A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)

A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.

开始日期2026-04-10

申办/合作机构

AstraZeneca PLC

CTIS2024-520027-88-00

/ Not yet recruiting临床2期

PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CAMIZESTRANT PLUS RIBOCICLIB IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE (HR+) BREAST CANCER (THE CADILLAC STUDY)

开始日期2025-12-31

申办/合作机构-

NCT07195227

/ Not yet recruiting临床2期

Phase II Study to Evaluate the Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Hormone Receptor Positive (HR+) Breast Cancer

This trial will study a type of breast cancer defined by the expression of hormone receptor in the cancer cells (HR+). Patients will be treated with ribociclib, a cyclin-dependent kinase inhibitor, and camizestrant, a selective estrogen receptor degrader (SERD) and complete ER antagonist. The main purpose of the Study is to analyze the efficacy (to find out how effective a treatment is) of ribociclib in combination with camizestrant in patients with advanced HR+ breast cancer who have received endocrine therapy (ET) in early breast cancer setting for at least 5 years, of which at least 2 years with aromatase inhibitor (AI). Ribociclib plus camizestrant efficacy will be determined by assessing the period from treatment initiation until disease progression, defined as progression free survival (PFS).
The anticipated favorable clinical benefits of the combination of ribociclib and camizestrant therapy are projected to outweigh the risks of this treatment. This Study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.

开始日期2025-12-01

申办/合作机构

Medica Scientia Innovation Research SL

100 项与卡米司群相关的临床结果

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100 项与卡米司群相关的转化医学

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100 项与卡米司群相关的专利（医药）

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项与卡米司群相关的文献（医药）

2026-02-01·JACC-Basic to Translational Science

Selective Estrogen Receptor Degraders Induce Bradycardia by Modulating Nuclear Estrogen Signaling

Article

作者: Patel, Jaymin M ; Narvaez-Paliza, Jose Max ; Rosas Diaz, Andrea Nathalie ; More Verde, Luis ; Urias, Monica ; Kurella, Shreya ; Basu, Sandeep ; Asnani, Aarti ; Curtin, Casie

Selective estrogen receptor degraders (SERDs) are emerging therapies for estrogen receptor-positive (ER+) breast cancer. However, certain oral SERDs, including giredestrant and camizestrant, have been associated with bradycardia in clinical trials. To elucidate the underlying molecular mechanism, we used chemical biology and genetic approaches in a zebrafish model of SERD-induced bradycardia. Giredestrant and camizestrant induced significant bradycardia in wild-type zebrafish embryos, whereas fulvestrant and amcenestrant (SERDs that do not induce bradycardia in patients) did not alter heart rate. Cotreatment with ER agonists rescued bradycardia, suggesting an ER-mediated mechanism. Mutations in gper, esr2a, and esr2b did not confer resistance to SERD-induced bradycardia, whereas esr1 mutant embryos were protected. These findings demonstrate that SERD-associated bradycardia is mediated through Esr1 signaling, supporting an on-target adverse effect.

2026-02-01·CTS-Clinical and Translational Science

Open‐Label Study Assessing Relative and Absolute Bioavailability of Oral Camizestrant Formulations and Food Effects in Healthy Postmenopausal Women

Article

作者: Klinowska, Teresa ; Maudsley, Rhiannon ; Gränfors, Malin ; Lindemann, Justin P. O. ; Mathewson, Alastair M. ; McDermott, John ; Taylor, Nigel ; Brier, Tim ; Gangl, Eric T. ; Sykes, Andy ; Roe, Chris ; Li, Yan ; Engman, Helena ; Kirova, Bistra ; Menakuru, Somasekhar R. ; Bragg, Ryan A.

ABSTRACT:

Camizestrant is the next‐generation oral selective estrogen receptor degrader and complete estrogen receptor antagonist in Phase 3 development for hormone receptor‐positive breast cancer. To investigate the impact of manufacturing changes during pivotal Phase 3 studies, this open‐label, randomized crossover study of 32 postmenopausal healthy volunteers determined the relative bioavailability of a tablet used in early clinical studies (Phase 1 tablet), a tablet designed for late‐phase development (prototype Phase 3 tablet), and an oral solution. Absolute oral bioavailability in the fasted state (using a [ 14 C] camizestrant intravenous microtracer) and effects of a high‐fat meal on the prototype Phase 3 tablet were also determined. The geometric mean ratios (GMRs) of the prototype Phase 3/Phase 1 tablets (% [90% CI]) for Cmax and AUC, respectively were 98.7 (87.4–111.5) and 97.4 (92.6–102.5) at 75 mg ( n = 15), and 96.6 (86.9–107.5) and 100.4 (96.2–104.9) at 300 mg ( n = 15). GMRs of the prototype Phase 3 tablet/oral solution for Cmax and AUC were 96.2 (85.3–108.7) and 99.5 (94.6–104.6) at 75 mg ( n = 15). Fed‐to‐fasted Cmax and AUC GMRs were 106.2 (94.3–119.7) ( n = 16) and 109.8 (104.4–115.5) ( n = 15) at 75 mg ( n = 16), and 115.9 (104.3–128.7) and 102.3 (98.0–106.8) at 300 mg ( n = 15). Absolute oral bioavailability at 75 mg ( n = 6) and 300 mg ( n = 6) was 42.5% (36.8%–49.0%) and 55.1% (48.5%–62.5%). The formulations showed similar exposures, supporting the planned manufacturing changes. Camizestrant exhibited moderate bioavailability; exposures were similar under fasted and high‐fat meal conditions, supporting its administration with or without food.

2026-02-01·ESMO Open

Camizestrant in combination with capivasertib for women with ER-positive, HER2-negative advanced breast cancer: results from SERENA-1

Article

作者: Lindemann, J P O ; Maudsley, R ; Oliveira, M ; Klinowska, T ; Twelves, C ; Baird, R D ; Gibbons, L ; Moreno, I ; Vaklavas, C ; Brier, T ; Jack, T ; Sykes, A ; Morrow, C J ; Ciardullo, C ; Bermejo de Las Heras, B ; Mathewson, A M ; Victoria Ruiz, I ; Armstrong, A C

BACKGROUND:

Camizestrant, the next-generation oral selective estrogen receptor degrader and complete estrogen receptor (ER) antagonist, has previously demonstrated superiority over fulvestrant in patients with ER-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Capivasertib is a selective AKT inhibitor recommended with fulvestrant for patients with PIK3CA/AKT1/PTEN-altered ER-positive, HER2-negative advanced breast cancer. Here, we report data from Parts I and J of SERENA-1 (NCT03616587), evaluating the safety, tolerability, pharmacokinetics and efficacy for the combination of camizestrant and capivasertib.

PATIENTS AND METHODS:

SERENA-1 is a phase I, open-label, multi-part trial of camizestrant alone and in combination with other anticancer agents in women with ER-positive, HER2-negative advanced breast cancer. In parts I and J, participants received oral camizestrant 75 mg (once daily) in combination with oral capivasertib 400 mg (4 days on, 3 days off).

RESULTS:

Participants (n = 29) had a median of two previous lines of therapy in the advanced setting; 55.2% had received fulvestrant and 89.7% had received a cyclin-dependent kinase 4/6 inhibitor. Camizestrant in combination with capivasertib had a well-tolerated safety profile, with diarrhea (75.9%) and nausea (44.8%) being the most common adverse events. Median t_max was achieved ∼4 hours and ∼2 hours post dose for camizestrant and capivasertib, respectively. Clinical benefit at 24 weeks was seen in 51.7% of participants, and median progression-free survival was 8.3 months.

CONCLUSION:

In these pretreated participants, camizestrant 75 mg in combination with capivasertib 400 mg was well tolerated, with a side effect profile consistent with each drug as monotherapy, and showed encouraging evidence of clinical efficacy.

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项与卡米司群相关的新闻（医药）

2026-03-11

·氨基观察

乳腺癌超级重磅炸弹“大爆冷”

氨基观察-创新药组原创出品作者 | 武月 “你不可能看了lidERA 的结果而不相信（改变标准疗法）会成为现实。” 1个月前，罗氏制药CEO在2025年财报电话会议上信心满满，在她看来，其口服SERD药物Giredestrant，成为雌激素受体阳性（ER+）乳腺癌治疗新一线疗法的潜力十足。因为Giredestrant已经在多个重要领域（包括新辅助治疗、辅助治疗以及复杂的晚期患者群体）观察到积极数据，这增强了罗氏对Giredestrant的关键三期临床persevERA研究（用于一线治疗ER阳性、HER2阴性转移性乳腺癌）的信心。在市场看来，罗氏要一改乳腺癌格局，打造乳腺癌新王牌，就需要拿下最肥沃的ER阳性乳腺癌一线市场。所有人的目光，都集中在persevERA研究上。然而，事与愿违。3月9日，罗氏宣布persevERA研究失败。消息一出，罗氏股价盘中一度下跌7.5%。罗氏强调Giredestrant的商业核心在于已获成功的辅助治疗（lidERA研究），只不过海外分析师的分歧已然凸显：Jefferies在结果公布后，直接将其峰值销售预期从74亿美元砍至15亿美元；Barclays则持乐观态度，认为市场尚未充分定价Giredestrant辅助治疗的潜力，并预计其销售峰值可达65亿美元。分歧之下，这款被罗氏寄予厚望的口服SERD，前景究竟几何？ / 01 / 一线“意外”失利在市场看来，persevERA试验的失败，直接击中了Giredestrant商业化的核心命脉——ER+乳腺癌一线治疗适应症。作为乳腺癌最主要的分子亚型，ER+/HER2-乳腺癌约占所有乳腺癌病例的70%，GLOBOCAN 2022数据显示，全球年新发乳腺癌230万例，ER+/HER2-亚型年新发约161万例，ER+乳腺癌市场空间高达200-300亿美元，而一线治疗市场更是是所有乳腺癌药物的必争之地。针对ER+／HER2-乳腺癌的主要治疗手段是内分泌治疗，SERD并非首选，但地位举足轻重，市场规模也并不小。罗氏则希望Giredestrant能够成为下一代一流内分泌疗法，为此开展了ERA系列临床开发计划，覆盖前线、辅助、晚期各阶段治疗。 persevERA则是将Giredestrant联合CDK4/6抑制剂Ibrance，与目前的临床标准方案（传统激素联合Ibrance）进行头对头对比，希望借此拿下一线市场。之所以说此次失利“意外”，是因为Giredestrant已在多个重要领域（包括新辅助治疗、辅助治疗以及复杂的晚期患者群体）观察到积极数据，这增强了市场对persevERA研究的信心。然而，尽管Giredestrant已接连拿下两项关键3期胜利：用于晚期二线治疗的evERA研究，以及2025年底公布阳性结果的、用于早期辅助治疗的lidERA研究，尤其后者首次证明了口服SERD在降低早期乳腺癌复发风险上，显著优于标准内分泌治疗，覆盖了约55%的辅助治疗人群。最终persevERA三期研究仍未能达到主要终点，无法显著改善患者的无进展生存期（PFS）。这意味着，它无法证明自己比现有的激素疗法更好，失去了成为一线治疗首选药物的可能。这并非Giredestrant首次遭遇挫折。早在2022年，其用于晚期乳腺癌二线治疗的二期acelERA研究就曾错失主要终点，当时罗氏选择继续推进多项三期试验，并取下了两项胜利的成果。但这一次一线临床的失利，让市场对其成为乳腺癌“新王牌”的预期产生了分歧。 / 02 / 市场的预期分歧目前，Giredestrant凭借evERA试验的亮眼数据，已向FDA提交上市申请，锁定二线治疗市场，后续也即将申报辅助治疗适应症。只不过，关于Giredestrant远期销售空间，以及罗氏此前的预期，海外分析师出现了明显分歧。悲观者如Jefferies分析师Michael Leuchten，认为这彻底打破了Giredestrant数十亿美元销售预期，并将其峰值调整为12亿瑞士法郎（约15亿美元）。而此前，有分析师认为Giredestrant的全球销售额有望冲击100亿美元，甚至更高。罗氏也对其信心满满，尽管公司官方给出的峰值销售指引是“超过30亿美元”，但管理层的实际预期要高得多。罗氏CEO在电话会上多次强调、重申Giredestrant成为ER新一线药物，尤其是在辅助用药领域的广阔前景。当然，此次一线临床失败后，乐观者依然存在，如Barclays分析师则认为市场尚未充分定价Giredestrant辅助治疗的商业潜力，预计其在辅助治疗领域的年销售峰值将达65亿美元。因此，这场分歧的核心，聚焦于Giredestrant的辅助治疗潜力，以及罗氏对其商业核心的定位。罗氏强调lidERA试验的成功才是giredestrant真正的商业核心，将市场注意力从一线失利转移至辅助治疗的优势上。其信心源自lidERA试验的核心数据。在辅助治疗领域，Giredestrant在无浸润性疾病生存期（IDFS）方面显示出统计学显著且具有临床意义的改善，相对于标准内分泌治疗，风险比为0.7；且无CDK4/6抑制剂相关副作用。更关键的是，这是首个在辅助治疗中证明优于标准内分泌治疗的口服SERD药物，打破了辅助治疗领域20年以来无新药突破的瓶颈。并且，罗氏强调在高达200-300亿美元的ER+乳腺癌市场中，辅助治疗（包括初始治疗和维持治疗）占比高达三分之二，是比一线治疗更广阔的细分市场。在总生存期方面，尽管目前数据尚不成熟，但已观察到积极趋势，若后续数据持续完善，将进一步强化其在辅助治疗领域的竞争力。更重要的是，罗氏曾强调，辅助治疗和一线治疗是截然不同的治疗场景，患者人群、治疗目标、临床需求均存在差异，persevERA试验的失败，并不影响Giredestrant在辅助治疗领域的临床价值，其有机会真正成为辅助治疗领域新的标准治疗方案。毕竟，lidERA辅助治疗的阳性数据是实打实的，且是口服SERD领域的首个突破，具备差异化竞争优势。 / 03 / 早期市场的较量开始了即便已经在二线、辅助治疗领域取得亮眼数据，也不代表能在一线治疗中复制成功。肿瘤疾病的复杂性、患者人群的差异、联合用药的相互作用，都可能让试验结果出现变数。这并不只是Giredestrant需要面对的现实，而是创新药研发的赌桌上，从来没有永远的赢家，关键在于，如何把握住难得的成功。需要说明的是，在早期乳腺癌辅助治疗中取得临床突破十分不易。当前乳腺癌辅助治疗虽存在长期用药的安全性问题，但标准方案已将疗效基线拉到极高水平：ER+/HER2-患者，术后标准内分泌治疗5年无病生存率可达85%-95%。这更能凸显Giredestrant的lidERA试验成功的意义。只不过，争议依然存在，辅助治疗的商业潜力，是否会受到persevERA试验结果的拖累？此前，业内就对此争论不休。而如今市场也在担忧，一线试验的失败，可能会影响医生和市场对该药整体临床价值的判断，进而影响其辅助治疗领域的市场渗透。这也是Michael Leuchten悲观的根源。其认为Giredestrant未能显示出与CDK4/6抑制剂联用时的额外获益，这会削弱早期coopERA、evERA和lidERA研究中的积极信号。未来Giredestrant能否撑起罗氏的期待，取决于两个关键点：一是辅助治疗数据的持续稳定性，二是其在辅助治疗领域的获批及市场渗透速度。毕竟，乳腺癌作为兵家必争之地，口服SERD赛道的竞争只会愈发激烈，尤其是在乳腺癌早期市场。此前，礼来肿瘤业务总裁也表示辅助治疗才是口服SERD类药物的真正目标领域。在Imlunestrant放弃二线广泛适应症后，礼来将口服SERD的未来押注于辅助治疗领域，正在开展的Ember-4试验，已完成8000名患者招募，是其史上最大规模的肿瘤临床试验。辅助治疗的临床研究，随访周期极长，通常需要随访5年。因此，礼来能否拿下辅助治疗还需要时间的验证。礼来之外，阿斯利康的Camizestrant也在持续推进研发，不仅取得了一线治疗3期（SERENA-6）的关键突破，也在积极推进ER+/HER2-早期乳腺癌的研究。在这样的格局下，Giredestrant必须加快速度，巩固其先发优势。在更远的未来，谁能成为真正的赢家，仍需临床数据的终极检验与PK。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

临床3期财报临床失败

2026-03-11

·CPHI制药在线

虽败犹荣？罗氏如何在一线治疗失利中，为口服SERD找到黄金赛道

关注并星标CPHI制药在线 --扫码领取CPHI China2026展会门票-- 3月9日，罗氏公布了口服选择性雌激素受体下调剂giredestrant的III期persevERA研究数据。这项针对ER阳性、HER2阴性局部晚期或转移性乳腺癌一线治疗的研究，没有达到主要终点。在意向治疗人群中，giredestrant联合哌柏西利相比来曲唑联合哌柏西利，未能显著改善无进展生存期。图源：罗氏官网这类结果通常会被视为一个纯粹的坏消息，甚至可能直接导致项目终止。但罗氏首席医学官LeviGarraway博士在新闻稿中表示，尽管persevERA研究未达主要终点，公司对giredestrant成为早期和晚期ER阳性乳腺癌新的标准内分泌治疗方案的潜力仍然充满信心。当一线治疗的数据折戟沉沙，他们口中的“信心”到底从何而来？ 01 如何看待“虽败犹荣”？罗氏新闻稿中的表述到：没有达到统计学意义的改善，但观察到了数值上的改善。在临床试验的严苛语境下，“未达统计学显著差异”意味着在主要终点的预设分析中，治疗组与对照组的差异可能是由偶然性造成的。这直接关涉到监管审批，基于这样的数据，FDA和EMA几乎不可能批准该适应症。 “数值上的改善”又是什么？这通常指风险比小于1，但置信区间过宽，跨越了1.0的边界，或者P值大于0.05。这种“有获益趋势但不确定”的状态，对于内部决策和后续研究设计而言，是极其重要的信号。为什么会出现数值改善而非显著改善？一种可能是疗效确实存在，但不够强，或者被全人群的异质性稀释。在一线内分泌敏感人群中，来曲唑联合哌柏西利本身就是强效的标准方案。giredestrant想要在此基础上超越来曲唑，需要非常明显的疗效提升幅度。从结果看，giredestrant在全人群中没能做到这一点。但这也引出了精准医疗时代常见的议题：“全人群胜利”是否还是唯一的标准？罗氏的信心源于其另一项III期研究evERA的积极结果。就在2026年2月，罗氏宣布FDA已受理基于evERA研究的新药上市申请，并授予了处方药使用者费用法案日期为2026年12月18日。对比这两项研究的设计，能看出罗氏的考虑。 persevERA（此次失败的试验）：针对的是内分泌敏感的一线患者，使用的是“giredestrant+哌柏西利”对比“来曲唑+哌柏西利”。这是全人群的正面战场，比拼的是谁的内分泌基础更好。 evERA（此前成功的试验）：针对的是内分泌耐药的经治患者（既往接受过CDK4/6抑制剂治疗），使用的是“giredestrant+依维莫司”对比“标准内分泌治疗+依维莫司”。该研究的共同主要终点特意包括了ESR1突变人群。 evERA公布的数据显示，在ESR1突变人群中，giredestrant联合疗法降低了62%的疾病进展或死亡风险，风险比为0.38。即使在全体意向治疗人群中，也降低了44%的风险，风险比为0.56。这一正一反两项研究，勾勒出giredestrant的适用人群。它或许不是一个能通杀所有早期患者的药物，但很可能是在特定耐药人群、尤其是ESR1突变人群中不可替代的精准治疗选择。所以，罗氏的信心不是对数据的无视，而是战略性的调整。他们承认在一线治疗中未能击败芳香化酶抑制剂，但认为在精准筛选后的后线耐药人群中，giredestrant有潜力成为新的标准口服组合疗法。这是基于生物标志物的判断，也是向FDA递交申请的主要依据。 02 CDK4/6抑制剂的红海博弈：辅助治疗才是“诗与远方”? Garraway博士在声明中还特意强调：“我们相信，giredestrant与CDK4/6抑制剂联合用于辅助治疗具有发展前景。”在persevERA一线治疗失败后，为何要特意提“辅助治疗”？这就不得不谈CDK4/6抑制剂市场的残酷现状。目前，在一线晚期HR阳性乳腺癌治疗领域，CDK4/6抑制剂联合内分泌疗法已是铁板一块的标准治疗。辉瑞的哌柏西利、礼来的阿贝西利、诺华的瑞波西利已经瓜分了绝大部分市场。罗氏作为后来者，即使用的是自己的口服SERD，试图在这个拥挤的赛道上“虎口夺食”，难度极高。persevERA的失败，某种程度上也证实了在这个稳固的格局中插入新钉子是何等困难。竞争的蓝海正在向前线转移，也就是辅助治疗。随着monarchE和NATALEE研究的成功，CDK4/6抑制剂已大举进军早期乳腺癌的辅助治疗市场。这意味着，未来将会有大量患者在初诊后就接受CDK4/6抑制剂的辅助治疗。而这些患者一旦复发，她们就成为了“经CDK4/6抑制剂治疗后的耐药人群”，恰好就是evERA研究中的目标人群。现在的辅助治疗是患者术后接受来曲唑或阿那曲唑联合阿贝西利或瑞波西利，未来的复发治疗中，这些患者需要新的方案，此时肿瘤可能已经出现了ESR1突变。罗氏的giredestrant加依维莫司方案正好填补这一空白。所以，罗氏并非要在晚期一线这个局部市场与辉瑞直接竞争。通过lidERA研究布局辅助治疗，通过evERA研究布局耐药后治疗，罗氏是在构建一个从早期到晚期的覆盖。persevERA的失败虽然可惜，但并不致命，因为它不是罗氏战略版图中的唯一支柱。只要辅助治疗和后线治疗能够站稳，giredestrant依然可以覆盖从早期到晚期的病程。 03 对口服SERD领域的影响过去几年，口服SERD领域堪称“尸骨累累”。赛诺菲的amcenestrant因疗效不佳，临床开发已基本终止；阿斯利康的camizestrant虽然表现出了部分阳性结果，但在不同研究中数据波动较大。这个领域的研发难度超出了业界预期，如何平衡口服生物利用度、ER降解能力和安全性，且在与老药氟维司群（注射剂）和芳香化酶抑制剂的对比中胜出，门槛极高。罗氏的giredestrant是这一赛道最受瞩目的选手之一。此次persevERA的失利，无疑再次印证了，在一线内分泌敏感的全人群中，想要超越芳香化酶抑制剂，难度超乎想象。那么，谁最有可能成为“best-in-class”？如果只看一线全人群，可能目前所有口服SERD都面临挑战。但如果换一个视角，即“在特定人群中击败现有疗法”，那么格局就很清晰了。罗氏凭借evERA研究中针对ESR1突变人群高达62%的风险降低数据，已经率先叩开了FDA的大门。这一定位极其精准。ESR1突变是导致内分泌耐药的主要原因之一，尤其是在经过CDK4/6抑制剂治疗后，突变比例可高达40%。在这个细分市场，giredestrant有望成为第一个获批的口服SERD组合疗法。未来的新王登基，可能不再需要像氟维司群当年那样作为“全线”的挽救治疗。新王可能是多个并列的“分封王”，一个专攻ESR1突变的后线治疗，一个专攻PIK3CA突变的联合疗法，一个专攻辅助治疗的强化。罗氏正在用evERA和lidERA，试图锁定其中的两个关键王座。 04 罗氏如何用pionERA等研究对冲风险？罗氏为giredestrant布局了五项III期临床研究，除了已经读出结果的persevERA、evERA、lidERA，还有仍在进行中的pionERA和heredERA。这种布局体现了风险管理的思路。人群上相互补充，evERA打后线耐药人群，persevERA打一线敏感人群，lidERA打辅助治疗人群。即使一线敏感人群受挫，后线和辅助依然可以支撑。联合用药也多元化，除了与最常见的CDK4/6抑制剂哌柏西利联用，罗氏还在探索与mTOR抑制剂依维莫司联用，与双靶向HER2疗法联用应对HER2阳性HR阳性患者，以及在内分泌耐药人群中与医生选择的CDK4/6抑制剂联用。特别值得注意的是pionERA研究。该研究纳入的是对辅助内分泌治疗耐药的患者，允许联合医生选择的CDK4/6抑制剂，可以是阿贝西利、瑞波西利或哌柏西利中的任何一种。这种设计贴近真实临床，如果成功，giredestrant将成为一种能灵活搭配不同CDK4/6抑制剂的内分泌基础用药，降低临床使用门槛。因此，persevERA的失败虽然让罗氏的一线布局受挫，但并未动摇其基本盘。只要evERA顺利获批，lidERA能维持辅助治疗的积极势头，pionERA能填补内分泌耐药一线治疗的空白，giredestrant的商业化拼图依然完整。这正是罗氏敢于在失败中仍表露“信心”的底气所在——他们手里不止一张牌。 05 对药物研发范式的启示跳出giredestrant这一个案，这次事件为行业提供了一个参考案例，如何看待失败，以及如何在失败中寻找机会。过去追求的是重磅炸弹，一个药治百病。但在肿瘤生物学日益复杂的今天，这种模式越来越难持续。罗氏在giredestrant上的表现，展示了一种新的研发思路，不再执著于全人群的胜利，而是深耕生物学机制，在细分人群中寻找确证性证据。在evERA研究中，他们甚至将其设为共同主要终点，并对入组人群进行了富集。这是一种认知上的转变，承认药物有其特定的适用边界，比试图讨好所有人更接近科学事实。对国内创新药企来说，有几点值得借鉴。一是临床试验设计需要更精细的考虑，在跟进热门靶点时，如果只是重复全人群的一线III期研究，一旦遇到大药企的对手，很容易因为疗效不够突出而失败。是否可以考虑富集特定突变人群，是否可以在后线治疗中寻找更精准的定位。二是数据需要分层解读。罗氏对数值改善的重视，以及将其与evERA的数据联系起来看，是内部决策科学性的体现。国内药企在面对不太理想的临床数据时，能否顶住资本市场的压力，沉下心去做生物标志物分析，找出那部分真正获益的人群，往往决定了项目的生死。三是构建多项研究的组合而非单一项目。罗氏为giredestrant布局五项III期，这种投入虽然大，但分散了风险。国内药企虽然资源有限，但在立项之初就应规划好，药物在哪个阶段最能体现差异化，如果主攻方向失败，备用的开发路径是什么。 06 结语罗氏giredestrant，所谓虽败犹荣，荣的不是失败本身，而是面对失败时基于科学理解的冷静判断，以及多项研究布局所给予的战略缓冲。当一款药在一线受挫，却能因为ESR1突变的数据被推向监管审批，还能因为在辅助治疗的突破被寄予厚望，这本身就是药物研发范式变化的缩影。口服SERD的竞争远未结束，而罗氏依然处在关键位置。推荐阅读：《2026年10项“临门一脚”关键III期临床读数》 END 智药研习社近期直播来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

2026-03-11

·动脉网

Enhertu在美国被授予优先审查，作为HER2阳性早期乳腺癌患者的术后辅助治疗Enhertu granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer

AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment.. 阿斯利康和第一三共的Enhertu（trastuzumab deruxtecan）补充生物制品许可申请（sBLA）已在美国获得受理，并被授予优先审评资格，用于治疗经新辅助HER2靶向治疗后仍有残留侵袭性疾病的HER2阳性乳腺癌成年患者。The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the third quarter of 2026.. 美国食品药品监督管理局（FDA）对申请的药物给予优先审查，如果获批，这些药物将通过展示安全性或疗效的改进、预防严重疾病或提高患者依从性，提供比现有治疗方案显著的改进。《处方药使用者费用法案》日期，即FDA作出监管决定的行动日期，预计在2026年第三季度。Enhertu was recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need. Enhertu最近在这一适应症上获得了FDA授予的突破性疗法认定（BTD）。BTD旨在加速用于治疗严重疾病并满足显著未满足医疗需求的潜在新药的开发和监管审评。The sBLA also is being reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. 该补充生物制品许可申请（sBLA）也正在Orbis项目下进行审查，该项目为参与的国际合作伙伴提供了一个同时提交和审查肿瘤药物的框架。Around one in five breast cancers are considered HER2-positive, a subtype that is often associated with aggressive disease and poor prognosis.1-3 Currently, approximately half of patients with HER2-positive early breast cancer have residual disease following neoadjuvant treatment (before surgery), putting them at an increased risk of disease recurrence.4-9 Despite receiving additional treatment in the post-neoadjuvant setting with current standards of care, some patients still experience tumour progression to metastatic disease, where the five-year survival rate drops from nearly 90% to approximately 30%.10,11. 大约五分之一的乳腺癌被认为是HER2阳性，这种亚型常与侵袭性疾病和不良预后相关。目前，约一半的HER2阳性早期乳腺癌患者在新辅助治疗（术前）后仍有残留病灶，使他们面临更高的疾病复发风险。尽管在术后接受了当前标准治疗，部分患者仍会出现肿瘤进展为转移性疾病，此时五年生存率从接近90%下降到约30%。Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “While there has been significant progress in treating HER2-positive early breast cancer, managing patients at a higher risk of recurrence remains challenging. With this Priority Review, we move closer to bringing Enhertu to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure.”. 阿斯利康肿瘤血液学研发执行副总裁苏珊·加尔布雷思表示：“虽然在治疗HER2阳性早期乳腺癌方面取得了显著进展，但管理复发风险较高的患者仍然具有挑战性。通过此次优先审查，我们离将Enhertu应用于术后辅助治疗更近一步，为更多患者提供实现长期持续疗效的机会以及潜在的治愈途径。”Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “For patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease. This Priority Review reinforces the potential of Enhertu to become a new standard of care for HER2-positive early breast cancer based on the results of DESTINY-Breast05.”. 第一三共的全球研发主管武下健（Ken Takeshita）表示：“对于在新辅助治疗后仍有残留侵袭性疾病的患者，确定手术后的额外治疗方案，对进一步降低复发风险和预防疾病进展为转移性癌症至关重要。此次优先审查基于DESTINY-Breast05试验的结果，进一步证实了Enhertu成为HER2阳性早期乳腺癌新护理标准的潜力。”The sBLA is based on data from the DESTINY-Breast05 Phase III trial presented at the European Society for Medical Oncology (ESMO) 2025 Congress and subsequently published in The New England Journal of Medicine.1 该sBLA基于在2025年欧洲医学肿瘤学会（ESMO）大会上公布并随后发表于《新英格兰医学杂志》的DESTINY-Breast05 III期试验数据。In the trial, Enhertu significantly reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% compared with trastuzumab emtansine (T-DM1; based on a hazard ratio [HR] of 0.47; 95% confidence interval [CI] 0.34-0.66; p<0.0001) as a post-neoadjuvant treatment for patients with HER2-positive breast cancer. 在试验中，与恩美曲妥珠单抗（T-DM1）相比，Enhertu作为HER2阳性乳腺癌患者的新辅助治疗后疗法，显著降低了浸润性疾病复发或死亡的风险（无浸润性疾病生存期 [IDFS]），减少了53%（基于风险比 [HR] 0.47；95%置信区间 [CI] 0.34-0.66；p<0.0001）。Enhertu demonstrated a three-year IDFS rate of 92.4% compared with 83.7% with T-DM1. IDFS findings were consistent across all prespecified subgroups.. Enhertu 显示出三年无病生存率 (IDFS) 为 92.4%，而 T-DM1 为 83.7%。IDFS 结果在所有预设亚组中保持一致。Enhertu also significantly reduced the risk of disease recurrence or death (disease-free survival [DFS]), a key secondary endpoint, by 53% versus T-DM1 (HR 0.47; 95% CI 0.34-0.66; p<0.0001). Further, Enhertu lowered the risk of distant disease recurrence (distant recurrence-free interval) by 51% and the risk of brain metastases (brain metastasis-free interval) by 36% compared with T-DM1 (HR 0.64; 95% CI 0.35-1.17).. Enhertu 还显著降低了疾病复发或死亡的风险（无病生存期 [DFS]），这一关键的次要终点相较于 T-DM1 减少了 53%（HR 0.47；95% CI 0.34-0.66；p<0.0001）。此外，与 T-DM1 相比，Enhertu 将远端疾病复发风险（远端无复发生存期）降低了 51%，脑转移风险（无脑转移生存期）减少了 36%（HR 0.64；95% CI 0.35-1.17）。The safety profile of Enhertu observed in DESTINY-Breast05 was consistent with its known profile with no new safety concerns identified. Enhertu 在 DESTINY-Breast05 中观察到的安全性特征与其已知特征一致，未发现新的安全性问题。Regulatory submissions for Enhertu based upon DESTINY-Breast05 are also under review in the EU and Japan. In addition, an sBLA for Enhertu followed by paclitaxel, trastuzumab and pertuzumab (THP) currently is under review in the US for the neoadjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 trial.. 基于DESTINY-Breast05的Enhertu监管提交也正在欧盟和日本接受审查。此外，根据DESTINY-Breast11试验的结果，美国目前正在审查Enhertu联合紫杉醇、曲妥珠单抗和帕妥珠单抗（THP）的补充生物制品许可申请（sBLA），用于HER2阳性早期乳腺癌患者的新辅助治疗。Enhertu is already approved in more than 90 countries as a treatment for patients with HER2-positive metastatic breast cancer. Enhertu已在90多个国家获批用于治疗HER2阳性转移性乳腺癌患者。Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Enhertu 是一种特别设计的 HER2 靶向 DXd 抗体药物偶联物 (ADC)，由第一三共发现，并与阿斯利康联合开发和商业化。Post-neoadjuvant treatment for HER2-positive early breast cancer HER2阳性早期乳腺癌的新辅助治疗后的治疗Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.12 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.12 In the US, more than 320,000 cases of breast cancer are diagnosed annually with more than 42,000 deaths.13. 乳腺癌是全球第二大常见癌症，也是导致癌症相关死亡的主要原因之一。2022年，全球诊断出超过两百万例乳腺癌病例，导致超过665,000人死亡。在美国，每年诊断出超过320,000例乳腺癌病例，并有超过42,000人死亡。HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.14 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.14 Approximately one in five cases of breast cancer are considered HER2-positive.2-3. HER2是一种在多种肿瘤（包括乳腺癌）表面表达的酪氨酸激酶受体生长促进蛋白。HER2蛋白的过度表达可能是由于HER2基因扩增引起的，并且在乳腺癌中常与侵袭性疾病和不良预后相关。大约五分之一的乳腺癌病例被认为是HER2阳性。For patients with HER2-positive early breast cancer, achieving pCR with neoadjuvant treatment is the earliest indicator of improved long-term survival.9 However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence.4-9. 对于HER2阳性早期乳腺癌患者，通过新辅助治疗达到病理完全缓解（pCR）是长期生存改善的最早指标。然而，大约一半接受新辅助治疗的患者未能实现pCR，这使他们面临更高的疾病复发风险。Despite receiving additional treatment for residual disease in the post-neoadjuvant setting, some patients still experience invasive disease or death, and current treatment options have shown limited impact on central nervous system recurrence.11 In the US, around 16,000 patients with HER2-positive early breast cancer receive treatment in the post-neoadjuvant setting (after surgery) each year.15. 尽管在新辅助治疗后的残留病灶接受了额外治疗，但一些患者仍经历侵袭性疾病或死亡，且目前的治疗方案对中枢神经系统复发的影响有限。在美国，每年大约有16,000名HER2阳性早期乳腺癌患者在新辅助治疗后（术后）接受治疗。DESTINY-Breast05 DESTINY-乳腺癌05DESTINY-Breast05 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus T-DM1 in patients with HER2-positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. DESTINY-Breast05是一项全球性、多中心、随机、开放标签的III期临床试验，评估Enhertu（5.4mg/kg）与T-DM1在HER2阳性早期乳腺癌患者中的疗效和安全性，这些患者在接受新辅助治疗后乳腺或腋窝淋巴结中仍有残留浸润性疾病，并具有高复发风险。High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.. 高复发风险被定义为出现无法手术的癌症（新辅助治疗前）或新辅助治疗后病理证实腋窝淋巴结阳性。The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS. IDFS is defined as the time from randomisation until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed disease-free survival. Other secondary endpoints include overall survival, distant recurrence-free interval, brain metastases-free interval and safety.. DESTINY-Breast05 的主要终点是研究者评估的 IDFS。IDFS 定义为从随机化到首次出现侵袭性局部、腋窝或远处复发或任何原因导致死亡的时间。关键次要终点是研究者评估的无病生存期。其他次要终点包括总生存期、无远处复发生存期、无脑转移生存期和安全性。DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov. DESTINY-Breast05 在亚洲、欧洲、北美、大洋洲和南美招募了 1,635 名患者。有关该试验的更多信息，请访问 ClinicalTrials.gov。Enhertu EnhertuEnhertu 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 programme 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是一种靶向HER2的抗体药物偶联物（ADC）。Enhertu采用第一三共公司的专有DXd ADC技术设计，是第一三共肿瘤学产品组合中的主要ADC，也是阿斯利康ADC科学平台中最先进的项目。Enhertu由一种HER2单克隆抗体通过四肽可裂解连接子连接多个拓扑异构酶I抑制剂有效载荷（一种依沙替康衍生物，DXd）组成。Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test based on the results from the DESTINY-Breast09 trial. Enhertu（5.4mg/kg）联合帕妥珠单抗在美国被批准作为一线治疗，用于不可切除或转移性HER2阳性（IHC 3+或ISH+）乳腺癌成年患者，这是基于DESTINY-Breast09试验的结果，由FDA批准的检测方法确定。Enhertu (5.4mg/kg) is approved in more than 90 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（5.4mg/kg）已在全世界90多个国家/地区获批，用于治疗先前接受过基于抗HER2治疗方案的不可切除或转移性HER2阳性（IHC 3+或ISH+）乳腺癌成年患者。这些患者无论是在转移性治疗阶段，还是在新辅助或辅助治疗阶段接受治疗，并在治疗期间或完成治疗后六个月内出现疾病复发，依据的是DESTINY-Breast03试验的结果。Enhertu (5.4mg/kg) is approved in more than 90 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（5.4mg/kg）已在全世界90多个国家/地区获批，用于治疗不可切除或转移性HER2低表达（IHC 1+ 或 IHC 2+/ISH-）的乳腺癌成年患者。这些患者在转移性环境中曾接受过先前的系统治疗，或在完成辅助化疗期间或完成后六个月内出现疾病复发，该批准基于DESTINY-Breast04试验的结果。Enhertu (5.4mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (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（5.4mg/kg）已在全世界60多个国家/地区获批，用于治疗不可切除或转移性激素受体（HR）阳性、HER2低表达（IHC 1+ 或 IHC 2+/ISH-）或HER2极低表达（IHC 0且有膜染色）的乳腺癌成年患者，这些患者通过当地或地区批准的检测方法确定，并基于DESTINY-Breast06试验的结果，在转移性环境中接受过一种或多种内分泌治疗后出现疾病进展。Enhertu (5.4mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours 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. Enhertu（5.4mg/kg）已在全世界70多个国家/地区获得批准，用于治疗肿瘤具有激活HER2（ERBB2）突变的不可切除或转移性非小细胞肺癌（NSCLC）成年患者，这些突变通过当地或地区批准的检测方法检测到，并且患者已基于DESTINY-Lung02和/或DESTINY-Lung05试验的结果接受过先前的系统治疗。Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.. 在中国和美国，这一适应症的持续批准可能取决于在确证性试验中对临床益处的验证和描述。Enhertu (6.4mg/kg) is approved in more than 80 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-Gastric06 trials. Enhertu（6.4mg/kg）已在全世界80多个国家/地区获批，用于治疗先前接受过基于曲妥珠单抗治疗方案的局部晚期或转移性HER2阳性（IHC 3+ 或 IHC 2+/ISH+）胃或胃食管交界处（GEJ）腺癌成年患者，该批准基于DESTINY-Gastric01、DESTINY-Gastric02和/或DESTINY-Gastric06试验的结果。Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.. 在中国，继续批准此适应症可能取决于在确证性试验中对临床益处的验证和描述。Enhertu (5.4mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Enhertu（5.4mg/kg）已在全世界10多个国家/地区获批，用于治疗先前接受过系统性治疗且基于DESTINY-PanTumor02、DESTINY-Lung01和DESTINY-CRC02试验的有效性结果，没有满意替代治疗方案的不可切除或转移性HER2阳性（IHC 3+）实体瘤成年患者。Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.. 在美国，继续批准该适应症可能取决于在确证性试验中对临床益处的验证和描述。Enhertu clinical development programme Enhertu临床开发计划A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers. 一项全面的全球临床开发计划正在进行中，评估Enhertu作为单一疗法、与其他癌症药物联合或序贯治疗多种HER2靶向癌症的疗效和安全性。Daiichi Sankyo collaboration 第一三共合作AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and Datroway (datopotamab deruxtecan) 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.. 2019年3月，阿斯利康和第一三共达成全球合作，共同开发和商业化Enhertu，并于2020年7月就Datroway（datopotamab deruxtecan）展开合作，但日本地区除外，第一三共在该地区对每种ADC拥有独家权利。第一三共负责Enhertu和Datroway的生产和供应。AstraZeneca in breast cancer 阿斯利康在乳腺癌领域Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.. 基于对乳腺癌生物学的日益深入的理解，阿斯利康正在挑战并重新定义当前乳腺癌分类与治疗的临床模式，致力于为有需要的患者提供更有效的治疗方案——其宏伟目标是终有一天消除乳腺癌作为致死原因。AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. 阿斯利康拥有一个全面的已批准和有前景的在研化合物组合，这些化合物利用不同的作用机制来应对生物多样性丰富的乳腺癌肿瘤环境。With Enhertu, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and are exploring its potential in earlier lines of treatment and in new breast cancer settings. 通过Enhertu，阿斯利康和第一三共旨在改善先前接受过治疗的HER2阳性、HER2低表达和HER2超低表达转移性乳腺癌的预后，并正在探索其在更早治疗阶段及新的乳腺癌环境中的潜力。In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP-2-directed ADC, Datroway, and next-generation oral SERD and potential new medicine camizestrant.. 在HR阳性的乳腺癌治疗领域，阿斯利康通过基础药物Faslodex（氟维司群）和Zoladex（戈舍瑞林）持续改善患者预后，并致力于通过首创的AKT抑制剂Truqap（卡匹瓦塞替），TROP-2导向的抗体药物偶联物Datroway，以及下一代口服SERD和潜在新药camizestrant重塑HR阳性治疗格局。PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer.. PARP抑制剂Lynparza（奥拉帕利）是一种已被研究用于早期和转移性乳腺癌患者（携带遗传性BRCA突变）的靶向治疗选择。阿斯利康与默沙东（MSD，美国和加拿大地区称为默克公司）继续在这些领域对Lynparza进行研究。阿斯利康还在探索saruparib（一种强效且选择性的PARP1抑制剂）与camizestrant联合使用在BRCA突变、激素受体阳性、HER2阴性的晚期乳腺癌中的潜力。To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab). 为了给三阴性乳腺癌（一种侵袭性乳腺癌）患者带来亟需的治疗选择，阿斯利康正与第一三共合作，评估Datroway单药以及与免疫疗法Imfinzi（durvalumab）联合使用的潜力。AstraZeneca in oncology 阿斯利康在肿瘤学领域AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. 阿斯利康正引领一场肿瘤学的革命，其雄心在于为各种形式的癌症提供治愈方案。通过遵循科学，深入理解癌症及其所有复杂性，发现、开发并交付改变生命的药物给患者。The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. 公司的重点是一些最具挑战性的癌症。正是通过不懈的创新，阿斯利康建立了业内最多样化的产品组合和研发管线之一，有望催化医学实践的变革，并改善患者的治疗体验。AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. 阿斯利康有重新定义癌症护理并有朝一日消除癌症作为死亡原因的愿景。AstraZeneca 阿斯利康AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. 阿斯利康（LSE/STO/NYSE：AZN）是一家全球领先的、以科学为导向的生物制药公司，专注于肿瘤学、罕见疾病以及包括心血管、肾脏与代谢、呼吸与免疫学在内的生物制药领域处方药的发现、开发和商业化。Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca.. 总部位于英国剑桥的阿斯利康创新药物在全球125多个国家销售，被全球数百万患者使用。请访问astrazeneca.com，并在社交媒体上关注该公司@AstraZeneca。Contacts 联系人For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. 要了解如何联系投资者关系团队的详细信息，请点击这里。要联系媒体，请点击这里。References 参考文献Source:astrazeneca.com 来源：astrazeneca.com

100 项与卡米司群相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	申请上市	加拿大	AstraZeneca Canada, Inc.	2025-10-01
HR阳性/HER2阴性乳腺癌	申请上市	澳大利亚	AstraZeneca PLC	2025-05-05
早期乳腺癌	临床3期	美国	AstraZeneca PLC	2023-03-31
早期乳腺癌	临床3期	中国	AstraZeneca PLC	2023-03-31
早期乳腺癌	临床3期	日本	AstraZeneca PLC	2023-03-31
早期乳腺癌	临床3期	阿根廷	AstraZeneca PLC	2023-03-31
早期乳腺癌	临床3期	澳大利亚	AstraZeneca PLC	2023-03-31
早期乳腺癌	临床3期	奥地利	AstraZeneca PLC	2023-03-31
早期乳腺癌	临床3期	比利时	AstraZeneca PLC	2023-03-31
早期乳腺癌	临床3期	巴西	AstraZeneca PLC	2023-03-31

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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


NCT04644068 (PETRA, SABCS2025)	临床1/2期	复发性HER2阴性乳腺癌 ER positive \| HER2 negative \| BRCA1/2 mutation ... 更多	38	Saruparib + Camizestrant	壓鑰觸窪醖衊糧鏇願範(膚顧製衊餘膚簾簾鬱衊) = 觸鏇積鏇鑰製遞蓋醖夢觸鹹膚簾鹹繭膚鹽繭顧 (夢餘壓鹽選觸鹽鏇製艱 ) 更多	积极	2025-12-10
				Saruparib + Camizestrant (BRCA1/BRCA2 mutation or PALB2 mutation)	範蓋衊網獵襯鑰鹹築顧(艱鹽衊製齋衊壓積蓋觸) = 繭製襯糧範顧衊繭鬱觸憲鹽簾顧構簾觸艱壓蓋 (鏇築蓋築觸蓋壓鹽艱鬱, 4.4 ~ 7.3)
NCT04964934 (SERENA-6, ESMO2025) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌一线 HER2 Negative \| ESR1 Mutation \| HR Positive	315	Camizestrant + CDK4/6i	艱繭餘觸糧築壓壓齋願(製願窪遞願鑰憲鹹遞繭) = 廠築繭遞壓積齋範壓積鹹艱憲壓網膚觸艱觸淵 (膚遞範築觸範鑰壓壓壓 ) 更多	积极	2025-10-17
				Aromatase inhibitor + CDK4/6i	艱繭餘觸糧築壓壓齋願(製願窪遞願鑰憲鹹遞繭) = 鏇觸遞積蓋齋鬱夢鏇遞鹹艱憲壓網膚觸艱觸淵 (膚遞範築觸範鑰壓壓壓 ) 更多
NCT04964934 (SERENA-6, ESMO2025)	临床3期	HR阳性/HER2阴性乳腺癌一线 ESR1m \| HR+ \| HER2-	310	camizestrant+CDK4/6i	襯壓襯艱範簾鹽遞選鬱(鹽餘觸鏇繭齋觸壓襯淵) = 窪製襯積鹹網齋廠糧廠積築蓋鏇膚簾餘蓋鹽艱 (膚鑰鹹製顧蓋觸鹽選簾 ) 更多	积极	2025-10-17
				aromatase inhibitor + CDK4/6i	襯壓襯艱範簾鹽遞選鬱(鹽餘觸鏇繭齋觸壓襯淵) = 範構願顧獵壓鬱獵衊餘積築蓋鏇膚簾餘蓋鹽艱 (膚鑰鹹製顧蓋觸鹽選簾 ) 更多
ESMO2025	N/A	晚期乳腺癌 HR+ \| HER2-	16	Camizestrant	-	积极	2025-10-17
				Ribociclib plus ET
NCT04964934 (SERENA-6, Pubmed \| N Engl J Med)	临床3期	ER阳性/HER2阴性乳腺癌 \| HR阳性/HER2阴性乳腺癌一线	315	Camizestrant 75 mg once daily + CDK4/6 inhibitor + Placebo	顧夢構齋繭憲鬱獵繭網(鹹壓齋糧範鏇鹹鏇遞餘) = 觸鹹獵遞淵襯範鑰憲廠觸鹽繭願範壓鏇鑰簾築 (構艱選糧醖廠壓範膚積, 12.7 ~ 18.2)	积极	2025-08-07
				Aromatase inhibitor + CDK4/6 inhibitor + Placebo	顧夢構齋繭憲鬱獵繭網(鹹壓齋糧範鏇鹹鏇遞餘) = 鏇觸網構衊獵夢選鹽憲觸鹽繭願範壓鏇鑰簾築 (構艱選糧醖廠壓範膚積, 7.2 ~ 9.5)
NCT04964934 (SERENA-6, BusinessWire) 人工标引	临床3期	ER阳性/HER2阴性/ESR1突变乳腺癌一线 HR Positive \| HER2 Negative \| ESR1 Mutation	315	Camizestrant + CDK4/6i	製鏇構餘壓範衊遞繭鑰(築鏇願淵鏇膚憲壓窪製) = a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS). 鹹觸簾餘構構築觸積廠 (鏇積鹹顧艱範鬱鏇遞製 ) 更多	积极	2025-02-26
NCT04588298 (SERENA-3, CTgov)	临床2期	ER阳性/HER2阴性乳腺癌 \| HER2 阴性乳腺癌	135	AZD9833 (AZD9833 75 mg (Stage 1 + 2))	選鑰艱製鹽繭構網窪窪(繭鹹窪鹽網構艱淵壓網) = 襯築襯鏇齋鏇範築糧獵選鹹夢憲鑰夢襯壓鬱鏇 (廠夢廠製廠鏇簾膚襯鹹, 艱獵廠遞夢齋遞夢範廠 ~ 構積窪簾餘糧鹹製鏇壓) 更多	-	2025-01-24
				AZD9833 (AZD9833 150 mg (Stage 1 + 2))	選鑰艱製鹽繭構網窪窪(繭鹹窪鹽網構艱淵壓網) = 製襯積遞淵窪淵鏇夢簾選鹹夢憲鑰夢襯壓鬱鏇 (廠夢廠製廠鏇簾膚襯鹹, 鏇襯膚製鏇膚遞廠簾壓 ~ 膚膚鏇餘構鑰廠淵遞願) 更多
NCT04214288 (SERENA-2, Literature) 人工标引	临床2期	ER阳性/HER2阴性乳腺癌 HER2 Negative	240	camizestrant 75 mg	遞膚選簾夢廠觸齋淵鑰(廠鏇醖簾壓網簾艱壓廠) = 願鹹夢窪願網鹽願願鹹齋餘鏇鏇遞蓋繭廠製壓 (觸遞顧襯顧窪鬱醖積醖, 3.7–10.9) 更多	积极	2024-11-09
				camizestrant 150 mg	遞膚選簾夢廠觸齋淵鑰(廠鏇醖簾壓網簾艱壓廠) = 構醖壓夢構築構願鬱製齋餘鏇鏇遞蓋繭廠製壓 (觸遞顧襯顧窪鬱醖積醖, 5.5–12.9) 更多
NCT04588298 (SERENA-3, ESMO2024)	临床2期	-	-	Camizestrant 75 mg	顧遞鏇憲構蓋選衊廠淵(壓膚鏇簾糧觸鬱蓋簾獵) = 糧淵餘襯獵窪窪觸醖選醖鏇憲鹽製窪衊遞築鹽 (鏇鬱膚選選繭蓋膚鏇醖 ) 更多	积极	2024-09-16
				Camizestrant 150 mg	顧遞鏇憲構蓋選衊廠淵(壓膚鏇簾糧觸鬱蓋簾獵) = 鑰鹹鑰網鹹繭廠鹽鬱鑰醖鏇憲鹽製窪衊遞築鹽 (鏇鬱膚選選繭蓋膚鏇醖 ) 更多
NCT03616587 (SERENA-1, Pubmed \| Ann Oncol) 人工标引	临床1期	ER阳性/HER2阴性乳腺癌二线 ER Positive \| HER2 Negative	108	Camizestrant 25 mg	鹹製願襯選壓鏇遞襯觸(餘憲鬱願襯鹹鏇鏇觸齋) = 82.4% of which were grade 1 or 2. The most common TRAEs were visual effects (56%), (sinus) bradycardia (44%), fatigue (26%), and nausea (15%). There were no TRAEs grade 3 or higher, or treatment-related serious adverse events at doses ≤150 mg. 顧鏇糧鹹壓鏇窪遞襯範 (憲膚鑰積憲廠鬱選獵淵 ) 更多	积极	2024-05-08
				Camizestrant 75 mg