Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

开始日期2026-01-01

申办/合作机构

The University of Chicago

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

NCT06891833

/ Not yet recruiting临床2/3期

A Randomized Controlled Phase II/III Clinical Study of BL-M07D1 + Pertuzumab With or Without Taxane Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

This trial is a registered phase III, randomized, open and multicenter study to evaluate the efficacy and safety of BL-M07D1 + Pertuzumab in combination with or without taxane regimen in the neoadjuvant treatment of HER2-positive breast cancer. The study is divided into a single-arm study phase (Phase II) and a randomized controlled study phase (Phase III).

开始日期2025-04-01

申办/合作机构

四川百利药业有限责任公司

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100 项与帕妥珠单抗相关的临床结果

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100 项与帕妥珠单抗相关的转化医学

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100 项与帕妥珠单抗相关的专利（医药）

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1,817

项与帕妥珠单抗相关的文献（医药）

2025-06-01·Journal of Cancer Policy

Availability, affordability and health insurance coverage of breast cancer services in Iran - An analysis based on the Universal Health Coverage-Service Planning Delivery and Implementation tool

Article

作者: Bijlmakers, Leon ; Heydari, Majid ; Nouhi, Mojtaba ; Goudarzi, Zahra

BACKGROUND:

As part of efforts to achieve Universal Health Coverage for priority conditions in Iran, it is crucial to evaluate the breast cancer service package and identify aspects that may require adjustment. This study analyzes the current state of breast cancer service supply, service delivery platforms, health insurance coverage, and patient co-payment levels.

METHODS:

The Universal Health Coverage Compendium (UHCC) developed by WHO served to list and distinguish various types of breast cancer services. Information from health insurance agencies in Iran was obtained on actual service provision in the country. The Universal Health Coverage Service Planning Delivery and Implementation (UHC-SPDI) tool was used to assess the scope of breast cancer service delivery in Iran and human workforce levels, and to identify possible gaps in service coverage.

RESULTS:

All 73 actions listed as breast cancer services in the UHC-SPDI are provided in the Iranian healthcare system, with a strong reliance on out-patient centers and hospitals rather than primary health care facilities as service delivery platforms, reflecting suboptimal integration of service delivery. Eighty-seven percent of the services are recognized and accepted by health insurance agencies, with cost coverage levels ranging from 20% for magnetic resonance imaging to 100% for intravenous targeted therapy for metastasis. Genomic tests and four medicines (Pembrolizumab, Pertuzumab, Anastrozole, and Fluorouracil) are not covered by health insurance.

CONCLUSION:

The UHC-SPDI has offered an instrumental framework for a comprehensive assessment of Iran's national breast cancer service package composition by connecting it to the service delivery system and human resources competencies. There is room for improvement of the breast cancer service package in Iran, not only in terms of their health insurance coverage, but also in terms of their actual delivery.

2025-06-01·BREAST

A composite 18F-FDG PET/CT and HER2 tissue-based biomarker to predict response to neoadjuvant pertuzumab and trastuzumab in HER2-positive breast cancer (TBCRC026)

Article

作者: Vaklavas, Christos ; Kachergus, Jennifer M ; Ma, Yaohua ; Winer, Eric ; Valero, Vincente ; Solnes, Lilja B ; Rimawi, Mothaffar ; Denbow, Rita ; Huang, Chiung-Yu ; Storniolo, Anna Maria ; Carter, Jodi M ; Abramson, Vandana G ; Cimino-Mathews, Ashley ; Thompson, E Aubrey ; Stearns, Vered ; Leal, Jeffrey P ; Krop, Ian ; Hennessy, Maeve A ; Wahl, Richard L ; Wolff, Antonio C ; Specht, Jennifer ; Connolly, Roisin M ; Carey, Lisa A

BACKGROUND:

Early metabolic change on PET/CT was predictive of response to neoadjuvant trastuzumab/pertuzumab (HP) in TBCRC026. We hypothesized that a composite biomarker incorporating PET/CT and HER2 tissue-based biomarkers could improve biomarker performance.

METHODS:

83 patients with estrogen receptor-negative/HER2-positive breast cancer received neoadjuvant HP alone [pathologic complete response (pCR) 22 %]. PET/CT was performed at baseline and 15 days post initiation of therapy (C1D15). Promising imaging biomarkers included ≥40 % SULmax decline between baseline and C1D15, and C1D15 SULmax ≤3. Baseline tissue-based biomarkers included HER2-enriched intrinsic subtype (72 %, 46/64; NanoString), tumor HER2 protein abundance (median log2 13.5, range log2 7.1-15.9; NanoString DSP), and HER2 3+ (83 %, 64/77; immunohistochemistry). Logistic regressions were fitted to predict pCR with HER2/PET-CT biomarkers. The C statistic assessed overall prediction power. The optimal composite score cut-off was determined by maximizing Youden's index.

RESULTS:

Factors most predictive for pCR in single predictor models included C1D15 SULmax (OR 0.43; p = 0.007, c = 0.77), % reduction in SULmax (OR 1.03, p = 0.006, c = 0.72) and tumor HER2 protein abundance (OR 1.75; p = 0.01, c = 0.76). The composite of C1D15 SULmax and % reduction in SULmax and their interaction term, had improved probability (c = 0.89 from c = 0.78), with high sensitivity (100 %) and negative predictive value (100 %). The addition of tumor HER2 protein did not further improve prediction power (c = 0.90).

CONCLUSION:

The HER2/PET-CT biomarker had high prediction power for pCR, however was not superior to the prediction power of PET/CT alone. Non-invasive PET/CT biomarkers may facilitate a response-guided approach to neoadjuvant therapy, allowing intensification and de-intensification of treatment, pending further evaluation.

2025-04-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

HER2-targeted therapies: Unraveling their role in biliary tract cancers

Review

作者: Mungo, Benedetto ; Ziogas, Dimitrios C ; Ziogas, Ioannis A ; Kontis, Elissaios ; Theocharopoulos, Charalampos ; Gogas, Helen

Biliary tract cancers (BTCs) constitute a heterogeneous group of malignancies with rising incidence and limited therapeutic options in advanced stages, leading to increased overall mortality. Extensive genomic profiling has identified key oncogenic drivers in BTCs that represent promising therapeutic targets and could change the treatment paradigm. Evidence suggests improved survival outcomes for patients with actionable molecular alterations who received matched targeted therapies. Human epidermal growth factor receptor 2 (HER2) is a receptor tyrosine kinase and proto-oncogene that has been extensively studied as a prognostic biomarker and a therapeutic target in multiple solid organ malignancies. Recent clinical trials on the combination of trastuzumab with tucatinib, FOLFOX, or pertuzumab for previously treated, HER2-positive, advanced BTCs have shown improved outcomes compared to current second-line therapies. Early evidence from observational studies on trastuzumab-containing regimens as first-line suggests promising efficacy. Furthermore, the recent tumor-agnostic approval of trastuzumab deruxtecan for HER2-positive solid tumors has formally introduced HER2-directed agents in the BTC therapeutic arsenal. This review aims to summarize the rapidly evolving landscape of HER2-directed agents for BTCs, highlighting current evidence of survival benefit. Beginning with a concise presentation of the structural and functional aspects of HER2, we detail the frequency and prognostic significance of HER2 alterations in BTCs and discuss all available preclinical and clinical data on anti-HER2 agents tested for BTCs.

484

项与帕妥珠单抗相关的新闻（医药）

2025-03-26

·BiG生物创新社

从自免到肿瘤，风卷残云的皮下制剂开发逻辑

作者｜Bio-three 皮下制剂的药物在依从性方面具有显著优势，成为自免性等慢性疾病领域药物开发的重要考量因素之一。如今，皮下制剂的这股风潮也吹到了肿瘤领域。近期，第一三共和阿斯利康先后和韩国Alteogen达成合作，引进后者的新型透明质酸酶技术ALT-B4用于开发下一代肿瘤药物。除了依从性的因素，到底是因为竞争格局使然，是否还另有玄机？本文简要进行分析。近年来Alteogen新型透明质酸酶技术的合作方 01 延长产品生命周期此前罗氏两款HER2单抗药物曲妥珠单抗（Herceptin）以及帕妥珠单抗（Perjeta）联合用药策略，成为HER2阳性乳腺癌新辅助治疗和辅助治疗的标准治疗方案。但是两者的美国专利均在2024年相继失效。在此基础上，罗氏在2020年推出了两者的皮下复方制剂Phesgo。 HER2抗体皮下复方制剂Phesgo（罗氏官网）皮下复方制剂Phesgo的出现，将此前2-6小时的注射时间缩短至5-8分钟，依从性大为提高。更重要的是，随着曲妥珠单抗和帕妥珠单抗专利相继失效，Phesgo也接过了产品生命周期的接力棒，上市5年来产品转化率已经达到46%，稳住了罗氏在此领域的整体市场份额。 HER2抗体皮下复方制剂Phesgo（罗氏官网）不久之后，BMS的O药和默沙东的K药这两大PD-1单抗药物的专利也将于2026-2028年间相继失效。显然，开发皮下制剂有望进一步延长其产品生命周期。 Keytruda和Opdivo历年销售额 02 减少输注副反应强生的EGFR/c-Met双抗Amivantamab皮下制剂，已经获批用于EGFR突变的非小细胞肺癌一线治疗，其注射时间从此前的3.4-6.5小时显著减少到0.4-0.6个小时，大幅提高药物依从性，临床有效性方面也取得了非劣的结果。 Amivantamab皮下制剂临床结果（2024 WCLC）安全性方面，Amivantamab皮下制剂则显著改善，输液整体不良反应从66%降低到13%，静脉血栓栓塞的发生率也降低了30%以上，患者满意度大幅提高。 Amivantamab皮下制剂临床结果（2024 WCLC）大分子药物基于药物形式的特殊性，主要以静脉输注为主，输注相关的不良反应不可避免，对于肿瘤免疫药物和双抗药物其输注反应更为严重，ADC药物此前报道的输注不良反应最高可达15%。此前，阿斯利康虽然没有透漏与Alteogen具体合作的产品，猜测除了ADC药物还有双抗药物。无论是剂量更高的PD-1相关双抗，还是剂量没那么高的CD3双抗，其输注反应和CRS（细胞因子释放综合征）反应，或和其注射路径均有一定关系。此外，特别是随着不同药物之间的联用更为普遍，输注过程中的不良反应或将叠加，如果不能控制药物的输注反应，可能会显著限制药物的进一步应用，因此这些新型抗体的皮下开发显得更为紧迫，康宁杰瑞开发了全球首创的HER2双抗+PD-L1抗体的皮下复方制剂。康宁杰瑞HER2双抗+PD-L1抗体的皮下复方制剂JSKN033（康宁杰瑞官网） 03 皮下制剂的挑战皮下制剂确实对于药物具有以上的各类优势，但是其开发的挑战仍然不小，高浓度情况下药物的成药性将受到挑战。透明质酸酶及降黏剂的使用也并非万能，如何控制高浓度制剂的稳定性，这在非肿瘤和肿瘤药物中一样突出。除了成药性的挑战，皮下给药的路径下也会增加淋巴/抗原呈递细胞暴露风险，这样就进一步加剧了ADA免疫原性产生。以PD-1/L1抗体为例，几款PD-1及PD-L1皮下制剂均达到了非劣性的临床终点，但是O药和T药的皮下制剂的ADA显著增加。不过，K药基本维持不变，一方面可能和K药本身的特性有关，一方面也和其使用的透明质酸酶ALT-B4有关。 PD-1/L1皮下制剂ADA比较对于CD3类的双抗，虽然皮下制剂的采用能够减少部分Cmax带来的不良作用，但是基于特定的T细胞激活能力和药物剂量，已经比较显著的ADA和CRS作用是否在皮下制剂下更为显著，这同样需要关注。 CD3类双抗的开发策略（Clin Pharmacol Ther. 2024 Aug;116(2):315-327）综上所述，在下一代药物的开发过程中，基于竞争局势升级的使然，不仅仅自免药物，肿瘤药物的依从性也摆到相对重要的位置。基于生物利用度的限制，对于抗肿瘤药物，虽然皮下制剂很难在疗效方面取得显著的提升，但是在延长产品生命周期和安全性提升方面具有一定优势，会逐步成为常规手段，但是挑战仍然不小。共建Biomedical创新生态圈！如何加入BiG会员？

抗体药物偶联物专利无效

2025-03-24

·ioncology

从历史到当下——HER2阳性乳腺癌亚洲患者二线治疗新进展

点击蓝字，关注我们编者按：乳腺癌是全球女性最常见的恶性肿瘤，为患者带来了沉重的身体和心理负担。其中，HER2阳性乳腺癌占乳腺癌的四分之一左右，既往HER2阳性乳腺癌治疗手段有限，传统化疗效果欠佳，患者生存率较低。随着曲妥珠单抗的问世，HER2阳性乳腺癌走上了靶向治疗之路，单克隆抗体（包括曲妥珠单抗、帕妥珠单抗等）、酪氨酸激酶抑制剂（TKI，如拉帕替尼、吡咯替尼等）以及抗体-药物偶联物（ADC，如T-DM1、T-DXd等）的不断涌现和更新，使HER2阳性乳腺癌患者的预后也得到了显著提升。近年来，亚洲地区的乳腺癌发病率逐年增长，因此针对亚洲乳腺癌患者的治疗策略备受关注。本文将从HER2阳性乳腺癌患者的二线治疗方案更迭出发，深入分析ADC在HER2阳性乳腺癌亚洲患者治疗中的重要地位和价值，为临床实践带来新的思考与选择。 HER2阳性晚期乳腺癌患者抗HER2治疗历史变迁 HER2阳性乳腺癌因其独特的病理特征，导致肿瘤细胞增殖活跃、侵袭性强。且相较于其他亚型乳腺癌，HER2阳性乳腺癌疾病进展更快，预后更差。早期针对HER2阳性乳腺癌的治疗手段有限，传统化疗效果欠佳，患者生存率较低。2001年，H0648g研究结果公布[1]，标志HER2阳性晚期乳腺癌进入新的治疗时代。该研究不仅奠定了曲妥珠单抗晚期一线标准治疗的地位，同时也揭开了HER2阳性乳腺癌靶向治疗的序幕。CLEOPATRA研究结果的公布[2]，使曲妥珠单抗+帕妥珠单抗（HP）为基础的双靶联合方案成为了当前一线治疗的标准治疗。随后，其他类型抗HER2治疗药物的加入（如基于PHILA研究结果，吡咯替尼联合曲妥珠单抗和多西他赛方案获NMPA批准上市），使HER2阳性晚期乳腺癌有了更多的选择，也使得HER2阳性晚期乳腺癌患者的一线治疗方案不断更新。在一线治疗中，大分子单抗、TKI联合治疗方案不断刷新着患者生存。然而，当患者出现疾病进展后，二线治疗选择一度陷入困境。早期尝试过多种方案，诸如更换不同的化疗药物组合、换用TKI方案等，但疗效均不理想，患者的中位无进展生存期（PFS）较短，生活质量也受到严重影响。III期EMILIA研究结果的公布[3]，为HER2阳性乳腺癌二线治疗带来了重大变革，也使得ADC药物在HER2阳性晚期乳腺癌二线治疗领域大展拳脚。该研究结果显示，T-DM1较拉帕替尼联合卡培他滨显著延长了患者的中位mPFS（9.6个月vs 6.4个月，HR=0.65；95% CI：0.55～0.77；P＜0.001）。自此，T-DM1在较长时期内确立了其作为HER2阳性乳腺癌二线标准治疗方案的地位，为HER2阳性乳腺癌二线治疗奠定了坚实基础，也为后续更多新型治疗方案的研发提供了重要参考。二线治疗的突破与变革 T-DXd是乳腺癌领域继T-DM1之后获批的第二个抗HER2 ADC，它通过人源化单克隆抗体部分曲妥珠单抗将细胞毒化合物拓扑异构酶Ⅰ抑制剂定向携带到乳腺肿瘤细胞内，从而发挥抗肿瘤作用。DESTINY-Breast03研究是一项开放标签、多中心、随机、对照的III期临床试验，旨在评估T-DXd对比T-DM1在HER2阳性不可切除或转移性乳腺癌患者中的疗效和安全性。 DESTINY-Breast03研究前期全人群结果显示[4]，T-DXd较T-DM1显著延长了mPFS（28.8个月 vs 6.8个月，HR=0.33；95% CI：0.26～0.43；P＜0.0001），也带来了显著的中位总生存期获益（mOS；两组均未达到；HR=0.64；95% CI：0.47～0.87；P=0.0037），以及更高的客观缓解率（ORR：79.0% vs 35.0%）；安全性方面，两组3级及以上治疗相关不良事件（TEAEs）的发生率相似。基于此，T-DXd成为了全球公认的替代T-DM1用于HER2阳性乳腺癌二线治疗的标准方案。亚洲患者的疗效与安全性验证值得注意的是，亚洲乳腺癌患者在全球占比已超过35%，死亡数占全球死亡总数的50%，且呈逐年增长态势[5]。由于亚洲人群在遗传背景、生活方式等方面与其他地区人群存在差异，对治疗的反应也不尽相同。此前针对亚洲HER2阳性乳腺癌二线治疗的研究相对较少，多参考全球整体研究结果进行治疗。但近年来，随着对亚洲人群研究的深入，发现亚洲患者在接受传统二线治疗时，部分药物的疗效和安全性可能与全球平均水平有所差异，这也促使医学研究者更加重视对亚洲人群的针对性研究，期望能为亚洲HER2阳性乳腺癌患者制定更适宜的二线治疗方案。近期，《Cancer Science》杂志在线发表了DESTINY-Breast03研究亚洲人群的亚组分析结果，进一步验证了T-DXd在亚洲HER2阳性乳腺癌患者中的疗效与安全性[6]。该分析共纳入了309例来自亚洲国家或地区的患者，包括中国大陆、中国台湾、中国香港、韩国和日本等地。患者的中位年龄为53.9岁，在转移性乳腺癌阶段接受过中位≥2线治疗（1线41.7%、2线20.1%、≥3线38.2%），58.6%接受过帕妥珠单抗治疗，22.3%存在脑转移病史，17.5%的患者存在基线脑转移。亚洲人群中T-DXd组149例，T-DM1组160例，两组基线特征匹配均衡。至数据截止日期（2022年7月25 日），T-DXd组中位随访时间为29.0个月，T-DM1组中位随访时间为26.0个月。结果显示，T-DXd组与T-DM1组由盲法独立中心审查（BICR）评估的mPFS为25.1个月vs 5.4个月（HR=0.30；95% CI：0.22～0.41）；12个月PFS率为71.2% vs 25.0%，24个月PFS率为50.4%和18.0%。 △DESTINY-Breast03研究亚洲人群PFS T-DXd组与T-DM1组研究者评估的mPFS为26.3个月 vs 7.0个月（HR 0.30；95% CI：0.22～0.41）。在激素受体状态、既往帕妥珠单抗治疗、基线内脏转移、既往治疗线数和基线脑转移等亚组中，均观察到了T-DXd一致的PFS获益。 △DESTINY-Breast03研究亚洲人群PFS亚组分析 T-DXd组与T-DM1组mOS未达到（95% CI：NE～NE）vs 37.7个月（95% CI：30.3～NE）（HR=0.62；95% CI 0.42～0.91）；两组12个月OS率为93.8% vs 84.0%，24个月OS率为76.6% vs 65.9%。 △DESTINY-Breast03研究亚洲人群OS T-DXd组较T-DM1组具有更高的客观缓解率（ORR），为75.8% vs 31.3%；达到完全缓解（CR）的患者为31（20.8%）例 vs 12（7.5%）例；达到部分缓解（PR）的患者为82（55.0%）例vs 38（23.8%）例；维持疾病稳定的患者为30（20.1%）例vs 67（41.9%）例；临床获益率（CBR）为86.6% vs 40.0%；中位缓解持续时间（DOR）为未达到（95% CI：16.9～NE）vs 13.8个月（95% CI：8.2～34.7）。后续治疗方面，研究期间T-DXd 组和T-DM1组分别有76.2%和93.7%的患者中止治疗，治疗完成后，分别有54.4%和72.5%的患者接受新的系统治疗，至数据截止时，T-DXd组与T-DM1组分别有22.8%和34.3%的患者在后续系统治疗中出现疾病进展（PD）。研究者评估的从随机化到下一线治疗首次记录到疾病进展的mPFS2在T-DXd组和T-DM1组分别为41.2个月 vs 19.6个月（HR=0.46；95% CI：0.32～0.65）。 △DESTINY-Breast03研究亚洲人群后续治疗及缓解状况安全性方面，T-DXd的中位治疗持续时间为15.4个月（范围0.7～44.0），T-DM1为5.5个月（0.7～39.3）。对T-DXd组147例患者和T-DM1组159例患者的安全性评估显示，药物相关的≥3级治疗相关不良事件（TEAE）发生率为49.0% vs 46.5%，药物相关的严重TEAE为10.9% vs 7.5%，未见药物相关TEAE导致的死亡。T-DXd最常见的≥3级药物相关TEAE为中性粒细胞减少（25.9%）、血小板减少（12.9%）、白细胞减少（10.2%）、贫血（9.5%）和疲劳（8.8%）；T-DM1最常见的≥3级药物相关TEAE则为血小板减少（34.6%）、天冬氨酸氨基转移酶升高（6.9%）、丙氨酸氨基转移酶升高（5.7%）和中性粒细胞减少（5.7%）。 △DESTINY-Breast03研究亚洲人群安全性表现在临床比较关注的间质性肺病（ILD）/肺炎方面，T-DXd组有19例患者（12.9%）发生了药物相关ILD/肺炎，未见3级及以上事件；T-DM1组有4例患者（2.5%）发生了药物相关ILD/肺炎，1级和2级各2例，也未见3级及以上事件。T-DXd组与T-DM1组药物相关ILD/肺炎事件的首次出现中位时间为246.0天（范围：41～674） vs 355.0天（207～499）。大多数患者在数据截止时均已恢复。 △DESTINY-Breast03研究亚洲人群药物相关ILD/肺炎表现总结与展望在DESTINY-Breast03研究中，亚洲患者约占研究总人群60%。此项研究的亚组分析显示，在既往曲妥珠单抗（±帕妥珠单抗）和紫杉醇经治的亚洲HER2阳性晚期乳腺癌中，T-DXd较T-DM1具有更大的临床获益，在T-DXd具有更长治疗持续时间的背景下，T-DXd与T-DM1≥3级以上的不良事件表现相似。此项亚组分析结果与DESTINY-Breast03研究整体人群获益一致，在PFS获益方面，亚洲人群使用T-DXd获得了显著且持续的改善，HR为0.30。亚洲人群在减少疾病进展或死亡风险的幅度（70%）略高于整体人群（67%）。安全性方面，亚洲人群常见药物相关TEAE及其发生率与总体人群表现相似，值得注意的是，日本人群在T-DXd相关ILD/肺炎的发生率高于亚洲人群、也高于全球人群，尽管未见到≥3级的事件。研究者认为，日本人群更高的ILD/肺炎发生比例可能与生物学因素或日本特定的监测和管理实践有关。总之，在该项研究的亚洲人群亚组分析中，新一代抗体药物偶联物（ADC）相较于传统治疗方案，在无进展生存期（PFS）和总生存期（OS）方面均显示出显著改善，并且安全性表现与整体人群一致。这一结果进一步验证了该类新型治疗方案在亚洲HER2阳性晚期乳腺癌二线治疗中的重要价值和临床意义。参考文献：（滑动查看） 1、Slamon, D J et al. “Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.” The New England journal of medicine vol. 344,11 (2001): 783-92. doi:10.1056/NEJM200103153441101 2、Swain S M, Miles D, Kim S B, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study[J]. The Lancet Oncology, 2020, 21(4): 519-530. 3、Verma, Sunil et al. “Trastuzumab emtansine for HER2-positive advanced breast cancer.” The New England journal of medicine vol. 367,19 (2012): 1783-91. doi:10.1056/NEJMoa1209124 4、Hurvitz Sara A,Hegg Roberto,Chung Wei-Pang,et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial.[J] .Lancet, 2023, 401: 105-117. 5、Arnold M, Morgan E, Rumgay H, et al. Current and future burden of breast cancer: global statistics for 2020 and 2040. Breast. 2022;66:15‐23. doi: 10.1016/j.breast.2022.08.010 6、Iwata H, Xu B, Kim SB, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in Asian patients with HER2-positive metastatic breast cancer. Cancer Sci. 2024;115(9):3079-3088. doi:10.1111/cas.16234 审批编号：CN-20250324-00007 （来源：《肿瘤瞭望》编辑部）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。

临床结果抗体药物偶联物临床3期上市批准多肽偶联药物

2025-03-14

·FiercePharma

Roche settles UPenn suit alleging patent infringement by Herceptin, 3 other breast cancer meds

A resolution between the University of Pennsylvania and Roche’s Genentech comes just days after a federal judge signed an order pausing the case. Some three years after the University of Pennsylvania claimed four of Roche’s breast cancer meds infringed its intellectual property, the parties have managed to resolve the dispute just weeks before a jury trial was set to start.Penn and Roche’s Genentech unit have settled the lawsuit Penn originally brought to a Delaware federal court in 2022, which accused the drugmaker of infringing a now-expired patent on methods of tumor treatment pioneered at the university’s Abramson Cancer Center.In turn, the case has been dismissed with prejudice, meaning neither party can retry their claims in court, according to a decision filed Friday in the U.S. District Court for the District of Delaware. The case was set to go before a jury March 31, Bloomberg Law reports. Details on the exact terms of the settlement agreement were not disclosed in Friday’s filing. The resolution comes just days after federal Judge Jennifer Hall signed an order pausing the case “pending performance of certain obligations under the settlement agreement reached by the parties,” according to a separate filing in the Delaware court.The stay on the case required that Penn and Genentech file a stipulation of dismissal or a joint update on their deliberations by March 24.Genentech confirmed with Fierce Pharma on Friday that "the parties have amicably resolved the dispute," though the company's spokesperson did not comment further on the outcome. Penn’s 2022 complaint against Genentech revolves around a patent, dubbed ‘558, that was originally granted to the school in December 2009.The ‘558 patent covers a method developed at Penn’s Perelman School of Medicine to treat patients with ErbB protein-mediated tumors by administering an antibody followed by radiation, according to the original lawsuit.According to the university’s lawyers, the treatment approach closely resembles that outlined in the FDA approvals for four of Roche’s anti-ErbB antibodies in breast cancer: intravenous Herceptin and the drug’s subcutaneous counterpart Herceptin Hylecta, plus Perjeta and Phesgo.By marketing that quartet of cancer meds, Roche infringed Penn’s ‘558 patent, the school’s lawyers argued in the 2022 lawsuit.Further, Penn’s legal team suggested the Genentech unit was “willfully blind to the fact that its acts were infringing” and contended that the company must have been aware of the school’s patent because Roche explicitly tried blocking foreign counterparts to the intellectual property at the European Patent Office in 2007, 2016 and 2019.In addition to seeking a ruling that Roche willfully infringed the ‘558 patent, Penn was originally pursuing an unspecified sum in damages as well as an ongoing licensing fee for Roche’s alleged use of its invention. The four breast cancer drugs at the center of the lawsuit continue to rake in sizable sales for Roche, though only Phesgo—which is the youngest of the quartet with its first approval in 2020—managed to grow in 2024 overall.For the entire year, Phesgo increased (PDF) sales 62% to 1.74 billion Swiss francs (nearly $2 billion), Roche reported in late January. Herceptin sales fell 11% to 1.38 billion Swiss francs ($1.5 billion) over the same period, while Perjeta’s 2024 sales dropped to 3.6 billion Swiss francs ($4 billion) versus roughly 3.8 billion Swiss francs in 2023.

专利侵权上市批准

100 项与帕妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05446	帕妥珠单抗	L01XC13	DB06366

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
HER2阳性结直肠癌	日本	Chugai Pharmaceutical Co., Ltd.	2022-03-28
早期乳腺癌	澳大利亚	Roche Products Pty Ltd.	2013-05-06
乳腺癌	美国	Genentech, Inc.	2012-06-08
HER2阳性乳腺癌	美国	Genentech, Inc.	2012-06-08
转移性乳腺癌	美国	Genentech, Inc.	2012-06-08

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
膀胱癌	临床3期	英国	Hoffmann-La Roche, Inc.	2023-03-07
结直肠癌	临床3期	英国	Hoffmann-La Roche, Inc.	2023-03-07
胆囊肿瘤	临床3期	英国	Hoffmann-La Roche, Inc.	2023-03-07
血液肿瘤	临床3期	英国	Hoffmann-La Roche, Inc.	2023-03-07
肺癌	临床3期	英国	Hoffmann-La Roche, Inc.	2023-03-07
卵巢癌	临床3期	英国	Hoffmann-La Roche, Inc.	2023-03-07
胰腺癌	临床3期	英国	Hoffmann-La Roche, Inc.	2023-03-07
前列腺癌	临床3期	英国	Hoffmann-La Roche, Inc.	2023-03-07
唾液腺肿瘤	临床3期	英国	Hoffmann-La Roche, Inc.	2023-03-07
皮肤肿瘤	临床3期	英国	Hoffmann-La Roche, Inc.	2023-03-07

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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


NCT02205047 (INNOVATION, ASCO_GI2025) 人工标引	临床2期	HER2阳性胃癌 HER2 Positive	172	Chemotherapy alone	糧齋蓋鹽鑰衊鹽鑰遞簾(顧醖齋廠範鏇獵衊簾憲) = 齋遞觸顧鑰範壓觸襯壓齋醖遞觸艱築壓齋簾遞 (選網衊鹹鹹鬱鑰遞窪構 ) 更多	不佳	2025-01-23
				Chemotherapy + Trastuzumab	糧齋蓋鹽鑰衊鹽鑰遞簾(顧醖齋廠範鏇獵衊簾憲) = 蓋廠獵餘遞鏇遞壓鑰鏇齋醖遞觸艱築壓齋簾遞 (選網衊鹹鹹鬱鑰遞窪構 ) 更多
NCT03365882 (S1613, Pubmed) 人工标引	临床2期	RAS/BRAF 野生型HER2 阳性结直肠癌二线 \| 三线 HER2 Positive	54	Trastuzumab plus Pertuzumab	醖糧構積鑰鹽壓鏇艱觸(襯夢鏇選餘簾衊網鬱範) = 網鬱繭鹽鏇願糧築襯襯餘齋艱襯築襯齋窪齋選 (顧願積衊鹹網艱壓窪築, 1.9 ~ 7.6) 更多	积极	2025-01-06
				Cetuximab plus Irinotecan	醖糧構積鑰鹽壓鏇艱觸(襯夢鏇選餘簾衊網鬱範) = 夢鬱壓廠簾構網艱蓋窪餘齋艱襯築襯齋窪齋選 (顧願積衊鹹網艱壓窪築, 1.6 ~ 6.7) 更多
NCT05275010 (CTgov)	临床1期	-	151	Handheld Syringe+Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (Arm 1: PH FDC SC Using a Handheld Syringe)	積繭鏇醖簾憲廠餘願積(餘鑰餘夢構艱鹹淵鹹鹹) = 艱壓繭齋製醖鹹蓋衊艱襯製壓淵製鏇繭衊膚觸 (衊簾鹹網鏇顧鑰築繭壓, 27.5) 更多	-	2024-09-23
				On-Body Delivery System (Arm 2: PH FDC SC Using the OBDS)	積繭鏇醖簾憲廠餘願積(餘鑰餘夢構艱鹹淵鹹鹹) = 鬱顧築願構範築艱遞膚襯製壓淵製鏇繭衊膚觸 (衊簾鹹網鏇顧鑰築繭壓, 23.2) 更多
ESMO2024	N/A	HER2阳性乳腺癌新辅助 HER2	339	TCH	憲齋淵願廠蓋壓範衊衊(觸積艱齋齋壓醖遞遞鏇) = 顧網齋憲衊廠構願選鏇構窪齋蓋鹹艱鏇鹽觸蓋 (艱構積襯夢蓋淵鑰範蓋 )	不佳	2024-09-16
				TCHP	憲齋淵願廠蓋壓範衊衊(觸積艱齋齋壓醖遞遞鏇) = 鏇獵廠構醖蓋願積積夢構窪齋蓋鹹艱鏇鹽觸蓋 (艱構積襯夢蓋淵鑰範蓋 )
NCT02091141 (MyPathway, CTgov)	临床2期	晚期恶性实体瘤 \| 膀胱癌 \| 胆道癌 ... 更多	673	Trastuzumab+Pertuzumab (Trastuzumab Plus Pertuzumab)	衊構淵願艱餘蓋鬱遞積 = 遞淵繭醖壓壓艱範簾鹽衊餘顧簾範願餘窪憲製 (夢醖鑰觸築鬱鑰憲選鬱, 蓋鏇衊觸衊鹹積願積積 ~ 窪範鬱構鹹衊製鹹鬱衊) 更多	-	2024-07-23
				atezolizumab (Atezolizumab)	衊構淵願艱餘蓋鬱遞積 = 鏇鹽艱蓋膚獵繭顧繭壓衊餘顧簾範願餘窪憲製 (夢醖鑰觸築鬱鑰憲選鬱, 築構範願鏇鹽廠齋繭糧 ~ 鏇繭窪選廠憲艱築衊構) 更多
NCT06136897 (CTgov)	临床2期	恶性实体肿瘤	35	Radiologic Examination+Trastuzumab+pertuzumab	鬱積鑰築壓夢鬱憲顧觸 = 鏇艱糧簾醖憲顧廠餘鹽憲餘繭膚觸艱簾構範鏇 (構選遞蓋範衊範餘淵醖, 醖鑰顧範遞鏇淵鬱艱積 ~ 窪築醖壓鏇願壓夢糧鹹) 更多	-	2024-06-25
NCT05749016 (ASCO2024) 人工标引	临床2期	晚期 HER2 阳性乳腺癌新辅助 HER2 Positive	28	Inetetamab + Pertuzumab + Paclitaxel + Carboplatin (TCbIP)	積襯鹽齋壓遞簾廠構網(觸壓鹹憲顧範鹽餘製構) = 鏇製蓋壓壓鬱願觸窪網簾範艱積簾鬱餘繭積糧 (廠淵襯蓋衊壓鏇簾糧窪 ) 更多	积极	2024-05-24
				Trastuzumab + Pertuzumab + Paclitaxel + Carboplatin (TCbHP)	積襯鹽齋壓遞簾廠構網(觸壓鹹憲顧範鹽餘製構) = 網淵顧範製簾製窪鹹淵簾範艱積簾鬱餘繭積糧 (廠淵襯蓋衊壓鏇簾糧窪 ) 更多
NCT04538742 (DESTINY-Breast07, ASCO2024) 人工标引	临床1/2期	HER2阳性转移性乳腺癌一线 HER2 Positive	130	T-DXd 5.4 mg/kg	衊顧夢鬱範壓膚憲醖願(網鬱積鹽顧顧齋範構築) = 願繭選淵鹹獵鹹簾範觸範衊觸蓋構窪鹹繭鑰顧 (願壓構淵鏇簾構餘襯鏇 ) 更多	积极	2024-05-24
				T-DXd 5.4 mg/kg + pertuzumab 420 mg	衊顧夢鬱範壓膚憲醖願(網鬱積鹽顧顧齋範構築) = 鹽糧選蓋鬱鹽製遞鹽廠範衊觸蓋構窪鹹繭鑰顧 (願壓構淵鏇簾構餘襯鏇 ) 更多
JPRN-UMIN000027938 \| JPRN-jRCTs021180027 \| NCT03264547 (EMERALD, ASCO 12024 \| ASCO 22024) 人工标引	临床3期	HER2阳性乳腺癌一线 HER2 Positive	446	Eribulin + HP	膚窪鑰糧鹹廠糧積構鏇(鹹蓋獵壓夢鹽糧積獵壓) = 製齋觸網鹹糧糧網築醖簾獵齋蓋鏇壓廠遞糧選 (憲齋網觸範襯襯鬱齋繭 ) 更多	积极	2024-05-24
				Docetaxel/paclitaxel + HP	膚窪鑰糧鹹廠糧積構鏇(鹹蓋獵壓夢鹽糧積獵壓) = 膚壓淵製顧觸鹹網蓋壓簾獵齋蓋鏇壓廠遞糧選 (憲齋網觸範襯襯鬱齋繭 ) 更多
NCT03716180 (DAPHNe, ASCO2024)	临床2期	HER2阳性乳腺癌新辅助 ctDNA+	98	Neoadjuvant THP	壓繭網觸網繭遞獵憲窪(夢觸顧窪衊構鏇構繭範) = 廠獵憲遞壓艱構衊觸壓願製鏇夢築艱憲繭構鑰 (鬱壓鑰鑰製遞蓋壓選壓 )	积极	2024-05-24