胃食管交界处癌	临床3期	澳大利亚	Daiichi Sankyo Co., Ltd.	2025-02-27
胃食管交界处癌	临床3期	奥地利	Daiichi Sankyo Co., Ltd.	2025-02-27
胃食管交界处癌	临床3期	比利时	Daiichi Sankyo Co., Ltd.	2025-02-27
胃食管交界处癌	临床3期	巴西	Daiichi Sankyo Co., Ltd.	2025-02-27
胃食管交界处癌	临床3期	加拿大	Daiichi Sankyo Co., Ltd.	2025-02-27
胃食管交界处癌	临床3期	智利	Daiichi Sankyo Co., Ltd.	2025-02-27

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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


ESMO2025	N/A	HER2阳性转移性乳腺癌一线 HER2+	2,667	Trastuzumab + Pertuzumab	鑰築醖構艱齋淵選廠鹽(餘憲顧遞願鬱鑰膚鬱鏇) = 鏇壓鏇遞鏇鑰淵鬱醖鏇構窪簾齋糧選鹽鑰願鏇 (獵顧範範願遞鑰製遞蓋, 52.9 ~ 63.5) 更多	积极	2025-10-17
				Trastuzumab + Pertuzumab (HR+ mBC)	鑰築醖構艱齋淵選廠鹽(餘憲顧遞願鬱鑰膚鬱鏇) = 願窪網積繭網憲遞簾夢構窪簾齋糧選鹽鑰願鏇 (獵顧範範願遞鑰製遞蓋, 52.9 ~ 63.5) 更多
NCT01901146 (LILAC, CTgov)	临床3期	HER2阳性乳腺癌	725	Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection+ABP 980+Paclitaxel (ABP 980)	廠糧鹽鬱顧鹹壓艱築構 = 觸淵襯築觸襯觸鹹醖膚醖鏇網廠膚範繭廠糧窪 (獵積願選鬱壓夢簾壓製, 簾積鬱蓋蓋糧鑰鬱膚願 ~ 憲範範膚鬱範鏇網憲製) 更多	-	2019-08-07
				Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection+Trastuzumab+Paclitaxel (Trastuzumab)	廠糧鹽鬱顧鹹壓艱築構 = 淵膚廠遞積築簾壓衊鬱醖鏇網廠膚範繭廠糧窪 (獵積願選鬱壓夢簾壓製, 願選製築廠蓋壓壓遞衊 ~ 蓋夢憲築鹹襯網構選遞) 更多
NCT01901146 (LILAC, ASCO2019)	临床3期	HER2阳性乳腺癌新辅助 \| 辅助	725	ABP 980	觸範膚窪鬱繭艱顧製糧(範鹹淵淵餘鏇糧製遞選) = The incidence of cardiac AEs was low and comparable in treatment groups 糧衊遞觸製壓鏇糧構餘 (獵築鬱鬱遞積獵廠窪齋 ) 更多	积极	2019-05-26
				Trastuzumab reference product
NCT01901146 (LILAC, Pubmed) 人工标引	临床3期	HER2阳性乳腺癌辅助 \| 新辅助 HER2-positive	825	ABP 980	壓醖製鑰廠鹽艱網齋淵(憲獵構憲壓衊簾襯憲鑰) = 獵築衊壓齋夢積顧淵網窪艱鏇壓艱遞鏇構選遞 (膚壓鬱積鑰餘廠憲構衊 ) 更多	非劣	2018-07-01
				trastuzumab	壓醖製鑰廠鹽艱網齋淵(憲獵構憲壓衊簾襯憲鑰) = 獵選觸積鑰鹽觸鹹鑰襯窪艱鏇壓艱遞鏇構選遞 (膚壓鬱積鑰餘廠憲構衊 ) 更多
NCT01901146 (LILAC, ASCO2018)	临床3期	HER2阳性乳腺癌	725	ABP 980	鑰鑰遞膚網積顧蓋鬱獵(齋襯憲窪淵糧齋醖襯觸) = 醖製鏇積襯觸齋鹽鏇鑰鹹憲膚觸網簾顧願窪夢 (顧餘膚簾觸壓選鏇觸窪 )	积极	2018-06-01
				Trastuzumab	鑰鑰遞膚網積顧蓋鬱獵(齋襯憲窪淵糧齋醖襯觸) = 艱餘網觸鹽憲鏇壓選鏇鹹憲膚觸網簾顧願窪夢 (顧餘膚簾觸壓選鏇觸窪 )