A Phase II Clinical Study on Precision Treatment of Rare Tumours in China Guided by Patient-Derived Tumor Organoids (PDO) and Next-Generation Sequencing (NGS)

The objective of this Phase II, open-label, multicenter, non-randomised controlled clinical trial is to guide precision treatment for patients with rare tumours based on Patient-Derived Organoids/Next-Generation Sequencing drug screening.

开始日期2025-01-01

申办/合作机构

北京大学深圳医院（北京大学深圳临床医学院）

ChiCTR2400092967 / Suspended临床2期IIT

The study of the safety and efficacy of palbociclib combined with anlotinib in the treatment of CDK4/6 inhibitor-resistant HR+ breast cancer

开始日期2024-12-01

申办/合作机构-

NCT06739395 / Recruiting临床2期IIT

A Pan-Cancer Basket, Real World, Open-label, Multicenter Study on Molecular Matching Therapy Guided by Molecular Tumor Boards (MTB) for Pan Solid Tumor Patients With Standard Treatment Exhaustion

The main purpose of this study is to explore the feasibility of selecting treatment plans based on genomic variations guided by MTB in patients with advanced refractory solid tumors.

开始日期2024-11-01

申办/合作机构

天津医科大学第二医院

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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2,016

项与哌柏西利相关的文献（医药）

2025-03-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Three sample preparation methods for clinical determination of CDK4/6 inhibitors with endocrine therapy in breast cancer patient plasma using LC-MS: Cross-validation (red), ecological (green) and economical (blue) assessment

Article

作者: Mlinarić, Zvonimir ; Turković, Lu ; Sertić, Miranda ; Lovrić, Mila ; Silovski, Tajana ; Nigović, Biljana

Cyclin D-dependent kinase 4/6 inhibitors palbociclib, ribociclib and abemaciclib, in combination with aromatase inhibitors anastrozole and letrozole or oestrogen receptor degrader fulvestrant, are being assessed as candidates for therapeutic drug monitoring. An ideal bioanalytical method for their determination in patient plasma samples is therefore of high interest, as there is no routine reference method yet available in the clinical practice. In this work, three sample preparation approaches - dispersive liquid-liquid microextraction (DLLME), solid-phase extraction (SPE), and newly developed phospholipid removal (PLR) for LC-MS determination of these six drugs are comprehensively assessed. The methods are validated in the clinically relevant linear ranges with remarkable precision (RSD ≤6.9 %) and accuracy (bias -13.6 - 11.8 %). To compare the procedures in a real-world setting, they are applied on 38 samples from breast cancer patients. The differences between paired results are below 20 % for more than 92 % of the repeats and the RSD is ≤13.1 % between the corresponding results. Statistical comparison of the results reveals excellent overall agreement between the methods (Lin's concordance correlation coefficient ≥0.9969, maximal Bland-Altman bias 6.3 %). DLLME proved to be the most ecologically acceptable method due to the high degree of miniaturisation (AGREEprep score 0.44), PLR enabled very high sample throughput and cost-effectiveness (BAGI 72.5), while SPE showed the best analytical performance (redness score 100). All three methods are suitable for their designated purpose, and the choice of the ideal method can be made based on the scope of application, available funds and equipment and desired ecological footprint.

2025-02-01·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR CELL RESEARCH

Enhanced radiotherapy susceptibility in NSCLC through palbociclib-mediated PP5 inhibition

Article

作者: Chen, Grace ; Wang, Cheng-Yi ; Huang, Chao-Yuan ; Chen, Li-Ju ; Hong, Shiao-Ya

Radiotherapy remains a cornerstone in the treatment of non-small cell lung cancer (NSCLC), yet radioresistance often limits its efficacy. Identifying molecular targets that enhance radiosensitivity is crucial to offering both curative and palliative benefits for patients with NSCLC. Utilizing bioinformatics analysis, our study revealed significantly higher expression of PP5 in NSCLC tissues compared to normal tissues. Kaplan-Meier survival analysis also showed that high PP5 expression correlates with poorer overall survival, particularly in patients undergoing radiotherapy, suggesting a role for PP5 in radioresistance. We further demonstrated that PP5 is a critical target of palbociclib, distinct from CDK4/6, influencing radiosensitivity in NSCLC. Palbociclib enhanced radiotherapy susceptibility by inducing sustained DNA damage and AMPK activation. The subsequent cellular event is apoptosis rather than autophagy. Furthermore, the enhanced efficacy of combination therapy was counteracted by an AMPK inhibitor and PP5 activator, underscoring the importance of these pathways in mediating the response. Our findings provide compelling evidence that targeting PP5 can significantly enhance the therapeutic outcomes of radiotherapy in NSCLC. This research offers valuable insights into new combination therapy strategies, highlighting the potential of PP5 as a novel therapeutic target to overcome radioresistance.

2025-02-01·CANCER LETTERS

TFAP2C-DDR1 axis regulates resistance to CDK4/6 inhibitor in breast cancer

Article

作者: Hall, Matthew D ; Zhou, Shuyan ; Shen, Min ; Li, Zhuqing ; Seto, Edward ; Zhang, Ya-Qin ; Zhu, Wenge ; Peng, Changmin ; Mughal, Muhammad Jameel ; Zhang, Yi

Breast cancer is the predominant malignancy with the majority of cases are characterized as HR+/HER2-subtype. Although cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) have shown remarkable efficacy in treating this subtype when combined with endocrine therapy, the development of resistance to these inhibitors remains a significant clinical obstacle. Hence, there is an urgent need to explore innovative therapies and decipher the underlying mechanisms of resistance to CDK4/6i. In this study, we employed quantitative high-throughput combination screening (qHTCS) and genomics/proteomics approaches to uncover the molecular mechanisms driving resistance to CDK4/6i (palbociclib) in breast cancer. The comprehensive analyses revealed DDR1 as a potential factor implicated in mediating resistance to CDK4/6i. Specifically, DDR1 inhibition in combination with palbociclib exhibited remarkable synergistic effects, reducing cell survival signaling and promoting apoptosis in resistant cells. In-vivo xenograft model further validated the synergistic effects, showing a significant reduction in the resistant tumor growth. Exploration into DDR1 activation uncovered TFAP2C as a key transcription factor regulating DDR1 expression in palbociclib resistant cells and inhibition of TFAP2C re-sensitized resistant cells to palbociclib. Gene set enrichment analysis (GSEA) in the NeoPalAna trial demonstrated a significant enrichment of the TFAP2C-DDR1 gene set from patitens after palbociclib treatment, suggesting the possible activation of the TFAP2C-DDR1 axis following palbociclib exposure. Overall, this study provides crucial insights into the novel molecular landscape of palbociclib resistance in breast cancer, suggesting TFAP2C-DDR1 axis inhibition as a promising strategy to overcome resistance.

970

项与哌柏西利相关的新闻（医药）

21 小时之前

·复宏汉霖

产品速递 | HLX78治疗ESR1突变ER+/HER2-乳腺癌的国际多中心III期临床研究完成中国首例患者给药

2024年12月24日，复宏汉霖（2696.HK）宣布，HLX78（lasofoxifene，拉索昔芬片）联合阿贝西利（CDK4/6 抑制剂）用于治疗既往接受过芳香化酶抑制剂（AI）治疗、雌激素受体α基因（ESR1）突变的雌激素受体阳性（ER+）、人表皮生长因子受体2阴性（HER2-）局部晚期或转移性乳腺癌患者的国际多中心III期临床研究（ELAINE-3研究，NCT05696626）完成中国首例患者给药。目前，该研究正同步于美国、加拿大、欧盟等国家和地区招募受试者。乳腺癌是全球发病率第二高的癌症，据GLOBOCAN数据显示，2022年全球乳腺癌新发病例约230万，中国乳腺癌新发病例逾35.7万[1]。雌激素受体（Estrogen receptor，ER）阳性乳腺癌占乳腺癌总数的60%-70%[2]。内分泌治疗是ER+乳腺癌的主要治疗手段，其中最常使用的芳香化酶抑制剂（aromatase inhibitor，AI）已被美国国立综合癌症网络（NCCN）和中国临床肿瘤学会（CSCO）等指南推荐成为ER+/HER2-乳腺癌患者的辅助及一线标准治疗方法[3,4]，然而几乎所有经AI治疗的患者会产生原发性或获得性耐药[5]，其中ESR1获得性突变最为常见，高达40%，被认为是内分泌治疗重要耐药机制[6]，目前针对ESR1突变的ER+/HER2-乳腺癌治疗方案有限，存在较大治疗需求。 HLX78是公司自Sermonix Pharmaceuticals, Inc. 许可引进的一款临床在研口服选择性雌激素受体调节剂 (selective estrogen receptor modulator，SERM) ，在ESR1突变的ER+/HER2-转移性乳腺癌的治疗中具有强大的靶向治疗作用。在已完成的两项II期临床研究（ELAINE-1和ELAINE-2研究）中，针对ESR1突变肿瘤，lasofoxifene作为单药或联合CDK4/6抑制剂使用均展现出抗肿瘤活性[7-8]。从lasofoxifene对雌激素受体突变的生物利用度和药物活性来看，该候选药物有望为内分泌治疗后产生获得性耐药ESR1突变的患者群体带来希望，并有望在晚期ER+乳腺癌的精准医学治疗中发挥关键作用。未来，公司也将继续以患者为中心，聚焦未满足的临床需求，垂直深耕乳腺癌领域领域，加快推进该项国际多中心临床试验进展，并以不断的创新与突破为更多病患带来更多质高价优的治疗方案。【参考文献】 [1] Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35. [2] Ignatiadis M, Sotiriou C. Luminal breast cancer: from biology to treatment[J]. Nat Rev Clin Oncol, 2013, 10(9): 494-506. doi: 10.1038/nrclinonc.2013.124. [3] Chinese Society of Clinical Oncology (CSCO) Breast Cancer guidelines 2023. [4] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.5.2023 [5] Rozeboom B, Dey N, De P. ER+ metastatic breast cancer: past, present, and a prescription for an apoptosis-targeted future. Am J Cancer Res. 2019;9(12):2821-2831. Published 2019 Dec 1. [6] Spoerke JM, Gendreau S, Walter K, et al. Heterogeneity and clinical significance of ESR1 mutations in ER-positive metastatic breast cancer patients receiving fulvestrant. Nat Commun. 2016;7:11579. Published 2016 May 13. doi:10.1038/ncomms11579 [7] Goetz MP, Bagegni NA, Batist G, et al. Lasofoxifene versus fulvestrant for ER+/HER2- metastatic breast cancer with an ESR1 mutation: results from the randomized, phase II ELAINE 1 trial. Ann Oncol. 2023;34(12):1141-1151. doi:10.1016/j.annonc.2023.09.3104 [8] S. Damodaran, C.C. O’Sullivan, A. Elkhanany, I.C. Anderson, M. Barve, S. Blau, M.A. Cherian, J.A. Peguero, M.P. Goetz, P.V. Plourde, D.J. Portman, H.C.F. Moore, Open-label, phase II, multicenter study of lasofoxifene plus abemaciclib for treating women with metastatic ER+/HER2− breast cancer and an ESR1 mutation after disease progression on prior therapies: ELAINE 2. Ann Oncol. 2023;34(12):1131-1140. doi:10.1016/j.annonc.2023.09.3103. 关于ELAINE-3研究本研究是一项开放标签、随机、对照、多中心的III期研究，旨在比较HLX78联合阿贝西利和氟维司群联合阿贝西利治疗ER+/HER2–的局部晚期或转移性乳腺癌的男性和绝经前/后女性患者的有效性、安全性和耐受性，患者在接受芳香化酶抑制剂联合哌柏西利或瑞波西利作为一线内分泌治疗转移性疾病后出现疾病进展且携带ESR1基因突变。符合条件的受试者将以1:1的比例随机分配，接受HLX78（每日5毫克，口服）联合阿贝西利或氟维司群联合阿贝西利。本研究的主要目标是评估各治疗组的无进展生存期（PFS），评估采用盲态独立中心评估（BICR）基于实体瘤评价标准（RECIST）1.1进行。次要目标为评估其他终点，包括客观缓解率、总生存期、临床获益率、缓解持续时间、至缓解时间、至细胞毒性化疗时间、生活质量和安全性。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，3款产品在国际获批上市，25项适应症获批，4个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖50多个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌、食管鳞状细胞癌和非鳞状非小细胞肺癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 First Chinese Patient Dosed for Phase 3 MRCT on ER+/HER2- Breast Cancer of HLX78 Shanghai, China, December 24, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient in China has been dosed in the international multi-centre Phase 3 clinical trial (ELAINE-3, NCT05696626) of HLX78 (oral lasofoxifene) in combination with abemaciclib (a CDK4/6 inhibitor) in patients with locally advanced or metastatic estrogen receptor-positive (ER+)/Human epidermal growth factor receptor 2-negative (HER2-) breast cancer who have disease progression on an aromatase inhibitor (AI) in combination with CDK4/6 inhibitor and have an estrogen receptor α gene (ESR1) mutation. ELAINE-3 is currently recruiting subjects in the United States, Canada, the European Union, in addition to other countries and regions. Breast cancer is the second most diagnosed cancer in the world, according to GLOBOCAN 2022. There were around 2.3 million new cases of breast cancer in 2022 globally, including more than 357,000 in China.[1] ER+ breast cancer comprises 60-70% of all breast cancers.[2] Endocrine therapy remains the mainstay treatment for ER+ breast cancer and the most widely used class of aromatase inhibitor (AI) has been recommended by the National Comprehensive Cancer Network (NCCN) and Chinese Society of Clinical Oncology (CSCO) guidelines to be the adjuvant and first-line standard of care for patients with ER+/HER2- breast cancer.[3,4] However, almost all patients treated with AIs in the advanced setting develop resistance[5], with ESR1 mutations being one of the most prevalent alterations, present in up to 40% of patients and a significant mechanism of resistance to endocrine therapy[6]. Currently, there are limited treatment options for ER+/HER2- breast cancer with ESR1 mutations, and thus a large clinical need exists. HLX78 (lasofoxifene) is an oral selective estrogen receptor modulator (SERM) licensed by Henlius for Asia from Sermonix Pharmaceuticals, Inc. It has demonstrated robust target engagement in ER+/HER2- metastatic breast cancer, particularly in the presence of ESR1 mutations. In two completed Phase 2 clinal studies (ELAINE-1 and ELAINE-2), lasofoxifene has demonstrated anti-tumour activity against tumours with ESR1 mutations as monotherapy and in combination with a CDK4/6 inhibitor.[7,8] Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, and, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer. In the future, Henlius will continue to adopt a patient-centric approach, focusing on unmet clinical needs. The company will delve deeply into the breast cancer field and expedite the development of the international multi-center clinical trial ELAINE-3, aiming to bring more high-quality, affordable, and innovative treatments to patients worldwide. About ELAINE-3 This is a phase 3, open label, controlled, randomized, multicenter study comparing the efficacy, safety, and tolerability of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib for the treatment of men and pre- and postmenopausal women with locally advanced or metastatic ER+/HER2− breast cancer who have disease progression on an aromatase inhibitor in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation. Eligible participants will be randomized at 1:1 to receive lasofoxifene (5 mg/day, oral administration) combined with abemaciclib or fulvestrant combined with abemaciclib. The primary objective of this study is to evaluate the progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 as determined by blinded independent central review of each treatment arm. The secondary objectives are to evaluate other endpoints, including objective response rate, overall survival, clinical benefit rate, duration of response, time to response, time to cytotoxic chemotherapy, quality of life, and safety. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 25 indications are approved worldwide, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (nsNSCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. 联系方式媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

CSCO会议临床3期临床1期临床2期

2024-12-23

·GlobeNewswire-Health Care

Bionano Announces Publication from Johns Hopkins School of Medicine Showing that OGM Outperformed Multiple Cytogenetic Assays in a Study of Bone and Soft Tissue Tumor Analysis

In the largest study to date of bone and soft tissue tumors, OGM detected 100% of the variants found by multiple standard techniques, including karyotyping, fluorescent in-situ hybridization (FISH) & gene fusion assaysOGM was also more sensitive, including detection of diagnostic or pathogenic variants missed by karyotype in 74% (14/19) of cases that failed or were negative by karyotypingWhen OGM results and next-generation sequencing (NGS) results were combined, diagnostic and pathogenic structural variants (SVs), copy number variants (CNVs), and/or single nucleotide variants (SNVs) were found in ~98% of cases, a substantially greater rate than when karyotyping, FISH and NGS are used SAN DIEGO, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced a publication in Modern Pathology by a group of researchers at the Johns Hopkins University School of Medicine, showing that optical genome mapping (OGM) can outperform traditional techniques in analysis of bone and soft tissue tumors. Several prior publications have shown the utility of OGM compared to traditional cytogenetics in studies of hematologic malignancies, however, data on the application of OGM in solid tumors has been relatively sparse. This study provides compelling support for extending the utility of OGM in cancer beyond hematologic malignancies to solid tumors. Key findings: OGM detected all variants revealed by conventional cytogenetics: OGM showed 100% concordance, identifying all pathogenic variants detected by standard of care cytogenetic methods. The specificity of OGM was assessed to be 100%, i.e. OGM correctly identified the same pathogenic SVs and CNVs detected by standard of care/routine cytogenetics (karyotyping and FISH).OGM detected pathogenic variants missed by karyotyping: In 74% of cases with normal or failed karyotype, OGM detected diagnostic or pathogenic SVs that were missed by karyotyping. Further, in 6 cases that failed to yield any karyotyping results due to culture failure, OGM detected pathogenic SVs in all of them. Variants found by OGM but missed by standard of care included the EWSR1::ETV1 fusion, which is a key molecular hallmark of clear cell sarcoma and helps to differentiate it from other soft tissue sarcomas and melanomas.OGM resolved complex cancer genomes: Study authors found that OGM data could re-characterized and better defined complex structural rearrangements including chromoanagenesis in 27% of cases and complex 3-6-way translocations in 15% of cases when compared to traditional cytogenetic methods.OGM combined with NGS found pathogenic variants in 98% of cases, a substantially greater rate than when karyotyping, FISH and NGS are used: The integrated approach of the combination of OGM and NGS resulted in the detection of pathogenic SVs and sequence variants in ~98% of cases. OGM was 100% concordant with NGS for aneuploidy detection.OGM findings have the potential to qualify subjects for targeted therapies that otherwise would not have been possible: The authors state that several of the OGM findings could result in the potential for these cases to qualify for either targeted treatments or clinical trials. For example, cases with potential to be treated by CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib), TRK inhibitors (larotrectinib, entrectinib), pan-FGFR inhibitors (erdafitinib or futibatinib) were highlighted. Erik Holmlin, president and chief executive officer of Bionano commented, “Approximately 50% of bone and soft tissue tumor samples fail to reveal actionable information for proper classification of disease, prognosis and therapeutic management because they either fail to culture or because traditional techniques in cytogenetics lack adequate sensitivity and specificity to reliably detect relevant variants. We have seen increasing evidence for OGM as a valuable alternative to cytogenetic methods in blood cancers, and we are thrilled to see researchers at Johns Hopkins publishing this compelling case for extending OGM’s utility to bone and soft tissue tumors.” The full research publication is available at: https://doi-org.libproxy1.nus.edu.sg/10.1016/j.modpat.2024.100684 About Bionano Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through optical genome mapping (OGM) solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. The Company also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also offers OGM-based diagnostic testing services. For more information, visit www.bionano.com or www.bionanolaboratories.com. Bionano’s products are for research use only and not for use in diagnostic procedures. Forward-Looking Statements of Bionano Genomics This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “can,” “could,” “potential,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, OGM’s utility for applications in bone and soft tissue cancers; OGM’s ability to detect SVs and CNVs concordant with traditional cytogenetic methods, including karyotyping and FISH; OGM’s ability to detect SVs and CNVs not detected with transitional cytogenetic methods; the utility and ability of OGM to detect diagnostically relevant or pathogenic SVs and CNVs; the ability of OGM and NGS in combination to detect more SVs than when combining karyotyping, FISH and NGS; the potential for OGM to be useful in qualifying subjects for targeted therapies or clinical trials; the utility of OGM for uses described in the publication referenced in this press release; the ability of OGM to re-characterized and better defined complex structural rearrangements when compared to traditional cytogenetic methods; OGM’s ability and utility for adoption across a wider spectrum of cancers including blood, bone and soft tissue cancers and the increase in adoption and utilization as an alternative to traditional cytogenetic methods; the utility of OGM for applications in areas reported in this press release; and other statements that are not historical facts. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: global and macroeconomic events, such as recent and potential bank failures, supply chain disruptions, global pandemics, inflation, and the ongoing conflicts between Ukraine and Russian and Israel and Hamas, on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; the failure of OGM to prove useful for applications in bone and soft tissue cancers; the failure of OGM to detect SVs concordant with traditional cytogenetic methods, including karyotyping and FISH; the failure of OGM to detect SVs and CNVs not detected with transitional cytogenetic methods; the failure of OGM to detect diagnostically relevant or pathogenic SVs and CNVs; the failure of OGM to prove useful for applications described in the publication referenced in this press release; the failure of OGM to be more widely adopted across a wider spectrum of cancers including blood, bone and soft tissue cancers and the increase in adoption and utilization as an alternative to traditional cytogenetic methods; the failure of OGM and NGS in combination to detect more SVs than when combining karyotyping, FISH and NGS; the failure of OGM to be useful in qualifying subjects for targeted therapies or clinical trials; the failure of OGM to prove useful for applications in areas reported in this press release; the failure of OGM to re-characterized and better defined complex structural rearrangements when compared to traditional cytogenetic methods future publications that contradict the findings of the publication referenced in this press release; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; our ability to effectively manage our uses of cash, and our ability to continue as a “going concern”; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2023 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. CONTACTSCompany Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionano.com Investor Relations:David HolmesGilmartin Group+1 (858) 888-7625IR@bionano.com

寡核苷酸

2024-12-22

·药渡

全球畅销肿瘤药图鉴

作者：布布随着对癌症医治的需求不断上升，促进了高效医治方法的进展，尤其是精确医疗和免疫疗法的提升。这些革新带来了庞大的经济收益，2024年抗癌药品市场实现了关键进展，销售业绩突出。 Keytruda (pembrolizumab) · 首次获批时间：2014年9月14日 · 开发商：默沙东 · 模态：单抗 · 作用机制：PD-1抑制剂（免疫检查点抑制剂） · 获批适应症：黑色素瘤、转移性非小细胞肺癌、头颈癌、霍奇金淋巴瘤、尿路上皮癌、胃癌、宫颈癌、肝细胞癌、默克尔细胞癌、肾细胞癌、食道癌、子宫内膜癌、鳞状细胞癌、肝细胞癌、乳腺癌、胆道肿瘤、恶性胸膜间皮瘤 · 2024年Q3销售额：74.29亿美元 · 2024年Q3销售额同比变化：17% · 销售额变化动力：Keytruda销售额增长的推动因素包括全球对早期适应症的接受度增加，包括三阴性乳腺癌 (TNBC)、肾细胞癌 (RCC) 和非小细胞肺癌 (NSCLC)，以及全球对转移性适应症的持续强劲需求。 · 关键专利到期：2028年 · 预计峰值销售额：312.8亿美元（2027年） Darzalex (daratumumab) · 首次获批时间：2015年11月16日 · 开发商：强生/Genmab · 模态：单抗 · 作用机制：抗 CD38 单体 · 获批适应症：多发性骨髓瘤 · 2024年Q3销售额（净销售额）：30.16亿美元 · 2024年Q3（净）销售额同比变化：21% · 销售额变化动力：Darzalex Q3销售额增长的主要动力来源于其在治疗多发性骨髓瘤中的持续成功和广泛应用。尤其是在全球市场的扩展和联合治疗中的应用增长显著，例如在澳大利亚，其销售额在补贴政策下同比大幅增长。 · 关键专利到期：2032年 · 预计峰值销售额：168.7亿美元（2028年） Opdivo (nivolumab) · 首次获批时间：2014年12月22日 · 开发商：百时美施贵宝 · 模态：单抗 · 作用机制：PD-1抑制剂（免疫检查点抑制剂） · 获批适应症：黑色素瘤、转移性非小细胞肺癌、肾细胞癌、霍奇金淋巴瘤、头颈癌、尿路上皮癌、结直肠癌、肝细胞癌、食道癌、恶性胸膜间皮瘤、胃癌 · 2024年Q3销售额：23.6亿美元 · 2024年Q3销售额同比变化：4% · 销售额变化动力：作为成熟的PD-1抑制剂，Opdivo的销售增长已趋于稳定，市场需求不如其推出初期那么强劲。另外，FDA正在考虑是否缩小Opdivo在PD-L1阴性胃癌和食管癌中的适应症范围，这种不确定性可能使一些医生对该药物的使用更加谨慎，从而影响其销售表现。对于一款专利即将到期的超级重磅炸弹，Opdivo销售额增长势头减缓也是必然的现象。 · 关键专利到期：2028年 · 预计峰值销售额：134.5亿美元（2027年） Tagrisso (Osimertinib) · 首次获批时间：2015年12月13日 · 开发商：阿斯利康 · 模态：小分子 · 作用机制：表皮生长因子受体 (EGFR) 酪氨酸激酶抑制剂 (TKI)，可与某些 EGFR 突变形式（T790M、L858R 和外显子 19 缺失）结合，这些突变形式在接受一线 EGFR-TKI 治疗后在非小细胞肺癌 (NSCLC) 肿瘤中占主导地位。 · 获批适应症：非小细胞肺癌 · 2024年Q3销售额：16.7亿美元 · 2024年Q3销售额同比变化：14% · 预计峰值销售额：102.7亿美元（2028年） Imbruvica（Ibrutinib） · 首次获批时间：2013年11月13日 · 开发商：强生/艾伯维 · 模态：小分子 · 作用机制：布鲁顿酪氨酸激酶（BTK）不可逆强效共价抑制剂。它与 BTK 活性位点 (Cys481) 中的半胱氨酸残基形成共价键，从而抑制 BTK。BTK 的抑制在 B 细胞受体信号传导中发挥作用，Ibrutinib的抑制作用可防止下游底物（如 PLC-γ）的磷酸化。 · 获批适应症：慢性淋巴细胞白血病、瓦尔登斯特伦巨球蛋白血症、移植物抗宿主病等 · 2024年Q3销售额：8.28亿美元（艾伯维）、7.53亿美元（强生） · 2024年Q2销售额同比变化率：-8.8%（艾伯维）、-6.8%（强生） · 销售额变化原因：Imbruvica在2024年第三季度销售额同比下降的主要原因是其面临着来自新疗法的竞争压力以及市场环境的变化，特别是针对B细胞受体通路的靶向疗法，例如acalbrutinib（Calquence）等。 · 关键专利到期：2036年 Xtandi（enzalutamide） · 首次获批时间：2012年8月31日 · 开发商：安斯泰来/辉瑞 · 模态：小分子 · 作用机制：第二代抗雄激素，可阻断前列腺癌中的雄激素和雄激素受体 (AR) 的活性。Enzalutamide可以抑制细胞生长并诱导细胞凋亡。 · 获批适应症：前列腺癌 · 2024年Q3销售额：5.61亿美元（辉瑞）；安斯泰来第三季度数据尚未公布 · 2024年Q3销售额同比变化：28%（辉瑞） · 销售额变化动力：Xtandi 的运营收入增长的主要原因是由于 2023 年第四季度获批后，非转移性去势敏感前列腺癌 (nmCSPC) 适应症的采用带来了强劲的需求。 · 关键专利到期：2027年 Revlimid（lenalidomide） · 首次获批时间：2005年12月27日 · 开发商：百时美施贵宝 · 模态：小分子 · 作用机制：Lenalidomide通过改变细胞因子产生 (抑制促炎细胞因子的产生)、调节 T 细胞共刺激和增强 NK 细胞介导的细胞毒性来发挥免疫调节作用。 · 获批适应症：骨髓增生异常综合征、多发性骨髓瘤、淋巴瘤、滤泡性淋巴瘤 · 2024年Q3销售额：14.12亿美元 · 2024年Q3销售额同比变化率：-1% · 销售额变化原因：仿制药上市 Verzenio (abemaciclib) · 首次获批时间：2017年9月28日 · 开发商：礼来 · 模态：小分子 · 作用机制：Abemaciclib 是细胞周期依赖性蛋白激酶 4 (CDK4) 和 6 (CDK6) 的双重抑制剂，它们参与细胞周期并在活动失调时促进癌细胞生长。 · 适应症：乳腺癌 · 2024年Q3销售额：13.7亿美元 · 2024年Q3销售额同比变化：32% · 销售额变化动力：主要得益于晚期或转移性乳腺癌中的应用得到更广泛的接受。随着更多的患者和医疗提供者使用Verzenio，药物的市场需求显著上升，进一步推动了销售增长。 · 关键专利到期：2031年 Imfinzi (durvalumab) · 首次获批时间：2017年5月1日 · 开发商：阿斯利康 · 模态：单抗 · 作用机制：Durvalumab属于免疫检查点抑制剂。Durvalumab 是PD-L1的阻断抗体，可促进攻击肿瘤细胞的正常免疫反应。 · 适应症：非小细胞肺癌、小细胞肺癌、胆道肿瘤、肝细胞癌、子宫内膜癌等 · 2024年Q3销售额：12.03亿美元 · 2024年Q3销售额同比变化率：13% Ibrance (palbociclib) · 首次获批时间：2015年2月3日 · 开发商：辉瑞 · 模态：小分子 · 作用机制：细胞周期依赖性激酶 CDK4 和 CDK6 选择性抑制剂。 · 适应症：乳腺癌 · 2024年Q3销售额：12.44亿美元 · 2024年Q3销售额同比变化：-13% · 销售额变化原因：Ibrance面临来自其他CDK4/6抑制剂的强烈竞争，特别是来自诺华的Kisqali和礼来的Verzenio。这些药物在临床数据上有所突破，尤其是在延长患者总生存期方面表现得更为突出。 · 关键专利到期：2027年 Tecentriq (atezolizumab) · 首次获批时间：2016年5月18日 · 开发商：罗氏 · 模态：单抗 · 作用机制：PD-L1抑制剂 · 适应症：非小细胞肺癌、小细胞肺癌、肝细胞癌、黑色素瘤、肺泡软组织肉瘤 · 2024年Q3销售额：10.38亿美元 · 2024年Q3销售额同比变化：0% · 关键专利到期：2032年 · 预计峰值销售额：76.5亿美元（2028年） Kisqali (ribociclib) · 首次获批时间：2017年3月13日 · 开发商：诺华 · 模态：小分子 · 作用机制：细胞周期依赖性激酶 (CDK) 4 和 6 的抑制剂 · 适应症：乳腺癌 · 2024年Q3销售额：7.87亿美元 · 2024年Q3销售额同比变化：43% · 销售额变化动力：得益于在 HR+/HER2- 晚期乳腺癌中的总体生存益处得到越来越多的认可以及 1 类 NCCN 指南推荐。 · 关键专利到期：2036年 · 预计峰值销售额：69.7亿美元（2028年） Calquence (acalabrutinib) · 首次获批时间：2017年10月31日 · 开发商：阿斯利康 · 模态：小分子 · 作用机制：布鲁顿酪氨酸激酶 (BTK) 抑制剂 · 适应症：套细胞淋巴瘤；慢性淋巴细胞白血病 · 2024年Q3销售额：8.13亿美元 · 2024年Q3销售额同比变化：24% · 关键专利到期：2036年 · 预计峰值销售额：40.2亿美元（2028年） Lynparza (olaparib) · 首次获批时间：2014年12月19日 · 开发商：阿斯利康 · 模态：小分子 · 作用机制：聚 ADP 核糖聚合酶 (PARP) 抑制剂 · 适应症：卵巢癌、输卵管癌、腹膜癌、乳腺癌、胰腺癌、前列腺癌 · 2024年Q3销售额：7.78亿美元 · 2024年Q3销售额同比变化：11% · 关键专利到期：2029年 · 预计峰值销售额：39.3亿美元（2027年） Carvykti (ciltacabtagene autoleucel) · 首次获批时间：2022年2月28日 · 开发商：强生 · 模态：细胞疗法 · 作用机制：针对 BCMA 的 CAR-T · 适应症：多发性骨髓瘤 · 2024年Q3销售额：2.86亿美元 · 2024年Q3销售额同比变化：87.7% · 销售额变化动力：CARVYKTI 是第一个也是唯一一个相较于标准疗法能够显著延长多发性骨髓瘤患者二线治疗总生存期的细胞疗法。 · 预计峰值销售额：38.9亿美元（2028年） Pluvicto (lutetium lu 177 vipivotide tetraxetan) · 首次获批时间：2022年3月23日 · 开发商：诺华 · 模态：多肽药物偶联物 · 作用机制：放射性配体治疗剂 · 适应症：前列腺癌 · 2024年Q3销售额：3.86亿美元 · 2024年Q3销售额同比变化：50% · 销售额变化动力：第三季度销售额受益于欧洲一次性收入扣除调整。由于供应现在不受限制，重点是增加现有 RLT （Radioligand Therapy）站点的份额，同时开设新站点和转诊途径，并吸引新患者。 · 预计峰值销售额：38.7亿美元（2028年） Ref. Merck Announces Third-Quarter 2024 Financial Results. Merck & Co. Press Release. 31. 10. 2024. Manalac, T. J&J Gets Q3 Beat, Raises Full-Year Guidance on Strong Darzalex Sales. Biospace. 15. 10. 2024. Bristol Myers Squibb Reports Third Quarter Financial Results for 2024. BMS Press Release. 31. 10. 2024. Johnson & Johnson Reports Q3 2024 Results. J&J Press Release. 15. 10. 2024. AbbVie Reports Third-Quarter 2024 Financial Results. AbbVie Press Release. 30. 10. 2024. 药渡媒体商务合作媒体公关 | 新闻&会议发稿张经理：18600036371（微信同号）点击下方“药渡“，关注更多精彩内容免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇

专利到期免疫疗法上市批准

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
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,

后查看更多信息

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

适应症

分期

评价

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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


NCT03644186 (TOUCH, CTgov)	临床2期	ER阳性/HER2阳性乳腺癌 \| HER2阳性乳腺癌 \| HR阳性/HER2阳性乳腺癌	147	Trastuzumab+Paclitaxel+pertuzumab (Paclitaxel Plus Trastuzumab and Pertuzumab)	願選鹹淵製範鹹簾衊簾(鬱繭廠夢淵壓願衊製簾) = 蓋網艱餘糧構艱鏇範遞範製憲襯積淵壓觸積衊 (願廠築製鏇醖積顧醖鹽, 網鏇餘餘簾顧觸鏇願壓 ~ 醖淵窪願鹽鏇餘鏇窪簾) 更多	-	2024-12-13
				Trastuzumab+Letrozole+palbociclib+pertuzumab (Palbociclib Plus Letrozole Plus Trastuzumab and Pertuzumab)	願選鹹淵製範鹹簾衊簾(鬱繭廠夢淵壓願衊製簾) = 構襯範壓艱製蓋蓋製範範製憲襯積淵壓觸積衊 (願廠築製鏇醖積顧醖鹽, 膚齋鑰膚鏇繭獵繭願鹹 ~ 憲齋餘襯構廠夢繭齋窪) 更多
NCT02947685 (PATINA, Company_Website) 人工标引	临床3期	HR阳性/HER2阳性乳腺癌一线 HER2 Positive \| Hormone Receptor Positive	518	IBRANCE + anti-HER2 therapy + endocrine therapy	觸構獵獵選夢艱糧壓顧(憲鬱製網憲齋膚艱鹹觸) = 網鹽壓築窪齋衊構壓遞鏇鏇鏇餘醖襯選製衊廠 (築鬱艱醖齋餘艱遞鹹壓, 32.4 ~ 60.9) 更多	积极	2024-12-12
				Anti-HER2 therapy + endocrine therapy	觸構獵獵選夢艱糧壓顧(憲鬱製網憲齋膚艱鹹觸) = 觸窪廠獵遞窪廠簾憲艱鏇鏇鏇餘醖襯選製衊廠 (築鬱艱醖齋餘艱遞鹹壓, 23.3 ~ 38.6) 更多
NCT06390839 (CTgov)	临床2期	难治恶性实体肿瘤 \| 晚期恶性实体瘤 \| 晚期淋巴瘤 ... 更多	43	Computed Tomography+palbociclib	廠憲醖選衊鹽衊築齋觸(鹹觸鏇網餘糧淵蓋選襯) = 壓醖積壓願艱壓積觸築製襯獵夢蓋餘艱齋構醖 (構鬱醖廠顧壓衊鬱顧鏇, 鹽糧艱醖壓鬱廠齋淵製 ~ 夢夢遞衊築餘齋遞廠鑰) 更多	-	2024-12-10
NCT02491983 (PARSIFAL, CTgov)	临床2期	转移性HER2阴性乳腺癌 \| ER阳性/HER2阴性乳腺癌 \| 转移性乳腺癌	486	Letrozole+palbociclib (Arm A)	窪鏇鑰糧觸網艱鑰鑰網(夢顧襯憲願蓋襯膚鏇簾) = 窪積願衊壓襯廠壓艱築鏇衊鹹衊願壓製築壓壓 (網憲築壓壓願餘齋廠簾, 膚齋繭繭鏇窪壓艱鬱網 ~ 鏇鬱膚製製餘範糧簾遞) 更多	-	2024-12-09
				Fulvestrant+palbociclib (Arm B)	窪鏇鑰糧觸網艱鑰鑰網(夢顧襯憲願蓋襯膚鏇簾) = 蓋衊鬱鑰遞獵築顧衊願鏇衊鹹衊願壓製築壓壓 (網憲築壓壓願餘齋廠簾, 製簾鑰淵網鬱衊膚積窪 ~ 壓製願願襯製構窪壓獵) 更多
NCT05361655 (Pubmed \| Oncologist)	N/A	心血管疾病 \| 转移性乳腺癌一线 HR+ \| HER2−	469	Palbociclib plus aromatase inhibitor	蓋夢遞觸鹽夢鹽選蓋築(窪廠積築築鬱簾淵艱壓) = 窪襯壓鹹鹽觸獵窪鬱膚範顧顧糧襯壓積範膚膚 (窪廠淵簾廠膚艱襯鹽窪 ) 更多	积极	2024-12-06
				Aromatase inhibitor alone	蓋夢遞觸鹽夢鹽選蓋築(窪廠積築築鬱簾淵艱壓) = 鹹構鏇憲願膚鏇鑰壓夢範顧顧糧襯壓積範膚膚 (窪廠淵簾廠膚艱襯鹽窪 ) 更多
NCI-MATCH (Pubmed \| Clin Cancer Res)	临床2期	CDK4- \| CDK6 amplification	-	Palbociclib 125 mg	壓網醖糧壓膚淵製築選(廠觸願憲鹽願齋餘襯壓) = 簾壓選艱繭憲鑰齋艱築觸範餘網膚遞齋網襯鹽 (遞醖鬱鬱構醖範鑰醖醖 ) 更多	不佳	2024-12-03
Pubmed \| NPJ Breast Cancer	N/A	HR阳性/HER2阴性乳腺癌	-	Palbociclib plus Letrozole	選鏇艱襯糧衊觸製鏇遞(蓋醖網餘糧憲淵夢範糧) = 窪醖網醖構鑰餘蓋齋鹹遞衊夢觸鑰獵淵膚艱艱 (鹹獵繭鬱鏇鑰鏇鬱製壓 ) 更多	-	2024-11-26
NCT03280303 (POLARIS, Pubmed \| Oncologist)	N/A	HR阳性/HER2阴性乳腺癌一线 \| 二线 hormone receptor-positive \| human epidermal growth factor receptor 2-negative	1,250	Palbociclib + Endocrine Therapy in 1L setting	範蓋觸糧繭顧繭鹽夢觸(築鬱觸廠築廠選襯鏇醖) = 醖選積鑰齋艱膚蓋淵願構蓋觸膚廠壓醖壓鹽鏇 (獵簾範範積齋餘鏇構壓, 42.0 ~ not estimable) 更多	积极	2024-10-30
				Palbociclib + Endocrine Therapy in ≥2L setting	範蓋觸糧繭顧繭鹽夢觸(築鬱觸廠築廠選襯鏇醖) = 鬱壓夢遞積鬱夢鹽鹽觸構蓋觸膚廠壓醖壓鹽鏇 (獵簾範範積齋餘鏇構壓, 31.2 ~ 40.8) 更多
NCT04191499 (INAVO120, FDA) 人工标引	临床2/3期	PIK3CA突变/HR阳性/HER2阴性乳腺癌 Hormone Receptor Positive \| HER2 Negative \| PIK3CA Mutation	325	Inavolisib 9 mg + Palbociclib + Fulvestrant	構醖膚繭鏇顧鹹範餘鹽(壓窪願簾顧選觸鑰範衊) = 窪糧窪範鏇齋窪簾艱襯簾選壓膚遞獵製鏇餘獵 (顧選淵廠顧膚選齋願鹹, 11.3 ~ 20.5) 更多	积极	2024-10-10
				Placebo + Palbociclib + Fulvestrant	構醖膚繭鏇顧鹹範餘鹽(壓窪願簾顧選觸鑰範衊) = 範製齋願繭夢衊積願糧簾選壓膚遞獵製鏇餘獵 (顧選淵廠顧膚選齋願鹹, 5.6 ~ 9.3) 更多
Phase II trial (ASTRO)	临床2期	转移性乳腺癌 ctDNA	35	Palbociclib	鑰鏇選繭壓構鹽選鏇鏇(鬱鬱範餘憲製壓遞廠膚) = 膚憲艱製襯鹽壓積膚範壓積憲觸顧蓋製膚鑰窪 (遞構艱範選網顧積顧壓 ) 更多	积极	2024-10-01