This study is to explore the efficacy and safety of the first-line treatment of HER2 positive recurrent/metastatic breast cancer with Inetetamab combined with Pertuzumab or Pyrotinib combined with chemotherapy, hoping to have better clinical benefits and provide a new treatment mode for targeted treatment.

开始日期2024-10-17

申办/合作机构

Sun Yat-Sen Memorial Hospital

NCT06578299 / Not yet recruiting临床4期IIT

The Real World Study of First Line Treatment of HER2 Positive Recurrent/Metastatic Breast Cancer With Inetetamab Combined With Paclitaxel With/Without Pertuzumab（INTPOWER）

This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic characteristics, efficacy and safety. The results of this study are helpful to further understand the efficacy and safety of HER2 positive patients with recurrent/metastatic breast cancer who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab in the first line, and help clinical decision-making.

开始日期2024-08-30

申办/合作机构

复旦大学

NCT05980208 / Not yet recruitingN/AIIT

A Real-world Study of Inetetamab for First-line Treatment of HER2-positive Inoperable Locally Advanced or Relapsed Metastatic Breast Cancer

This is a prospective, multicenter, real-world study aimed at evaluating the efficacy and safety of inetetamab+chemotherapy or inetetamab+pyrotinib+chemotherapy or inetetamab+pertuzumab+chemotherapy in the treatment of HER2 positive inoperable locally advanced or recurrent metastatic breast cancer. The research results will provide new targeted treatment strategies for HER2 positive breast cancer patients.

开始日期2023-09-01

申办/合作机构

湖南省肿瘤医院

100 项与伊尼妥单抗相关的临床结果

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100 项与伊尼妥单抗相关的转化医学

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100 项与伊尼妥单抗相关的专利（医药）

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项与伊尼妥单抗相关的文献（医药）

2024-11-06·Journal of Translational Internal Medicine

Inetetamab for injection in combination with vinorelbine weekly or every three weeks in HER2-positive metastatic breast cancer: A multicenter, randomized, phase II clinical trial

Article

作者: Gan, Lu ; Cao, Wenming ; Xie, Ning ; Chen, Yuru ; Shao, Xiying ; Chen, Shaoping ; Yang, Xiuli ; Wang, Xiaojia ; Zheng, Yabing ; Wang, Xinshuai ; Ouyang, Quchang ; Yang, Hua ; Chen, Zhanhong ; Huang, Jian

AbstractObjectiveWe aimed to investigate the pharmacokinetics, safety, efficacy, and immunogenicity of different dosing regimens (weekly and every three weeks) of inetetamab in combination with vinorelbine in human epidermal growth factor receptor 2 (HER2)+ patients with metastatic breast cancer who had received one or more chemotherapy regimens.MethodsHER2+ patients with metastatic breast cancer who had received one or more chemotherapy regimens were included. Eligible patients received inetetamab administered weekly or every three weeks in combination with vinorelbine injection chemotherapy. Pharmacokinetics, safety, efficacy, and immunogenicity were compared between the groups.ResultsSixty HER2+ patients were randomized into a single-week administration group ( n = 29) and a three-week administration group ( n = 31). After the final dose in the single-week administration group and the three-week administration group, the mean Cmax values were 79.773 μg/mL and 146.083 μg/mL; the mean Cmin values were 30.227 μg/mL and 11.926 μg/mL; the mean AUCtau values were 7328.443 μg·h/mL and 22647.101 μg·h/mL; and the mean Cav values were 43.622 μg/ mL and 44.935 μg/mL, respectively. The best overall response (BOR) rates at 24 weeks and unconfirmed BOR rates at 24 weeks were both 40.7% in the single-week dosing group and 40.7% in the three-week dosing group, and the 24-week confirmed disease control rates (DCRs) were 88.9% and 81.5%, respectively. The incidence of adverse events (AEs) was generally consistent across all levels.ConclusionThere were slight differences in the mean Cmax, Cmin, AUCtau and Cav between the three-week dosing group and the single-week dosing group, and the mean steady-state concentrations of Cav were comparable; however, there were no differences in efficacy, safety or immunogenicity between the two groups.

2024-10-01·Cancer Innovation

Inetetamab combined with sirolimus and chemotherapy for the treatment of HER2‐positive metastatic breast cancer patients with abnormal activation of the PI3K/Akt/mTOR pathway after trastuzumab treatment

Article

作者: Liu, Feng ; Ma, Fei ; Zhao, Jiuda ; Sun, Jing ; Li, Chenghui ; Li, Qiao ; Lv, Dan ; Wang, Mengyuan ; Sun, Xiaoying ; Shi, Yehui ; Cai, Li

AbstractBackgroundWe explored the efficacy and safety of inetetamab combined with sirolimus and chemotherapy for the treatment of human epidermal factor receptor 2 (HER2)‐positive metastatic breast cancer patients with abnormal activation of the PI3K/Akt/mTOR (PAM) pathway after trastuzumab treatment.MethodsFor this prospective multicenter clinical study, HER2‐positive metastatic breast cancer patients with PAM pathway mutations confirmed by histology or peripheral blood genetic testing were enrolled from July 2021 to September 2022. Patients were randomly assigned to a trial or control group. The patients in the trial group received inetetamab combined with sirolimus and chemotherapy, while the control group patients received pyrotinib and chemotherapy. The RECIST v1.1 standard was used to evaluate efficacy. Descriptive statistics were used to summarize the clinicopathological features, and the Kaplan–Meier method was used to generate survival curves. The log‐rank test was used to compare progression‐free survival (PFS) between the two groups.ResultsA total of 59 HER2‐positive metastatic breast cancer patients with abnormal activation of the PAM pathway were included, of which 37 received inetetamab combined with sirolimus and chemotherapy treatment and 22 received pyrotinib and chemotherapy treatment. The median PFS was 4.64 months in the inetetamab group and 5.69 months in the pyrotinib group, with no statistically significant difference (p = 0.507). The objective response rates were 27.3% for the inetetamab group and 29.4% for the pyrotinib group. The safety assessment indicated that the adverse event (AE) incidences were 86.1% (31/36) in the inetetamab group and 78.9 (15/19) in the pyrotinib group, with 9 (25%) and four (21.1%) Grade 3/4 AEs in the inetetamab and pyrotinib groups, respectively.ConclusionsFor metastatic HER2‐positive breast cancer patients with abnormal PAM pathway activation and previous trastuzumab treatment, the combination of inetetamab with sirolimus and chemotherapy is equivalent to the combination of pyrotinib and chemotherapy. Therefore, this regimen could be a treatment option for PAM pathway‐activated metastatic HER2‐positive breast cancer patients.

2024-05-01·Current Cancer Drug Targets

The Efficacy and Safety of Inetetamab and Pyrotinib in Combination with Vinorelbine for Second-line Therapy and Beyond in HER2-positive Metastatic Breast Cancer: A Single-institution Clinical Experience

Article

作者: Chen, Kan ; Hong, Yi ; Chen, Mulan ; Lin, Lin ; Wang, Lili ; Li, Chongyin ; Liu, Jian ; Chen, Xinhua ; Wu, Fan ; Huang, Weiwei ; Wu, Xiufeng ; Li, Nani

Background and Objective:This study aimed to observe the efficacy and safety of inetetamab and pyrotinib in combination with vinorelbine in second-line therapy and beyond in HER2-positive metastatic breast cancer (MBC).Methods:Patients with HER2-positive MBC admitted to our hospital from January 2016 to December 2021 were selected. For patients who could not receive antibody‒drug conjugates (ADCs) during second-line (2nd-line) or third-line and beyond (≥ 3rd-line) anti-HER2 therapy, inetetamab + pyrotinib + vinorelbine was used for treatment until unacceptable adverse events occurred or the disease progressed, as evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 every 2 cycles. The progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR), and adverse reactions were recorded. Multivariate Cox regression analysis was performed to explore the prognostic factors influencing the curative effect.Results:Overall, 52 patients were included; 13 patients received 2nd-line treatment, and 39 patients received ≥ 3rd-line treatment. The median PFS (mPFS) for all patients treated with inetetamab + pyrotinib + vinorelbine was 7 months. The mPFS of the 2nd-line subgroup was significantly better than that of the ≥ 3rd-line subgroup (17 vs. 5 months, P = 0.001). The mPFS of the subgroups that received trastuzumab (H) or trastuzumab and pertuzumab (HP) only was significantly better than that of the H or HP and tyrosine kinase inhibitor (TKI) subgroups (8 vs. 5 months, P = 0.030). The mPFS of the HER2 resistance subgroup was better than that of the HER2 refractoriness subgroup (14 vs. 7 months, P = 0.025). Cox regression analysis showed that the treatment line (2nd-line more so than ≥ 3rd-line) was an independent prognostic factor for PFS. In addition, the ORR and CBR of 2nd-line patients were significantly higher than those of ≥ 3rd-line patients (69.2% vs. 30.8% and 92.3% vs. 64.1%, respectively). The most common hematological toxicities were leukopenia and neutropenia, and the most common nonhematological toxicity was diarrhea.Conclusion:Inetetamab and pyrotinib in combination with vinorelbine have good efficacy in ≥ 2nd-line treatment of HER2-positive MBC with controllable toxicity, and the combination is a new treatment option, especially for patients who cannot use ADCs in 2nd-line treatment.

项与伊尼妥单抗相关的新闻（医药）

2024-11-19

·医药笔记

三生国健：IL-17抗体申报上市

▎Armstrong 2024年11月19日，三生国健IL-17A抗体的上市申请获得NMPA受理，用于治疗斑块性银屑病。三生国健已经全面转型自免赛道，已有益赛普、健尼哌、赛普汀三款产品上市。 608为三生国健自主研发的IL-17A抗体，后续强直性脊柱炎、非放射性中轴性脊柱关节炎的二期临床也在高效入组过程中。三生国健后续布局的自免管线还有IL-4R抗体、IL-5抗体、IL-1β抗体、BDCA2抗体等。总结诺华IL-17A抗体Cosentyx 2023年的销售额为50亿美元，国内方面，智翔金泰、恒瑞医药的IL-17A抗体已经获批上市。此外，康哲药业的IL-23抗体已经获批上市，康方生物的IL-12/IL-23抗体、百奥泰的乌司奴单抗、信达生物的IL-23抗体已经申报上市。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

抗体药物偶联物上市批准

2024-11-18

·恒瑞医药

2024 SABCS前瞻︱恒瑞医药创新药26项乳腺癌领域研究将闪耀国际学术盛会

2024年第47届圣安东尼奥乳腺癌研讨会（SABCS）将于12月10日至13日在美国圣安东尼奥举行。作为乳腺癌研究领域规模最大、最负盛名的学术盛会之一，SABCS旨在为国际学术界、医生和研究人员提供乳腺癌及癌前乳腺疾病的实验生物学、病因学、预防、诊断和治疗的最新相关信息。本次大会，恒瑞医药共有人表皮生长因子1/2/4（HER1/HER2/HER4）靶向药物吡咯替尼、CDK4/6抑制剂达尔西利、PD-1抑制剂卡瑞利珠单抗、多靶点受体酪氨酸激酶抑制剂法米替尼、TPO受体激动剂海曲泊帕、PARP抑制剂氟唑帕利、VEGFR2抑制剂阿帕替尼、HER2抗体偶联药物（ADC）SHR-A1811等8款创新药的26项研究入围[1]，其中3项口头报告，3项壁报焦点（Poster Spotlight），20项壁报展示。本文特做梳理，一同浏览恒瑞医药在乳腺癌领域的系列重磅创新成果。 1. 摘要号：GS3-06 文章题目：卡瑞利珠单抗联合化疗新辅助治疗早期或局部晚期三阴性乳腺癌：一项随机、双盲、III期试验 Neoadjuvant camrelizumab plus chemotherapy (chemo) for early or locally advanced triple-negative breast cancer (TNBC): a randomized, double-blind, phase 3 trial 汇报形式：口头报告作者：邵志敏单位：复旦大学附属肿瘤医院 2. 摘要号：GS1-03 文章题目：吡咯替尼或安慰剂联合曲妥珠单抗与多西他赛用于未经治疗的转移性HER2阳性乳腺癌：III期PHILA试验的无进展生存（PFS）预设最终分析 Pyrotinib or placebo in combination with trastuzumab and docetaxel for untreated HER2-positive metastatic breast cancer (mBC): prespecified final analysis of progression-free survival (PFS) of the phase 3 PHILA trial 汇报形式：口头报告作者：徐兵河单位：中国医学科学院肿瘤医院 3. 摘要号：GS1-04 文章题目：HER2靶向抗体药物偶联物SHR-A1811新辅助治疗HER2阳性早期乳腺癌：一项前瞻性、随机、开放标签的II期试验 HER2-Directed Antibody-Drug Conjugate SHR-A1811 in the Neoadjuvant Treatment of HER2-positive Early Breast Cancer: a Prospective, Randomized, Open-label, Phase 2 Trial 汇报形式：口头报告作者：李俊杰单位：复旦大学附属肿瘤医院 4. 摘要号：PS2-01 文章题目：达尔西利联合来曲唑或阿那曲唑作为一线治疗HR+/HER2-晚期乳腺癌：III期DAWNA-2试验无进展生存（PFS）预设的最终分析 Dalpiciclib versus placebo in combination with letrozole or anastrozole as first-line treatment for women with HR+/HER2- advanced breast cancer: prespecified final analysis of progression-free survival of the phase 3 DAWNA-2 trial 汇报形式：焦点壁报作者：徐兵河单位：中国医学科学院肿瘤医院 5. 摘要号：PS3-07 文章题目：SHR-A1811新辅助治疗HR阳性、HER2低表达乳腺癌患者：一项开放标签、单臂、二阶段II期临床试验的第一阶段结果 SHR-A1811 as Neoadjuvant Treatment in Patients with HR-Positive, HER2-low Breast Cancer: The first-stage results from an open-label, single-arm, two-stage, phase II clinical trial 汇报形式：焦点壁报作者：刘真真单位：河南省肿瘤医院 6. 摘要号：PS8-08 文章题目：SHR-A1811（一种抗HER2 ADC）在391例经多线治疗的HER2表达或突变的晚期实体瘤中的疗效与安全性：一项全球多中心首次人体临床I期研究 Efficacy and safety of SHR-A1811, an anti-HER2 antibody-drug conjugate (ADC), in 391 heavily pretreated multiple solid tumors with HER2-expression or mutations: a global, multi-center, first-in-human, phase 1 study 汇报形式：焦点壁报作者：姚和瑞单位：中山大学孙逸仙纪念医院 7. 摘要号：P1-02-12 文章题目：海曲泊帕治疗乳腺癌患者癌症治疗引起的血小板减少症的疗效与安全性：一项前瞻性II期研究 Prospective phase II study on the efficacy and safety of hetrombopag for the treatment of cancer therapy-induced thrombocytopenia in patients with breast cancer 汇报形式：壁报展示作者：姜晗昉单位：北京大学肿瘤医院 8. 摘要号：P1-04-12 文章题目：优化吡咯替尼在HER2阳性早期高风险乳腺癌中的耐受性：一项多中心、随机、三队列研究 Optimizing Tolerability of Pyrotinib in HER2-Positive Early-Stage High-Risk Breast Cancer: A Multicenter, Randomized, Three-Cohort Study 汇报形式：壁报展示作者：厉红元、程巧单位：重庆医科大学附属第一医院 9. 摘要号：P1-05-24 文章题目：SHR-A1811在HER2阳性乳腺癌新辅助治疗中疗效的生物标志物与空间决定因素 Biomarkers and Spatial Determinants of SHR-A1811 Efficacy in Neoadjuvant Treatment for HER2-Positive Breast Cancer 汇报形式：壁报展示作者：邵志敏单位：复旦大学附属肿瘤医院 10. 摘要号：P1-06-01 文章题目：卡瑞利珠单抗联合治疗三阴性乳腺癌的疗效与安全性：一项系统性综述与荟萃分析 Efficacy and Safety of Camrelizumab Combination Therapy in Triple-Negative Breast Cancer: A Systematic Review and Meta-Analysis 汇报形式：壁报展示作者：Moazzam Shahzad 11. 摘要号：P2-09-28 文章题目：达尔西利联合内分泌治疗晚期乳腺癌伴内脏危象患者：一项多中心、前瞻性、外部对照II期研究 Dalpiciclib plus endocrine therapy for visceral crisis in advanced breast cancer: a multicenter, prospective, external controlled phase 2 study 汇报形式：壁报展示作者：马飞、莫红楠单位：中国医学科学院肿瘤医院 12. 摘要号：P2-11-06 文章题目：新辅助化疗联合卡瑞利珠单抗对比单纯化疗治疗局部晚期免疫调节型三阴性乳腺癌患者：一项前瞻性、随机、开放标签II期试验 Neoadjuvant chemotherapy plus camrelizumab vs. chemotherapy in patients with locally advanced immunomodulatory triple-negative breast cancer: a prospective, randomized, open-label, phase 2 trial 汇报形式：壁报展示作者：陈力单位：复旦大学附属肿瘤医院 13. 摘要号：P2-12-22 文章题目：口服CDK4/6抑制剂达尔西利联合内分泌治疗在激素受体阳性、HER2阴性女性乳腺癌辅助治疗中的多中心、单臂Ⅱ期临床试验 A multicenter, single arm, phase II clinical trial of oral CDK4/6 inhibitor dalpiciclib in combination with endocrine therapy in adjuvant treatment for hormone receptor positive, HER2 negative female breast cancer 汇报形式：壁报展示作者：欧阳杰单位：东莞东华医院 14. 摘要号：P3-11-24 文章题目：白蛋白紫杉醇联合曲妥珠单抗和吡咯替尼新辅助治疗HER2阳性早期或局部晚期HER2富集亚型乳腺癌：一项多中心、单臂、II期试验 Neoadjuvant Nab-paclitaxel combined with Trastuzumab and Pyrotinib for HER2-enriched subtype of HER2-positive early or locally advanced breast cancer: A multicenter, single-arm, phase 2 trial 汇报形式：壁报展示作者：周文斌单位：江苏省人民医院 15. 摘要号：P3-11-26 文章题目：达尔西利联合来曲唑、帕妥珠单抗和曲妥珠单抗新辅助治疗HR+/HER2+乳腺癌的II期研究 A Phase II study of dalpiciclib combined with letrozole, pertuzumab and trastuzumab as neoadjuvant therapy in HR+/HER2+ breast cancer 汇报形式：壁报展示作者：曾晓华、梁新瑞单位：重庆市肿瘤医院 16. 摘要号：P3-12-22 文章题目：吡咯替尼、皮下曲妥珠单抗和卡培他滨新辅助治疗HER2阳性早期乳腺癌：一项前瞻性、单臂、多中心研究 Neoadjuvant Therapy with Pyrotinib, Subcutaneous Trastuzumab, and Capecitabine for HER2-Positive Early Breast Cancer: A Prospective, Single-Arm, Multicenter Trial 汇报形式：壁报展示作者：张丽娜单位：天津市肿瘤医院 17. 摘要号：P5-05-02 文章题目：GQ1001（新一代HER2靶向ADC）联合吡咯替尼治疗HER2阳性转移性乳腺癌经治患者的药代动力学特征和初步疗效：一项Ib期临床试验 Pharmacokinetic profile and preliminary efficacy of GQ1001, a next generation HER2-targeting ADC, combined with pyrotinib in pretreated patients with HER2-positive metastatic breast cancer: A phase 1b clinical trial 汇报形式：壁报展示作者：王碧芸单位：复旦大学附属肿瘤医院 18. 摘要号：P5-05-07 文章题目：伊尼妥单抗联合吡咯替尼和卡培他滨/长春瑞滨治疗曲妥珠单抗经治耐药的HER2阳性转移性乳腺癌的前瞻性、多中心、单臂临床研究 A prospective, multicenter, single-arm clinical study of inetetamab combined with pyrotinib and capecitabine/vinorelbine in the treatment of HER2-positive metastatic breast cancer resistant to previous trastuzumab treatment 汇报形式：壁报展示作者：薛妍单位：西安国际医学中心医院 19. 摘要号：P5-05-09 文章题目：德曲妥珠单抗联合吡咯替尼一线治疗HER2阳性不可切除或转移性乳腺癌：一项探索性、多中心、单臂、Ib/II期研究（TROPHY） Trastuzumab deruxtecan combined with pyrotinib in first-line HER2-positive unresectable or metastatic breast cancer: an exploratory, multi-center, single-arm, phase Ib/II study (TROPHY) 汇报形式：壁报展示作者：樊英单位：中国医学科学院肿瘤医院 20. 摘要号：P5-05-14 文章题目：伊尼妥单抗联合吡咯替尼和化疗治疗HER2阳性转移性乳腺癌患者的真实世界治疗模式与临床结果：一项多中心回顾性研究 Real-World Treatment Patterns and Clinical Outcomes of Inetetamab combined with pyrotinib plus chemotherapy in Her-2 positive metastatic breast cancer patients : a multi-center retrospective study 汇报形式：壁报展示作者：周欢欢单位：浙江省肿瘤医院 21. 摘要号：P5-05-24 文章题目：维迪西妥单抗（RC48-ADC）联合吡咯替尼治疗曲妥珠单抗经治的HER2阳性复发或转移性乳腺癌：一项Ib/II期研究 RC48-ADC (Disitamab vedotin, a HER2-directed antibody-drug conjugate) in Combination with Pyrotinib for Trastuzumab-treated HER2-Positive Recurrent or Metastatic Breast Cancer: A Phase Ib/II Study 汇报形式：壁报展示作者：周鑫、梁新瑞单位：重庆市肿瘤医院 22. 摘要号：P5-07-20 文章题目：伊尼妥单抗联合吡咯替尼和白蛋白结合型紫杉醇新辅助治疗HER2阳性早期及局部晚期乳腺癌患者的前瞻性、开放标签、单臂II期临床研究：临床试验最新进展 A prospective, open-label, single-arm phase II clinical study of inetetamab in combination pyrotinib & albumin-bound paclitaxel for neoadjuvant treatment of patients with HER2+ early & locally advanced breast cancer: updates on clinical trial 汇报形式：壁报展示作者：李南林单位：空军军医大学西京医院 23. 摘要号：P5-07-23 文章题目：吡咯替尼联合曲妥珠单抗和芳香化酶抑制剂新辅助治疗HER2+/HR+乳腺癌的疗效与安全性：一项单臂、多中心、II期探索性研究 Efficacy and Safety of Pyrotinib Combined with Trastuzumab and Aromatase Inhibitor in Neoadjuvant Treatment of HER2+/HR+ Breast Cancer: A Single-Arm, Multi-Center Phase II Exploratory Study 汇报形式：壁报展示作者：葛洁单位：天津市肿瘤医院 24. 摘要号：P5-09-17 文章题目：基于SNF分型的多组学精准医学在CDK4/6抑制剂治疗失败的HR+/HER2-晚期乳腺癌中的应用：Linux试验（产品：卡瑞利珠单抗、法米替尼、氟唑帕利、阿帕替尼） Precision medicine based on similarity network fusion (SNF) subtypes of multi-omics in CDK4/6 inhibitor failed HR+/ HER2- advanced breast cancer: the Linux trial 汇报形式：壁报展示作者：邵志敏单位：复旦大学附属肿瘤医院 25. 摘要号：P5-09-28 文章题目：吡咯替尼联合曲妥珠单抗及达尔西利、来曲唑术前治疗早期或局部晚期HR阳性、HER2阳性乳腺癌的Ⅱ期前瞻性探索性临床研究（Chefoo-TP48） A phase Ⅱ, prospective exploratory clinical study of neoadjuvant pyrotinib plus trastuzumab, dalpiciclib, and letrozole for patients with HR-positive, HER2-positive early or locally advanced breast cancer (Chefoo-TP48) 汇报形式：壁报展示作者：乔广东、丛义滋单位：烟台毓璜顶医院 26. 摘要号：P5-09-29 文章题目：曲妥珠单抗联合吡咯替尼和卡培他滨作为HER2阳性早期乳腺癌新辅助治疗后未达病理完全缓解的术后辅助治疗：一项多中心II期研究 Trastuzumab Combined with Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in NonPathological Complete Response HER2-Positive Early Breast Cancer Following Neoadjuvant Therapy: A Multicenter Phase II study 汇报形式：壁报展示作者：王川单位：福建医科大学附属协和医院本次SABCS，恒瑞医药将亮相的8款创新药的26项重磅研究，覆盖了多种乳腺癌亚型，涉及一线、辅助、新辅助等多个疾病阶段适应症人群，将展现公司多款不同作用机制的创新产品布局乳腺癌治疗领域的实力，也将向世界展示中国乳腺癌领域的研发创新力量。作为创新型国际化制药企业，恒瑞医药多年来深入践行“科技为本、为人类创造健康生活”的使命，针对高发肿瘤领域持续进行创新研发，已在国内获批上市17款1类创新药、4款自研2类新药。未来，恒瑞医药将继续坚持“以患者为中心”的理念，重创新，强研发，力争研制出更多更好的新药，努力守护患者健康生活和生命质量。参考资料： 1.https://sabcs.org/FullProgram 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：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 | 慢病创新里程碑！恒瑞首个自免创新药夫那奇珠单抗获批上市恒瑞医药新突破！中国首个自研阿片类镇痛创新药富马酸泰吉利定获批上市 | 国际化 | 海外BD再传捷报！恒瑞医药GLP-1类创新药组合实现海外许可恒瑞医药与默克达成合作，携手推进癌症创新疗法 | 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”

临床3期临床结果抗体药物偶联物临床2期临床成功

2024-11-14

·ioncology

2024 ESMO ASIA丨一文纵览上消化道肿瘤领域精彩壁报！

编者按 2024年欧洲肿瘤内科学会亚洲年会（ESMO ASIA 2024）将于当地时间12月6~8日在新加坡召开，届时将公布多项全球及亚太地区的最新科研和临床进展，进一步推动领域内的学术交流。目前大会官网已披露了摘要标题，《肿瘤瞭望消化时讯》特此整理了食管癌、胃癌、胰腺癌等上消化道肿瘤领域的摘要标题，带您快速浏览大会的精彩资讯！胃癌 183P-HER2过表达或无过表达时胃腺癌对新辅助化疗的反应：一项前瞻性观察研究作者：Pratap K.Deb（印第安纳州加尔各答） 157P-腹膜转移胃癌分化轨迹和耐药特征的单细胞表征作者：Haoxin Peng（中国北京） 158P-SOX方案联合伊尼妥单抗一线治疗HER2阳性晚期胃癌的最新疗效与安全性作者：Ying Kong（中国济南） 159P-B细胞的空间组织在胃癌预测和预后中的作用作者：Ryan Tay（新加坡） 160P-胃癌腹膜转移的腹膜生态位进化和微环境重塑作者：Joseph J.Zhao（新加坡） 161P-评估口服维生素B12治疗胃癌患者全胃切除术后维生素B12缺乏症的多中心随机对照试验的Ⅱ期研究作者：Three Aoyama（日本横滨） 162P-围手术期FLOT治疗胃癌和胃食管交界处癌实现PCR的疗效：单机构经验的回顾性分析作者：Xue Ru Ting（乔治市，MY） 163P-腹腔镜辅助胃切除术和常规胃切除术胃癌患者术后饮食摄入量的比较作者：Junya Morita（日本横滨） 164P-一项评估安罗替尼联合特瑞普利单抗作为一线方案治疗PS 2晚期胃癌患者的疗效和安全性的开放标签、单臂、Ⅱ期试验作者：刘可（中国上海） 165P-局部晚期胃癌新辅助治疗后病理完全缓解的预后分析：一项全国性、多中心、回顾性研究作者：Jie Chen（中国上海） 166P-幽门螺杆菌感染胃癌样本中CHOP、GRP94和干性状态之间的相互作用作者：Fatemeh Alizadeh（马什哈德，爱尔兰） 167P-与老年Ⅱ/Ⅲ期胃癌患者早期复发相关的因素：一项回顾性队列研究作者：Yu-Hsuan Shih（台中市） 168P-肌肉减少症作为接受手术和辅助化疗的Ⅱ~Ⅲ期胃癌患者的预后指标作者：Jeong Eun Kim（韩国光明） 169P-真实世界研究中PD-1抑制剂、曲妥珠单抗和一线化疗治疗HER-2阳性晚期胃癌的疗效和预后作者：刘宝瑞（中国南京） 170P-通过多模式血浆游离DNA分析鉴别恶性和良性胃病变作者：Ho D.Vo（越南胡志明市） 171P-一项关于80岁及以上Ⅱ/Ⅲ期胃癌患者辅助S-1化疗的多中心调查作者：Ai Harinauchi（日本） 172P-环状RNA谱确定circATXN1失调可作为胃癌的一个增殖因子和预后标志物作者：Jie Chen（中国上海） 173P-胃腺癌位置重要吗？来自单个肿瘤中心的回顾性研究作者：Alaaeldin Shablak（英国南安普敦） 175P-副干酪乳杆菌ZJUZ2-3通过3-IAA抑制NF-κB通路来抑制胃肿瘤发生作者：Rui Yang（中国杭州） 176P-DHX9及其靶基因AURKA通过PI3K/AKT和TNF信号通路在胃癌中的功能和机制作者：Zuhua Chen（中国武汉） 177P-HGF介导的MAP17在胃癌细胞增殖和转移中的重要作用作者：ByeongIl Jang（韩国大邱）食管癌 178P-KEYNOTE-859研究更新：帕博利珠单抗+化疗治疗晚期HER2阴性胃癌或胃食管结合部（G/GEJ）癌作者：Lina Yin（美国凯尼尔沃思） 179P-个性化微小残留病分析可预测接受根治性放疗的食管癌的预后作者：Lin-Rui Gao（中国北京） 180P-微创海绵细胞学检查在食管鳞状细胞癌和胃贲门腺癌筛查中的应用评估作者：Zhiyuan Fang（中国北京） 181P-围手术期亚叶酸、奥沙利铂、多西紫杉醇和S-1（LOTS）治疗局部晚期胃癌或胃食管结合部腺癌的疗效、安全性及游离DNA分析：一项前瞻性Ⅱ期试验作者：Chih Chieh Yen（台南市中环） 182P-东亚地区HER2阳性局部晚期或转移性胃或胃食管结合部腺癌患者的真实世界治疗模式作者：Do-Youn Oh（韩国首尔） 144P-辅助放化疗在食管角化鳞状细胞癌治疗中的作用作者：Mohamed Z.Elkarany（亚历山大市，EG） 186P-每周对比每月新辅助顺铂和氟尿嘧啶放化疗方案在局部区域食管鳞状细胞癌中的疗效和安全性作者：Cheng-Lun Lai（台湾台中市） 187P-卡瑞利珠单抗在晚期食管癌中的有效性、安全性和使用模式：基于来自三项前瞻性观察性队列研究的987例患者的个体病例数据（IPD）汇总分析作者：鲁智豪（中国北京） 188P-原发肿瘤和淋巴结病理消退对新辅助化疗免疫治疗后局部晚期食管鳞状细胞癌患者复发和生存率的影响作者：Yixin Li（中国南京） 189P-NC18（一种新型HER2靶向ADC）对Enhertu耐药CDX模型的优越的抗肿瘤活性作者：Zhi Li（中国北京） 190P-替雷利珠单抗治疗食管癌的系统评价和荟萃分析作者：Hashim Talib Hashim（Karbala） 191P-来自印度南部的资源有限环境中接受多模式治疗的非转移性癌食管患者的真实世界数据作者：Ravi Teja R.Matta（印第安纳州拉贾蒙德里） 192P-探索氯硝柳胺在食管鳞状细胞癌中对EHMT2的调节作用作者：I-Chen Wu（台湾高雄市） 193P-DCLK1的激酶活性驱动其在食管鳞状细胞癌中的促干性作用作者：Yuping Yang（中国福州） 194P-呋喹替尼联合S-1治疗一线免疫治疗失败后ESCC患者的剂量探索结果更新作者：Ningning Li（中国北京） 195P-miR-10a-5p靶向TFAP2C促进食管癌的顺铂耐药作者：Kiran Pasbola（印第安纳州新德里） 196P-可切除胃和胃食管结合部癌的围手术期FLOT+免疫治疗的系统评价和荟萃分析作者：Lorenz Fort E.Revillas（奎松市，菲律宾） 198P-新辅助多西他赛加顺铂、5-FU治疗可切除局部晚期食管鳞状细胞癌后，辅助纳武利尤单抗治疗的疗效和安全性作者：Nozomu Ogura（日本） 244P-基因组分析检测对胃肠道神经内分泌癌治疗结果的影响作者：Toshiki Ozato（日本冈山） 263TiP-TroFuse-015：TROP2定向抗体-药物偶联物sac-TMT对比医生选择的方案治疗经治转移性胃食管腺癌的Ⅲ期研究作者：Kohei Shitara（日本） 264TiP-一项评估德曲妥珠单抗（trastuzumab deruxtecan，T-DXd）联合rilvegostomig和化疗治疗HER2阳性（HER2+）和HER2低表达的胃或胃食管结合部腺癌（GEJA）患者的Ⅰb/Ⅱ期开放标签研究：DESTINY-Gastric03研究第4部分作者：Yelena Y.Janjigian（美国纽约） 265TiP-Ⅰ/Ⅱ期开放标签、伞式平台设计的研究药物联合或不联合pembrolizumab和/或化疗对既往接受过PD-（L）1抑制剂治疗的晚期食管癌患者的研究：KEYMAKER-U06子研究作者：Sean Kato（日本） 266TiP-替雷利珠单抗联合S-1对于新辅助免疫化疗后根治性切除术后残留原发病灶和淋巴结阴性食管鳞状细胞癌患者的疗效：一项Ⅱ期多中心试验（PPIO-008）作者：Yingjian Wang（中国重庆） 267TiP-CHAPTER-GIST-101：pimitespib联合伊马替尼治疗伊马替尼难治性胃肠道间质瘤患者的Ⅰ期研究作者：WeiPeng Yong（新加坡）胰腺癌 250P-评估液体活检衍生的循环肿瘤DNA（ctDNA）作为预测生物标志物对早期胰腺癌治疗反应的影响作者：Hashim Talib Hashim（Karbala） 252P-XELOXIRI方案在不可切除胰腺导管腺癌患者中的安全性和有效性作者：Biyang Cao（中国北京） 253P-预后营养指数是接受新辅助化疗和手术切除的胰腺癌患者继续S-1辅助化疗的独立危险因素作者：Shinnosuke Kawahara（日本横滨） 255P-NALLONG研究的亚洲队列中既往接受过脂质体伊立替康治疗的转移性胰腺导管腺癌长期幸存者的真实世界结果作者：Chang hoon Yoo（韩国首尔） 256P-胰腺导管腺癌中的PIK3CA突变作者：Omali Pitiyarachchi（澳大利亚兰德威克） 257P-“H”至“H”精准新辅助化疗可提高胰腺癌的可切除率作者：Yonggang He（中国重庆） 258P-真实世界背景下晚期胰腺癌患者治疗方案和总生存期的当前趋势作者：Hiroshi Imaoka（日本） 259P-伊立替康脂质体为基础的方案在中国晚期胰腺癌患者中的应用：一项前瞻性、多中心、观察性真实世界研究作者：Jin Xu（中国上海） 260P-NALIRIFOX作为基于吉西他滨的化疗后转移性胰腺癌的后续治疗：单中心真实世界经验作者：Hisn-Chen Lin（台湾嘉义市）（来源：肿瘤瞭望消化时讯）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床2期放射疗法

100 项与伊尼妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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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
乳腺癌	中国	三生国健药业（上海）股份有限公司	2020-06-17

未上市

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适应症	最高研发状态	国家/地区	公司	日期
HER2阳性乳腺癌	临床2期	中国	三生国健药业（上海）股份有限公司	2023-03-24
肿瘤	临床2期	中国	三生製藥	2022-01-30

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05749016 (ESMO2024) 人工标引	临床2期	HER2阳性乳腺癌新辅助	39	Inetetamab + Pertuzumab + Paclitaxel + Carboplatin (TCbIP)	(鬱構淵糧憲壓襯襯憲淵) = 願鑰獵憲遞鏇淵鹽繭網壓鑰醖範壓製憲憲簾繭 (簾範醖網憲鹹膚夢夢淵 ) 更多	积极	2024-09-16
				Inetetamab + Pertuzumab + Paclitaxel + Carboplatin (TCbIP) (hormone receptor negative)	(鬱構淵糧憲壓襯襯憲淵) = 構廠構憲夢願範築繭選壓鑰醖範壓製憲憲簾繭 (簾範醖網憲鹹膚夢夢淵 )
NCT05749016 (Pubmed) 人工标引	临床2期	晚期 HER2 阳性乳腺癌新辅助	-	Inetetamab + Pertuzumab + Taxanes + Carboplatin (TCbIP)	(夢顧鏇醖窪獵淵範簾襯) = 憲網積廠觸憲襯鏇遞淵醖窪憲醖憲構淵壓壓鹽 (襯襯糧襯醖遞艱衊蓋製 ) 更多	积极	2024-07-22
				Trastuzumab + Pertuzumab + Taxanes + Carboplatin (TCbHP)	(夢顧鏇醖窪獵淵範簾襯) = 蓋壓餘襯網築壓齋簾襯醖窪憲醖憲構淵壓壓鹽 (襯襯糧襯醖遞艱衊蓋製 ) 更多
NCT05749016 (ASCO2024) 人工标引	临床2期	晚期 HER2 阳性乳腺癌新辅助	28	Inetetamab + Pertuzumab + Paclitaxel + Carboplatin (TCbIP)	(繭夢顧鬱積齋選鹹網糧) = 齋積襯鏇積夢構鬱壓獵鑰簾艱鹹鹽鏇繭選選鬱 (糧艱艱淵窪夢齋選構鏇 ) 更多	积极	2024-05-24
				Trastuzumab + Pertuzumab + Paclitaxel + Carboplatin (TCbHP) (propensity score matching)	(繭夢顧鬱積齋選鹹網糧) = 鏇蓋築築蓋構選淵鹽膚鑰簾艱鹹鹽鏇繭選選鬱 (糧艱艱淵窪夢齋選構鏇 ) 更多
ASCO2024	N/A	HER2阳性转移性乳腺癌 HER2-positive	500	Inetetamab	(願廠淵醖壓餘夢壓艱顧) = 31.4% 餘夢醖顧夢鬱艱鬱顧遞 (鬱積餘積積鹹淵鑰窪艱 ) 更多	积极	2024-05-24
				Inetetamab+Tyrosine Kinase Inhibitors+Chemotherapy
NCT03321981 (CTgov)	临床2期	HER2阳性乳腺癌 \| 转移性乳腺癌 \| ER阳性HER2低表达乳腺癌	105	Zenocutuzumab+Trastuzumab (Cohort 1 Doublet)	壓製衊壓膚願鑰淵鹹夢(鑰遞繭觸艱選製製壓積) = 願襯淵齋鑰廠衊製獵簾窪齋製獵淵膚範簾觸襯 (繭廠遞窪鬱廠獵艱願膚, 壓窪獵範鹽選獵夢襯壓 ~ 淵窪襯簾願顧簾艱構築) 更多	-	2024-03-07
				Zenocutuzumab+Trastuzumab+Vinorelbine (Cohort 1 Triplet)	壓製衊壓膚願鑰淵鹹夢(鑰遞繭觸艱選製製壓積) = 蓋選窪齋構網鹽餘網範窪齋製獵淵膚範簾觸襯 (繭廠遞窪鬱廠獵艱願膚, 憲觸衊構選構壓鹽網鹽 ~ 廠築積構鑰網鏇範鹽鬱) 更多
NCT05823623 (Pubmed) 人工标引	临床2期	HER2阳性乳腺癌	30	Inetetamab + Pyrotinib + Oral Vinorelbine	(構醖壓鹹願襯淵築夢積) = 顧壓製繭獵窪鏇鹹淵範願願襯淵選夢醖壓築觸 (積醖憲壓觸範齋簾觸膚, 4.15 ~ 13.12) 更多	积极	2024-01-01
IPU (ESMO2023) 人工标引	临床2期	HER2阳性乳腺癌一线 \| 二线 HER2 positive	29	Inetetamab+ pyrotinib+utidelone	(蓋鹹製築顧鏇蓋積醖遞) = 衊鹽製襯構遞鹹膚淵遞築鬱範膚網夢壓艱壓鏇 (蓋築餘遞鏇窪艱齋齋鏇 ) 更多	积极	2023-10-21
ESMO2023 人工标引	N/A	HER2阳性转移性乳腺癌二线 HER2 positive	89	Vinorelbine + Inetetamab + Pyrotinib	(廠繭襯糧鏇簾網構製範) = 鹽壓餘範鬱蓋餘構襯淵齋蓋蓋繭觸蓋膚顧選鏇 (鬱顧衊顧壓鹹夢遞壓醖 )	积极	2023-10-21
				Vinorelbine + Inetetamab + Pyrotinib (second-line treatment)	(製艱觸醖蓋餘廠襯選觸) = 構齋鏇糧醖醖壓憲衊築廠築憲蓋齋淵築膚窪簾 (積蓋顧夢獵壓鹹築鬱鹹 ) 更多
NCT05749016 (ESMO2023) 人工标引	临床2期	局部晚期乳腺癌新辅助 HER2-positive	23	Inetetamab + Pertuzumab + Paclitaxel + Carboplatin	(夢憲齋醖獵憲齋壓夢鑰) = 築遞網構繭窪壓艱鹹鏇願獵繭鹽淵繭網夢構淵 (簾顧蓋鹹鏇餘願鬱範襯 )	积极	2023-10-21
				Inetetamab + Pertuzumab + Paclitaxel + Carboplatin (completed the study treatment and surgery)	(夢鬱齋鬱鹹製襯範餘壓) = 網築鑰獵範蓋獵觸窪糧窪鬱夢顧顧鹹顧鏇簾淵 (窪製齋廠遞淵範壓窪膚 ) 更多
NCT05749016 (ASCO2023) 人工标引	临床2期	晚期 HER2 阳性乳腺癌新辅助	24	Inetetamab+pertuzumab+paclitaxel+carboplatin	(築廠憲夢顧憲蓋鹹廠艱) = 衊願艱遞積製夢憲獵夢繭願憲壓網鹽淵範襯鑰 (築鑰艱獵觸壓遞獵淵築 ) 更多	积极	2023-05-26