Datopotamab Deruxtecan

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer. 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/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast09 phase 3 trial presented at the 2025 American Society of Clinical Oncology Annual Meeting and subsequently published in The New England Journal of Medicine. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU. In DESTINY-Breast09, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (hazard ratio: 0.56; 95% confidence interval [CI]: 0.44-0.71; p<0.00001) in patients (n=383) with HER2 positive metastatic breast cancer who had not received prior chemotherapy or HER2 targeted therapy or had received neoadjuvant or adjuvant HER2 targeted therapy more than six months before the diagnosis of advanced or metastatic disease. Median progression-free survival (PFS) was 40.7 months (95% CI: 36.5-not estimable [NE]) with Enhertu in combination with pertuzumab compared to 26.9 months (95% CI: 21.8-NE) with THP as assessed by blinded independent central review (BICR). The PFS benefit was consistent across subgroups, including the prespecified stratification factors of hormone receptor (HR) status, de novo or recurrent disease and PIK3CA mutation status. Confirmed objective response rate (ORR) was 85.1% (95% CI: 81.2-88.5) for Enhertu in combination with pertuzumab compared to 78.6% (95% CI: 74.1-82.5) with THP. There were 58 (15.1%) complete responses (CR) and 268 (70.0%) partial responses (PR) with Enhertu plus pertuzumab compared to 33 (8.5%) CRs and 271 (70.0%) PRs with THP. Median duration of response (DOR) for Enhertu plus pertuzumab exceeded three years (39.2 months) versus 26.4 months for THP. “Enhertu in combination with pertuzumab improved progression-free survival by more than one year compared with the current first-line standard of care, representing a meaningful advantage early in the treatment of patients with metastatic HER2 positive disease,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “Today’s positive CHMP opinion brings us closer to making Enhertu available in the EU as a first-line treatment option for eligible patients with HER2 positive metastatic breast cancer, marking an important milestone in moving this medicine earlier in the treatment pathway.” “HER2 positive metastatic breast cancer is an aggressive subtype, so starting patients on an effective HER2 targeted treatment early and continuing it for as long as they benefit can have a meaningful impact on long-term outcomes,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. “DESTINY-Breast09 sets a new benchmark with a median progression-free survival of more than three years, underscoring the potential of Enhertu plus pertuzumab to redefine first-line treatment for patients with HER2 positive metastatic breast cancer.” The safety pro Enhertu in combination with pertuzumab in DESTINY-Breast09 was consistent with the known profiles of each individual treatment with no new safety concerns identified. The most common grade 3 or higher treatment-related adverse events that occurred in patients treated with Enhertu in combination with pertuzumab (n=381) were neutropenia (23.9%), hypokalemia (10.2%), and anemia (8.4%). Interstitial lung disease (ILD) or pneumonitis occurred in 12.1% of patients treated with Enhertu in combination with pertuzumab as determined by an independent adjudication committee. The majority of ILD or pneumonitis events were low grade (grade 1 [n=17; 4.5% or grade 2 [n=27; 7.1%]). There were two grade 5 events (0.5%) of ILD or pneumonitis in the Enhertu plus pertuzumab arm. Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in India, Israel, Saudi Arabia, Singapore, South Korea, Switzerland, the United Arab Emirates and the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial. Enhertu is also under review in the EU for patients with HER2 positive breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment based on data from the DESTINY-Breast05 trial. DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2 positive metastatic breast cancer. Patients were randomized 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), HR status and PIK3CA mutation status. The primary endpoint of DESTINY-Breast09 is PFS as assessed by BICR in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, ORR, DOR, pharmacokinetics and safety. The investigational arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis. DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. Breast cancer is the most common cancer in women worldwide and the leading cause of cancer-related deaths among women. Approximately 2.4 million breast cancer cases were diagnosed in 2024, with more than 690,000 deaths globally.1 In Europe, approximately 540,000 cases of breast cancer are diagnosed annually, with more than 140,000 deaths.2 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or whose disease has progressed to metastatic disease are expected to live five years following diagnosis.3 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.4 HER2 protein overexpression may occur as a result of HER2 gene amplification.4 Approximately one in five cases of breast cancer is considered HER2 positive.5 HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.5 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.6,7,8 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.9,10 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) followed by THP is approved in China, Singapore and the U.S. as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11 trial. 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 the U.S. for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial. Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in India, Israel, Saudi Arabia, Singapore, South Korea, Switzerland, the United Arab Emirates and the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial. Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or 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 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic 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 have 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 100 countries/regions 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 80 countries/regions 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 90 countries/regions 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-Gastric04 trials. Enhertu (5.4 mg/kg) is approved in more than 45 countries/regions worldwide 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, DESTINY-CRC02 and/or HERALD trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 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 cancer medicines across multiple HER2 targetable cancers. 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. The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. REFERENCES: 1 World Health Organization. Global Status Report On Cancer 2026: The Future We Choose Together. Accessed July 2026. 2 World Health Organization. Breast Fact Sheet. Accessed July 2026. 3 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed July 2026. 4 Cheng X. Genes(Basel). 2024;15(7):903. 5 Tarantino P, et al.Ann Oncol. 2023;34(8):645-659. 6 Swain SM, et al. Lancet Oncol. 2020;21(4):519-530. 7 Blumenthal G, et al. Clin Cancer Res. 2013;19(18):4911-4916. 8 Tripathy D, et al. Oncologist. 2020;25(2):e214-e222. 9 Hall PS, et al. Presented at SABCS Annual Meeting 2023. 10 Hartkopf AD, et al. Geburtshilfe Frauenheilkd. 2024;84(5):459-469. The content above comes from the network. if any infringement, please contact us to modify.

正文共： 1000字 预计阅读时间： 3分钟 2026年7月27日，阿斯利康发布2026年半年度财报，总营收306.72亿美元，同比增长6%（按固定汇率CER计算，下同），其中产品收入销售288.96亿美元，同比增长5%。 截图均来自于：阿斯利康财报 从地区维度看，美国市场仍为阿斯利康第一大营收来源，上半年贡献128.9亿美元，同比增长8%；欧洲市场收入68.22亿美元，增长8%；新兴市场收入83.19亿美元，增长3%。 中国区表现最为引人关注。上半年中国区收入35.1亿美元，同比下滑5%。回顾2025年全年，中国区收入为66.54亿美元，同比增长4%；进入2026年，一季度中国区收入19.23亿美元，同比增长2%，但二季度表现疲软，拖累上半年整体增速转负。 从产品维度看，Farxiga®（达格列净） 是公司上半年最畅销药物，但受专利到期影响，上半年收入同比下滑11%至39.98亿美元。 Tagrisso®（奥希替尼）收入37.75亿美元，增长6%，稳居EGFR突变肺癌治疗全球领先地位。 Imfinzi®（度伐利尤单抗） 收入35.48亿美元，大增29%，受益于全球多癌种新增适应症持续放量。 从治疗领域看，上半年三大核心板块均实现增长： 肿瘤领域：收入141.23亿美元，同比增长15%，系公司业绩增长的核心驱动力。营收贡献主要得益于Tagrisso（奥希替尼）、Imfinzi（度伐利尤单抗）、Calquence®（阿可替尼）、Enhertu®（德曲妥珠单抗）、Truqap®（卡匹色替）等多款重磅产品的协同驱动。 呼吸与免疫（R&I）领域：收入47.50亿美元，同比增长9%； 罕见病领域：收入49.11亿美元，同比增长11%。 其中，Ultomiris®（瑞利珠单抗） 上半年销售额为25.84亿美元，同比增长14%；但另一款C5单抗Soliris®（依库珠单抗） 在后继产品冲击下，销售额同比下滑22%至7.78亿美元。 此外，低磷酸酯酶症新药Strensiq®（阿司福酶α）上半年斩获10.53亿美元，同比增长40%；神经纤维瘤疗法Koselugo®（司美替尼）贡献3.47亿美元，同比增长21%，两款产品增势迅猛，为罕见病板块注入新动能。 阿斯利康与第一三共合作开发的Enhertu®（德曲妥珠单抗） 上半年全球销售额达29.61亿美元，增长迅猛。其中，2026年第一季度单季销售额已达14.22亿美元，同比增长34%，刷新了ADC药物单季销售历史纪录。另一款合作ADC产品Datroway®（德达博妥单抗） 上半年贡献0.98亿美元，同比增幅超过6倍。 尽管在ADC赛道高歌猛进，阿斯利康也展现了务实的“断舍离”。财报披露，已终止两款自研ADC项目： Tilatamig samrotecan（EGFR/cMET ADC）：临床II期，因数据不理想停止。 AZD4360（CLDN18.2 ADC）：临床I期，因疗效原因终止。 CEO Pascal Soriot明确表示，“在早期阶段快速失败”非常重要，以便将资源重新部署到更有前景的项目上。 参考资料： 1.https://www.astrazeneca.com/media-centre/press-releases/2026/h1-and-q2-2026-results.html 2.其他公开资料 封面图来源：药时代团队 9.5亿美元打水漂？Ipsen豪赌失败 2026-07-27 14.5亿美元引入！赛诺菲重磅药物终止AD研发 2026-07-25 减重22.6%仅是入场券？礼来三靶点新药卡在这三关 2026-07-24 106亿美元收购见成效！GSK肺癌新药获批上市 2026-07-23 版权声明/免责声明 本文为原创文章。 本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。 文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。 如有任何问题，请与我们联系。 衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩内容！