A Global, Interventional, Open-label Trial of T-DXd-based Therapy Followed by Palbociclib, Endocrine Therapy and Dual HER2 Blockade in First-line HER2+/ HR+ Advanced or Metastatic Breast Cancer and Retreatment With T-DXd (DB-Guide)

This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.

开始日期2026-09-04

申办/合作机构

Daiichi Sankyo Co., Ltd.

[+1]

NCT07748208

/ Not yet recruiting临床2期

A Phase II Prospective, Open-Label Safety Study of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer and Type 2 Diabetes

This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.

开始日期2026-09-01

申办/合作机构

Hoffmann-La Roche Ltd.

JPRN-jRCTs031260249

/ Recruiting临床2期

A randomized study of Trastuzumab deruxtecan Against Second-line endocrine Therapy In hormone receptor-positive, HER2-low/ultralow metastatic breast cancer (TRANSITION)

开始日期2026-06-29

申办/合作机构-

100 项与哌柏西利相关的临床结果

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100 项与哌柏西利相关的转化医学

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100 项与哌柏西利相关的专利（医药）

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3,433

项与哌柏西利相关的文献（医药）

2026-12-31·Journal of Pharmaceutical Policy and Practice

Economic evaluation of cyclin-dependent kinases 4 and 6 inhibitors in advanced hormonal receptor-positive and human epidermal growth factor receptor 2 negative breast cancer: a nationwide budget impact analysis

Article

作者: Hamad, Anas ; Shafei, Laila ; Hisham Al-Ziftawi, Nour ; Mohamed Ibrahim, Mohamed Izham ; Bojassoum, Salha ; Elazzazy, Shereen

Background:

Several trials demonstrated improvements in clinical outcomes associated with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors in breast cancer patients. The challenge remains regarding their high costs. Ribociclib and Abemaciclib are cost-effective in Qatar. Yet, their affordability was not studied. This budget impact analysis (BIA) is to assess the affordability of adopting CDK4/6 inhibitors in Qatar over five years duration (2024-2028).

Methods:

We ran a BIA to evaluate two scenarios: (1) Increasing abemaciclib's market share from 20% to 60%, replacing both palbociclib and ribociclib. (2) Assuming equal market share for both ribociclib and abemaciclib up to 80%, reducing palbociclib's share. The analysis considered treatment costs, patient population, and disease prevalence. All data were retrieved from the National Center for Cancer Care and Research, and costs were presented in Qatari Riyals (QAR). Sensitivity analyses were run to ensure the robustness of the conclusion. All results were compared to Qatar's budget threshold, which is QAR 453,822.

Results:

Based on a total of 173 patients using CDK4/6 inhibitors, increasing abemaciclib's market share to 60% yielded cumulative savings of QAR 14 million over five years, which is around QAR 14,613 per patient per year. However, equally increasing ribociclib's and abemaciclib's market share to 80% resulted in a modest budget increase, remaining within acceptable thresholds. Sensitivity analyses confirmed the robustness of these findings, showing that cost reductions and higher uptake rates further enhanced savings.

Conclusion:

Abemaciclib is a budget-saving option for HR+/HER2- breast cancer in Qatar, should it replace the market share by up to 60% over five years. In addition, ribociclib and abemaciclib are affordable treatment options if they equally contributes to up to 80% of the market share for the eligible advanced breast cancer patients. The results supported the concept of allocating CDK4/6 inhibitors as they were found to be affordable to the Qatari healthcare system.

2026-12-01·MOLECULAR BIOLOGY REPORTS

Possible TLR-mediated immunostimulatory effect of Palbociclib in breast cancer

Article

作者: Sağ, Sevda ; Tomatir, Ayse Gaye ; Ergezgin, Huriye ; Bayav, Ibrahim ; Dodurga, Yavuz

BACKGROUND:

Palbociclib, which exerts its effect by inhibiting the cell cycle in cancer cells, is a CDK inhibitor used in the treatment of ER+/HER- breast cancer. In this study, we aimed to investigate the effect of Pablosiklib on TLR, which plays an important role in the immune response, in MCF-7 (ER+/HER2-) and MDA-MB-231 (ER-/PR-/HER2-) cell lines.

METHODS AND RESULTS:

The expression levels of TLR 1-10 genes, cell cycle-related genes (CDK4/6), and genes involved in the apoptotic pathway (Bcl-2, Bax, Cas-3) in MCF-7 and MDA-MB-231 cells treated with palbociclib were evaluated using the real-time PCR (qRT-PCR) method. Additionally, the levels of total retinoblastoma (RB) and phosphorylated retinoblastoma (pRB) proteins were analyzed using the Western blot method. CDK4/6 and pRB expression decreased in MCF-7 and MDA-MB-231 cells treated with palbociclib. Bax and Cas-3 expression increased, while Bcl-2 expression decreased. Changes in TLR expression were also observed.

CONCLUSIONS:

We believe that palbociclib not only stops the cell cycle and induces apoptosis in breast cancer cells, but also activates the immune response via TLRs.

2026-11-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

A PROTAC-inspired bifunctional small molecule recruits CDK6 to target EYA2 degradation and suppress breast tumor growth

Article

作者: Qin, Xiaoyu ; Wu, Zhaofeng ; Wang, Yu ; Yuan, Bin ; Kan, Chenchen ; Ma, Junting ; Zhou, Rui ; Liu, Mingming ; Luo, Qichao ; Zhang, Yanhui ; Zhao, Qun ; Gao, Jiahui ; Ai, Jiaxin

Cyclin-dependent kinase 6 (CDK6) has been reported to exert tumor-suppressive functions through its non-enzymatic activity and promotes the degradation of the oncogenic driver EYA2. This suggests a potential strategy for targeted protein degradation by exploiting endogenous protein-protein interactions. Here, we report the design and synthesis of a bifunctional small molecule, EC21, capable of simultaneously engaging CDK6 and EYA2. Structure-guided design based on the reported binding modes of palbociclib and the EYA2 inhibitor ETC-616 enabled the identification of EC21 as a lead compound. Biological studies demonstrated that EC21 effectively reduced EYA2 protein levels in breast cancer cells in a time- and concentration-dependent manner through a ubiquitin-proteasome-dependent process. Mechanistic investigations indicated that EC21 enhances the interaction between CDK6 and EYA2, thereby promoting EYA2 degradation. Functional analyses further revealed that EC21 disrupts DNA damage repair pathways and significantly suppresses breast cancer cell proliferation. Importantly, EC21 exhibited pronounced antitumor activity in a syngeneic breast cancer mouse model and reduced EYA2 protein levels in tumor tissues without apparent toxicity. Collectively, these findings demonstrate that pharmacological stabilization of the CDK6-EYA2 interaction represents a feasible strategy for inducing EYA2 degradation and provides a potential therapeutic approach for EYA2-driven breast cancer.

2,188

项与哌柏西利相关的新闻（医药）

20 小时之前

·药昭喵喵

药物信息调研-FDA资料

FDA（美国食品药品监督管理局）是全球最权威的药品监管机构之一，其官网提供了多个公开数据库，供公众查询药品的批准信息、说明书、审评报告等。以下是FDA药物信息查询的系统性指南。一、FDA及核心数据库简介 FDA下设药品审评与研究中心（CDER）和生物制品审评与研究中心（CBER），分别负责小分子化药和治疗性生物制品（如单抗）以及疫苗、血液制品等的监管。 FDA公开的核心药品数据库主要包括：序号数据库核心功能适用对象 1 Drugs@FDA 药品基本信息、说明书、审批历史、FDA审评报告所有获批人用药品（化药+治疗性生物制品） 2 橙皮书（Orange Book）化药参比制剂、专利信息、市场独占权、治疗等效性评价、合规仿制药清单化药仿制药研发、参比制剂选择 3 紫皮书（Purple Book）生物制品（含生物类似药）的许可信息生物药、生物类似药、生物制品 4 FDA Label 超过14万份药品标签的全文检索（黑框警告、不良反应、适应症）说明书深度检索 5 非活性成分数据库（Inactive Ingredient Database）药物辅料数据库辅料信息检索 6 溶出方法数据库（Dissolution Methods Database Search）溶出方法查询数据库为USP中尚无溶出度检测方法的药品提供方法参考 7 FDA指导原则各指导原则查询数据库所有获批人用药品（化药+治疗性生物制品）二、FDA药物信息全套实操查询步骤模块一：Drugs@FDA 为最核心的查询入口，查询审批记录、说明书、审评资料（通用首选）步骤 1：Drugs@FDA数据库查询界面 1. 直达网址：https://www.accessdata.fda.gov/scripts/cder/daf/ 2. FDA官网转入 1）打开FDA官网：https://www.fda.gov/； 2）在首页找到【Drugs】模块，点击； 3）找到【Drugs@FDA】模块，点击进入检索界面。步骤 2：检索方法在检索框中输入以下任一信息即可查询： 1）药品通用名 2）商品名 3）活性成分 4）申请号（NDA、ANDA或BLA号，均为6位数字） 5）药企名称建议：优先使用活性成分名称进行检索，这样能获得包含原研药和所有仿制药的更全面结果。举例：哌柏西利（palbociclib），活性成分检索补充检索方式： A-Z字母索引：首页 A-Z Drug Name，按首字母浏览药品；仅展示商品名，不会自动带出复方药、仿制药，适合定向查找单一原研品种。步骤 3：筛选检索结果列表关键标识识别： 1）NDA = 原研创新药；ANDA = 仿制药（简化新药）；BLA = 生物药； 2）Approved：正式获批上市；Tentative Approval：临时批准，暂无法在美国上市； 3）认准目标剂型、规格、给药途径，点击对应条目进入详情页。步骤 4：可获取的核心资料点击药品的申请号后，可以获取以下信息：核心资料包含以下四大模块：英文名称中文名称说明 Label 药品说明书当前最新版本及历史版本 Letter（Approval Letter）审批函：批准历史首次批准日期、补充申请记录 Reviews 深度审评报告FDA内部的详细审评文件，同时也包含Label和Letter文件 Summary Review 综合审评总结各专业审评汇总精简版在药品详情页点击 “Reviews” 选项卡，可查看并下载以下关键报告（PDF格式）：审评报告包括： 1) Product Quality Review(s) 产品质量审评报告（重点关注） 2) Clinical Pharmacology and Biopharmaceutics Review(s) 临床药理和生物药剂学审评报告 3) Clinical Review(s) 临床审评报告 4) Cross Discipline Team Leader Review 跨学科团队负责人审评报告 5) Office Director Memo 审评办公室主任审批备忘录 6) Clinical Microbiology/Virology Review(s) 临床微生物学/病毒学审评报告 7) Non-Clinical Review(s) 非临床审评报告 8) Proprietary Name Review(s) 商品名审评报告 9) Officer/Employee List 官员/雇员名单 10) Other Review(s) 其他审评报告 11) Risk Assessment and Risk Mitigation Review(s) 风险评估与风险管控（REMS）审评报告 12) Statistical Review(s) 统计学审评报告 13) Summary Review 总结审评报告（等同于 SBA 批准依据总结） 14) Administrative and Correspondence Documents 行政和通信文件（FDA 往来沟通函件）注：红色标注为药物研发常用。模块二：Orange Book橙皮书查找RLD参比制剂、专利、仿制药等效性步骤 1：进入橙皮书查询界面 1. 直达网址：https://www.accessdata.fda.gov/Scripts/cder/ob/index.cfm 2. FDA官网转入 1）打开FDA官网：https://www.fda.gov/； 2）在首页找到【Drugs】模块，点击； 3）找到【Orange Book】模块，点击进入橙皮书检索界面。步骤 2：检索方法在检索框中输入以下任一信息即可查询： 1）商品名 2）活性成分 3）受理号 4）申报企业 5）剂型 6）给药途径举例：哌柏西利（palbociclib），活性成分搜索步骤 3：筛选检索结果检索结果页重点查看关键字段： 1）RLD=Yes：FDA 官方指定参比制剂（一致性评价对标样品）；RS=Yes：官方对照标准品； 2）TE Code治疗等效等级： A 类（AB/AA）：与原研体内外等效，药房可直接替换使用； B 类：不等效，不能直接替代； 3）切换【Patent & Exclusivity】标签：查看绑定专利号、专利到期日、行政市场独占保护期； 4）Marketing Status：在售/退市/暂停上市状态。步骤 4：数据导出可下载全量药品、专利文本数据包，导入 Excel 批量整理；橙皮书每月更新一次专利与产品数据。模块三：Purple Book紫皮书（生物药专用）紫皮书专门针对通过BLA许可的生物制品（如单抗、细胞因子等）。步骤 1：进入紫皮书查询界面 1. 直达网址：https://purplebooksearch.fda.gov/ 2. FDA官网转入 1）打开FDA官网：https://www.fda.gov/； 2）在首页找到【Drugs】模块，点击； 3）找到【Drug Approvals and Databases】模块，点击； 4）找到【Purple Book】模块，点击进入紫皮书检索界面。步骤 2：检索方法输入通用名/商品名检索步骤 3：筛选检索结果 1）区分原研参照生物药、生物类似药、可互换生物制品；卡片标识一致代表临床可互换； 2）查询 BLA 审批编号、获批适应症、可比性审评相关资料。模块四：FDA Label 说明书全文深度检索网址：https://nctr-crs.fda.gov/fdalabel/ui/search 步骤 1：简单检索药品名+关键词（如 liver injury、black box warning），快速定位说明书对应段落；步骤 2：高级检索限定章节（BOXED WARNING 黑框警告、INDICATIONS 适应症、ADVERSE REACTIONS 不良反应）、上市时间、处方药/OTC类型；步骤 3：一键跳转回Drugs@FDA与橙皮书对应药品页面。模块五：非活性成分数据库即为辅料数据库（Inactive Ingredient Database）步骤 1：进入非活性成分数据库界面 1. 直达网址：https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm 2. FDA官网转入 1）打开FDA官网：https://www.fda.gov/； 2）在首页找到【Drugs】模块，点击； 3）找到【Drug Approvals and Databases】模块，点击； 4）找到【Inactive Ingredient Search for Approved Drug Products Search】模块，点击进入非活性成分数据库检索界面。步骤 2：检索方法及检索结果输入辅料名称检索举例：微晶纤维素Microcrystalline Cellulose 注：结合辅料占比及相关产品说明书中明确的日最大剂量计算该辅料是否在MDE要求内（儿童用药需单独考察）；以上结果可下载Excel文件。模块六：溶出方法数据库步骤 1：进入溶出方法数据库查询界面（Dissolution Methods Database Search） 1. 直达网址：https://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm 2. FDA官网转入 1）打开FDA官网：https://www.fda.gov/； 2）在首页找到【Drugs】模块，点击； 3）找到【Drug Approvals and Databases】模块，点击； 4）找到【Dissolution Methods Database Search】模块，点击进入溶出方法数据库查询界面。步骤 2：检索方法进入数据库后，可以通过以下方式搜索： 1）按药品名称搜索：在搜索框中输入药品通用名的任意部分，但至少输入3个字符，不支持中文； 2）查询所有药品：点击搜索页面上的 “Printable List of all Drugs in the Database” 链接，可以查看或下载完整的药品列表； 3）搜索复方制剂：复方制剂的活性成分按字母顺序排列，搜索时请使用斜杠/连接，且斜杠前后不要有空格，如果不确定正确写法，也可以分别搜索单个成分； 4）大小写不敏感，支持模糊检索。举例：哌柏西利palbociclib 步骤 3：筛选搜索结果搜索得到以下信息：注：除非另有说明，溶出试验温度通常为 37℃；FDA通常建议，在最后一个取样时间点，药物活性成分的溶出量应至少达到标示量的 70-85% (Q)。补充说明： 1）数据库用途：该数据库主要针对USP中尚无溶出度检测方法的药品，提供FDA仿制药办公室（OGD）推荐的溶出方法，若该品种药典已收载溶出方法，FDA 溶出库不会重复收录，直接查询 USP <711> 章节法定溶出方法； 2）方法并非强制：数据库中的方法仅供参考，FDA也接受基于充分数据支持的其它合理方法； 3）更新频率：数据库大约每季度更新一次（通常在4月、7月、10月、1月的第五个工作日）； 4）更多指导原则： FDA官网还发布了关于速释口服固体制剂溶出度测试的专项指南，可作为重要参考。模块七：FDA指导原则步骤 1：进入指导原则查询界面 1. 直达网址：https://www.fda.gov/regulatory-information/search-fda-guidance-documents 2. FDA官网转入 1）打开FDA官网：https://www.fda.gov/； 2）在首页找到【Drugs】模块，点击； 3）找到【Guidance, Compliance, and Regulatory Information】模块，点击； 4）找到【Guidances Drugs】模块，点击； 5）找到【Search All FDA Guidances】模块，点击进入指导原则检索界面。步骤 2：输入检索关键词 1. 精准关键词示例（以下常用） 1）质量源于设计：Quality by Design / QbD 2）CMC药学：impurities杂质、dissolution溶出、process validation工艺验证、stability稳定性 3）仿制药BE：bioequivalence、ANDA 4）ICH 协调指南：ICH Q8、ICH Q9、ICH Q10 5）基因毒性杂质：genotoxic impurities 2. 输入关键词，点击页面【Search】检索注：下面筛选面板精准缩小范围（核心筛选配置）筛选项化药研发标准选择含义 Product Drugs 限定只展示药品类指南，排除食品、器械、化妆品 FDA Organization CDER 化药选CDER；单抗/疫苗生物制品选CBER Topic CMC、Generic Drugs、Clinical Pharmacology、ICH 按研发方向归类 Draft or Final Final（正式版）做申报执行勾选；前期调研可同时勾选 Draft+Final Issue Date 可限定近1/2/3年筛选最新发布新规步骤 3：打开目标指南、下载 PDF 1）检索结果列表点击对应指南标题； 2）跳转页面内蓝色Download the Guidance (PDF)一键保存官方原版文件； 3）页面同时展示发布日期、修订历史、当初征求意见的公众反馈记录。举例：溶出指导原则，输入dissolution检索，得到以下结果补充说明：对于仿制药研发，FDA还专门发布了针对特定产品的指导原则（PSG），其中包含了生物等效性（BE）试验的设计建议等关键信息。查询入口：https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm 最新动态追踪： FDA会持续发布和更新指导原则，可通过以下方式保持关注： 1）订阅邮件：在“Search for FDA Guidance Documents”页面上，点击 “Subscribe to email updates” 按钮，可以订阅新发布指导原则的邮件通知。 2）查看CDER指导原则议程：访问 CDER Guidance Agenda 页面，可以了解CDER计划在未来发布的新草案和修订版指导原则。声明：以上为个人观点，欢迎交流讨论，转载发表请注明来源，感谢~

2026-08-10

·粉丝带港湾

7月乳腺癌新药盘点：国外3款获批、国内4款纳入优先审评，三阴、HER2阳性、HER2低表达都有新选择

编者按乳腺癌姐妹，欢迎来到粉丝带港湾。刚刚过去的7月，乳腺癌领域迎来了堪称“井喷式”的新药上市进展。今天我就围绕国内和国外两大板块来向大家介绍： ① 7月国外有哪些乳腺癌新药获批？对我们有什么参考价值？ ② 7月国内有哪些乳腺癌新药提交了或申报？哪些患者有希望了？国际新药接连获批，精准治疗再添利器 1、Camizestrant（卡米司群）药物介绍阿斯利康原研的新一代口服选择性雌激素受体降解剂（SERD），SERENA-6研究显示，可以将ESR1突变患者的无进展生存期从9.2个月延长至16个月。 7月进展欧盟委员会正式批准了的口服新药Camizestrant，联合CDK4/6抑制剂，用于一线治疗期间检测到ESR1突变且病情尚未进展的ER+/HER2-晚期乳腺癌患者。就在前不久，我正好和大家分享过另一款口服SERD依仑司群，那款药在我们国内已经正式获批了，您可以点击文末的往期链接重温学习。2、Datroway（德达博妥单抗）药物介绍这是一款靶向TROP2的抗体偶联药物（ADC），由阿斯利康与第一三共联合开发。TROPION-Breast02研究显示，相比传统化疗，这款新药将三阴乳腺癌中位总生存期（OS）延长到了23.7个月（化疗组为18.7个月），死亡风险下降了21%，显著改善了总生存期。 7月进展继今年5月在美国获批后，7月底正式获得欧盟委员会批准，单药一线治疗不适合PD-1/PD-L1抑制剂的不可切除或转移性三阴性乳腺癌患者。 3、Gedatolisib（莱托妥昔布）药物介绍由辉瑞原研的多靶点PI3K/mTOR通路抑制剂，可同时抑制所有I类PI3K亚型及mTORC1/2。IKTORIA-1研究显示，gedatolisib联合氟维司群和帕博利珠单抗方案能将中位PFS显著拉长至 9.3个月（单药对照组仅2.0个月）。 7月进展美国FDA正式批准了Gedatolisib联合氟维司群（可联合或不联合帕博西尼），用于经治的PIK3CA野生型HR+/HER2-局部晚期或转移性乳腺癌成人患者。看到这些国外率先获批的新药，您可能会担心“远水解不了近渴”。但实际上，国外获批恰恰是为进入国内铺路。我们期待国际前沿的新药能尽早踏入国内市场，给大家更多选择。国产药全面发力，适应症持续拓展 1、瑞康曲妥珠单抗药物介绍由恒瑞医药自主研发的靶向HER2的ADC（SHR-A1811），此前已获批HER2突变非小细胞肺癌和HER2阳性乳腺癌适应症。之前也已经详细介绍过啦。 7月进展目前这款ADC正在申报新适应症，用于既往未接受或接受过一线治疗的HER2低表达（IHC 1+或IHC 2+/ISH-）不可切除或转移性成人乳腺癌患者。该申请已获受理并被纳入优先审评。 2、恩维曲妥珠单抗药物介绍这是一款由石药集团研发的ADC（DP303c），同样靶向HER2。 7月进展 2026年7月，其上市申请获国家药监局受理，拟用于既往接受过一种或以上抗HER2药物治疗的不可切除或转移性HER2阳性成人乳腺癌。 3、芦康沙妥珠单抗药物介绍这是科伦博泰研发的靶向TROP2 ADC（SKB264/MK-2870），此前已在国内获批三阴乳腺癌后线治疗，以及EGFR突变非小细胞肺癌的后线治疗。 7月进展 7月30日提交申报了新适应症，针对复发或转移性三阴乳腺癌一线治疗，期望能将治疗战线前移。目前已纳入优先审评。 4、安尼妥单抗药物介绍这是由康宁杰瑞与石药集团联合开发的HER2双特异性抗体（KN026），可同时结合HER2的两个非重叠表位，有效阻断HER2信号通路。此前已在我国获批晚期胃癌适应症。 7月进展 2026年7月，该药两项适应症拟纳入优先审评：①联合多西他赛（白蛋白结合型）一线治疗不可切除或转移性HER2阳性成人乳腺癌；②联合多西他赛±卡铂新辅助治疗早期或局晚期HER2阳性成人乳腺癌。随后在8月初，其上市申请正式获国家药监局受理。写在最后就在整理这些资讯的过程中，我都不禁感叹：医学的进步，真的比想象中还要快。全球无数顶尖的科学家和医生，正在实验室里、在临床研究中，为您、为千千万万个病友拼命赶路。期待好药早日来到每个人身边！参考内容 [1] Turner NC, Oliveira M, Howell SJ, et al. Camizestrant versus standard endocrine therapy after detection of ESR1 mutations in early molecular progression of ER-positive, HER2-negative advanced breast cancer: SERENA-6 trial. New England Journal of Medicine. 2025. [2] AstraZeneca. Camizestrant positive CHMP opinion based on SERENA-6 trial results. 2026. [3] Bardia A, et al. Datopotamab deruxtecan versus investigator's choice of chemotherapy in previously untreated metastatic triple-negative breast cancer: TROPION-Breast02. Annals of Oncology. 2025. [4] Daiichi Sankyo and AstraZeneca. Datroway (datopotamab deruxtecan) regulatory update and TROPION-Breast02 results. 2026. [5] U.S. Food and Drug Administration. FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative advanced breast cancer. July 14, 2026. [6] VIKTORIA-1 Clinical Trial (NCT05501886). ClinicalTrials.gov. [7] Yao Y, et al. SHR-A1811, a novel HER2-targeting antibody-drug conjugate, in advanced solid tumors (HORIZON-X): a global phase 1 trial. Signal Transduction and Targeted Therapy. 2026. [8] ClinicalTrials.gov. NCT05814354. SHR-A1811 versus investigator's chemotherapy in HER2-low expressing recurrent/metastatic breast cancer. [9] Merck & Co., Inc. / Kelun-Biotech. SKB264 (MK-2870) clinical development program in triple-negative breast cancer. 2026. [10] 康宁杰瑞生物制药. KN026（安尼妥单抗）HER2双特异性抗体临床开发资料. 2026. [11] 国家药品监督管理局药品审评中心（CDE）. 2026年7月创新药优先审评审批公示信息. [12] 国家药品监督管理局（NMPA）药品批准及受理信息公开平台. 声明：本文仅用于医学知识科普与学习交流，不构成任何医疗建议或治疗方案推荐。药物使用请严格遵循主治医师指导，患者切勿自行用药、停药或调整治疗方案。如有任何诊疗相关问题，请及时咨询专业医生。临床试验存在严格筛选标准，详情可报名咨询医助老师，最终能否入组以研究中心评估为准。 📣 互动时间您是哪一种乳腺癌？现在在用什么治疗方案呢？欢迎给我留言。也记得点亮底部的“小爱心”，您的每一次转发都可能成为点亮别人希望的一盏灯❤️ 点击下方卡片关注我持续为您分享更多乳腺癌新药资讯 👇 往期推荐·点击阅读👇 点分享点推荐点点赞

2026-08-10

·ir.olema.com

Olema Oncology Reports Second Quarter 2026 Financial and Operating Results

Completed enrollment in the pivotal Phase 3 OPERA-01 trial; top-line data are now expected in the first quarter of 2027 Presented initial Phase 1 clinical data for OP-3136 at the 2026 ASCO Annual Meeting Announced a clinical trial collaboration and supply agreement with Bayer to evaluate darolutamide in combination with OP-3136 in metastatic castration-resistant prostate cancer Ended the second quarter with $461.1 million in cash, cash equivalents, and marketable securities SAN FRANCISCO, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today reported financial and operating results for the second quarter ended June 30, 2026. “Our commitment to transforming the metastatic breast cancer treatment paradigm remains resolute as we continue to advance palazestrant as a potentially differentiated endocrine therapy across multiple regimens. Importantly, enrollment in our pivotal OPERA-01 Phase 3 trial is complete and we now expect to report top-line data in the first quarter of 2027,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “Beyond palazestrant, we made significant progress with OP-3136, our novel KAT6 inhibitor. The initial monotherapy Phase 1 data, presented at ASCO, demonstrated that OP-3136 was well-tolerated and showed evidence of anti-tumor activity across multiple dose levels and various tumor types. These data, taken together with our first clinical collaboration for OP-3136, established with Bayer to evaluate OP-3136 in combination with darolutamide in metastatic castration-resistant prostate cancer, reinforce our confidence in its potential as a best-in-class, differentiated option for patients with advanced solid tumors.” Bohen continued, “Supported by a strong balance sheet, we are intently focused on execution in the second half of the year as we ramp preparations for our first potential commercial launch of palazestrant as a monotherapy, work to establish palazestrant as a potential combination agent of choice in breast cancer, and continue our transformation into a fully integrated oncology company.” Recent Progress Completed enrollment in the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in patients with second or third-line estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC). Presented initial Phase 1 clinical data for OP-3136 as a monotherapy in multiple solid tumor types and a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- MBC at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Announced a clinical trial collaboration and supply agreement with Bayer to evaluate OP-3136 in combination with darolutamide, Bayer's androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC). Completed enrollment in the Phase 1b/2 study of palazestrant in combination with atirmociclib in ER+/HER2- MBC. Advanced enrollment in the pivotal Phase 3 OPERA-02 trial and the Phase 1 study of OP-3136 as a monotherapy and in combination with fulvestrant and palazestrant in ER+/HER2- MBC. Anticipated Upcoming Events Initiate enrollment in the Phase 1b/2 study evaluating OP-3136 in combination with darolutamide in mCRPC in collaboration with Bayer in the fourth quarter of 2026. Report top-line data from the pivotal Phase 3 OPERA-01 trial in the first quarter of 2027. Second Quarter 2026 Financial Results Cash, cash equivalents, and marketable securities as of June 30, 2026, were $461.1 million. Net loss for the quarter ended June 30, 2026 was $63.2 million, as compared to $43.8 million for the quarter ended June 30, 2025. The increase in net loss for the second quarter was related to higher spending on clinical development and research and corporate-related activities related to late-stage clinical trials for palazestrant and the advancement of OP-3136. GAAP research and development (R&D) expenses were $57.8 million for the quarter ended June 30, 2026, as compared to $43.9 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and increased personnel-related costs to support expanding development activities, including an increase in non-cash stock-based compensation expense of $5.2 million, mainly due to higher grant prices in 2026 and higher headcount. These increases were partially offset by the $10.0 million milestone expense related to the Aurigene agreement that was recognized in the same period in 2025. Non-GAAP R&D expenses were $48.9 million for the quarter ended June 30, 2026, excluding $8.9 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $40.2 million for the quarter ended June 30, 2025, excluding $3.7 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release. GAAP G&A expenses were $9.4 million for the quarter ended June 30, 2026, as compared to $4.0 million for the quarter ended June 30, 2025. The increase in G&A expenses was primarily due to higher corporate-related costs that reflect continued investment in personnel and corporate infrastructure to support our expanding late-stage clinical development activities and anticipated future commercial operations, including an increase in non-cash stock-based compensation expense of $3.0 million, mainly due to higher grant prices in 2026, and an increase in professional fees of $1.8 million. Non-GAAP G&A expenses were $5.4 million for the quarter ended June 30, 2026, excluding $4.0 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended June 30, 2025, excluding $1.0 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release. About Olema Oncology Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.olema.com. About Palazestrant (OP-1250) Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01, and in combination with ribociclib in the ongoing pivotal Phase 3 clinical trial, OPERA-02. Palazestrant is also being evaluated in multiple Phase 1/2 studies in combination with ribociclib, palbociclib, alpelisib, everolimus, and atirmociclib. About OP-3136 OP-3136 is a novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies including palazestrant and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The Investigational New Drug (IND) application for OP-3136 was cleared by the U.S. Food and Drug Administration (FDA) in December 2024 and patients are currently enrolling in the Phase 1 clinical study. Non-GAAP Financial Information The results presented in this press release include both GAAP information and non-GAAP information. As used in this release, non-GAAP R&D expense is defined by Olema as GAAP R&D expense excluding stock-based compensation expense, and non-GAAP G&A expense is defined by Olema as GAAP G&A expense excluding stock-based compensation expense. We use these non-GAAP financial measures to evaluate our ongoing operations and for internal planning and forecasting purposes. We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool, and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. Other companies, including companies in our industry, may calculate similarly titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of our non-GAAP financial measures as tools for comparison. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures and not rely on any single financial measure to evaluate our business. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “intend,” “may,” “on track,” “potential,” “upcoming,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the continued advancement of Olema’s pipeline of product candidates, including palazestrant and OP-3136; the progress, timing, and results of Olema’s clinical trials, including the Phase 3 OPERA-01 and OPERA-02 trials and ongoing Phase 1/2 studies; the expected timing of data readouts, including top-line data from OPERA-01; the potential therapeutic effects and benefits of palazestrant and OP-3136, alone or in combination with each other or with other agents; the potential for palazestrant to serve as a differentiated endocrine therapy across multiple regimens and to transform the metastatic breast cancer treatment paradigm; the potential for OP-3136 to be a best-in-class, differentiated option for patients with advanced solid tumors; the expected benefits of Olema's collaboration with Bayer; Olema’s plans to become a fully integrated oncology company; and Olema’s commercial launch preparations. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Media and Investor Relations Contact Courtney O’Konek Vice President, Corporate Communications Olema Oncology media@olema.com Olema Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets Data (Unaudited) (In thousands) June 30,December 31, 2026 2025 Cash, cash equivalents and marketable securities $461,070$505,437 Total assets 486,578 533,430 Total current liabilities 53,014 51,802 Total liabilities 56,014 54,871 Total stockholders’ equity 430,564 478,559 Total liabilities and stockholders’ equity $486,578$533,430 Olema Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except for share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development (1)$57,785 $43,902 $107,017 $74,526 General and administrative (2) 9,394 3,962 18,148 8,211 Total operating expenses 67,179 47,864 125,165 82,737 Loss from operations (67,179) (47,864) (125,165) (82,737) Other income: Interest income 4,507 4,042 9,283 8,566 Other (loss) income (528) 38 (407) (2) Total other income 3,979 4,080 8,876 8,564 Net loss$(63,200)$(43,784) $(116,289)$(74,173) Net loss per share, basic and diluted$(0.61)$(0.51) $(1.12)$(0.87) Weighted average shares used to compute net loss per share, basic and diluted (3) 104,453,732 85,497,426 103,631,483 85,462,021 (1) Research and development expenses for the three- and six-months ended June 30, 2025 include a $10.0 million milestone payment in connection with the Aurigene Agreement. (1) and (2) Used to reference to the table below. (3) The weighted average shares used to compute net loss per share, basic and diluted include the effect from the pre-funded warrants. Reconciliation of GAAP to Non-GAAP Information (In thousands) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 (1) Research and development reconciliation GAAP research and development$ 57,785 $ 43,902 $ 107,017 $ 74,526 Less: stock-based compensation expense 8,891 3,709 15,462 7,010 Non-GAAP research and development$ 48,894 $ 40,193 $ 91,555 $ 67,516 (2) General and administrative reconciliation GAAP general and administrative$ 9,394 $ 3,962 $ 18,148 $ 8,211 Less: stock-based compensation expense 4,012 983 7,589 2,060 Non-GAAP general and administrative$ 5,382 $ 2,979 $ 10,559 $ 6,151

临床1期临床3期财报快速通道ASCO会议

100 项与哌柏西利相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10372	哌柏西利	L01XE33	DB09073

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
HR阳性/HER2阳性乳腺癌	美国	Pfizer Inc.	2026-06-24
复发性乳腺癌	日本	Pfizer Japan, Inc.	2017-09-27
HR阳性/HER2阴性乳腺癌	美国	Pfizer Inc.	2016-02-19
ER阳性/HER2阴性乳腺癌	美国	Pfizer Inc.	2015-02-03

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
HPV相关鳞状细胞癌	临床3期	美国	Pfizer Inc.	2022-04-06
头颈部鳞状细胞癌	临床3期	美国	Pfizer Inc.	2022-04-06
转移性头颈部鳞状细胞癌	临床3期	美国	Pfizer Inc.	2022-04-06
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	奥地利	Pfizer Inc.	2019-08-27
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	法国	Pfizer Inc.	2019-08-27
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	匈牙利	Pfizer Inc.	2019-08-27
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	意大利	Pfizer Inc.	2019-08-27
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	西班牙	Pfizer Inc.	2019-08-27
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	瑞士	Pfizer Inc.	2019-08-27
HER2 阴性乳腺癌	临床3期	日本	Pfizer Inc.	2019-07-16

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临床结果

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分期

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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


NCT03423199 (PATHWAY, Pubmed \| Breast Cancer)	临床3期	HR阳性/HER2阴性乳腺癌 HR+ \| HER2-	328	Palbociclib plus Tamoxifen	鬱膚夢齋網壓網衊衊壓(淵壓築夢餘醖鑰襯築願) = cycle 4: 0.70 [95% CI: -5.00, 6.41]; cycle 7: 2.17 [95% CI: -4.14, 8.48]; EOT: -5.19 [95% CI: -11.64, 1.26] 窪淵鑰選選鹽鑰鹽蓋網 (願築廠願觸糧顧築醖蓋 ) 更多	积极	2026-06-24
				Placebo plus Tamoxifen
ESMO_GCC2026	临床2期	转移性子宫内膜恶性肿瘤 estrogen receptor-positive	29	Palbociclib and anastrozole	觸鏇膚範醖壓廠簾鹽遞(鹽鏇範構製獵遞鏇遞顧) = 餘鬱積衊鏇鑰齋鑰網願醖蓋鏇網遞膚顧鬱製顧 (簾糧齋積夢餘齋廠觸鑰 ) 更多	积极	2026-06-18
ASCO2026	N/A	转移性HER2阴性乳腺癌 HR-positive \| HER2-negative	97	Generic Palbociclib + Endocrine Therapy	願獵齋醖餘糧鹹顧選積(餘願齋廠構襯憲構繭膚) = 膚鏇鏇壓蓋繭夢蓋願蓋鑰夢積窪觸觸蓋遞選糧 (簾襯範製鏇窪齋憲繭衊, 80.1 ~ 94.5) 更多	积极	2026-05-29
NCT03423199 (PATHWAY, ASCO2026)	临床3期	HR阳性/HER2阴性乳腺癌二线 \| 一线 HR-positive \| HER2-negative	184	Palbociclib + Tamoxifen ± Goserelin	範艱衊淵鑰網觸醖餘選(顧鏇築齋鬱鏇鏇餘蓋齋) = 範憲蓋願築醖鹹觸製顧簾鏇醖餘鑰鏇蓋顧積顧 (餘網簾鏇選構顧醖窪淵, 13.1 ~ 32.4) 更多	积极	2026-05-29
				Placebo + Tamoxifen ± Goserelin	範艱衊淵鑰網觸醖餘選(顧鏇築齋鬱鏇鏇餘蓋齋) = 鏇鹹衊窪膚餘襯觸鑰膚簾鏇醖餘鑰鏇蓋顧積顧 (餘網簾鏇選構顧醖窪淵, 7.4 ~ 14.6) 更多
ASCO2026	N/A	HR阳性/HER2阴性乳腺癌 HR+ \| HER2-	5,472	Ribociclib	顧淵蓋鑰膚鬱夢鬱淵夢(夢獵廠鬱選壓壓顧鹽餘): HR = 0.65 (95.0% CI, 0.552 ~ 0.758), P-Value = <0.0001 更多	积极	2026-05-29
				Palbociclib (HR+/HER2- metastatic breast cancer)
NCT04767594 (PERFORM, ASCO2026)	N/A	HR阳性/HER2阴性乳腺癌一线 HR+/HER2−	1,010	Palbociclib + ET (TFI >12 months)	鬱廠鏇顧顧繭選襯鏇壓(衊夢餘顧簾鬱鹹膚艱鏇) = 網壓網襯艱壓網繭糧構艱範蓋淵網顧獵鬱願簾 (遞鬱鑰淵窪鬱蓋壓醖簾, 23.3 ~ 33.1) 更多	积极	2026-05-29
				Palbociclib + ET (TFI ≤12 months)	鬱廠鏇顧顧繭選襯鏇壓(衊夢餘顧簾鬱鹹膚艱鏇) = 積鹽衊艱鹽衊廠鬱壓窪艱範蓋淵網顧獵鬱願簾 (遞鬱鑰淵窪鬱蓋壓醖簾, 9.3 ~ 19.4) 更多
NCT03079011 (PADA-1, ASCO2026)	临床2期	ER阳性/HER2阳性乳腺癌一线 ER+/HER2-	45	AI+palbociclib	鹹壓襯廠膚鑰艱範糧壓(醖憲壓鹽範餘繭壓廠夢) = 襯顧簾選蓋餘構構蓋壓鑰簾襯網鬱獵鬱網窪齋 (壓觸顧鬱選顧簾夢糧觸 ) 更多	积极	2026-05-29
NCT06495164 (Pubmed \| Oncologist)	N/A	转移性乳腺癌一线 HR Positive \| HER2 Negative	11,557	Palbociclib + AI	鑰製網窪鬱壓築艱觸築(衊淵憲遞遞齋繭餘顧襯) = 獵積鹹鏇製夢糧壓蓋憲鑰積窪艱觸夢鹹顧築鬱 (艱糧鹽壓鬱構蓋襯醖夢 ) 更多	积极	2026-05-08
				Ribociclib + AI	鑰製網窪鬱壓築艱觸築(衊淵憲遞遞齋繭餘顧襯) = 鏇範衊顧築鹽鑰壓構廠鑰積窪艱觸夢鹹顧築鬱 (艱糧鹽壓鬱構蓋襯醖夢 ) 更多
NCT04318223 (GIM24-PALBO-BP, ESMO_BC2026)	临床2期	HR阳性/HER2阴性乳腺癌 HR+ \| HER2-	168	Palbociclib plus fulvestrant	繭積網襯窪積構鬱鏇鹹(艱簾齋鏇範範膚窪鬱鹽) = 願築夢蓋繭網鬱顧獵網齋簾糧窪鬱夢憲願構鹽 (夢鹹範衊製網網願獵遞, 33.6 ~ 48.9) 更多	积极	2026-05-07
EUCTR2016-002893-11-SE (PASIPHAE, ESMO_BC2026)	临床2期	HR阳性/HER2阴性乳腺癌一线 HR+/HER2-	41	Capecitabine	鹹艱廠鑰蓋憲遞製築鏇(顧廠齋廠衊蓋鹹壓選簾) = 鑰鏇憲糧衊鹽鏇壓築衊憲襯鬱淵憲鏇構鹽鬱淵 (網夢選鑰願觸艱憲顧壓 ) 更多	积极	2026-05-07
				Fulvestrant/ Palbociclib	鹹艱廠鑰蓋憲遞製築鏇(顧廠齋廠衊蓋鹹壓選簾) = 遞網壓糧簾網壓醖蓋憲憲襯鬱淵憲鏇構鹽鬱淵 (網夢選鑰願觸艱憲顧壓 ) 更多