The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants.
The names of the study drugs involved in this study are:
Paclitaxel (a type of anti-microtubule agent)
Docetaxel (a type of anti-microtubule agent)
Nab-Paclitaxel (a type of anti-microtubule agent)
Trastuzumab (a type of IgG1 kappa monoclonal antibody)
Pertuzumab (a type of monoclonal antibody)
Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate)
Tucatinib (Tyrosine Kinase HER2 Inhibitor)
Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)

开始日期2024-11-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06429761 / Not yet recruiting临床4期

A PROSPECTIVE, MULTI-CENTER, PHASE 4, SINGLE ARM STUDY TO ASSESS THE SAFETY OF TRASTUZUMAB DERUXTECAN, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE IN INDIAN PATIENTS WITH UNRESECTABLE OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED A PRIOR ANTI-HER2-BASED REGIMEN

开始日期2024-09-30

申办/合作机构

AstraZeneca PLC

NCT06364410 / Not yet recruiting临床1期IIT

Phase 1 Study of Trastuzumab Deruxtecan (DS-8201a) in Combination With Azenosertib (ZN-c3) in HER2-Expressing/Amplified Cyclin E-Amplified Gastric/Gastroesophageal Junction Cancer and Other Solid Tumors With HER2 Expression

This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive and cyclin E amplified gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors. It inhibits a protein called Wee1. Inhibition of the Wee1 protein can make tumor cells more vulnerable to chemotherapy drugs, leading to tumor cell death. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone.

开始日期2024-08-30

申办/合作机构

National Cancer Institute

100 项与德曲妥珠单抗相关的临床结果

登录后查看更多信息

100 项与德曲妥珠单抗相关的转化医学

登录后查看更多信息

100 项与德曲妥珠单抗相关的专利（医药）

登录后查看更多信息

488

项与德曲妥珠单抗相关的文献（医药）

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

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.

2024-04-04·The oncologist

Real-World Outcomes of Trastuzumab Deruxtecan in Patients With HER2+ Metastatic Breast Cancer: The DE-REAL Study

Article

作者: Caputo, Roberta ; Marinelli, Daniele ; Scagnoli, Simone ; Alesini, Daniele ; Fabbri, Agnese ; Rossi, Luigi ; Pisegna, Simona ; Palazzo, Antonella ; Botticelli, Andrea ; De Laurentiis, Michelino ; Santini, Daniele ; D'Auria, Giuliana ; Strigari, Lidia ; Scafetta, Roberta ; Paris, Ida ; Palleschi, Michela ; Giampaglia, Marianna ; Marchetti, Paolo ; Curigliano, Giuseppe ; Ballatore, Zelmira ; Tedesco, Beatrice ; Verrazzo, Annarita ; Barberi, Vittoria ; Pantano, Francesco ; Vernieri, Claudio ; Fabi, Alessandra ; Lambertini, Matteo ; Sposetti, Caterina

Abstract:

Background:

Trastuzumab deruxtecan (T-DXd) demonstrated unprecedented efficacy in patients with pretreated HER2+ metastatic breast cancer (mBC). However, few data are available about its efficacy in routine clinical practice. In this multicenter retrospective study, we examined effectiveness and safety of T-DXd in a real-world population.

Methods:

Clinico-pathological information about patients with HER2+ mBC who received T-DXd were collected from 12 Italian hospitals. HER2 status was determined locally. Patients who received at least one administration of T-DXd, as any therapy line for advanced disease were included in the analysis. The primary endpoint was real-word PFS (rwPFS).

Results:

One hundred and forty-three patients were included. Median age was 66 (range: 37-90), and 4 men were included. Hormone receptor (HR) status was positive in 108 (75%) patients and negative in 35(25%). T-DXd was administered as first, second, third, or subsequent lines in 4 (3%), 16 (11%), 42 (29%), and 81 (57%) patients, respectively. Among 123 patients with measurable disease, the ORR was 68%, and the DCR was 93% (9 CRs, 74 PRs, and 30 SD). Nine (7%) patients had a primary resistance to T-DXd. With a median follow-up of 12 months, the median rwPFS was 16 months. RwPFS was 84%, 59%, and 39% at 6, 12, and 18 months, respectively. A favorable trend in rwPFS was reported in patients receiving T-DXd as I/II line versus further lines (17 vs. 15 months; P = .098). Any-grade toxicity was registered in 84 patients (59%). Most common adverse events (AEs) reported were nausea (33%), neutropenia (21%), and asthenia (21%). Liver toxicity and diarrhea were uncommon (5% and 1%). Severe toxicities was registered in 18% of patients, and the most frequent were neutropenia, nausea/vomiting, and ILD observed in 15, 2, and 3 patients. AEs led to dose reduction in 37 patients (26%). Dose reduction and AEs do not affect patients’ response and survival outcomes.

Conclusions:

Efficacy and safety of T-DXd were confirmed in an unselected real-world population of HER2+ mBC. These results are consistent with the results of known findings, and no new safety concerns were reported.

2024-03-15·Cancer

HER2‐low heterogeneity between primary and paired recurrent/metastatic breast cancer: Implications in treatment and prognosis

Article

作者: Zheng, Dan ; Yang, Wentao ; Hu, Xichun ; Jin, Yizi ; Wu, Jiong ; Zhong, Xiaorong ; Guo, Qing ; Lin, Mingxi ; Zeng, Cheng ; Zhang, Jian ; Shao, Zhi-Ming ; Luo, Ting

Abstract:

Background:

With the largest sample size to date, the authors’ objective was to investigate the incidence of primary‐to‐metastatic human epidermal growth factor 2 (HER2) conversion and the predictors for such conversion. Moreover, no previous studies have evaluated the prognosis of patients who have negative HER2 expression (HER2‐0) versus low HER2 expression (HER2‐low) when HER2 status was assessed based on all recurrent/metastatic lesions.

Methods:

The authors included 1299 patients who had available HER2 status of primary breast tumors and paired recurrent/metastatic lesions at Fudan University Shanghai Cancer Center and West China Hospital.

Results:

In total, 370 patients (28.5%) experienced primary‐to‐metastatic HER2 conversion. Intrapatient intermetastasis spatial heterogeneity and temporal heterogeneity of HER2 were detected. When assessing HER2 based on recurrent/metastatic tumors, patients who had HER2‐0 tumors had significantly shorter overall survival than those who had HER2‐low tumors in the overall population and in the estrogen receptor (ER)‐negative subgroup. However, when assessing HER2 based on primary tumors, there was no difference in overall survival between patients who had HER2‐0 versus HER2‐low tumors. Moreover, patients who had tumors that converted from HER2‐0 to HER2‐low had longer overall survival than those who had consistent HER2‐0 status in the ER‐negative subgroup. By combining four predictors (ER status, Ki67 index, biopsy site, and disease‐free interval), the authors established the first prediction tool to estimate the probability of HER2‐0 tumors converting to HER2‐low/positive tumors.

Conclusions:

Intrapatient primary‐to‐metastatic and intermetastatic HER2 heterogeneity were observed in this large‐scale cohort study. When evaluating HER2 based on recurrent/metastatic tumors, an overall survival difference was observed between patients who had HER2‐0 versus HER2‐low, recurrent/metastatic breast tumors. The developed prediction tool might help clinicians screen out patients with primary HER2‐0 tumors that have a high probability of HER2 status conversion and recommend them for re‐biopsy, thus helping to screen out candidate patients for trastuzumab deruxtecan treatment.

2,215

项与德曲妥珠单抗相关的新闻（医药）

2024-07-01

·E药经理人

辉瑞“挖”诺华战将掌舵肿瘤商业化，决战肿瘤“五霸”，还差点啥？

销售额占比接近1/2的产品专利将到期、增速已疲软，430亿美元世纪并购后核心产品陷增长困境，三天前官宣的辉瑞肿瘤商业化新负责人如何收拾这笔“烂摊子”？撰文| 润屿 Erin 编辑| 顿河润屿 2023年，116亿美元抗肿瘤业务收入，一款专利将到期、增速已疲软的产品就占到一半。增长压力下，辉瑞豪掷430亿美元将ADC先驱Seagen收入麾下，力图换来多款重磅炸弹“希望之星”。这笔收购的完成在2023年短暂拯救了辉瑞持续下滑的股价。然而此后，辉瑞的股价至今仍在27～29美元之间徘徊，Seagen带来的市值高点似乎也在1700亿美元止步不前。于是，辉瑞在2024年重振旗鼓，成立肿瘤事业部，提出2030年拥有至少8种重磅抗肿瘤药物，新产品占肿瘤业务总收2/3的目标。有Seagen的加持，数量不在话下。但在质量上，前有罗氏、BMS、默沙东等公认的肿瘤“五霸”封路，后有诺华、第一三共等源源不断的新品上市，狼环伺虎下，辉瑞又将如何突出重围？这或许也是三天前辉瑞从诺华挖来商业化负责人Tina Deignan的原因，这位曾经的“O”药灵魂人物，率领诺华两大核药在美商业化的“老将”，如何重领辉瑞“硬刚”肿瘤五霸，直面新品冲击？ O药战将如何“盘活”辉瑞肿瘤销售？ 2023年12月，伴随Seagen的加入，辉瑞进行了一次组织架构调整，成立“the Pfizer Oncology Division”（辉瑞肿瘤事业部），并任命辉瑞肿瘤业务研发主管Chris Boshoff担任该事业部的负责人、执行副总裁。同时，辉瑞肿瘤事业部的调整还“以人才为中心”进行了相应的调整，根据肿瘤药物的早期研发、临床开发、商业化等环节分别任命了相应的主管。本次Tina Deignan的加入就是接替原来商业化负责人Suneet Varma的职位。Suneet Varma即将在2025年初从该职位退休。值得一提的是，辉瑞肿瘤事业部于今年1月1日启用后，Chris Boshoff还在今年2月的投资者活动上宣布了辉瑞的野心，“公司的目标是到2030年拥有至少八种重磅抗肿瘤药物，重点发力乳腺癌、泌尿生殖系统肿瘤、血液肿瘤和胸腔癌症，并且来自新产品/新适应证的收入将占到肿瘤药物总收入的三分之二。” 其实从产品数量上来看，在提出这一目标时，辉瑞已经手握Ibrance（哌柏西利），Inlyta（阿昔替尼）和Xtandi（恩扎卢胺）三款重磅药物，再加上Seagen的ADC产品Padcev、Adcetris、Tivdak，以及目前辉瑞/Seagen正在高速增长的诸多抗肿瘤药物，2030年8款重磅药物的目标对于辉瑞来说简直轻而易举。不过，尽管对于数量目标十拿九稳，辉瑞最大的挑战其实是新产品/新适应证占据抗肿瘤总收入的三分之二——这是一个质量上的目标。要知道，如今在哌柏西利之后，辉瑞的重磅炸弹产品其实已经出现了断层。2023年抗肿瘤业务总收入才116亿美元，哌柏西利收入就几乎占据了一半。如何在六年时间内使创新产品销售快速放量，并成为业绩发展的新动能，辉瑞缺的不仅是爆款产品，更是为实现产品商业价值更精密的布局。其中，人才无疑是关键要素之一。从Tina Deignan的履历上来看，其实是业内少有曾经兼具肿瘤免疫疗法、放射疗法商业化经验的商业化负责人。 Tina Deignan拥有柏林圣三一学院免疫学博士学位和柏林商学院商业研究硕士学位。 2007年，Tina Deignan加入BMS，在此后的15年间，一路从产品经理做到美国免疫学负责人。自2014年O药首次在FDA获批后，Tina Deignan也是O药美国商业化团队的主要负责人之一，几乎伴随O药最重要的市场准入阶段。而在2022年，Tina Deignan加入诺华后，也是诺华核药疗法的美国商业化团队的“灵魂人物”之一，两大核心重磅产品Lutathera和Pluvicto在美国的商业化都少不了Tina Deignan的身影。据悉，Pluvicto已经是全球销售额最高的核药产品，在2023年已经实现了9.8亿美元销售额，增速高达260%，美国市场贡献了主要收入。而辉瑞与安斯泰来合作的产品雄激素受体信号转导抑制剂恩扎卢胺（Xtandi），已经于2023年11月获批新适应证早期前列腺癌，是诺华Pluvicto的直接竞争对手。此外，辉瑞在2023年10月推出的Braftovi-Mektovi组合疗法，用于治疗携带BRAF V600E突变的转移性非小细胞肺癌（NSCLC）患者，也直击阻击诺华Tafinlar-Mekinist组合疗法的市场。 “新东家”和“老东家”的“正面刚”是一方面，对于Tina Deignan的挑战还有如何盘活辉瑞的成熟产品。另一个棘手的问题是，辉瑞CEO曾将公司在抗肿瘤业务的发展定为公司的头等大事，接下来，在这位抗肿瘤药物商业化拥有20年丰富经验的“老将”的加盟下后，辉瑞又将如何与BMS、罗氏等老牌选手“硬刚”？推荐阅读 * 辉瑞困于辉瑞 * 辉瑞“硬刚”肿瘤五霸，BMS大裁员，罗氏再砍管线，Q1营收TOP10药企仍在阵痛中… 对战肿瘤“五霸”，辉瑞到底差什么？很明显，无论是制定花钱花在刀刃上的调整计划，还是肿瘤业务的组织架构迅速配合到位，辉瑞明显已经正式出击了。但是，他能在2030年实现8款重磅级肿瘤药的目标吗？他能单挑肿瘤五大“霸主”——默沙东、BMS、罗氏、强生和阿斯利康吗？悬念非常大。肿瘤“五霸”内部混战本身就很激烈：争百亿元级重磅畅销药排位，比拼肿瘤业务总收入，争肿瘤领域新型技术产品布局，最关键的，是在争夺下一个大药大爆的机会。但从新冠一梦中苏醒过来的辉瑞，既缺早期研发能力，又缺成熟或潜在的重磅炸弹产品。过去很长一段时间，辉瑞肿瘤管线十分丰富，已获批抗肿瘤药不低于20款，但最大的问题是，始终缺乏爆款。收购Seagen之前，辉瑞抗肿瘤药主要是上述三款小分子药——哌柏西利，阿昔替尼和恩扎卢胺。成为肿瘤业务支柱的，只有哌柏西利。但可惜的是，这款产品的“花期”太短，由于后继竞争者强势进攻，以及临床试验数次失利，辉瑞没能坚守哌柏西利50亿美元重磅药物的地位。作为内分泌治疗进入靶向时代后全球首款上市的CDK4/6抑制剂，哌柏西利的出现，具有划时代意义。2020年，哌柏西利突破50亿美元大关。2019至2021年，哌柏西利均在辉瑞销售额TOP3产品之列。但自竞品礼来阿贝西利上市后，由于阿贝西利打入各市场的策略和节奏把控得较好，很快就造成了较强劲的威胁。近几年，哌柏西利销售额在全球市场增速放缓，2022年同比下降6%，2023年，延续下降趋势，降幅同样为6%。2023年，该产品营收额已跌出50亿美元开外。2027年，哌柏西利专利届满，留给辉瑞的时间，其实不多了。在失守50亿美元大药的同时，辉瑞肿瘤业务存在一个最大的问题是，目前没有一个产品立马接续。 2023年，辉瑞的肿瘤业务部门表现不佳。在初级保健、专业护理和肿瘤三大业务板块中，肿瘤业务营收占比最低，为116.27亿美元，较上一年下滑了4%，比起其余两大业务表现相对较为弱势。同时，这一收入情况，与肿瘤“五霸”比起来，还存在较大的差距。如果仅按照主要产品收入来看，2023年，拥有K药、O药的默沙东与BMS肿瘤业务收入均在260亿美元以上水平，罗氏逾200亿美元，强生、AZ也在170亿美元之上。关键是，尽管都遇到了专利悬崖等危机，但“五霸”中多数企业能够再坚守几年市场地位，抑或是产品销售额已无限趋近百亿美元水平，又或是已经找到了潜在重磅炸弹。但于辉瑞而言，除了哌柏西利，目前能够支撑肿瘤业务收入的产品，似乎力量是受限的。 2023年，辉瑞销售额排名前20的产品中，肿瘤药仅贡献了3款，除了哌柏西利，剩下两款小分子药，销售额均限于10亿美元上下水平。其中，恩扎卢胺（Xtandi，前列腺癌领域）销售额在2023年出现小幅下降，至11.91亿元，该药同样也将在2027年失去专利保护。辉瑞有意识地将肿瘤业务KPI，放在了发展大分子药物上，他将Seagen的几款产品，视作扭转肿瘤业务的拐点。不能忽略的是，今年Q1，辉瑞抗肿瘤领域的收入同比增长了19%，表现算很亮眼，辉瑞强调由收购Seagen而获得的4种产品，带来了重磅增长潜力。但从长期来看，Seagen这几款产品竞争力如何？ Seagen四款产品分别是Adcetris、Padcev、Tivdak、Polivy，其中三款为“first-in-class”的ADC药物，一款为合作ADC药物。在2023年被辉瑞收购之前，四款药物能为Seagen带来了17亿美元的收入。不过，Evaluate Pharma数据显示，2023年，辉瑞/Seagen的ADC销售额为19.52亿美元。这样来看，Seagen的ADC收入增速并不快。值得注意的是，Evaluate Pharma预测，2028年，第一三共的ADC收入将由2023年的24.59亿美元增长至99.98亿美元，说明有DS-8201等明星产品加持，市场给到的预期非常高。但与此同时，Evaluate Pharma预计2028年辉瑞/Seagen的ADC收入达52.77亿美元，据此推算，按现有辉瑞的商业化产品实力，实现2030年的销售既定目标，是有一些难度的。那么如何实现预期，一边要看焕新的肿瘤业务团队能不能打赢这场仗，另一边要看辉瑞能不能不能在剩下的6年时间里，诞生一款增速相当快的肿瘤产品。今年Q1，辉瑞启动了三项关键的III期研究，包括选择性CDK4抑制剂atirmociclib的首次III期试验，以及Elrexfio用于治疗多发性骨髓瘤的第四次III期临床试验。但系列后期产品何时上市，潜力如何，能否抵御同疾病领域市场竞争？这仍是悬在辉瑞头上的一个大问题。回复“逆商”，了解电子期刊详情精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

抗体药物偶联物并购专利到期高管变更

2024-07-01

·BioSpace

Daiichi Sankyo Wins $47M in ADC Patent Arbitration With Seagen, Pfizer Dispute Looms

Pictured: Business partners discussing the terms of a contrac/iStock, AmnajKhetsamtip Daiichi Sankyo announced on Friday that it has won its patent arbitration dispute with Seagen, which will pay the Japanese multinational $47 million in attorneys’ fees and costs, plus interest. Seagen and Daiichi Sankyo have for years been locked in a patent battle over technologies used in the Japanese pharma’s AstraZeneca-partnered antibody-drug conjugate (ADC) Enhertu (fam-trastuzumab deruxtecan-nxki). In August 2022, an arbitrator ruled in favor of Daiichi Sankyo finding that Seagen’s claims were invalid. According to Daiichi Sankyo, the arbitrator awarded the company around $45.5 million in attorneys’ fees and costs, which Seagen challenged and sought to have vacated. However, a federal court denied the appeal on April 2024 and tacked on interest to Daiichi Sankyo’s award for a total of $47 million. Pfizer, which acquired Seagen for $43 billion in March 2023, failed to appeal the ruling before a set deadline, officially handing Daiichi Sankyo the victory. Despite Friday’s win, the larger patent battle between Pfizer and Daiicihi Sankyo may not yet be over. In January 2024, the U.S. Patent and Trademark Office ruled that Seagen’s contentious patent 10,808,039—which protects the use of auristatin peptides in ADCs via a specific linker technology—is invalid. Seagen has also racked up legal victories in recent years. A civil action suit it filed in 2020—over the same patent infringement issue—ended in a jury victory in April 2022, awarding the company $41.82 million in damages. The District Court for the Eastern District of Texas also ruled in favor of Seagen in October 2023 with Daiichi Sankyo having to pay 8% royalty on all Enhertu sales from April 1, 2022 through November 4, 2024. The patent dispute between Seagen and Daiichi Sankyo stretches back to 2008, when they signed a partnership that used Seagen’s ADC technology to develop therapies against solid tumors, according to Genetic Engineering & Biotechnology News. The collaboration ended in 2015. In 2019, Seagen claimed that Daiichi Sankyo owed it a portion of the Japanese pharma’s $6.9 billion contract with AstraZeneca. Enhertu, which at the time was still under development and was the centerpiece of the AstraZeneca deal, used underlying technology that was formed between 2008 and 2015 when the companies were still partners, Seagen alleged. In response, Daiichi Sankyo filed a Declaratory Judgement in November 2019 maintaining that Seagen’s claims were without merit. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

并购专利侵权引进/卖出

2024-06-30

·赛柏蓝

2024年医保目录调整启动｜这些药品大降价

编者按：本文来自新康界，作者慧玲；赛柏蓝授权转载，编辑yuki 7月1日起，2024年医保药品目录调整正式开启申报工作。这是从2018年国家医保局成立以来，连续第七年的调整。实际上，每年医保目录调整前，药品降价已成为部分药企的常规操作。主动降价，也被视作相关药企积极参与医保谈判的诚意之举。据新康界统计，6月以来已有不少未进医保的药品主动申请降价，包括卡度尼利单抗、德曲妥珠单抗、维泊妥珠单抗、抗骨增生片等品种，降幅分别达到53.4%、22%、7%、6%。 6月部分主动下调价格的药品情况 01 未进医保，去年大卖近14亿在国家医保局发布目录调整信息后不久，有消息称，康方生物下调了其双抗新药卡度尼利单抗（开坦尼）的价格，单支价格从原先的13220元/125mg/瓶降至6166元/125mg/瓶，降幅53.4%。同日，康方生物确认了这一价格且取消赠药，称这一价格将给予患者购药更大灵活性，并表示将积极参加今年医保谈判。据悉，卡度尼利单抗上市后一直靠自费市场，此次降价后年治疗费用约为44万元，正好能挤入今年医保谈判的门槛。但康方生物表示，降价是为参加医保做出的调整。卡度尼利的年费用只是回到了没有赠药方案的水平，并不存在所谓大幅降价。目前康方正在积极筹备卡度尼利进医保的相关材料。抗癌药卡度尼利单抗是国内首个双特异性抗体，2022年6月，卡度尼利单抗踩线获批上市，但没有在当年进入医保目录，反而在自费市场表现十分亮眼。刚上市半年，卡度尼利单抗大卖5亿元，2023全年销售额达到13.58亿元，同比增长149%。仅从等级医院市场销售情况来看，卡度尼利单抗在2023年销售额同比上涨928.9%，达1.71亿元；2024年一季度销售4.7千万元。面对今年医保目录的调整，卡度尼利单抗似乎已做好准备。卡度尼利单抗全国等级医院销售情况截至2023年底，继国内第六个获批上市的PD-L1，同时也是第四个国产PD-L1——索卡佐利单抗年底获批上市后，目前国内共有17个获批上市的PD-(L)1产品，其中有11款PD-1、6款PD-L1，涉及超过10个瘤种和相关的泛瘤种。 17个产品中，有9个产品共22项申请正处于扩展新适应症的上市申请中，另外还有7个产品共计9项申请正在NDA新药首次上市申请中。然而2023年版（2024年1月开始执行）的医保目录中，只有4个国产品牌继续续约，未新增进口品牌或其他国产品牌进入目录。迫于PD-1竞争的愈演愈烈，康方生物或试图通过将卡度尼利单抗降价的方式，以减轻医保基金的压力，从而提高进医保概率。 02 多款重磅药物主动降价 2024年医保目录调整已然成为影响未来发展的风向标，包括PD-1、罕见病药物、慢病药物、抗病毒药物和新兴治疗领域等。 6月14日，据辽宁省药品和医用耗材集中采购网发布的《关于执行淡竹叶配方颗粒等175个药品主动降价结果的通知》，注射用维泊妥珠单抗药品价格从10400元/30mg/瓶主动降价至9580元/30mg/瓶，价格下降7%，虽调价幅度不大，但依据市场规则价格也有所松动。 6月19日，湖北省医疗保障局对近期主动申请下调挂网价的部分挂网药品进行了审核及公示。共包括98个主动下调价格的药品，如吉林一正药业的抗骨增生片，价格从403.2元/瓶下调至377.66/瓶，降幅达6%。值得一提的是，湖南科伦制药是此次降幅最为明显的企业。其上榜的注射用头孢曲松钠本身已是医保产品，价格从464元/2g下调至44.88元/2g、214.5元/1g下调至26.4元/1g，分别降幅达90%、88%。据悉，阿斯利康的德曲妥珠单抗也于近日主动申报药品降价，由原先的8860元/支降为6912元/支，降幅达22%，并同步取消慈善赠药，也展现出了参与新一轮医保谈判的决心。随着医保目录工作调整的开启，多个药品赶在6月30日之前压线获批，为国谈而努力。6月25日，国家药监局官网发布130个产品受理号获批，其中有26款新药、4个过评、超100个报产申请。其中几款产品都卡在了新国谈到来之际。如海思科的1类新药考格列汀片，用于2型糖尿病，是全球首个超长效DPP-4抑制剂且双周口服降糖药。此前已有恒瑞的瑞格列汀、科伦的曲格列汀，如今考格列汀片也加入了国内DDP4药物竞争。同样卡点新国谈资质的，还有绿叶制药的注射用罗替高汀微球、南京优科的氯维地平乳状注射液等。注射用罗替高汀微球每周给药一次，是全球首个治疗帕金森病的长效缓释微球制剂；南京优科的氯维地平乳状注射液是国内首家，用于高血压治疗。 03 18款罕见病药物有望纳入医保目录自诺西那生钠注射液国谈成功后，越来越多高值罕见病药被纳入国家医保目录，如2023年被纳入目录的艾加莫德α注射液(20ml:0.4g/瓶）、依库珠单抗注射液（30ml:300mg/瓶）。在纳入医保前，两款药物的价格分别为1.03万元/瓶、1.9万元/瓶，目前价格分别为0.56万元/瓶、0.25万元/瓶。价格降幅最低超40%，最高近80%。由于《第二批罕见病目录》的发布时间晚于2023年国家医保目录调整工作正式启动节点，因此2024年的国家医保目录调整是首次覆盖《第二批罕见病目录》相关病种。据统计，2023年及之前在国内获批已商业化的罕见病药中，共有27种罕见病的25种治疗药物未纳入医保，其中，18种药物在国内的年治疗费用为数十万元至百万元，这类罕见病药将成为2024年国家医保目录调整的重点关注对象。包括阿那白滞素注射液、布罗索尤单抗注射液、氯马昔巴特口服溶液、塞奈吉明滴眼液、依马利尤单抗注射液、注射用丹曲林钠、达妥昔单抗β注射液、那西妥单抗注射液和吸入用一氧化氮等。 END 内容沟通：郑瑶（13810174402）医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

上市批准生物类似药

100 项与德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
-	德曲妥珠单抗	L01XC	DB14962

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阳性胃腺癌	韩国	Daiichi Sankyo Co., Ltd.	2022-09-19
HR阳性/HER2阳性乳腺癌	韩国	Daiichi Sankyo Co., Ltd.	2022-09-19
HER2突变型非小细胞肺癌	美国	Daiichi Sankyo, Inc.	2022-08-11
HER2低表达乳腺癌	澳大利亚	AstraZeneca Pty Ltd.	2021-10-08
HER2阳性胃食管结合部腺癌	美国	Daiichi Sankyo, Inc.	2021-01-15
HER2阳性胃癌	日本	Daiichi Sankyo Co., Ltd.	2020-09-25
HER2阳性乳腺癌	美国	Daiichi Sankyo, Inc.	2019-12-20

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
HER2阳性实体瘤	申请上市	美国	Daiichi Sankyo Co., Ltd.	2024-01-29
HER2阳性实体瘤	申请上市	美国	AstraZeneca Pharmaceuticals LP	2024-01-29
晚期胆管癌	临床3期	日本	AstraZeneca PLC	2024-06-26
晚期胆管癌	临床3期	奥地利	AstraZeneca PLC	2024-06-26
晚期胆管癌	临床3期	比利时	AstraZeneca PLC	2024-06-26
晚期胆管癌	临床3期	巴西	AstraZeneca PLC	2024-06-26
晚期胆管癌	临床3期	加拿大	AstraZeneca PLC	2024-06-26
晚期胆管癌	临床3期	德国	AstraZeneca PLC	2024-06-26
晚期胆管癌	临床3期	荷兰	AstraZeneca PLC	2024-06-26
晚期胆管癌	临床3期	韩国	AstraZeneca PLC	2024-06-26

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


NCT04494425 (DESTINY-Breast06, ASCO2024) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌二线 HER2-low \| HER2-ultralow \| HR+	866	Trastuzumab deruxtecan (HER2-low)	襯遞壓艱衊蓋夢選鹽顧(壓鹽廠淵築積觸窪淵積) = 築製鑰積糧鏇齋製廠簾選窪餘鹹淵壓遞醖艱簾 (願膚構製鹹範鑰廠網襯 ) 更多	积极	2024-06-02
				Physician’s choice of chemotherapy (HER2-low)	襯遞壓艱衊蓋夢選鹽顧(壓鹽廠淵築積觸窪淵積) = 網鏇廠構廠艱構簾膚鹽選窪餘鹹淵壓遞醖艱簾 (願膚構製鹹範鑰廠網襯 ) 更多
NCT04482309 (DP-02 \| DESTINY-PanTumor02, ASCO2024) 人工标引	临床2期	实体瘤 \| 膀胱癌 HER2	41	Trastuzumab deruxtecan	構觸製夢壓網艱遞膚遞(淵膚醖鑰製衊衊窪觸範) = 顧網蓋糧憲繭簾願製範窪艱網積襯鬱觸製襯廠 (鏇衊鑰範鬱製鑰廠艱膚, 24.2 ~ 55.5) 更多	积极	2024-05-24
				Trastuzumab deruxtecan (HER2 IHC 3+)	構觸製夢壓網艱遞膚遞(淵膚醖鑰製衊衊窪觸範) = 襯襯獵觸遞廠壓遞蓋糧窪艱網積襯鬱觸製襯廠 (鏇衊鑰範鬱製鑰廠艱膚, 29.9 ~ 80.2) 更多
NCT03529110 (DESTINY-Breast03, ASCO2024) 人工标引	临床3期	HER2阳性转移性乳腺癌 HER2 Positive	524	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg	淵襯鑰夢壓醖膚鑰廠蓋(艱觸衊憲衊築夢選鏇製) = 簾構醖淵壓製範鹹壓鹹膚獵範築齋鏇繭構蓋遞 (鑰鬱觸簾築積壓醖選構, 23.7 ~ 40.0) 更多	优效	2024-05-24
				Trastuzumab emtansine (T-DM1) 3.6 mg/kg	淵襯鑰夢壓醖膚鑰廠蓋(艱觸衊憲衊築夢選鏇製) = 艱積糧鏇艱糧淵願憲遞膚獵範築齋鏇繭構蓋遞 (鑰鬱觸簾築積壓醖選構, 6.8 ~ 8.3) 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	積壓齋艱膚齋簾艱鹹願(壓範製襯觸夢網鏇鏇窪) = 構願觸顧糧繭齋鹹蓋簾壓積夢觸網鹹選糧壓壓 (簾鏇遞壓蓋蓋積網網廠 ) 更多	积极	2024-05-24
				T-DXd 5.4 mg/kg + pertuzumab 420 mg	積壓齋艱膚齋簾艱鹹願(壓範製襯觸夢網鏇鏇窪) = 範構範膚廠構顧齋餘鏇壓積夢觸網鹹選糧壓壓 (簾鏇遞壓蓋蓋積網網廠 ) 更多
DB02 or DB03 (ASCO2024)	N/A	转移性乳腺癌三线 HER2+	280	Trastuzumab deruxtecan	膚構壓齋壓繭夢範襯膚(範觸衊夢鹽獵鬱簾積壓) = 簾蓋獵簾鹹衊鑰醖糧範淵願鏇遞顧齋構簾壓膚 (艱製觸觸網鹽夢齋壓鏇 ) 更多	-	2024-05-24
NCT04644237 (DESTINY-Lung02, ASCO2024)	临床2期	HER2突变型非小细胞肺癌 HER2-mutant	-	Trastuzumab deruxtecan 5.4 mg/kg	觸壓積餘製鑰鏇襯憲遞(襯觸蓋淵鹹鏇夢夢築壓) = 構憲鑰餘襯選鬱遞遞選襯鏇選淵膚獵製鬱艱膚 (遞窪構蓋窪淵獵艱鏇艱 ) 更多	积极	2024-05-24
				Trastuzumab deruxtecan 6.4 mg/kg	觸壓積餘製鑰鏇襯憲遞(襯觸蓋淵鹹鏇夢夢築壓) = 構選醖夢願獵鏇鹽夢鏇襯鏇選淵膚獵製鬱艱膚 (遞窪構蓋窪淵獵艱鏇艱 ) 更多
DE-REAL (ASCO2024)	N/A	脑转移瘤 HER2-positive	143	Trastuzumab deruxtecan	鏇壓遞簾糧膚網構獵鏇(顧淵獵範範憲製醖選壓) = 衊遞窪獵蓋齋窪膚壓壓餘襯鑰積衊襯夢獵製鑰 (鬱鑰獵艱壓蓋憲醖膚願 ) 更多	积极	2024-05-24
NCT04482309 (DESTINY-PanTumor02 (DP-02), ASCO2024)	临床2期	头颈部肿瘤 HER2-expressing	267	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W	淵齋繭鬱壓製鬱顧構鏇(膚夢鹹鬱顧願糧膚積夢) = 構壓鑰繭鑰艱築糧積衊窪衊廠鹹壓範蓋鹽廠蓋 (鹽鏇構繭蓋網淵憲鏇鏇, 31.3 ~ 43.2)	积极	2024-05-24
NCT04644237 \| NCT03505710 \| NCT03248492 \| NCT03734029 \| NCT03523585 \| NCT02564900 \| NCT03529110 (ASCO2024)	N/A	恶心和呕吐 HER2+	1,449	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg	鑰鑰積積衊鑰廠壓齋廠(鹹淵壓構選廠顧淵遞淵) = 74.6% (n=1081) experienced nausea 醖襯築構築觸衊齋顧醖 (願餘鑰鑰醖鑰淵遞範積 ) 更多	积极	2024-05-24
ASCO2024	N/A	实体瘤 HER2+	-	Trastuzumab deruxtecan (T-DXd)	艱膚積積糧壓築襯網網(顧壓糧鹹鬱蓋憲襯選淵) = 憲壓鬱積鑰願構醖顧遞夢鬱簾願窪膚鹹選鹹餘 (膚衊夢夢壓襯顧餘獵淵 )	-	2024-05-24
				Control IgG-ADC	艱膚積積糧壓築襯網網(顧壓糧鹹鬱蓋憲襯選淵) = 鏇遞顧顧願構鑰觸廠鹽夢鬱簾願窪膚鹹選鹹餘 (膚衊夢夢壓襯顧餘獵淵 )