Palbociclib

New data from six landmark trials reinforce practice-changing results of Enhertu and Datroway across a broad spectrum of patients in breast and lung cancer Additional analyses from two trials of raludotatug deruxtecan in ovarian cancer demonstrate emerging potential in gynecological cancers TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 30 abstracts, including four late breaking presentations, in multiple cancers at the 2026 European Society for Medical Oncology (#ESMO26) Congress. New data from six landmark trials demonstrate the company’s progress toward advancing new standards of care for patients in breast and lung cancer, including the DESTINY-Breast05 ( 539RO ), DESTINY-Breast06 ( 4279P ), DESTINY-Breast09 ( LBA49 ), DESTINY-Breast11 ( 543RO ) and DESTINY-Lung04 ( LBA74 ) phase 3 trials of Enhertu ® (trastuzumab deruxtecan) and the TROPION-Breast02 ( LBA96 ) phase 3 trial of Datroway ® (datopotamab deruxtecan). Additional data at ESMO also will spotlight the company’s commitment to advancing research for patients with advanced ovarian cancer across lines of therapy. An updated analysis, including progression-free survival and duration of response, will be presented from the REJOICE-Ovarian01 ( 1331P ) phase 2/3 trial evaluating raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. A mini oral presentation will highlight preliminary findings from the REJOICE-Ovarian02 ( 1247RO ) phase 1b/2 trial evaluating raludotatug deruxtecan in combination with bevacizumab in patients with platinum-resistant ovarian cancer. “The promising data for raludotatug deruxtecan in ovarian cancer and the robust scientific innovation demonstrated across our pipeline reflects our progress in advancing research for patients across multiple types of cancer,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “Daiichi Sankyo continues to draw from its scientific and technological expertise to turn science into new medicines that can change the standard of care.” Data Demonstrate Benefit of DXd ADCs in Patients with Brain Metastases Research updates highlighting the impact of DXd ADCs in patients with brain metastases include late-breaking rapid oral and proffered paper presentations from the DESTINY-Breast09 ( LBA49 ) phase 3 trial evaluating Enhertu in combination with pertuzumab as a first-line treatment for patients with HER2 positive metastatic breast cancer and the TROPION-Breast02 ( LBA96 ) phase 3 trial evaluating Datroway as a first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option. Final overall survival results of the TUXEDO-3 ( 690O ) phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with active brain metastases from metastatic breast cancer, advanced non-small cell lung cancer (NSCLC) or leptomeningeal disease from any solid tumor will be presented as a proffered paper. New Data and Trials-in-Progress Presentations Across DXd ADC Portfolio Additional data highlighting new research across the DXd ADC portfolio include oral and poster presentations, including final results of the TALENT ( LBA23 ) phase 2 trial of Enhertu alone or in combination with anastrozole, or in sequence with chemotherapy, as neoadjuvant treatment for patients with HR positive, HER2 low early stage breast cancer. New data in NSCLC include the NeoCOAST-2 ( 4244RO ) phase 2 trial reporting event-free survival results, as well as findings on the association of ctDNA clearance with clinical outcomes in patients with resectable, early stage NSCLC treated with a combination of Datroway plus durvalumab and chemotherapy, and a retrospective analysis evaluating mechanisms of insensitivity to the Datroway payload in subgroups of patients with advanced NSCLC in the TROPION-Lung01 ( 4451P ) phase 3 trial. Updated findings from the EPOC2003 ( 2888P ) phase 2 trial evaluating neoadjuvant chemotherapy in combination with Enhertu in patients with HER2 positive gastric cancer: results from ESPERANZA ( 1014P ), an external comparator study evaluating Enhertu versus real-world standard of care as a second line or later treatment for patients with HER2 IHC 3+ solid tumors; and, the primary analysis evaluating patritumab deruxtecan monotherapy in patients with melanoma in the HERTHENA-PanTumor01 ( 2073RO ) phase 2 trial also will be presented. Trials-in-progress poster presentations include the DESTINY-Breast Guide ( 1795TiP ) prospective and interventional trial evaluating first-line treatment with Enhertu plus pertuzumab followed by palbociclib, endocrine therapy and dual HER2 blockade (trastuzumab plus pertuzumab), as well as retreatment with Enhertu following progression on maintenance therapy (palbociclib, endocrine therapy and trastuzumab plus pertuzumab) in previously untreated patients with HER2 positive advanced or metastatic breast cancer and the TROY ( 1335TiP ) phase 2 trial evaluating Enhertu in patients with recurrent ovarian cancer with disease progression on prior PARP inhibitor therapy. An overview of late-breaking, clinical data and trials-in-progress presentations from the ADC portfolio of Daiichi Sankyo includes: Presentation Title Author Abstract Presentation (CEST) LBAs Final results of TALENT: a neoadjuvant trial of T-DXd with or without anastrozole, or in sequence with chemotherapy for HER2-low, HR+ early-stage breast cancer S. Hurvitz LBA23 Proffered Paper Presentation Friday, October 23 1:30 pm – 3:00 pm First-line datopotamab deruxtecan (Dato-DXd) vs. chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: exploratory analysis of patients with brain metastases in TROPION-Breast02 R. Dent LBA96 Proffered Paper Presentation Saturday, October 24 8:30 am – 10:00 am First-line trastuzumab deruxtecan (T-DXd) in patients with HER2-mutant NSCLC: patient-reported outcomes from DESTINY-Lung04 S. Novello LBA74 Rapid Oral Presentation Saturday, October 24 8:30 am – 10:00 am DESTINY-Breast09 analysis of trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab for patients with HER2+ advanced/metastatic breast cancer and baseline brain metastases C. Saura LBA49 Rapid Oral Presentation Monday, October 26 10:15 am – 11:45 am Breast DESTINY-Breast11: MRI-assessed objective responses during neoadjuvant treatment with trastuzumab deruxtecan (T-DXd) followed by paclitaxel + trastuzumab + pertuzumab vs. dose-dense doxorubicin + cyclophosphamide followed by THP in HER2+ early breast cancer J.F. Boileau 543RO Rapid Oral Presentation Friday, October 23 4:15 pm – 5:45 pm Patient-reported outcomes from DESTINY-Breast05: health-related quality of life with trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with high-risk HER2 positive early breast cancer C. Barrios 539RO Rapid Oral Presentation Friday, October 23 4:15 pm – 5:45 pm Paired-biopsy multi-omic analysis reveals target-independent mechanisms of antibody-drug conjugate resistance in metastatic breast cancer P. Tarantino 4449RO Rapid Oral Presentation Monday, October 26 10:15 am – 11:45 am Trastuzumab deruxtecan (T-DXd) vs. physician’s choice of chemotherapy in HR+, HER2 low metastatic breast cancer: a DESTINY-Breast06 ctDNA molecular response analysis G. Curigliano 4279P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm Trastuzumab deruxtecan (T-DXd) + pembrolizumab in previously treated human epidermal growth factor receptor 2-expressing advanced or metastatic breast cancer: primary analyses of the breast cohorts from the open-label, multicenter, phase 1b study DS8201-A-U106 H. Rugo 1771P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm DESTINY-Breast Respond HER2 low Europe non-interventional study of trastuzumab deruxtecan (T-DXd) in HER2 low metastatic breast cancer: update on baseline characteristics and anti-emetic treatment J.Y. Pierga 12P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Improving accuracy in HER2 ultralow identification: multi-site validation of an AI-decision support tool B. Van der Vegt 1784P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Comparative evaluation of 7 artificial intelligence tools for HER2-low and ultralow scoring in breast cancer J.S. Frenel 287P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm A global, interventional, open-label trial of trastuzumab deruxtecan (T-DXd)-based therapy followed by palbociclib, endocrine therapy, and dual HER2 blockade in first-line human epidermal growth factor receptor positive, hormone receptor-positive advanced or metastatic breast cancer and retreatment with T-DXd (DESTINY-Breast Guide) S. Sammons 1795TiP Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Lung NeoCOAST-2: association of ctDNA clearance with clinical outcomes in a global platform phase 2 perioperative trial T. Cascone 4244RO Rapid Oral Presentation Sunday, October 25 8:30 am – 10:00 am Mechanisms of insensitivity to the datopotamab deruxtecan (Dato-DXd) payload in subgroups of patients with advanced non-small cell lung cancer in TROPION Lung01 N. Girard 4451P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer: IDeate-Lung01 updated results M. Ahn 3842P Poster Presentation Monday, October 26 12:00 pm – 12:45 pm Ovarian Raludotatug deruxtecan (R-DXd) + bevacizumab in participants with platinum-resistant recurrent ovarian cancer: results for cohort B-1 of the phase 1b/2 REJOICE-Ovarian02 study A. Oaknin 1247RO Rapid Oral Presentation Saturday, October 24 08:30 am – 10:00 am Raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer: an updated analysis of efficacy and tolerability from the phase 2 part of REJOICE-Ovarian01 K. Hasegawa 1331P Poster Presentation Monday, October 26 12:00 pm – 12:45 pm A randomized phase 2, open-label, multicenter, study of trastuzumab deruxtecan versus investigator’s choice chemotherapy in recurrent ovarian cancer that progressed on prior PARP inhibitor therapy: TROY (APGOT-OV14) J.Y. Lee 1335TiP Poster Presentation Monday, October 26 12:00 pm – 12:45 pm Gastric Quality-adjusted time without symptoms or toxicity (Q-TWiST) of trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with HER2+ unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma from DESTINY-Gastric04 M. Gumus 2925P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm Perioperative trastuzumab deruxtecan plus capecitabine and durvalumab in HER2 positive gastric or gastroesophageal junction cancer: a phase II study (EPOC2003) D. Takahari 2888P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm PanTumor Final results of the TUXEDO-3 phase II trial of patritumab deruxtecan (HER3-DXd) in active brain metastases and leptomeningeal disease M. Preusser 690O Proffered Paper Presentation Sunday, October 25 10:15 am – 11:45 am Patritumab deruxtecan (HER3-DXd) in melanoma after anti-PD-(L)1 therapy: primary analysis from HERTHENA-PanTumor01 M. McKean 2073RO Rapid Oral Presentation Sunday, October 25 10:15 am – 11:45 am ESPERANZA: Results from an external comparator study of trastuzumab deruxtecan in HER2 IHC3+ solid tumors F. Meric-Bernstam 1014P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of nine 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. Additional ADCs being developed by Daiichi Sankyo include DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING, and DS1025, which consists of a CD25 directed antibody attached to an immuno-oncology optimized cytotoxic payload. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610, DS3790 and DS1025 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo 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. For more information, please visit . Contacts MEDIA CONTACTS: Global: Jennifer Brennan Jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com

2015年到2024年8月，125个抗肿瘤新药获批，附条件获批品种的转常规批准率只有22%。新药跑得快，安全怎么跟上？ 这道题的答案，主要落在药师身上——按照国家卫健委2025版《新型抗肿瘤药物临床应用指导原则》，药师完成用药前靶点与适应证核查、用药中输注与毒性监测、用药后随访上报的全流程把关。 但真正卡脖子的地方在于：个体化处方审核无法被AI替代，审核需求与药师人力之间的矛盾越来越尖锐；同时，ADC、发泡类抗肿瘤药物一旦外渗，造成的皮下组织坏死、周围神经损伤是不可逆的永久性伤害。 两件事叠加，药师的压力不是“忙不忙得过来”的问题，而是“漏一项就可能出事”的问题。 错误没机会改，有些操作是不可逆的 说到最严重的后果，不是不良反应发生率上升，而是有些错误根本没有补救窗口。 一条是输注端的外渗。发泡类、ADC类抗肿瘤药物，如果输注过程中从血管渗漏到皮下组织，而药师没在前端把血管通路评估、溶媒种类、输注速度这些参数审到位，后果是皮下组织不可逆坏死、周围神经永久损伤。 抗肿瘤药物不同静脉给药方式展示 河北医科大学第四医院的药师在公开科普中明确强调过这一点——静脉给药无小事，溶媒/输注参数错误直接提升毒副反应风险，药物外渗可导致局部永久损伤。 另一条是给药顺序。典型案例：紫杉醇与顺铂联用，须先输紫杉醇再输顺铂。顺序一旦颠倒，骨髓抑制风险额外增加，且这种骨髓抑制可能是不可逆的。AI审方系统能记住“紫杉醇+顺铂”的配伍禁忌，但它无法结合患者当下的骨髓功能基线来做个体化判断。 对于附条件获批的新药，问题更复杂。按附条件上市的决策标准，罕见肿瘤样本量至少20例，非罕见肿瘤至少30例。北京大学人民医院药学部主任张晓红直言：“二三十例的样本量无疑还是比较小的。” 样本量小意味着罕见毒性和迟发性不良反应根本来不及在上市前暴露，药师只能边用边学、边学边守——而漏判的代价可能是患者承受终身后果。 同一种药、同样的剂量，为什么有人管用有人出事 这是浙江省肿瘤医院药剂科副主任药师钟里科经常被患者追问的问题。他的回答很直接：用药只是第一步，后面怎么吸收、代谢、排出去，每个人都不一样。 同样剂量的药进入体内，“留下来的量”和“停留的时间”取决于肝肾功能、代谢酶的活性、合并用药的情况。有人代谢快，药很快就排掉了；有人代谢慢，药物蓄积，毒副反应放大。 还有更隐蔽的——西柚（葡萄柚）会抑制肠道里CYP3A4酶的活性，这个酶参与很多抗肿瘤药的代谢，酶被抑制后，部分口服抗肿瘤药在肠道中的代谢减少，进入血液的药物浓度升高，副作用风险上升。服用维奈克拉、伊布替尼、帕博西尼等药物的患者，必须避开西柚及其制品。 这就是审方不能只靠AI的根本原因。AI可以机械匹配“维奈克拉+CYP3A4强抑制剂”的警示，但患者餐桌上有没有西柚、长期吃的保健品里是否含诱导/抑制成分、肝肾功能波动到什么程度需要调剂量——这些信息散落在病历、问诊、随访里，只有人能串起来。 上观新闻一篇关于处方审核的评论讲得很清楚：AI只能依托病历信息做简单判断，忽略复杂的临床背景，容易出现误判。 规定要求高质量完成一张处方审核通常需要1到3分钟，但面对抗肿瘤新药密集上市、人工审核需求激增的现实，药师的工作时长与审核质量之间的张力一直在加大。 对老年患者和肝肾功能异常者，剂量调整不是“一刀切”。以安罗替尼为例，65岁以上和65岁以下患者的安全性、有效性无明显差异，不需按年龄强行调剂量。但肝肾功能基线评估必须做，用药前两个月内要每月监测指标，根据异常程度阶梯式下调剂量。 这些判断，正是一线药师最容易在高峰时段简化掉的——不是不懂，是时间不够。 一线和三甲、专科和基层，差在哪 同样是抗肿瘤新药的用药安全审核，在不同级别的医院，操作空间是完全不同的。 在中国医学科学院肿瘤医院这样的专科肿瘤医院，有肿瘤专属智能化审方系统，设置了专职审方药师岗位，从治疗方案评估到不良反应识别、特殊人群剂量调整、输注建议、全周期随访，构成闭环。 肿瘤专科药学服务团队集体合影 中山大学肿瘤防治中心甚至为日间化疗中心配套建立了专门的一体化药房和静配中心，从审核端到输注端全程可控。 静配中心内使用生物安全柜配置抗肿瘤药 到了省级综合三甲医院，情况就紧了一扣。以上海市第一人民医院为例，创新药入院要过药事会那关，要求四分之三成员参会、三分之二赞成票通过，纪检办全程现场监督。 审核流程严，但这类医院也有灵活的地方——对于没进常规供应目录但有临床需求的药，通过临时采购绿色通道，半天内可以完成调配供患者使用。 最难受的是县级医院。浙江长兴县人民医院不把抗肿瘤创新药纳入院内常规用药目录，只开放临时采购通道满足单次临床需求。 抗肿瘤药进不来，意味着基层审核只能依赖通用审方规则去卡——靶点检测结果对不对、适应证是否在说明书范围内、有无药物间禁忌——而面对二三十例样本量支撑的新药，通用规则的覆盖能力是有边界的。 在京津冀第四届医药创新发展大会上，药学专家也勾画了“审核—监测—随访”的全程管理框架。天津自贸试验区还专门开辟了罕见肿瘤进口药的绿色通道，组建跨学科药学团队来配套保障。 同样是面对罕见病患者，有绿色通道的地方和没有的地方，患者能用的药就差一个“能不能批得下来”。 从河北医科大学第四医院药学部主任药师杜文力的角度看，这些差异背后有一个共同的问题：新药大量上市，质量良莠不齐，国外附条件获批品种转化为常规批准的比例有50%多，还有退市的，国内转化率只有22%。“如何选择这些新药，是药品遴选过程中必须重视的问题。” 不同机构用不同的策略在接这些药。专科医院用专属团队接，头部三甲用严审快通接，基层用临时采购接。但接不接得住，归根到底取决于有没有足够的人去执行个体化审方——而这个环节，目前没有统一的简化标准，也看不到被AI取代的时间表。