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]

NCT03112590

/ Completed临床1/2期IIT

A Phase I-II Study of Interferon-gamma Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer

This purpose of this study is to evaluate the safety and to find the optimal dose in participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who are given the combination of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab. This study will also look at other effects of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab, including its effect on this type of cancer.
Interferon-gamma is a biologically manufactured protein that is similar to a protein the body makes naturally. In the body, interferon gamma is produced by immune cells and helps to prevent serious infections.

开始日期2017-06-23

申办/合作机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+1]

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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 ; Armeanu-Ebinger, Sorin ; Bartels, Stephan ; Reinisch, Mattea ; 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 ; Pelz, Enrico ; Kostara, Athina ; 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.

2022-11-02·Immunopharmacology and immunotoxicology

Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer: a systematic review and network meta-analysis

Review

作者: Dong, Mei ; Liu, Tong ; Jin, Yao ; Liu, Duo

AIM:

Breast cancer is the most frequently diagnosed cancer in women and ranks second among causes for cancer related death in women. Trastuzumab originator (Herceptin) is a monoclonal antibody used as a standard treatment for breast and metastatic gastric cancer when the cancer cells over-express human epidermal growth factor receptor type 2 (HER2). As the patent of Trastuzumab has now expired, biosimilars are moving into the market. It is still controversial to chose which trastuzumab biosimilar has the best treatment of HER2-positive breast cancer patients. We conducted this network meta-analysis to explore the best trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.

METHODS:

PubMed, Cochrane library databases, China National Knowledge infrastructure (CNKI) and WanFang database up to November 2021 were systematically searched. The following search terms were used: 'trastuzumab originator', and 'trastuzumab biosimilar'. No language restriction was imposed. The reference lists of all retrieved articles were also reviewed to identify additional articles missed by using these search terms.

RESULTS:

We got 10 studies to conduct network meta-analysis to evaluate efficacy and serious adverse reactions among various trastuzumab biosimilars and trastuzumab originator. The overall response rate (ORR) and pathological complete response (pCR) of SB3 were worse than trastuzumab originator significantly, while the ORR and pCR of other trastuzumab biosimilars had not yet reached statistical differences compared with each other. The cumulative ranking curve (SUCRA) probability indicated that the ORR from best to worst was CT-P6, Herceptin, HLX02, PF-05280014, R-TPR-016, BCD-022, MYL-1401O, SB3, and the pCR from best to worst was PF-05280014, CT-P6, Herceptin, ABP-980, SB3. The serious adverse events (SAEs) of CT-P6 were more than Herceptin and MYL-1401O significantly, while the SAEs of other trastuzumab biosimilars had not statistical differences. The SUCRA probability indicated that the SAEs from best to worst was MYL-1401O, Herceptin, PF-05280014, SB3, HLX02, BCD-22, CT-P6.

CONCLUSION:

There was no statistical difference in both ORR and pCR of various trastuzumab biosimilars and Herceptin except SB3. The ORR and pCR of SB3 were worse than Herceptin. Both CT-P6 and PF-05280014 are better in the overall curative effect, but CT-P6 had the highest serious adverse reactions when compared with others. The PF-05280014 might be a better trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.

402

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2026-03-10

·抗体圈

第一三共/阿斯利康重磅 ADC 两个适应症拟纳入优先审评

3 月 10 日，CDE 官网显示，德曲妥珠单抗又有两个适应症拟纳入优先审评，分别为：1）适用于接受抗 HER2 新辅助治疗后仍残存侵袭性病灶的 HER2 阳性成人乳腺癌患者的治疗；2）单药适用于治疗既往接受过治疗或无满意替代治疗方案的不可切除或转移性 HER2 表达为 IHC 3+的成人实体瘤患者。截图来源：CDE 官网德曲妥珠单抗（DS-8201，商品名：优赫得®/Enhertu）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，DAR 值为 8。 2019 年 3 月，第一三共与阿斯利康达成了一项 69 亿美元合作，在全球范围内共同开发和商业化该产品。此前，德曲妥珠单抗已在国内获批 6 项适应症，包括：单药治疗既往接受过一种或一种以上抗 HER2 治疗、不可切除或转移性 HER2 阳性成人乳腺癌（2023/02）；单药治疗既往在转移性疾病阶段接受过至少 1 种系统治疗或在辅助化疗期间或完成辅助化疗之后 6 个月内复发，不可切除或转移性 HER2 低表达成人乳腺癌（2023/07）；单药治疗既往接受过两种或两种以上治疗方案的局部晚期或转移性 HER2 阳性成人胃或胃食管结合部腺癌（2024/08）；用于治疗存在 HER2 激活突变且既往接受过至少一种系统治疗的不可切除或转移性成人非小细胞肺癌 (2024/10)。用于HR 阳性、HER2 低表达或 HER2 超低表达乳腺癌成人患者(2025/12)。二线治疗 HER2 阳性成人胃或胃食管结合部腺癌患者(2026/1）。作为领跑 ADC 时代的重磅炸弹药物，德曲妥珠单抗自 2019 年 12 月首次获批以来，销售额连年上涨。2025 年，德曲妥珠单抗的销售额已达到 49.82 亿美元，同比增长 32.71%。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微信群！请注明：姓名+研究方向！版权声明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不本站。

2026-03-09

·生物药观察

FDA 授予ENHERTU优先审评资格，用于HER2阳性早期乳腺癌患者的新辅助后治疗

2026 年 3 月 9 日，第一三共与阿斯利康联合宣布，ENHERTU®（德曲妥珠单抗）的补充生物制品许可申请（sBLA）已获美国 FDA 受理并授予优先审评，用于治疗接受新辅助抗 HER2 靶向治疗后仍存在残余侵袭性病灶的 HER2 阳性（IHC 3 + 或 ISH+）成人乳腺癌患者。本次优先审评是继 FDA 于2025 年 12 月基于 DESTINY-Breast05 Ⅲ 期研究数据授予 ENHERTU突破性疗法认定之后的又一进展。该研究数据已在ESMO25年会公布，并发表于《新英格兰医学杂志》。FDA 的目标审批日期（PDUFA 日期）为2026 年 7 月 7 日。 DESTINY-Breast05 研究显示，在新辅助治疗后存在残余侵袭性病灶的 HER2 阳性乳腺癌患者中，作为新辅助后治疗：与恩美曲妥珠单抗（T-DM1）相比， ENHERTU 显著降低侵袭性疾病复发或死亡风险（IDFS）达 53%，风险比 HR=0.47；95% CI: 0.34–0.66；p<0.0001 ENHERTU 组3 年 IDFS 率为 92.4%（95%CI: 89.7–94.4），T-DM1 组为83.7%（95%CI: 80.2–86.7）所有预设亚组的 IDFS 获益结果均保持一致。数据同时显示：ENHERTU 较 T-DM1显著降低疾病复发或死亡风险 53%（HR=0.47），远处复发风险降低 51%（DRFI，HR=0.49），脑转移风险降低 36%（BMFI，HR=0.64） DESTINY-Breast05 中 ENHERTU 的安全性特征与已知一致，未发现新的安全性信号。 ENHERTU 组≥3 级治疗期间不良事件（TEAE）发生率：50.6%，T-DM1 组：51.9%。 ENHERTU 组发生率≥5% 的≥3 级 TEAE 主要为：中性粒细胞计数降低（15.5%），白细胞计数降低（10.1%），血小板计数降低（6.7%），中性粒细胞减少症（8.1%）。两组间质性肺病（ILD）/ 肺炎发生率均较低：ENHERTU 组：9.6%，T-DM1 组：1.6%，绝大多数 ILD / 肺炎为低级别（1 级或 2 级）。独立评审委员会判定：ENHERTU 组：7 例 3 级（0.9%），2 例 5 级（0.2%），T-DM1 组：无≥3 级 ILD / 肺炎事件基于 DESTINY-Breast05 的 ENHERTU 上市申请目前正在欧盟、日本审评中。此外，基于 DESTINY-Breast11 研究，ENHERTU 联合紫杉醇、曲妥珠单抗、帕妥珠单抗（THP）用于Ⅱ/Ⅲ 期 HER2 阳性乳腺癌新辅助治疗的 sBLA 也正在美国审评，PDUFA 日期为2026 年 5 月 18 日。本次优先审评进一步证实，基于 DESTINY-Breast05 结果，ENHERTU 有望成为HER2 阳性早期乳腺癌的新治疗标准。参考文献：DB05 2025ESMO.pdf

优先审批突破性疗法临床结果临床3期

2026-03-09

·BioSpace

ENHERTU® (fam-trastuzumab deruxtecan-nxki) granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer

Based on DESTINY-Breast05 Phase III trial results which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared with T-DM1 If approved, AstraZeneca and Daiichi Sankyo’s ENHERTU has the potential to become a new standard of care in this early breast cancer setting WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for ENHERTU ® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the US for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the third quarter of 2026. ENHERTU was recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need. The sBLA also is being reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. Around one in five breast cancers are considered HER2-positive, a subtype that is often associated with aggressive disease and poor prognosis. 1-3 Currently, approximately half of patients with HER2-positive early breast cancer have residual disease following neoadjuvant treatment (before surgery), putting them at an increased risk of disease recurrence. 4-9 Despite receiving additional treatment in the post-neoadjuvant setting with current standards of care, some patients still experience tumor progression to metastatic disease, where the five-year survival rate drops from nearly 90% to approximately 30%. 10,11 Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “While there has been significant progress in treating HER2-positive early breast cancer, managing patients at a higher risk of recurrence remains challenging. With this Priority Review, we move closer to bringing ENHERTU to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure.” Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “For patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease. This Priority Review reinforces the potential of ENHERTU to become a new standard of care for HER2-positive early breast cancer based on the results of DESTINY-Breast05.” The sBLA is based on data from the DESTINY-Breast05 Phase III trial presented at the European Society for Medical Oncology (ESMO) 2025 Congress and subsequently published in The New England Journal of Medicine . 1 In the trial, ENHERTU significantly reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% compared with trastuzumab emtansine (T-DM1; based on a hazard ratio [HR] of 0.47; 95% confidence interval [CI] 0.34-0.66; p28 days from date of onset, reduce dose 1 level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks. HER2-Positive, HER2-Low, and HER2-Ultralow Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg) ENHERTU as Monotherapy In patients treated with ENHERTU 5.4 mg/kg, ILD occurred in 12% of patients. Median time to first onset was 5.5 months (range: 0.9 to 31.5). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.9% of patients treated with ENHERTU. ENHERTU in Combination with Pertuzumab In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), ILD occurred in 12% of patients. Median time to first onset was 8.0 months (range: 0.6 to 33.8). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.5% of patients treated with ENHERTU in combination with pertuzumab. HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg) In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21). Neutropenia Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU monotherapy or ENHERTU in combination with pertuzumab. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] 38.3º C or a sustained temperature of ≥38º C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by 1 level. HER2-Positive, HER2-Low, and HER2-Ultralow Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg) ENHERTU as Monotherapy In patients treated with ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in 65% of patients. Nineteen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 2 to 939). Febrile neutropenia was reported in 1.2% of patients. ENHERTU in Combination with Pertuzumab In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), decreased neutrophil count occurred in 79% of patients. Median time to first onset was 22 days (range: 5 to 994). Twenty-nine percent had Grade 3 or 4 decreased neutrophil count. Febrile neutropenia was reported in 2.6% of patients. HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg) In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients. Left Ventricular Dysfunction Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is 20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of 20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF 6 months and 38% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (73%), nausea (72%), decreased hemoglobin (67%), decreased neutrophil count (65%), decreased lymphocyte count (60%), fatigue (55%), decreased platelet count (48%), increased aspartate aminotransferase (46%), increased alanine aminotransferase (44%), increased blood alkaline phosphatase (39%), vomiting (38%), alopecia (37%), constipation (32%), decreased blood potassium (32%), decreased appetite (31%), diarrhea (30%), and musculoskeletal pain (24%). ENHERTU in Combination with Pertuzumab The pooled safety population reflects exposure to ENHERTU 5.4 mg/kg in combination with pertuzumab intravenously every 3 weeks in 431 patients in DESTINY-Breast07 (n=50), and DESTINY-Breast09 (n=381). Among these patients, 86% were exposed for >6 months and 73% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (86%), decreased hemoglobin (80%), decreased neutrophil count (79%), nausea (74%), increased alanine aminotransferase (65%), diarrhea (64%), increased aspartate aminotransferase (63%), decreased lymphocyte count (61%), decreased platelet count (55%), increased blood alkaline phosphatase (54%), decreased blood potassium (54%), fatigue (53%), alopecia (48%), vomiting (46%), upper respiratory tract infection (32%), constipation (31%), decreased appetite (31%), decreased weight (28%), musculoskeletal pain (23%), abdominal pain (22%), and increased blood bilirubin (23%). HER2-Positive Metastatic Breast Cancer DESTINY-Breast09 The safety of ENHERTU 5.4 mg/kg in combination with pertuzumab was evaluated in DESTINY-Breast09, a randomized, three-arm, multicenter study including 763 patients with HER2-positive (IHC 3+ or ISH+) unresectable or metastatic breast cancer. Three hundred eighty-one patients received ENHERTU in combination with pertuzumab and 382 patients received THP (taxane [docetaxel or paclitaxel], trastuzumab, and pertuzumab). Among patients who received ENHERTU in combination with pertuzumab, the median duration of treatment was 22 months (range: 0.3 months to 44.5 months). Serious adverse reactions occurred in 27% of patients receiving ENHERTU in combination with pertuzumab. Serious adverse reactions in >1% of patients were diarrhea, pneumonia, febrile neutropenia, hypokalemia, vomiting, ILD, pulmonary embolism, and sepsis. Fatalities due to adverse reactions occurred in 3.4% of patients including pneumonia (n=3), ILD (n=2), sepsis (n=2), pulmonary embolism, septic shock, acute kidney injury, dyspnea, febrile neutropenia, and intestinal ischemia (one patient each). ENHERTU was discontinued for adverse reactions in 21% of patients. The most frequent adverse reaction (>2%) associated with permanent discontinuation was ILD/pneumonitis (6.6%). Dose interruptions due to adverse reactions occurred in 69% of patients. The most frequent adverse reactions (>2%) associated with dose interruption were COVID-19, neutropenia, upper respiratory tract infection, fatigue, anemia, hypokalemia, ILD/pneumonitis, thrombocytopenia, pneumonia, diarrhea, transaminase increased, leukopenia, cough, pyrexia, decreased appetite, and blood bilirubin increased. Dose reductions occurred in 46% of patients treated with ENHERTU in combination with pertuzumab. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, neutropenia, nausea, diarrhea, ILD/pneumonitis, thrombocytopenia, vomiting, transaminases increased, decreased weight, febrile neutropenia, and hypokalemia. The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (87%), decreased hemoglobin (80%), decreased neutrophil count (78%), nausea (75%), increased alanine aminotransferase (66%), diarrhea (64%), increased aspartate aminotransferase (62%), decreased lymphocyte count (62%), decreased platelet count (56%), increased blood alkaline phosphatase (55%), decreased blood potassium (54%), fatigue (53%), alopecia (48%), vomiting (46%), upper respiratory tract infection (33%), constipation (33%), decreased appetite (32%), decreased weight (30%), COVID-19 (28%), musculoskeletal pain (24%), increased blood bilirubin (23%), and abdominal pain (23%). DESTINY-Breast03 The safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least 1 dose of ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast03. The median duration of treatment was 14 months (range: 0.7 to 30) for patients who received ENHERTU. Serious adverse reactions occurred in 19% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were vomiting, ILD, pneumonia, pyrexia, and urinary tract infection. Fatalities due to adverse reactions occurred in 0.8% of patients including COVID-19 and sudden death (1 patient each). ENHERTU was permanently discontinued in 14% of patients, of which ILD/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 44% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, leukopenia, anemia, thrombocytopenia, pneumonia, nausea, fatigue, and ILD/pneumonitis. Dose reductions occurred in 21% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were nausea, neutropenia, and fatigue. The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (74%), decreased neutrophil count (70%), increased aspartate aminotransferase (67%), decreased hemoglobin (64%), decreased lymphocyte count (55%), increased alanine aminotransferase (53%), decreased platelet count (52%), fatigue (49%), vomiting (49%), increased blood alkaline phosphatase (49%), alopecia (37%), decreased blood potassium (35%), constipation (34%), musculoskeletal pain (31%), diarrhea (29%), decreased appetite (29%), headache (22%), respiratory infection (22%), abdominal pain (21%), increased blood bilirubin (20%), and stomatitis (20%). HER2-Low and HER2-Ultralow Metastatic Breast Cancer DESTINY-Breast06 The safety of ENHERTU was evaluated in 434 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast06. Contacts Media Inquiries Fiona Cookson +1 212 814 3923 US Media Mailbox: usmediateam@astrazeneca.com Read full story here

临床3期临床结果优先审批突破性疗法ASCO会议

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	獵獵齋繭艱艱壓獵襯構(選範齋顧構憲製獵鏇醖) = 齋範醖觸製壓壓觸鹹艱獵鹽製鏇鬱淵鏇簾簾廠 (襯簾鑰糧艱艱鑰繭選願, 52.9 ~ 63.5) 更多	积极	2025-10-17
				Trastuzumab + Pertuzumab (HR+ mBC)	獵獵齋繭艱艱壓獵襯構(選範齋顧構憲製獵鏇醖) = 餘選鬱鏇齋艱艱蓋壓艱獵鹽製鏇鬱淵鏇簾簾廠 (襯簾鑰糧艱艱鑰繭選願, 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)	願鏇鹽醖構襯醖窪糧範 = 選構鏇廠顧憲壓範顧醖顧衊範齋獵願顧鹹餘鹽 (鹹艱範衊夢觸憲製製蓋, 衊醖鹽構廠鹽願顧願夢 ~ 壓艱襯廠壓壓積窪構壓) 更多	-	2019-08-07
				Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection+Trastuzumab+Paclitaxel (Trastuzumab)	願鏇鹽醖構襯醖窪糧範 = 願糧糧壓鬱鑰網製廠蓋顧衊範齋獵願顧鹹餘鹽 (鹹艱範衊夢觸憲製製蓋, 範憲顧鏇襯襯蓋選糧衊 ~ 艱築鏇衊艱獵醖夢餘壓) 更多
NCT01901146 (LILAC, ASCO2019)	临床3期	HER2阳性乳腺癌新辅助 \| 辅助	725	ABP 980	簾鹽夢艱遞鬱構製膚構(選夢壓構遞襯鑰餘積顧) = The incidence of cardiac AEs was low and comparable in treatment groups 繭簾簾壓窪衊積觸糧衊 (蓋選襯觸窪蓋餘構積壓 ) 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	憲襯簾醖鹹積壓鬱顧鹹(襯鏇淵壓獵鏇簾廠壓窪) = 醖壓齋顧淵遞夢艱窪壓構憲積窪網蓋鑰築醖網 (齋蓋膚襯餘壓壓願廠範 ) 更多	非劣	2018-07-01
				trastuzumab	憲襯簾醖鹹積壓鬱顧鹹(襯鏇淵壓獵鏇簾廠壓窪) = 製餘壓鬱醖廠齋鏇積積構憲積窪網蓋鑰築醖網 (齋蓋膚襯餘壓壓願廠範 ) 更多
NCT01901146 (LILAC, ASCO2018)	临床3期	HER2阳性乳腺癌	725	ABP 980	範糧簾醖網願廠齋糧製(膚積壓淵夢齋膚範醖蓋) = 膚蓋窪範遞範憲淵衊簾艱觸簾餘繭製遞鹹選鹹 (憲壓製製觸衊淵構觸製 )	积极	2018-06-01
				Trastuzumab	範糧簾醖網願廠齋糧製(膚積壓淵夢齋膚範醖蓋) = 築願艱醖觸鬱顧醖鏇鏇艱觸簾餘繭製遞鹹選鹹 (憲壓製製觸衊淵構觸製 )