Optimizing Neoadjuvant Therapy for HER2-Positive Breast Cancer Based on Dynamic Efficacy Monitoring: A Trial of Trastuzumab Plus Pyrotinib and Albumin-Bound Paclitaxel Followed by SHR-A1811 Plus Pertuzumab（OnThePath Trial）

This study aims to optimize neoadjuvant therapy for HER2-positive breast cancer by implementing a dynamic monitoring-guided treatment strategy. Patients will initially receive trastuzumab, pyrotinib, and albumin-bound paclitaxel. Those who do not achieve a radiological response after Cycle 2 will switch to SHR-A1811 (a HER2-targeted antibody-drug conjugate) combined with pertuzumab. The primary objective is to evaluate whether this sequential treatment strategy improves the pathological complete response (pCR) rate while maintaining safety. The study will also explore the value of dynamic efficacy monitoring in guiding treatment adjustments and assess the safety and tolerability of the regimens.

开始日期2025-09-01

申办/合作机构

河北医科大学第四医院

NCT04419181

/ Suspended临床2期IIT

A Feasibility Study of De-escalation of Chemotherapy in Patients with Early-Stage HER2 Positive Breast Cancer

The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.

开始日期2025-08-11

申办/合作机构

University of Rochester

NCT06589830

/ Not yet recruiting临床2期

A Phase 2 Study to Evaluate TL938 Combined With Trastuzumab in Patients With HER2-positive Metastatic Colorectal Cancer

This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.

开始日期2025-07-01

申办/合作机构

苏州韬略生物科技股份有限公司

100 项与曲妥珠单抗相关的临床结果

登录后查看更多信息

100 项与曲妥珠单抗相关的转化医学

登录后查看更多信息

100 项与曲妥珠单抗相关的专利（医药）

登录后查看更多信息

13,987

项与曲妥珠单抗相关的文献（医药）

2025-12-31·Human Vaccines & Immunotherapeutics

Discussion on the mechanism of HER2 resistance in esophagogastric junction and gastric cancer in the era of immunotherapy

Review

作者: Li, Weiling ; Zhao, Jun ; Fan, Wenxuan ; Gao, Yangjun ; Hu, Wenqing ; Su, Fei ; Zhang, Yan ; Zhang, Xiaoling ; Du, Yunyi

Human epidermal growth factor receptor 2 (HER2) is a critical biomarker and therapeutic target in gastric/gastroesophageal junction (G/GEJ) cancers, despite the initial success of HER2-targeted therapies, such as trastuzumab, resistance to these drugs has emerged as a major impediment to effective long-term treatment. This review examines the mechanisms of drug resistance in HER2-positive G/GEJ cancer, the primary mechanisms of resistance explored include alterations in the HER2 receptor itself, such as mutations and changes in expression levels, as well as downstream signaling pathways, and interactions with the tumor microenvironment (TME). Furthermore, the review discusses the Novel therapeutic approaches, including the use of antibody-drug conjugates (ADCs) and combination therapies are assessed for their potential to enhance outcomes. By integrating recent research findings and clinical trials, this review aims to provide oncologists and researchers with insights into developing more effective treatments for patients with drug-resistant HER2-positive G/GEJ cancer.

2025-12-31·mAbs

Hybrid IgE-IgG1 antibodies (IgEG): a new antibody class that combines IgE and IgG functionality

Article

作者: Partington, Leanne ; Grandits, Melanie ; Bax, Heather J. ; Amin, Oliver E. ; Birtley, James ; Devlin, John ; Wilson, Tim ; Palhares, Lais C. G. F. ; Karagiannis, Sophia N. ; FitzGerald, Kevin ; Macleod, Olivia ; Hardaker, Elizabeth

IgG-based anti-cancer therapies have achieved promising clinical outcomes, but, especially for patients with solid tumors, response rates vary. IgE antibodies promote distinct immune responses compared to IgG and have shown anti-tumoral pre-clinical activity and preliminary efficacy and safety profile in clinical testing. To improve potency further, we engineered a hybrid IgE-IgG1 antibody (IgEG), to combine the functions of both isotypes. Two IgEGs were generated with variable regions taken from trastuzumab (Tras IgEG) and from a novel anti-HER2 IgE (26 IgEG). Both IgEGs expressed well in mammalian cells and demonstrated IgE-like stability. IgEGs demonstrated both IgE and IgG1 functionality in vitro. A lack of type I hypersensitivity associated with IgEG incubation with human blood is suggestive of acceptable safety. In vivo, IgEGs exhibited distinct pharmacokinetic profiles and produced anti-tumoral efficacy comparable to IgE. These findings highlight the potential of IgEG as a new therapeutic modality in oncology.

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

HER-2 SMASH

Article

作者: Şahin İnan, Zeynep Deniz ; Özkaraca, Mustafa ; Yulak, Fatih ; Altun, Ahmet ; Lacın, Burak Batuhan ; Öztürk, Ayşegül ; Alandağ, Celal

PURPOSE:

Human epidermal growth factor-2 (HER-2) targeted drugs are used in only HER-2 overexpressed cancers. However, only a small portion of these cancer types are HER-2 overexpressed. In this study, we aimed to upregulate HER-2 receptors in MCF-7 breast cancer and HT-29 colon cancer cell cultures, which these cells are not HER-2 upregulated in natural status.

METHODS:

We used a 10-day non-cytotoxic lapatinib dose to upregulate HER-2 receptors. HER-2 levels of these cell lines were tested with ELISA and immunofluorescence tests before and after 10 days of lapatinib administration. After upregulation of HER-2, we administered trastuzumab, and T-DM1 to these cell lines to observe whether there is an increase in anticancer activity. We used a cell viability test to show the cytotoxicity of trastuzumab and T-DM1. Also, we used ELISA and immunofluorescence for HER-2 pathway proteins to understand the mechanism of increased anti-cancer activity.

RESULTS:

We showed that administration of lapatinib for 10 days leads to overexpression of HER-2 receptors on both MCF-7 and HT-29 cells. A significant increase in the cytotoxicity of trastuzumab or T-DM1 was observed after 10 days of lapatinib administration.

CONCLUSION:

We named this method the smash method, which is the volleyball term. In volleyball, the ball is raised while low and quickly hits the ground again, just like we do with the HER-2 receptor. The smash method can switch HER-2 negative or HER-2 low tumors into HER-2 overexpressed, iatrogenically. Thus, we can use her2-targeted therapies in all cancer patients instead of a small portion.

1,831

项与曲妥珠单抗相关的新闻（医药）

2025-05-31

·PipelineReview

ENHERTU® Reduced the Risk of Death by 30% Versus Ramucirumab Plus Paclitaxel as a Second-Line Therapy in Patients with HER2 Positive Unresectable or Metastatic Gastric Cancer in DESTINY-Gastric04 Phase 3 Trial

TOKYO, Japan & BASKING RIDGE, NJ, USA I May 31, 2025 I Positive results from the DESTINY-Gastric04 phase 3 trial showed ENHERTU ® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to ramucirumab plus paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Results will be presented today as a late-breaking oral presentation ( LBA #4002 ) at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting and simultaneously published in The New England Journal of Medicine . ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). In the primary endpoint analysis of OS, ENHERTU reduced the risk of death by 30% versus ramucirumab plus paclitaxel (hazard ratio [HR]: 0.70; confidence interval [CI]: 0.55-0.90; p=0.0044). Median OS was 14.7 months with ENHERTU (n=246) versus 11.4 months with ramucirumab plus paclitaxel (n=248). In the secondary endpoint analysis of progression-free survival (PFS), ENHERTU demonstrated a 26% reduction in the risk of disease progression or death versus ramucirumab plus paclitaxel (HR: 0.74; 95% CI: 0.59-0.92; p=0.0074) as assessed by investigator. Median PFS was 6.7 months with ENHERTU versus 5.6 months with ramucirumab plus paclitaxel. A confirmed objective response rate (ORR) of 44.3% (95% CI: 37.8-50.9) was seen in patients treated with ENHERTU with seven complete responses (CR) and 97 partial responses (PR) versus an ORR of 29.1% (95% CI: 23.4-35.3) with three CRs and 66 PRs in the ramucirumab plus paclitaxel arm (p=0.0006). Median duration of response (DOR) was 7.4 months (95% CI: 5.7-10.1) in the ENHERTU arm and 5.3 months (95% CI: 4.1-5.7) in the ramucirumab plus paclitaxel arm. Disease control rate (DCR) was 91.9% (95% CI: 87.7-95.1) with ENHERTU versus 75.9% (95% CI: 70.0-81.2) with ramucirumab plus paclitaxel. Improvements in OS and PFS with ENHERTU were consistent across subgroups. “Gastric cancer is particularly challenging to treat, especially in the advanced stages where the five-year survival rate remains low,” said Kohei Shitara, MD, Chief, Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan and lead investigator in the DESTINY-Gastric04 trial. “The superior overall survival demonstrated in DESTINY-Gastric04 confirms that ENHERTU could become the global standard of care in the second-line metastatic setting of HER2 positive gastric cancer or gastroesophageal junction cancer.” The safety profile of ENHERTU in DESTINY-Gastric04 was consistent with previous gastric cancer clinical trials with no new safety concerns identified. The most common grade 3 or higher treatment related adverse events occurring in patients treated with ENHERTU were neutropenia (28.7%), anemia (13.9%), thrombocytopenia (8.6%), leukopenia (7.4%) and fatigue (7.0%). Interstitial lung disease (ILD) or pneumonitis occurred in 13.9% of patients treated with ENHERTU and 1.3% treated in the ramucirumab plus paclitaxel arm. In the ENHERTU arm, the majority of ILD or pneumonitis events were low grade (grade 1 [n=7; 2.9%] or grade 2 [n=26; 10.7%]) except for one grade 3 ILD event (0.4%) as determined by an independent adjudication committee. In the ramucirumab plus paclitaxel arm, there were two grade 3 (0.9%) and one grade 5 (0.4%) ILD events. “ENHERTU continues to deliver impressive results with these new data from DESTINY-Gastric04, which represent the first time a HER2 directed medicine has demonstrated a survival benefit in a randomized phase 3 trial in the second-line HER2 positive metastatic gastric cancer setting,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Similar to our strategy in other tumor types, we continue to pursue the development of ENHERTU in earlier stages of gastric cancer and have recently initiated phase 3 trials evaluating ENHERTU as part of a combination regimen as a first-line treatment in patients HER2 positive metastatic disease.” “Patients with HER2 positive metastatic gastric cancer who experience progression after first-line treatment have historically faced poor outcomes,” said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. “These results showed that ENHERTU reduced the risk of death by nearly one-third in patients with previously treated HER2 positive metastatic gastric cancer, reinforcing the benefit of ENHERTU in this setting.” ENHERTU is currently approved in more than 70 countries in the second-line or third-line metastatic setting of HER2 positive gastric cancer based on DESTINY-Gastric01 , a randomized phase 2 trial, and DESTINY-Gastric02 and DESTINY-Gastric06 , two single-arm phase 2 trials. Daiichi Sankyo and AstraZeneca are currently evaluating ENHERTU in the first-line metastatic setting through the DESTINY-Gastric05 and ARETEMIDE-Gastric01 phase 3 trials. The majority of patients in the DESTINY-Gastric04 trial had received no prior treatment with an immune checkpoint inhibitor (84.1% in the ENHERTU arm and 84.7% in the ramucirumab plus paclitaxel arm) and had two or more metastatic sites (70.3% in the ENHERTU arm and 69.8% in the ramucirumab plus paclitaxel arm). Median duration of follow-up was 16.8 months in the ENHERTU arm and 14.4 months in the ramucirumab plus paclitaxel arm. Median treatment duration was 5.4 months (range: 0.7-30.3) with ENHERTU and 4.6 months (range: 0.9-34.9) with ramucirumab plus paclitaxel. Of the patients that discontinued treatment from the ramucirumab plus paclitaxel arm, 52 (21.0%) proceeded to receive ENHERTU and 12 (4.8%) disitamab vedotin post-trial. As of the data cut-off of October 24, 2024, 18.9% of patients receiving ENHERTU and 18.5% receiving ramucirumab plus paclitaxel remained on study treatment. Summary of DESTINY-Gastric04 Primary Analysis Results About DESTINY-Gastric04 DESTINY-Gastric04 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (6.4 mg/kg) versus ramucirumab and paclitaxel in patients with HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen. The primary endpoint is OS. Secondary endpoints include investigator-assessed progression-free survival, objective response rate, duration of response, disease control rate and safety. In March 2025, an Independent Data Monitoring Committee recommended unblinding DESTINY-Gastric04 based on the superior efficacy of ENHERTU seen at a planned interim analysis. DESTINY-Gastric04 enrolled 494 patients in Asia, Europe and South America. For more information about the trial, visit ClinicalTrials.gov . About HER2 Positive Gastric Cancer Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth leading cause of cancer-related death. 1 Approximately one million cases of gastric cancer were diagnosed in 2022. 1 Gastric cancer is associated with a poor prognosis, particularly in advanced stages of the disease where the five-year survival rate is 5% to 10%. 2 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including gastric cancer. 3 Approximately one in five gastric cancers are considered HER2 positive. 3,4 Prior to the results of the DESTINY-Gastric04 trial of ENHERTU, no other HER2 directed medicine has demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial. 5 About ENHERTU ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. ENHERTU (5.4 mg/kg) is approved in more than 80 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. ENHERTU (5.4 mg/kg) is approved in more than 80 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. ENHERTU (5.4 mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that has progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. ENHERTU (5.4 mg/kg) is approved in more than 60 countries worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 ( ERBB2 ) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (6.4 mg/kg) is approved in more than 70 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 , DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (5.4 mg/kg) is approved in Brazil, Israel, Russia, Saudi Arabia, Taiwan, U.K. and the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02 , DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About the ENHERTU Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other anti-cancer therapies across multiple HER2 targetable cancers. 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 DATROWAY ® 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 DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where 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. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which 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, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. Please see accompanying full Prescribing Information , including Boxed WARNINGS, and Medication Guide . 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 www.daiichisankyo.com . SOURCE: Daiichi Sankyo

临床结果临床3期上市批准ASCO会议引进/卖出

2025-05-31

·恒瑞医药

2025 ASCO年会开幕！恒瑞医药15款创新药共70项抗肿瘤领域研究成果精彩亮相

芝加哥当地时间5月31日，2025年美国临床肿瘤学会（ASCO）年会正式开幕。作为国际肿瘤学领域最权威、最具影响力的年度盛会之一，全球顶尖专家齐聚于此，探讨、分享当前国际最前沿的肿瘤学科研成果和肿瘤治疗技术。恒瑞医药已连续15年携重磅研究成果参加ASCO年会。本届年会，恒瑞医药共有72项研究入选，其中创新药研究70项。包括4项口头报告（Oral）、5项快速口头报告（Rapid Oral）、27项壁报展示（Poster）、36项线上发表（Publication Only）[1]。研究成果涵盖消化系统肿瘤、乳腺癌、肺癌、妇科肿瘤、泌尿肿瘤、黑色素瘤、头颈肿瘤、肉瘤、鼻咽癌、血液肿瘤和硬纤维瘤等十余个肿瘤治疗领域。涉及的创新药包括8款已上市创新产品：注射用卡瑞利珠单抗（艾瑞卡®）、甲磺酸阿帕替尼片（艾坦®）、马来酸吡咯替尼片（艾瑞妮®）、羟乙磺酸达尔西利片（艾瑞康®）、阿得贝利单抗注射液（艾瑞利®）、氟唑帕利胶囊（艾瑞颐®）、注射用瑞康曲妥珠单抗（艾维达®，研发代号：SHR-A1811）、苹果酸法米替尼胶囊（艾比特®），以及7款未上市创新产品：抗PD-L1/TGF-βRII双抗瑞拉芙普-α（SHR-1701）、IL-15融合蛋白SHR-1501、双特异性抗体SHR-2017、全人源抗CTLA-4单克隆抗体SHR-8068、抗体偶联药物（ADC）SHR-1826、SHR-A1912、SHR-A2102。2类新药盐酸伊立替康脂质体注射液（II）（越优力®）及国内首仿药昂丹司琼口溶膜（艾其速®）各有1项研究入选。019项研究入选口头报告和快速口头报告凸显恒瑞硬核研发实力本次ASCO年会，恒瑞医药4项研究入选口头报告，5项研究入选快速口头报告，创新药成果涵盖多个前沿治疗领域，其学术价值与临床意义获得国际同行高度认可，不仅体现了公司在抗肿瘤新药研发领域的国际领先水平，更向全球学术界展示了中国医药创新的硬核实力。由中山大学肿瘤防治中心徐瑞华教授牵头，恒瑞自主研发的靶向c-MET ADC药物SHR-1826治疗实体瘤的一项I期临床研究成功入选口头报告[2]。该研究共纳入116例受试者，其中非小细胞肺癌（NSCLC）受试者72例。44%的受试者既往接受过≥3线的系统性抗肿瘤治疗。在58例可评估的NSCLC患者中，客观缓解率（ORR）达39.7%，疾病控制率（DCR）达94.8%。疗效覆盖不同c-MET表达水平患者。在所有的72例NSCLC中，中位无进展生存期（PFS）为6.8个月（95% CI，4.5–7.2）。该研究结果表明，SHR-1826在重度经治的实体瘤患者中展现出良好的安全性和耐受性；在NSCLC患者中表现出富有前景的抗肿瘤活性和持久缓解的潜力，且疗效不严格依赖于MET的高表达水平，有望进一步研究给广大患者带来新的福音。由上海交通大学附属胸科医院钟华教授、钟润波教授团队开展的一项Nectin-4靶向抗体偶联药物SHR-A2102治疗晚期实体瘤患者的I期研究成功入选口头报告[3]。该研究共纳入369例晚期实体瘤患者，中位年龄59岁；ECOG PS 1分85.6%；64.0%的患者接受过≥2线既往系统性治疗。在304例可评估疗效的患者中，ORR为35.2%（95% CI，29.8-40.9），DCR为84.2%（95% CI，79.6-88.1）。SHR-A2102在多种肿瘤类型中均表现出具有临床意义的抗肿瘤活性，不同亚型NSCLC的ORR为25%-43.5%；三阴性乳腺癌（TNBC）与HR阳性/HER2阴性乳腺癌ORR分别达56%与65%；头颈部鳞状细胞癌（HNSCC）ORR达50%。所有瘤种的DCR为73%-100%，显示出广泛的疾病控制能力。该研究结果表明，SHR-A2102在经多线治疗的实体瘤患者中展现出可控的安全性和广谱抗肿瘤活性。由复旦大学附属肿瘤医院季冬梅教授团队开展的一项瑞康曲妥珠单抗（SHR-A1811）治疗唾液腺癌的研究成功入选口头报告[4]。该研究共纳入33例晚期唾液腺癌患者，其中21例HER2过表达患者ORR为85.7%，DCR为100%；12例HER2低表达患者ORR为30.0%，DCR为100%。没有患者因治疗相关不良事件（TRAE）而停止治疗。该研究结果表明，SHR-A1811在HER2阳性和HER2低表达的晚期唾液腺癌中显示出有希望的疗效，并具有可控的安全性。由海军军医大学第二附属医院（上海长征医院)肖建如教授、杨诚教授团队开展的卡瑞利珠单抗联合阿帕替尼治疗晚期或难治性脊索瘤的单臂、开放标签、Ⅱ期研究成功入选口头报告[5]。该研究共有33例患者纳入疗效与安全性分析。根据RECIST 1.1，7例患者（21.2%，[95% CI，9.0-38.9]）达到部分缓解（PR），6个月DCR为85.2%（23/27），中位PFS为18.1个月（95% CI，11.0-28.5）。根据Choi标准，16例患者（48.5%，[95% CI，30.8-66.5]）达到PR，6个月DCR为77.7%（21/27），中位PFS为15.3个月（95% CI，10.6-NE）。研究结果表明，卡瑞利珠单抗联合阿帕替尼在脊索瘤的治疗中展现出良好的疗效与可控的安全性。02乳腺癌领域：吡咯替尼、达尔西利引领治疗新突破在乳腺癌领域，吡咯替尼、达尔西利、卡瑞利珠单抗、阿帕替尼、阿得贝利单抗、瑞康曲妥珠单抗（SHR-A1811）、SHR-2017，或产品间联合或联合化疗，共有19项研究入选（包括3项快速口头报道和7项壁报展示以及9项线上发表）。其中吡咯替尼占据7项、达尔西利占据6项，进一步巩固其在乳腺癌治疗中的地位。此外，瑞康曲妥珠单抗（SHR-A1811）、阿得贝利单抗相关研究入选快速口头报告，获得业内广泛关注。由复旦大学附属肿瘤医院邵志敏教授团队、天津市肿瘤医院郝继辉教授团队开展的DAWNA-A研究：达尔西利（Dalp）联合内分泌治疗（ET）用于HR+/HER2-早期乳腺癌的III期随机对照研究的首次中期分析结果成功入选快速口头报告[6]。该研究共纳入5274例患者，Dalp+ET组的侵袭性无病生存期（iDFS）显著优于安慰剂+ET组HR=0.56（95% CI，0.43–0.71），iDFS获益在各分层因素及基线亚组中表现一致；次要终点无病生存期（DFS）和远处无病生存期（DDFS）均支持Dalp+ET组的疗效优势。该研究结果表明，在ET治疗的基础上增加联合达尔西利能显著改善iDFS，且安全性可耐受。由河南省肿瘤医院闫敏教授团队牵头开展的瑞康曲妥珠单抗（SHR-A1811）治疗HER2阳性乳腺癌脑转移的最新结果成功入选快速口头报告[7]。该研究评估了SHR-A1811单药或联合贝伐珠单抗治疗HER2阳性乳腺癌脑转移（BCBM）的疗效与安全性。共入组58例患者，96.6%曾接受抗HER2治疗。截至2024年12月31日，确认的颅内ORR：单药组为84.4%，联合用药组为72.7%；两组DCR均为100%；单药组中位PFS为13.2个月，联合用药组尚未成熟。该研究结果表明，SHR-A1811单药或联合贝伐珠单抗均可获得较高的颅内缓解率。由复旦大学附属肿瘤医院张剑教授团队牵头开展的阿得贝利单抗联合贝伐珠单抗及顺铂/卡铂治疗合并脑转移的三阴性乳腺癌（TNBC）患者的II期临床研究成功入选快速口头报告[8]。研究共入组35例伴有活动性脑转移的TNBC患者，所有患者接受阿得贝利单抗、贝伐珠单抗，以及顺铂或卡铂的三联治疗方案。在ITT人群中，中枢神经系统客观缓解率（CNS-ORR）为77.1%，经确认的CNS-ORR为71.4%。在23例发生疾病进展的患者中，69.6%的患者首次进展发生在脑部。中位PFS为7.6个月（95% CI，5.7-11.5），而CNS-PFS为10个月（95% CI，7.4-12.6），中位OS为16个月（95% CI，11.7至未达到）。研究结果表明，阿得贝利单抗联合贝伐珠单抗及顺铂/卡铂展现出良好的颅内抗肿瘤活性，能够延长中枢神经系统无进展生存期（CNS-PFS）和OS，且具有良好的安全性。03消化系统肿瘤领域：卡瑞利珠单抗续写新篇章在消化系统肿瘤领域，卡瑞利珠单抗、阿帕替尼、阿得贝利单抗、SHR-8068等药物，共有30项研究入选（包括8项壁报和22项线上发表）。其中卡瑞利珠单抗占据21项，全面展现其显著特点与潜力，再次成为ASCO舞台焦点之一，续写国产PD-1抑制剂新篇章。此外，近年来在肺癌领域取得一系列突破的阿得贝利单抗也在积极探索新的适应症，本次ASCO大会分别有肝癌、胆管癌、胰腺癌等5项相关研究入选。这些新老药物前沿研究的不断出现，有望为消化系统肿瘤患者带来更多获益！04其他肿瘤领域：多点开花，彰显国际竞争力在肺癌、妇科肿瘤、淋巴瘤、膀胱癌、头颈肿瘤、黑色素瘤、肉瘤、鼻咽癌、脊索瘤、唾液腺癌、胸腺癌、硬纤维瘤、涎腺导管癌等其他多个疾病领域，卡瑞利珠单抗、阿帕替尼、阿得贝利单抗、吡咯替尼、达尔西利、氟唑帕利、法米替尼、瑞康曲妥珠单抗（SHR-A1811）、SHR-1501、瑞拉芙普-α（SHR-1701）、SHR-1826、SHR-A1912、SHR-A2102等抗肿瘤创新药相关研究一共入选了4项口头报告、2项快速口头报告、12项壁报展示和4项线上发表，彰显了恒瑞医药强劲的研发实力。此外，昂丹司琼口溶膜在防治化疗导致的恶心呕吐方面展现出了良好的疗效，本次ASCO年会有1项研究线上发表。由北京大学肿瘤医院宋玉琴教授团队牵头开展的“SHR-A1912联合治疗在B细胞非霍奇金淋巴瘤中的Ib/II期研究”入选大会快速口头报告[9]。剂量递增阶段的结果显示，1.8 mg/kg为SHR-A1912与R-GemOx联合治疗B细胞非霍奇金淋巴瘤的Ⅱ期试验推荐剂量（RP2D）。共有37例复发难治弥漫大B细胞淋巴瘤（DLBCL）患者接受了SHR-A1912 1.8 mg/kg联合R-GemOx方案（利妥昔单抗、吉西他滨、奥沙利铂）治疗（62.2%的受试者对上一线治疗难治，56.8%的受试者为原发难治），ORR为70.3%（95% CI，53.0-84.1），完全缓解率（CRR）为54.1%（95% CI，36.9-70.5），6个月持续缓解率为95.5%(95% CI，71.9-99.3)。研究结果表明，SHR-A1912联合R-GemOx展现出强大的抗肿瘤活性，有望成为复发难治DLBCL患者的新的治疗选择，进一步改善患者的预后。由北京大学肿瘤医院郭军教授团队开展的“卡瑞利珠单抗联合阿帕替尼、替莫唑胺新辅助治疗可切除的Ⅱ/Ⅲ期肢端黑色素瘤：CAP 03-NEO研究”成功入选大会快速口头报告[10]。在研究第一阶段接受手术的28例患者中，16例（57.1%）出现病理缓解，其中7例（25.0%）病理完全缓解（pCR），5例接近pCR，4例病理部分缓解（pPR）。此外，12例患者（42.9%）实现了主要病理缓解（MPR）。截止到2025年4月，中位无事件生存期（EFS）尚未到达，12个月的EFS率为77.6%（95% CI，56.7- 89.3%）。新辅助治疗并未增加手术并发症。该研究结果表明，卡瑞利珠单抗联合阿帕替尼、替莫唑胺新辅助治疗可切除的Ⅱ/Ⅲ期肢端黑色素瘤具有前景，支持该研究进入第二阶段以进一步评估其治疗Ⅲ期患者的疗效与安全性。《“健康中国2030”规划纲要》提出到2030年，要实现总体癌症5年生存率提高15%的战略目标。抗肿瘤药物是癌症患者控制和治疗疾病的重要希望。作为创新型国际化制药企业，恒瑞医药长期坚持“科技为本，为人类创造健康生活”的使命，针对肿瘤等严重威胁人类生命健康的疾病开展科研攻关，已上市的23款创新药中抗肿瘤创新药占比过半。公司另有90多个自主创新产品正在临床开发，近400多项临床试验在国内外开展。恒瑞医药连续15年携创新产品研究成果登上ASCO年会，体现了公司强大的抗肿瘤药物研发实力，也让国际肿瘤学界看到更多中国力量。未来，恒瑞医药将继续坚持“以患者为中心”的理念，力争研制出更多的新药、好药，服务“健康中国”，惠及全球患者。参考来源：[1]https://meetings.asco.org/abstracts-presentations/search?query=*&q=2025%20ASCO%20Annual%20Meeting[2]Phase 1 study of SHR-1826, a c-MET–directed antibody-drug-conjugate (ADC), in advanced solid tumors. ASCO 2025：Oral abstract 106.[3]Phase 1 trial of SHR-A2102, a nectin-4–directed antibody drug conjugate (ADC), in advanced solid tumors. ASCO 2025：Oral abstract 107.[4]SHR-A1811 in HER2-expressing salivary gland cancers: Preliminary efficacy and safety results. ASCO 2025：Oral abstract 6006.[5]Camrelizumab plus apatinib in patients with advanced or refractory chordoma: A single-arm, open-label, phase 2 trial. ASCO 2025：Oral abstract 11503.[6]Dalpiciclib (Dalp) plus endocrine therapy (ET) as adjuvant treatment for HR+/HER2– early breast cancer (BC): The randomized, phase 3, DAWNA-A trial. ASCO 2025：Rapid Oral abstract 515.[7]HER2-ADC trastuzumab rezetecan (SHR-A1811) in HER2-positive breast cancer with brain metastases: Update results from REIN trial. ASCO 2025：Rapid Oral abstract 1017.[8]A phase II clinical study of adebrelimab and bevacizumab combined with cisplatin/carboplatin in triple-negative breast cancer patients with brain metastases. ASCO 2025：Rapid Oral abstract 1018.[9]CD79b-targeted antibody-drug conjugate (ADC) SHR-A1912 in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) in relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL): Data from a phase 1b/2 study. ASCO 2025：Rapid Oral abstract 7013.[10]Neoadjuvant camrelizumab plus apatinib and temozolomide for resectable stage II/III acral melanoma: The CAP 03-NEO trial. ASCO 2025：Rapid Oral abstract 9512.声明：1.本新闻旨在分享学术前沿动态，仅供医疗卫生专业人士基于学术目的参阅，非广告用途。2.恒瑞医药不对任何药品和/或适应症作推荐。3.本新闻中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。撰稿：肿瘤中央医学事务部排版：程梦真责编：李玉莹往期精选| 研发创新 |恒瑞创新药瑞坦宁®获批，用于预防成人高度致吐性化疗引起的急性和迟发性恶心呕吐| 国际化 |恒瑞医药再次与德国默克集团达成合作，推进辅助生殖领域口服GnRH拮抗剂商业化落地恒瑞医药与默沙东就Lp(a)抑制剂HRS-5346签订独家许可协议| 重磅奖项 |喜报！恒瑞医药荣获2023年度国家科技进步奖恒瑞医药连续六年入选全球制药企业50强榜单！| 社会公益 |“健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国恒瑞医药集团向中国扶贫基金会捐赠3000万设立“健康帮扶基金”

ASCO会议临床1期临床结果抗体药物偶联物申请上市

2025-05-31

·GlobeNewswire-Health Care

New data show Roche’s Itovebi significantly extended survival in a certain type of HR-positive advanced breast cancer

The ItovebiTM (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone1The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis2,3New data are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine1 Basel, 31 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive final results from the overall survival (OS) analysis of the phase III INAVO120 study. These data showed ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement in overall survival for people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-resistant, locally advanced or metastatic breast cancer.1 The results are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM).1 "For the first time, a PI3K pathway-targeted drug has shown it can help people with this breast cancer subtype live longer," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Itovebi exemplifies our continued commitment to improve survival rates for people with this common PIK3CA mutation, for whom more effective treatment options are needed.” “The landmark data for the inavolisib-based regimen showed not only a doubling in progression-free survival, but importantly that it extended lives and gave people more time without chemotherapy,” said Professor Nicholas Turner, Lead Study Author and Professor of Molecular Oncology at The Institute of Cancer Research, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, London, United Kingdom. “These results give us confidence that this regimen could become the new standard of care in the first-line setting, having demonstrated a substantial benefit on patient outcomes and quality of life.” The Itovebi-based regimen demonstrated a meaningful OS benefit compared with palbociclib and fulvestrant alone.1 The median OS was 34.0 months (95% CI: 28.4–44.8) for people in the Itovebi arm, compared with 27.0 months (95% CI: 22.8–38.7) in the palbociclib and fulvestrant arm (stratified hazard ratio [HR]=0.67; 95% CI: 0.48–0.94, p-value=0.0190 [boundary=0.0469]).1 The benefit seen in delaying cancer progression was maintained in the updated analysis, with the Itovebi-based regimen showing a consistent improvement in median progression free survival of 17.2 months versus 7.3 months (stratified HR=0.42; 95% CI: 0.32-0.55) in the comparator arm.1 The Itovebi-based regimen also led to a statistically significant improvement in objective response rate (the percentage of patients whose signs of cancer completely disappear or their tumours shrink significantly after treatment) and ad-hoc exploratory analyses showed it substantially delayed time to chemotherapy by approximately two years (stratified HR=0.43; 95% CI: 0.30-0.60).1 No new safety signals were observed at the time of the final OS analysis, with a low discontinuation due to adverse events supporting good tolerability.1 The Itovebi-based regimen is approved in the United States, Switzerland, Canada, Australia, United Arab Emirates and China. In May, it received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), with a final decision regarding the approval expected from the European Commission in the near future. Data from the INAVO120 study are currently under review with other global health authorities. Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations.4-7 We are exploring additional studies in breast cancer and other tumour types with the hope of providing the benefit of this targeted therapy to more people with PIK3CA mutations. About Itovebi TM (inavolisib)Itovebi is an oral, targeted treatment that has been shown to provide well-tolerated and durable disease control in people with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer, who often have a poor prognosis and are in urgent need of new treatment options.2,3,8 Itovebi has been designed to help minimise the overall burden and toxicity of treatment and is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms, and unique mechanism of action that facilitates the degradation of mutated PI3K alpha.9,10 About the INAVO120 studyThe INAVO120 study [NCT04191499] is a phase III, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.4 The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm.4 The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomisation in the clinical trial to the time when the disease progresses, or a patient dies from any cause.4 Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.4 Beyond INAVO120, Itovebi is currently being investigated in three additional company-sponsored phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations:5-7 in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine combination therapy (INAVO121; NCT05646862).in combination with pertuzumab plus trastuzumab for subcutaneous injection (SC) versus pertuzumab plus trastuzumab for SC and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239).in combination with CDK4/6 inhibitor and letrozole versus placebo plus a CDK4/6 inhibitor and letrozole in the first-line setting in PIK3CA-mutated HR-positive/HER2-negative, endocrine-sensitive breast cancer (INAVO123; NCT06790693). About hormone receptor (HR)-positive breast cancerHR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases.11,12 A defining feature of HR-positive breast cancer is that its tumour cells have receptors that attach to one or both hormones – oestrogen or progesterone – which can contribute to tumour growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options.12-14 The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors.3 About Roche in breast cancerRoche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including oestrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.11,12About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Turner NC, et al. INAVO120 Phase III trial final overall survival (OS) analysis of first-line inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC). Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, 2025 May 30-June 03; Chicago, USA. Abstract #1003.[2] Fillbrunn M, et al. PIK3CA mutation status, progression and survival in advanced HR+/HER2- breast cancer: a meta-analysis of published clinical trials. BMC Cancer. 2022;22(1):1002.[3] Anderson E, et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer. Int J Breast Cancer. 2020;2020:3759179.[4] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT04191499. [5] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05646862. [6] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05894239. [7] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123) [Internet; cited 2025 May]. Available from: https://clinicaltrials.gov/study/NCT06790693.[8] Turner NC, et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. NEJM. 2024;391(17):1584-96.[9] Juric D, et al. A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA-mutated hormone receptor-positive/HER2-negative (HR+/HER2–) metastatic breast cancer. Presented at San Antonio Breast Cancer Symposium, 2020 December 7-10; San Antonio, USA. Abstract #P5-17-05.[10] Hong R, et al. GDC-0077 is a selective PI3K alpha inhibitor that demonstrates robust efficacy in PIK3CA mutant breast cancer models as a single agent and in combination with standard of care therapies. Cancer Res. 2018;78(4):4-14.[11] National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2025 May]. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. [12] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696.[13] Tomas R and Barrios CH. Optimal management of hormone receptor positive metastatic breast cancer in 2016. Ther Adv Med Oncol. 2015;7(6):304-20.[14] Galipeau N, et al. Understanding key symptoms, side effects, and impacts of HR+/HER- advanced breast cancer: qualitative study findings. J Patient-Rep Outcomes. 2019;3(1):10. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: bruno.eschli@roche.com Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: kalm.loren@gene.com Attachment 31052025_INAVO120 study Itovebi_en

临床3期临床结果ASCO会议上市批准

100 项与曲妥珠单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D03257	曲妥珠单抗	L01XC03	DB00072

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
HER2阳性结直肠癌	日本	Chugai Pharmaceutical Co., Ltd.	2022-03-28
HER2阳性唾液腺癌	日本	Chugai Pharmaceutical Co., Ltd.	2021-11-25
HER2阳性胃癌	日本	Chugai Pharmaceutical Co., Ltd.	2011-03-10
胃癌	美国	Genentech, Inc.	2010-10-20
乳腺癌	日本	Chugai Pharmaceutical Co., Ltd.	2001-04-04
早期乳腺癌	欧盟	Roche Registration GmbH	2000-08-28
早期乳腺癌	冰岛	Roche Registration GmbH	2000-08-28
早期乳腺癌	列支敦士登	Roche Registration GmbH	2000-08-28
早期乳腺癌	挪威	Roche Registration GmbH	2000-08-28
HER2阳性乳腺癌	欧盟	Roche Registration GmbH	2000-08-28
HER2阳性乳腺癌	冰岛	Roche Registration GmbH	2000-08-28
HER2阳性乳腺癌	列支敦士登	Roche Registration GmbH	2000-08-28
HER2阳性乳腺癌	挪威	Roche Registration GmbH	2000-08-28
HER2阳性胃食管结合部腺癌	欧盟	Roche Registration GmbH	2000-08-28
HER2阳性胃食管结合部腺癌	冰岛	Roche Registration GmbH	2000-08-28
HER2阳性胃食管结合部腺癌	列支敦士登	Roche Registration GmbH	2000-08-28
HER2阳性胃食管结合部腺癌	挪威	Roche Registration GmbH	2000-08-28
HR阳性乳腺癌	欧盟	Roche Registration GmbH	2000-08-28
HR阳性乳腺癌	冰岛	Roche Registration GmbH	2000-08-28
HR阳性乳腺癌	列支敦士登	Roche Registration GmbH	2000-08-28

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
膀胱癌	临床3期	英国	-	2023-03-07
结直肠癌	临床3期	英国	-	2023-03-07
胆囊肿瘤	临床3期	英国	-	2023-03-07
血液肿瘤	临床3期	英国	-	2023-03-07
肺癌	临床3期	英国	-	2023-03-07
卵巢癌	临床3期	英国	-	2023-03-07
胰腺癌	临床3期	英国	-	2023-03-07
前列腺癌	临床3期	英国	-	2023-03-07
唾液腺肿瘤	临床3期	英国	-	2023-03-07
皮肤肿瘤	临床3期	英国	-	2023-03-07

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO2025	N/A	HER2阳性乳腺癌新辅助 \| 辅助	3,300	Trastuzumab-pertuzumab combined with taxanes	鹽齋鹽夢廠衊艱選憲醖(構簾憲艱願窪願齋壓蓋) = 餘醖鑰簾願鹽廠積鑰鬱廠鏇觸顧積醖積憲選選 (願鏇簾壓壓構壓鬱遞網, 14.52 ~ 21.32)	-	2025-05-30
				Trastuzumab-pertuzumab combined with eribulin	遞夢鑰遞範夢網選糧糧(觸觸範鬱齋鑰選繭襯築) = 壓窪願積簾醖製願鑰齋壓願鑰鬱製艱鑰積繭顧 (觸鬱壓積襯簾積顧鹹構, 0.65 ~ 0.85)
ASCO2025	N/A	HER2阳性乳腺癌 HER2 positive	76	Trastuzumab	淵糧鹽憲鬱淵淵衊窪夢(淵觸範範積鹽積鏇夢窪) = 艱壓鹽糧積範選醖積願顧遞襯遞醖鏇網窪淵獵 (憲範選鑰夢構觸窪艱築 ) 更多	-	2025-05-30
NCT04579380 (SGNTUC-019, ESMO_BC 12025 \| ESMO_BC 22025) 人工标引	临床2期	HER2阳性乳腺癌 ERBB2 Mutation (Activating)	31	Tucatinib 300 mg PO BID + Trastuzumab 8 mg/kg IV followed by 6 mg/kg Q3W	憲遞製鹽遞餘醖壓繭鹽(鬱廠網構壓憲廠餘淵簾) = 窪蓋積蓋範鬱顧蓋齋觸鬱衊網齋選繭壓繭遞醖 (餘積獵鏇窪襯築夢顧製, 26.9 ~ 58.2) 更多	积极	2025-05-16
ESMO_BC2025	N/A	药物不良反应	30,179,725	Trastuzumab	簾願鑰膚襯壓範遞獵醖(積鬱餘網選鏇夢選網範) = The PRR was found to be 16.257 ( 5.147; 51.345 ), ROR was 16.259 ( 5.147; 51.357 ) and Chi-Square was 28.102 for fingerprint loss 鬱鏇廠積鬱鏇廠鹽築網 (鏇窪廠壓憲蓋願鹹鬱糧 ) 更多	-	2025-05-14
NCT03161353 (PHERGain, ESMO_BC2025)	临床2期	HER2阳性乳腺癌新辅助 HER2 expression \| HR status	285	HP + endocrine therapy	遞蓋製鹹齋衊繭壓範範(艱夢遞鏇構鏇範鑰願獵) = The 3y-iDFS rate in pts with cT1/T2cN0 tumors was 98.3% (95%CI 96%-100%), with only two (1.7%) recurrences, one locoregional and one distant. 獵鏇鬱選艱製艱構範積 (壓網襯製繭獵願憲衊簾 )	积极	2025-05-14
ESMO_BC2025	N/A	HER2阳性转移性乳腺癌一线 HER2+	58	Trastuzumab and Pertuzumab with Taxanes	憲鑰膚繭簾積製積鏇蓋(憲醖鹽網膚衊窪鏇範簾) = 廠鬱簾艱壓選淵廠蓋顧簾願鏇廠蓋網壓獵簾憲 (構製積繭鬱獵衊壓齋鏇 ) 更多	-	2025-05-14
COPS5 inhibition synergizes the antitumor effect of trastuzumab by PTEN upregulation in HER2 amplified gastric cancer (AACR2025)	N/A	HER2阳性胃癌 HER2	-	COPS5 inhibition with CSN5i-3	餘繭鹽繭鏇積醖憲夢膚(齋淵構鏇糧繭繭憲願糧) = 構糧餘繭繭築築齋壓遞憲鏇艱憲獵鹽膚鬱鹽鏇 (鬱鏇選選顧淵淵壓夢鑰 ) 更多	积极	2025-04-29
				Trastuzumab	餘繭鹽繭鏇積醖憲夢膚(齋淵構鏇糧繭繭憲願糧) = 鑰築網範廠範淵築憲齋憲鏇艱憲獵鹽膚鬱鹽鏇 (鬱鏇選選顧淵淵壓夢鑰 ) 更多
NCT02205047 (INNOVATION, ASCO_GI2025) 人工标引	临床2期	HER2阳性胃癌 HER2 Positive	172	Chemotherapy alone	網齋構壓齋艱繭齋衊膚(窪積積餘範醖鬱憲簾築) = 鏇製蓋衊衊餘鑰鏇製糧窪構鏇壓鬱願壓願顧鬱 (夢積顧鏇選憲艱製簾選 ) 更多	不佳	2025-01-23
				Chemotherapy + Trastuzumab	網齋構壓齋艱繭齋衊膚(窪積積餘範醖鬱憲簾築) = 夢構顧憲構願襯繭醖積窪構鏇壓鬱願壓願顧鬱 (夢積顧鏇選憲艱製簾選 ) 更多
NCT05002127 (ASPEN-06, ASCO_GI2025) 人工标引	临床2/3期	HER2阳性胃食管腺癌 \| HER2阳性胃癌 HER2+	127	EvorpaceptEvorpacept (ALX148) + Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	鬱廠顧窪膚膚範艱餘鏇(膚積獵網鹹衊範顧夢淵) = 艱憲簾鹹觸窪餘淵鬱鏇鬱網襯鹹獵選築憲窪範 (顧窪顧網繭衊憲壓遞鏇 ) 更多	积极	2025-01-23
				Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	鬱廠顧窪膚膚範艱餘鏇(膚積獵網鹹衊範顧夢淵) = 範夢衊憲積獵鏇選簾選鬱網襯鹹獵選築憲窪範 (顧窪顧網繭衊憲壓遞鏇 ) 更多
JPRN-jRCTs031180006 (JCOG1301C \| Trigger, ASCO_GI2025) 人工标引	临床2期	HER2阳性胃癌 \| HER2阳性胃食管结合部腺癌辅助 HER2 Positive	46	S-1/cisplatin	鹹鬱艱觸淵窪願鑰繭鑰(衊鑰糧顧齋網膚淵遞選) = 網繭艱範製顧網鬱衊選襯範艱範膚壓壓齋齋齋 (鏇願範顧網艱網獵膚選 ) 更多	积极	2025-01-23
				S-1/cisplatin + Trastuzumab	鹹鬱艱觸淵窪願鑰繭鑰(衊鑰糧顧齋網膚淵遞選) = 獵艱鏇廠簾觸窪製簾鹹襯範艱範膚壓壓齋齋齋 (鏇願範顧網艱網獵膚選 ) 更多