A Phase I, Open-label, 2 Part, Fixed Sequence Study to Assess the Effect of Co-administration of Camizestrant (AZD9833) on the Pharmacokinetics of Midazolam Exposure (CYP3A4/5 Substrate) and of Carbamazepine (CYP3A4/5 Inducer) on Camizestrant Exposure in Healthy Post Menopausal Female Participants

This study will be conducted in order to determine the effect of repeated oral doses of camizestrant on the pharmacokinetics (PK) of midazolam and to determine the effect of repeated oral titrated doses of carbamazepine on the PK of camizestrant in healthy post-menopausal female participants.

开始日期2024-08-27

申办/合作机构

AstraZeneca PLC

NCT06380751

/ Recruiting临床3期

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer.

开始日期2024-08-01

申办/合作机构

AstraZeneca PLC

CTR20233662

/ Recruiting临床3期

CAMBRIA-2：在已完成根治性局部区域治疗且无疾病证据的中-高或高复发风险的 ER+/HER2- 早期乳腺癌患者中评估 Camizestrant（AZD9833，下一代口服选择性雌激素受体降解剂）对比标准内分泌治疗（芳香化酶抑制剂或他莫昔芬）作为辅助治疗的疗效和安全性的 III 期、开放标签、随机研究

主要疗效：通过评估无浸润性乳腺癌生存期 (IBCFS)，证明 Camizestrant ± 阿贝西利相较于标准内分泌治疗±阿贝西利有优效性。次要终点：通过评估无浸润性疾病生存期 (IDFS)、无远处复发生存期 (DRFS)、总生存期 (Overall Survival, OS)，证明 Camizestrant±阿贝西利相较于标准内分泌治疗±阿贝西利有优效性。通过评估出现给药中断或感觉至少“有点”受治疗副作用困扰的研究治疗时间的比例，证明 Camizestrant±阿贝西利具有更好的耐受性。评估患者报告的 Camizestrant±阿贝西利与标准内分泌治疗±阿贝西利相比的关节痛、潮热和阴道干燥治疗相关症状。评估接受 Camizestrant±阿贝西利与接受标准内分泌治疗±阿贝西利治疗的患者相比，患者报告的健康相关生活质量 (QoL)。评估根据研究方案接受至少 1 剂 Camizestrant 且至少有 1 个可报告 PK 浓度的患者中 Camizestrant 的稳态 PK。安全性：评估 Camizestrant±阿贝西利相较于标准内分泌治疗±阿贝西利的安全性。

开始日期2024-03-29

申办/合作机构

AstraZeneca AB

[+2]

100 项与 Camizestrant 相关的临床结果

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100 项与 Camizestrant 相关的转化医学

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100 项与 Camizestrant 相关的专利（医药）

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项与 Camizestrant 相关的文献（医药）

2025-03-16·Future Oncology

CAMBRIA-1 & CAMBRIA-2 phase III trials: camizestrant versus standard endocrine therapy in ER+/HER2– early breast cancer

Article

作者: Pistilli, Barbara ; Gioni, Ioanna ; Stuart, Mary ; Saini, Kamal S. ; Loibl, Sibylle ; Mayer, Ingrid A. ; Klinowska, Teresa ; Walding, Andrew ; Niikura, Naoki ; Gnant, Michael ; Nunes, Raquel ; Johnston, Simon ; Quintana, Angela ; Rastogi, Priya ; Tolaney, Sara M. ; Bachelot, Thomas ; Hamilton, Erika P. ; Park, Yeon Hee ; Syta, Emilia

Novel selective estrogen receptor degraders (SERDs) are a promising therapeutic option under investigation for patients with estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The efficacy of novel SERDs in the treatment of advanced disease has prompted investigation into their use in the early disease setting, to reduce breast cancer recurrence. Here, we describe the design and rationale of the phase III, randomized, open-label CAMBRIA-1 and CAMBRIA-2 studies. CAMBRIA-1 and CAMBRIA-2 are comparing the next-generation oral SERD camizestrant versus standard-of-care endocrine therapy (aromatase inhibitors or tamoxifen) in patients with ER-positive/HER2-negative early breast cancer, who are at intermediate or high risk of disease recurrence. CAMBRIA-1 is comparing 5 years of camizestrant versus endocrine therapy in patients who have already received 2-5 years of standard endocrine therapy, with or without cyclin-dependent kinase 4/6 inhibitors, and are without recurrence. CAMBRIA-2 is comparing 7 years of upfront adjuvant camizestrant versus endocrine therapy, with abemaciclib permitted in both treatment arms for the first 2 years. The primary endpoint for both studies is invasive breast cancer-free survival. Secondary endpoints include invasive disease-free survival, distant recurrence-free survival, overall survival, pharmacokinetics, patient-reported outcomes, safety and tolerability.Tweetable abstract: CAMBRIA-1 and CAMBRIA-2 are ongoing, randomized, open-label trials of adjuvant camizestrant, either as an upfront treatment or as a treatment after standard endocrine therapy, in patients with HR+/HER2- early breast cancer at intermediate to high risk of disease recurrence.Clinical Trial Registration: NCT05774951 (CAMBRIA-1); NCT05952557 (CAMBRIA-2).

2025-02-26·ACS Central Science

Single Dose of a Small Molecule Leads to Complete Regressions of Large Breast Tumors in Mice

Article

作者: Shapiro, David J. ; Fan, Timothy M. ; Boudreau, Matthew W. ; Bouwens, Brooke A. ; Hergenrother, Paul J. ; Zhu, Junyao ; Carrell, Hunter W. ; Lee, Yoongyeong ; Nelson, Erik R. ; Mulligan, Michael P. ; Mousses, Spyro

Patients with estrogen receptor α positive (ERα+) breast cancer typically undergo surgical resection, followed by 5-10 years of treatment with adjuvant endocrine therapy. This prolonged intervention is associated with a host of undesired side effects that reduce patient compliance, and ultimately therapeutic resistance and disease relapse/progression are common. An ideal anticancer therapy would be effective against recurrent and refractory disease with minimal dosing; however, there is little precedent for marked tumor regression with a single dose of a small molecule therapeutic. Herein we report ErSO-TFPy as a small molecule that induces quantitative or near-quantitative regression of tumors in multiple mouse models of breast cancer with a single dose. Importantly, this effect is robust and independent of tumor size with eradication of even very large tumors (500-1500 mm³) observed. Mechanistically, these tumor regressions are a consequence of rapid induction of necrotic cell death in the tumor and are immune cell independent. If successfully translated to human cancer patients, the benefits of such an anticancer drug that is effective with a single dose would be significant.

2025-01-27·Annual Review of Medicine

New Oral Selective Estrogen Receptor Degraders Redefine Management of Estrogen Receptor–Positive Breast Cancer

Review

作者: Pathak, Neha ; Oliveira, Mafalda

Oral selective estrogen receptor degraders (SERDs) are pure estrogen receptor antagonists that have the potential to overcome common resistance mechanisms to endocrine therapy in estrogen receptor–positive breast cancer. There are currently five oral SERDs in published and ongoing clinical trials—elacestrant, camizestrant, giredestrant, imlunestrant, and amcenestrant—with more in development. They offer a reasonably well-tolerated oral therapy option with low discontinuation rates in studies. This review summarizes the currently available literature on this new class of drugs.

121

项与 Camizestrant 相关的新闻（医药）

2025-03-13

·PRNewswire

VERZENIO's Market Potential Soars as Demand for CDK4/6 Inhibitors Grows | DelveInsight

As VERZENIO gains traction in early-stage treatments and broadens its approved uses, its revenue is expected to keep growing. While the global CDK4/6 inhibitor market remains highly competitive, VERZENIO's distinct clinical advantages and ongoing studies could contribute to further market expansion. LAS VEGAS, March 13, 2025 /PRNewswire/ -- DelveInsight's " VERZENIO Market Size, Forecast, and Market Insight Report" highlights the details around VERZENIO, which is a targeted treatment known as a CDK4/6 inhibitor. The drug is a non-chemotherapy oral tablet. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of VERZENIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Eli Lilly and Company's VERZENIO (abemaciclib) Overview VERZENIO (abemaciclib) is a prescription medication used to treat adults with HR-positive, HER2-negative breast cancer that has metastasized (spread to other parts of the body). It is administered orally and is prescribed in combination with an aromatase inhibitor as an initial endocrine-based therapy. Additionally, the drug is being developed for the treatment of prostate cancer. VERZENIO is approved for the following indications: In combination with endocrine therapy for the adjuvant treatment of adults with HR+/HER2-, node-positive, early-stage breast cancer at high risk of recurrence. In combination with an aromatase inhibitor as the initial endocrine-based therapy for adults with HR+/HER2- advanced or metastatic breast cancer. In combination with fulvestrant for adults with HR+/HER2- advanced or metastatic breast cancer that has progressed after prior endocrine therapy. As monotherapy for adults with HR+/HER2- advanced or metastatic breast cancer that has progressed following endocrine therapy and prior chemotherapy in the metastatic setting. Learn more about VERZENIO projected market size for breast cancer @ VERZENIO Market Potential HR+/HER2- breast cancer is the most common subtype of breast cancer, defined by the presence of estrogen and progesterone hormone receptors but lacking HER2 overexpression. This form of breast cancer generally has a favorable prognosis and is primarily managed with hormone therapy to suppress hormone-driven tumor growth. According to DelveInsight's estimates, around 211,000 new cases of HR+/HER2− breast cancer were reported in the US in 2024. Over the past decade, endocrine therapy has remained the cornerstone of treatment, including for cases with visceral involvement. The current preferred approach involves combining endocrine therapy—using aromatase inhibitors or fulvestrant—with CDK4/6 inhibitors. The approval of CDK4/6 inhibitors has significantly transformed the treatment landscape for HR+/HER2− breast cancer. Currently, five selective CDK4/6 inhibitors— ENHERTU, DATROWAY, IBRANCE, KISQALI, and VERZENIO—are used in combination with endocrine therapy. In November 2023, the FDA approved TRUQAP (capivasertib) in combination with FASLODEX for patients with advanced HR+/HER2− breast cancer harboring specific biomarker alterations (PIK3CA, AKT1, or PTEN). The NCCN Guidelines have designated KISQALI as the only Category 1 Preferred CDK4/6 inhibitor for first-line treatment in combination with an aromatase inhibitor, strengthening its position in the U.S. market. This led to KISQALI recovering its lost market share, with its U.S. revenue contribution rebounding to 50%, following declines to 46% in 2020, 36% in 2021, and 38% in 2022. In January 2025, the FDA approved DATROWAY for patients with unresectable or metastatic HR+/HER2- breast cancer (IHC 0, IHC 1+, or IHC 2+/ISH-) who had previously received endocrine-based therapy and chemotherapy. Additionally, ENHERTU was approved for patients with unresectable or metastatic HR+, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer that had progressed after at least one prior endocrine therapy in the metastatic setting. Also, in January 2025, Roche reported positive topline results from its Phase III INAVO120 trial, assessing ITOVEBI in combination with IBRANCE and fulvestrant for patients with PIK3CA-mutated HR+/HER2−, endocrine-resistant, locally advanced, or metastatic breast cancer. Among the seven major markets, the US accounted for the largest market share in HR+/HER2− breast cancer, generating USD 7.5 billion in revenue in 2023. The market is expected to experience substantial growth from 2025 to 2034, driven by the introduction of novel therapeutic options. Discover more about the breast cancer market in detail @ Metastatic HR+/HER2- Breast Cancer Market Report Emerging Competitors of VERZENIO Some of the competing emerging key players in HR+/HER2- breast cancer market are, Merck (KEYTRUDA), Arvinas (ARV-471 (vepdegestrant)), Olema Pharmaceuticals (OP1250 (palazestrant)), Celcuity (Gedatolisib), Roche (Giredestrant (RG6171, GDC-9545); Inavolisib), AstraZeneca and Daiichi Sankyo (Datopotamab Deruxtecan (Dato-DXd)), AstraZeneca (Camizestrant (AZD9833); Capivasertib), Eli Lilly (LY3484356/Imlunestrant), Sermonix Pharmaceuticals (Lasofoxifene), Veru Pharma (Enobosarm), DualityBio/BioNtech (DB-1303), Evgen Pharma (SFX-01), Carrick Therapeutics (Samuraciclib (CT-7001)), EQRx/G1 Therapeutics (Lerociclib), Immutep (Eftilagimod Alpha (LAG-3lg/IMP321)), and others. To know more about the number of competing drugs in development, visit @ VERZENIO Market Positioning Compared to Other Drugs Key Milestones of VERZENIO In 2024, Phase III trials did not meet primary endpoints or were terminated for futility. Negative Phase III CYCLONE-2 results, in which VERZENIO added to abiraterone did not meet the primary endpoint of improved radiographic progression-free survival (rPFS) in men with metastatic castration-resistant prostate cancer (mCRPC). In December 2023, Eli Lilly and Company presented results from the MONARCH 3 clinical trial at the 2023 San Antonio Breast Cancer Symposium (SABCS). Results from MONARCH 3 show a numerical improvement in overall survival (OS) of 13.1 months for women with HR+, HER2- metastatic breast cancer treated with VERZENIO plus an aromatase inhibitor in the intent-to-treat population and 14.9 months for women with visceral disease. In March 2023, the US FDA approved an expanded indication for VERZENIO in combination with endocrine therapy for the adjuvant treatment of adult patients with HR+/HER2−, node-positive, early breast cancer (EBC) at a high risk of recurrence. This expanded adjuvant indication removes the Ki-67 score requirement for patient selection. In February 2022, the CHMP adopted a positive opinion recommending a change to the terms of the marketing authorization for the medicinal product VERZENIO. VERZENIO, in combination with endocrine therapy, is indicated for the adjuvant treatment of adult patients with HR+/HER2− negative, node-positive early breast cancer at high risk of recurrence. In October 2021, the US FDA approved VERZENIO, in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with HR+/HER2−, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation. In September 2018, VERZENIO was approved in Europe for treating advanced HR+ breast cancer in women if the cancer has already spread to other parts of the body or is locally advanced. In September 2018, VERZENIO was approved for the treatment of patients with HR+/HER2− unresectable or recurrent breast cancer in combination with fulvestrant or an aromatase inhibitor (AI) in Japan. In February 2018, the US FDA approved VERZENIO in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for the treatment of postmenopausal women with HR+/HER2− advanced or metastatic breast cancer In September 2017, the US FDA approved VERZENIO in combination with an endocrine therapy to treat adult patients who have HR+/HER2− advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient's hormones (endocrine therapy). In October 2015, the US FDA granted Breakthrough Therapy Designation to abemaciclib for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer Discover how VERZENIO is shaping the breast cancer treatment landscape @ VERZENIO Breast Cancer VERZENIO Market Dynamics The oral administration of VERZENIO enhances patient convenience, while its expanded approval for the adjuvant treatment of adult patients with HR+/HER2- early breast cancer highlights its role as a differentiated CDK4/6 inhibitor in reducing the risk of recurrence. The rising prevalence of HR+/HER2- breast cancer is driving market demand for effective treatments like VERZENIO. Additionally, its demonstrated efficacy in combination with endocrine therapy and its ability to penetrate the central nervous system further strengthen its market position. Favorable reimbursement policies and increasing awareness among healthcare providers also contribute to its adoption. However, its adoption may be hindered by regulatory hurdles and potential side effects, including severe or life-threatening lung inflammation and serious liver problems. High treatment costs and access disparities in certain regions could also limit market penetration. Competition from other CDK4/6 inhibitors such as IBRANCE and KISQALI poses a challenge, along with concerns over long-term safety data. Additionally, the Phase III CYCLONE-2 trial failed to meet primary endpoints in mCRPC, which may impact its broader clinical prospects and investor confidence. Dive deeper to get more insight into VERZENIO's strengths & weaknesses relative to competitors @ VERZENIO Market Drug Report Table of Contents Related Reports CDK4/6 Inhibitor Market CDK4/6 Inhibitor Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CDK4/6 inhibitor companies including Pfizer, Prelude Therapeutics, G1 Therapeutics, Pepper Bio, among others. Metastatic HR+/HER2− Breast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HR+/HER2− breast cancer companies including Pfizer, Novartis, Stemline Therapeutics, Olema Pharmaceuticals, Arvinas, Immutep, AstraZeneca, Roche, Genentech, Evexta Bio, EQRx, Sermonix Pharmaceuticals, Celcuity, Veru Pharma, Evgen Pharma, Eli Lilly, Biotheryx, among others. HR+/HER2− Breast Cancer Pipeline HR+/HER2− Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HR+/HER2− breast cancer companies, including Regor Therapeuics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Seagen Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key breast cancer companies, including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准临床结果突破性疗法ASCO会议

2025-03-13

·生物制药小编

明星PROTAC，泯然众人矣

近日，辉瑞与Arvinas联合开发的雌激素受体（ER）靶向蛋白降解剂（PROTAC）vepdegestrant（ARV-471）在首个III期临床试验VERITAC-2中未能达到ITT（总体意向治疗）人群的主要终点，虽然辉瑞和Arvinas发现了ESR1m亚组患者的获批希望，市场的反馈却非常负面。消息发布后，Arvinas的股价截止当日收盘大跌52.73%。 vepdegestrant（ARV-471）的头上曾经有许多光环，例如全球首个进入III期临床的PROTAC，2021年数额最大的PROTAC交易，最有可能获批的PROTAC。现在，这些光环随着临床的失利而略显暗淡。为何市场也不接受亚组赛道 VERITAC-2试验针对的是624例接受过CDK4/6抑制剂和内分泌治疗的ER+/HER2-晚期或转移性乳腺癌患者，试验会比较vepdegestrant与阿斯利康的氟维司群（Faslodex）的疗效。被选择作为对照的Faslodex是目前ER+/HER2-乳腺癌的标准疗法，从机制上而言，虽然两者都是靶向雌激素受体α（ERα），但是Faslodex是通过竞争性结合雌激素受体并诱导其降解的，而且是通过肌肉注射油基制剂，这一点使得Faslodex在生物利用度上更差一些。而vepdegestrant则通过经典的PROTAC机制与ERα结合，招募E3泛素连接酶复合物（如CRBN），使ERα被泛素化标记，随后被细胞内的蛋白酶体识别并降解。由于vepdegestrant是口服药物，在便捷性上显然远胜Faslodex。2002年上市以来的Faslodex长期以来雄踞雌激素受体降解剂（SERD）宝座。如果vepdegestrant真的在ITT人群中取胜，是可以作为Faslodex平替的。问题是环境已经变了，随着众多二代三代的口服SERD疗法已经或即将上市，vepdegestrant作为口服药物的优势似乎正在消解。而这些口服SERD疗法在ESR1m亚组上似乎疗效也不弱。 2023年获批的elacestrant被发现在ESR1突变患者中也能降低45%的死亡率，而这次vepdegestrant的信息表明，在预设的ESR1突变亚组中，风险比（HR）超过预设目标0.6，超过0.6意味着至少能降低40%以上的死亡率，虽然没有公布实际数据，死亡率的降低可能不会和elacestrant的差太多。又例如礼来的Imlunestrant（LY3484356），这是一款可以穿透血脑屏障的SERD，在ESR1突变的患者中，Imlunestrant较标准内分泌治疗降低38%疾病进展或死亡风险，联合Verzenio（CDK4/6抑制剂，Abemaciclib）在全部人群中较单药Imlunestrant降低了43%进展或死亡风险。阿斯利康的camizestrant同样取得了积极的中期结果，Camizestrant作为一线治疗，在高度统计学意义和临床意义上显著改善了伴有新发ESR1肿瘤突变的晚期HR阳性乳腺癌患者的无进展生存期（PFS）。总结在这种情况下，vepdegestrant的未来市场前景不容乐观。vepdegestrant实际上并不能以PROTAC的技术特点在众多SERD中脱颖而出。参考来源： https://www.fiercebiotech.com/biotech/pfizer-arvinas-hormone-therapy-posts-mixed-survival-results-first-phase-3-test

蛋白降解靶向嵌合体临床3期临床结果

2025-03-11

·EndPoints

Arvinas, Pfizer’s PROTAC data fall short of hype in breast cancer

Arvinas and Pfizer’s targeted protein degrader has not managed to distinguish itself from other, similar breast cancer drugs, according to pivotal data released Tuesday. Results of the Phase 3 VERITAC-2 trial show that vepdegestrant extended progression-free survival in patients with mutated estrogen receptor genes, but not in the overall population. Arvinas’ shares $ARVN fell as much as 40% pre-market. The readout of VERITAC-2 was widely regarded as the first big test of a proteolysis-targeting chimera (PROTAC) drug. The hope was that a PROTAC would work in all comers, an achievement that has so far eluded the similar drugs known as SERDs — or selective estrogen receptor degraders. The Phase 3 trial assessed vepdegestrant monotherapy as a second-line treatment, following CDK4/6 inhibitors and hormone therapy, for estrogen receptor-positive, HER2-negative metastatic breast cancer. Arvinas and Pfizer said that vepdegestrant demonstrated a “statistically significant and clinically meaningful” improvement in progression-free survival over the hormone therapy Faslodex in the mutant population. The results in this cohort exceeded the prespecified target of a 40% cut in the risk of progression or death, though the partners did not give the actual figure. Significance was not reached in the intent-to-treat population, strongly suggesting that vepdegestrant has little effect in patients without mutations in the ESR1 gene, which codes for one of the two main types of estrogen receptors. Overall survival data were not mature at the time of the analysis, the companies said, with less than a quarter of the required number of events having occurred. Overall survival will continue to be monitored as a key secondary endpoint. The companies intend to present more VERITAC-2 results at a medical meeting later this year. They will also seek approval for the product, but a broad label encompassing wild-type patients is unlikely to be granted. If vepdegestrant is approved solely in mutant patients it would be on level terms with the only approved SERD, Menarini’s Orserdu. Analysts from Leerink wrote in a Feb. 3 note that if VERITAC-2 had demonstrated that best-in-class activity for vepdegestrant in both the mutants and in all comers, Arvinas’s market value could have tripled. Pfizer licensed vepdegestrant from Arvinas in 2021 for $1 billion upfront . Estrogen receptor degraders are intended to be more potent than inhibitors. Inhibitors bind transiently, blocking the action of the receptor only for a limited time. In contrast, degraders essentially destroy their target protein by co-opting the cell’s natural disposal systems. PROTACs, like vepdegestrant, bind to both the estrogen receptor and to what’s called the E3 ubiquitin. That recruits ubiquitin molecules to the receptor-PROTAC complex, which tags it for destruction by the proteasome. The proteasome is a complex of enzymes involved in breaking down intracellular proteins. This approach is distinct from SERDs, such as Eli Lilly’s imlunestrant and AstraZeneca’s camizestrant , both of which have scored recent Phase 3 successes in ESR1-mutant patients but have not been shown to work in wild-type subjects. SERDs enable receptor degradation via a more passive mechanism. Editor’s note: This article was updated to add Arvinas’ latest stock move.

临床3期临床结果

100 项与 Camizestrant 相关的药物交易

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研发状态

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
晚期乳腺癌	临床3期	美国	AstraZeneca PLC	2024-08-01
晚期乳腺癌	临床3期	中国	AstraZeneca PLC	2024-08-01
晚期乳腺癌	临床3期	日本	AstraZeneca PLC	2024-08-01
晚期乳腺癌	临床3期	阿根廷	AstraZeneca PLC	2024-08-01
晚期乳腺癌	临床3期	澳大利亚	AstraZeneca PLC	2024-08-01
晚期乳腺癌	临床3期	奥地利	AstraZeneca PLC	2024-08-01
晚期乳腺癌	临床3期	巴西	AstraZeneca PLC	2024-08-01
晚期乳腺癌	临床3期	保加利亚	AstraZeneca PLC	2024-08-01
晚期乳腺癌	临床3期	加拿大	AstraZeneca PLC	2024-08-01
晚期乳腺癌	临床3期	智利	AstraZeneca PLC	2024-08-01

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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


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 Hormone Receptor Positive \| HER2 Negative \| ESR1 Mutation	315	Camizestrant + CDK4/6i	選鹹衊獵憲襯遞醖糧夢(繭鹹襯淵範醖醖積網築) = a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS). 衊網衊構窪選窪築醖鑰 (憲簾蓋選範膚構餘構鹽 ) 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))	觸廠簾憲願蓋蓋憲鹽蓋(膚艱鬱糧襯觸鏇廠膚鑰) = 網襯鏇蓋簾壓壓鹹製醖獵衊餘糧顧淵膚積壓淵 (簾艱憲艱範選憲衊壓鹹, 顧壓蓋網網淵鬱鏇簾窪 ~ 觸艱醖鹹選鹽淵鏇遞夢) 更多	-	2025-01-24
				AZD9833 (AZD9833 150 mg (Stage 1 + 2))	觸廠簾憲願蓋蓋憲鹽蓋(膚艱鬱糧襯觸鏇廠膚鑰) = 積鑰窪觸艱選鏇繭選獵獵衊餘糧顧淵膚積壓淵 (簾艱憲艱範選憲衊壓鹹, 選鏇選壓艱觸憲鹹餘遞 ~ 膚鹽遞窪繭鑰餘鑰獵蓋) 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	繭觸蓋窪顧願窪襯淵鑰(遞鑰顧鑰壓選齋鑰鏇襯) = 餘鏇製鏇觸積顧觸淵簾膚鬱範膚壓鑰構齋淵淵 (網簾顧網範願糧願夢窪, 3.7–10.9) 更多	积极	2024-11-09
				camizestrant 150 mg	繭觸蓋窪顧願窪襯淵鑰(遞鑰顧鑰壓選齋鑰鏇襯) = 觸鏇壓齋築廠襯築衊構膚鬱範膚壓鑰構齋淵淵 (網簾顧網範願糧願夢窪, 5.5–12.9) 更多
NCT04588298 (SERENA-3, ESMO2024)	临床2期	-	-	Camizestrant 75 mg	夢積憲範淵製衊糧範糧(齋製衊築艱遞選網顧獵) = 鬱鬱願鹽遞壓襯製餘蓋襯築衊憲襯醖醖廠襯鹹 (餘簾鬱顧齋築繭遞獵願 ) 更多	积极	2024-09-16
				Camizestrant 150 mg	夢積憲範淵製衊糧範糧(齋製衊築艱遞選網顧獵) = 範餘簾夢窪蓋鬱簾糧選襯築衊憲襯醖醖廠襯鹹 (餘簾鬱顧齋築繭遞獵願 ) 更多
NCT03616587 (SERENA-1, Pubmed) 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	膚襯願艱範鹽觸鑰蓋簾(糧鹹築鏇構廠顧繭膚製) = 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. 窪顧願鑰網艱鏇廠獵製 (鹽壓艱遞壓鬱鑰製獵鑰 ) 更多	积极	2024-05-08
				Camizestrant 75 mg
NCT04214288 (SERENA-2, CTgov)	临床2期	ER阳性/HER2阴性乳腺癌	240	Fulvestrant	獵糧製齋醖觸網構願齋(艱淵觸積壓鬱顧積淵壓) = 艱鹽壓鏇獵鑰鏇糧壓獵顧鬱範膚簾構製餘膚願 (餘積艱選獵醖窪壓繭範, 鏇遞糧衊獵糧襯憲憲廠 ~ 鏇繭網鑰餘顧襯積獵顧) 更多	-	2023-12-12
NCT04711252 \| NCT03616587 \| NCT04964934 (SERENA-4, SERENA-6, SERENA-1, SABCS2023)	N/A	辅助 ESR1wt \| ESR1m \| Y537S mutation	-	Camizestrant (AZD9833) 75 mg	製鏇築餘衊鬱製憲窪淵(襯糧積鏇廠憲繭顧築醖) = 鏇顧鹽鹹積簾艱築製構艱獵製餘衊憲獵壓遞網 (夢鑰夢獵顧淵廠齋顧範 )	-	2023-03-01
				Placebo	製鏇築餘衊鬱製憲窪淵(襯糧積鏇廠憲繭顧築醖) = 顧餘範製糧餘積齋鑰鏇艱獵製餘衊憲獵壓遞網 (夢鑰夢獵顧淵廠齋顧範 )
NCT03616587 (SERENA-1, SABCS2023)	临床1期	ER阳性/HER2阴性乳腺癌 ESR1 mutations	24	Camizestrant 75 mg QD + Abemaciclib 150 mg BID	艱淵餘廠鹽鹹鏇築構憲(鹽壓繭齋膚積網衊顧窪) = 壓醖鹹壓鏇壓蓋醖構艱餘憲構蓋鏇繭鹽願簾壓 (繭蓋鹹繭構蓋蓋顧鬱夢 ) 更多	积极	2023-03-01
NCT03616587 (SERENA-1, ASCO2022) 人工标引	临床1期	ER阳性/HER2阴性乳腺癌 ER Positive \| HER2 Negative	25	palbociclib+AZD9833	鏇鹽夢鬱齋網繭觸襯襯(遞鑰鹹糧齋膚壓鑰鬱製) = 簾衊網壓膚膚膚顧廠願憲糧築築艱鏇艱壓壓選 (築膚繭膚製艱網鹹鏇鏇 ) 更多	积极	2022-06-02