This phase II trial tests the how well a precision medicine approach (serial measurements of molecular and architectural response to therapy [SMMART])-adaptive clinical treatment [ACT]) works in treating patients with sarcoma, prostate, breast, ovarian or pancreatic cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). SMMART testing uses genetic and protein tests to learn how cancer changes and to understand what drugs may work against a person's cancer or why drugs stop working. These test results are reviewed by a group of physicians and scientists during a SMMART tumor board who then recommend precision therapy.

开始日期2025-02-01

申办/合作机构

OHSU Knight Cancer Institute

[+3]

NCT06580314 / Not yet recruiting临床3期IIT

A Phase III Trial of One vs. Two Years of Maintenance Olaparib, With or Without Bevacizumab, in Patients With BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum Based Chemotherapy

This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.

开始日期2025-01-16

申办/合作机构

NRG Oncology

[+1]

NCT05952453 / Not yet recruiting临床2期IIT

A Phase II Study in Newly Diagnosed Stage III/IV Epithelial Ovarian Cancer Evaluating Carbo/Taxol/Pembro in Patients Receiving Neoadjuvant Chemotherapy (NACT) Followed by Olaparib/Pembro Maintenance

this is a trial evaluating three chemotherapy agents in patients with newly diagnosed ovarian cancer patients that are Stage III or Stage IV prior to surgery to remove the tumor. After surgery there will be additional chemotherapy given.

开始日期2025-01-01

申办/合作机构

The University of Alabama at Birmingham

[+1]

100 项与奥拉帕利相关的临床结果

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100 项与奥拉帕利相关的转化医学

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100 项与奥拉帕利相关的专利（医药）

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2,961

项与奥拉帕利相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Haematologic outcomes and associated clinical characteristics among patients receiving Olaparib therapy in the UAE: a retrospective chart review

Article

作者: Akour, Amal ; Ibrahim, Mariam ; Nabil, Said ; Kendakji, Saba ; ZainAlAbdin, Sham ; Aburuz, Salahdein ; Wahba, Lina

BACKGROUND:

Poly ADP ribose polymerase (PARP) inhibitors, such as Olaparib (Lynparza^®), are pivotal in treating certain cancers, particularly those linked to BReast CAncer gene (BRCA) mutations. Despite its established efficacy, Olaparib use is associated with various adverse events (AEs), notably haematologic toxicities, such as anaemia. This retrospective chart review study aimed to examine haematologic outcomes and associated factors in patients treated with Olaparib at a tertiary hospital in the UAE.

METHODS:

We reviewed the medical charts of patients prescribed Olaparib and focused on haematologic indices at a baseline of 1-month, 3-month and 6-month follow-up periods. Data were analysed to determine the AEs frequency, transfusions need and potential associated patients' clinical characteristics.

RESULTS:

This study included all patients who received Olaparib (n = 66). Most patients were females (n = 61; 92.4%) and the vast majority were non-smokers (97%) and free of hepatic disease. Themean age of the patients was 57.03-year-old (SD) = 12.06 years), and body mass index (BMI) was 28.16 (SD = 6.40) kg/m². A high rate of anaemia (70.8%) was detected among the patients during their Olaparib therapy. Approximately, one-third of the patients developed neutropenia and thrombocytopenia. Transfusion was needed in almost half of the patients. Glomerular filtration rate (GFR) and neutropenia were significantly correlated with moderate-severe anaemia (OR = 0.097, 95% CI: 0.011-0.88, p value = .038) and (OR = 9.04, 95% CI: 1.024-79.78, p value = .048), respectively.

CONCLUSIONS:

Our findings highlight the side effects of Olaparib therapy in terms of haematology which could be avoided. Further studies are needed to better understand the therapeutic management of Olaparib and the mitigation of haematologic complications.

2025-03-01·CURRENT PHARMACEUTICAL DESIGN

PARP Pioneers: Using BRCA1/2 Mutation-targeted Inhibition to Revolutionize Breast Cancer Treatment

Article

作者: Shah, Kamal ; Bhati, Akash ; Dewangan, Hitesh Kumar ; Aggarwal, Shagun ; Sharma, Navneet

Abstract::

Breast cancer stands on the second position in the world in being common and women happen to have it with high rate of about five-folds around the world. The causes of occurrence can matter with different humans be it external factors or the internal genetic ones. Breast cancer is primarily driven by mutations in the BRCA1 and BRCA2 susceptibility genes. These BC susceptibility genes encode proteins critical for DNA homologous recombination repair (HRR). Poly (ADP ribose) polymerases (PARP) are the essential enzymes involved in the repairing of the damaged DNA. So the inhibition of these inhibitors can be considered as the promising strategy for targeting cancers with defective damage in the deoxyribonucleic acid. Olaparib and talazoparib are PARP inhibitors (PARPi) are being employed for the monotherapies in case of the deleterious germline HER2-negative and BRCA-mutated breast cancer. The potency of PARP for trapping on DNA and causes cytotoxicity may have difference in the safety and efficacy with the PARPi. The PARPi have been found its place in the all different types of breast cancers and have shown potential benefits. The purpose of this review is to provide an update on the oral poly(ADP-ribose) polymerase (PARP) inhibitors for the improvement in the treatment and management of breast cancer.

2025-02-01·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE

Molecular mechanisms restoring olaparib efficacy through ATR/CHK1 pathway inhibition in olaparib-resistant BRCA1/2MUT ovarian cancer models

Article

作者: Mikula, Michał ; Statkiewicz, Małgorzata ; Gajek, Arkadiusz ; Rusetska, Natalia ; Szymczak-Pajor, Izabela ; Biegała, Łukasz ; Rogalska, Aneta ; Marczak, Agnieszka ; Śliwińska, Agnieszka

Resistance to olaparib inevitably develops in ovarian cancer (OC) patients, highlighting the necessity for effective strategies to improve its efficacy. Here, we established a novel olaparib-resistant patient-derived xenograft model of high-grade serous OC with BRCA1/2 mutations and examined the molecular characteristics of acquired resistance and resensitization to olaparib in treatment-naïve tumors in vivo. Olaparib-resistant xenografts were treated with olaparib, ATR inhibitor (ATRi, ceralasertib), CHK1 inhibitor (CHK1i, MK-8776) or their combinations. Proliferation, apoptosis, ATR/CHK1 activity, PARP signaling, DNA damage response (DDR), epithelial-to-mesenchymal transition (EMT), and MDR1 expression, were examined via RT-qPCR, western blot, and immunohistochemistry. Resistant tumors exhibited defects in PARP and ATR/CHK1 signaling, accompanied by altered expression of proteins involved in DDR and EMT. Olaparib rechallenge combined with ATR/CHK1 inhibitors showed promising synergistic effects on tumor growth inhibition. Mechanistically, combined treatments suppressed tumor proliferation without increasing apoptosis or necrosis, while inducing tumor cell vacuolization indicative of cell death. ATRi combined with olaparib induced or augmented downregulation of ATR, CHK1, PARP1, PARG, BRCA1, γH2AX, and PARylated protein expression, while reversing olaparib-induced upregulation of vimentin, BRCA2, and 53BP1. Our collective findings indicate that ATR/CHK1 pathway inhibition restores the olaparib efficacy in resistant BRCA1/2^MUT high-grade serous OC, highlighting promising approach for olaparib rechallenge of non-responsive patients. Uncovered mechanisms might improve our understanding of acquisition and overcoming resistance to olaparib in ovarian cancer.

969

项与奥拉帕利相关的新闻（医药）

2024-12-20

·ioncology

星海曼月刊·SABCS特辑丨李曼教授：深挖gBRACm对乳腺癌预后影响，解析PARPi最新循证

庆祝肿瘤瞭望原创文章突破10000篇肿瘤瞭望 2024年12月20日研究乳腺癌诊疗新动态领域新观念，星海曼月刊星海曼月刊·SABCS特辑刊号：NO.002 领域新观念，星海曼月刊。为了分享乳腺癌诊疗领域最新研究动态，大连医科大学附属第二医院李曼教授携手“肿瘤瞭望”开辟“星海曼月刊”专栏，每月为读者带来深入浅出的文献解析。时值第47届圣安东尼奥乳腺癌研讨会(SABCS)圆满落幕之际，全球乳腺癌诊疗迎来诸多前沿进展。“星海曼月刊”特别推出SABCS特辑，李曼教授与张蓝心医生共同聚焦BRCA基因胚系突变(gBRCAm)对乳腺癌预后影响，分享OlympiA研究最新数据进展，展望TBCRC 056研究为PARP抑制剂(PARPi)带来了更多可能。 01 GS1-08. BRCA BCY协作组研究：携带gBRCAm的年轻乳腺癌患者行降低风险手术能否改善生存？点评李曼教授：gBRCAm是导致年轻乳腺癌发生、发展的重要遗传因素。降低风险手术包括RRM及RRSO，已被证明可降低乳腺癌进展的风险，但对于生存结局是否获益仍未可知。这项大型国际、多中心研究的结果向我们展示了对于携带gBRCAm的年轻乳腺癌患者，这两种手术均有效降低了OS、DFS及BCFI的风险，显著改善了此类患者的生存预后。但值得注意的是，RRSO在携带gBRCA1m的乳腺癌患者中进行可能获益更多，而对于携带gBRCA2m患者获益的循证医学证据目前尚不充分。 02 GS1-09. OlympiA研究-更新长期随访结果点评李曼教授：BRCA基因编码产物参与DNA损伤同源重组修复，gBRCA1/2m会引起同源重组缺陷(HRD)，可与PARPi产生合成致死效应，即当BRCA1/2m引起HRD时，PARP能代偿BRCA的修复作用，而当两种DNA损伤修复途径均出现障碍，则促进肿瘤细胞凋亡。OlympiA研究是奠定了PARPi治疗gBRCAm突变乳腺癌的主要研究之一，在乳腺癌治疗史上具有重要地位。该研究经过中位6.1年的长期随访，证实了对于HER2阴性、携带gBRCAm且具有高复发风险的早期乳腺癌患者，在完成（新）辅助治疗后使用1年奥拉帕利强化治疗能够带来持续的显著获益，并且安全可控，毒性可耐受。 03 RF3-01. TBCRC 056研究：PARPi联合抗PD-1单抗新辅助治疗BRCA突变或PALB2突变ER+/HRE2-乳腺癌队列的结果点评李曼教授：PARPi已获得批准用于治疗携带gBRCA1/2m的晚期和早期治疗乳腺癌患者，并且在携带gPALB2m的患者中也初步显示出了疗效。临床前数据表明，PARPi的暴露可导致肿瘤内促炎性cGAS/STING通路的激活，通过招募更多CD8+ T细胞使得携带gBRCAm的肿瘤对免疫治疗敏感。基于此，TBCRC 056对PARPi与抗PD-1联合治疗进行了尝试，在HR+队列中取得了18.8%的pCR率，并且在第3周观察到sTILs平均绝对值增加了11.9%，为携带gBRCAm的HR+早期乳腺癌新辅助治疗提供一种新型联合治疗候选方案，未来期待后续研究数据进一步更新，不断优化HR+乳腺癌新辅助治疗新格局。圣安东尼奥年会进展频频，在胚系BRCA基因突变领域为我们带来了更多突破，既巩固了当前PARP抑制剂的地位，还开拓了未来乳腺癌领域的科研思路，期待未来更多的研究能够开花结果，进一步推动乳腺癌诊疗水平提升。专家简历李曼教授医学博士，教授，博士研究生导师大连医科大学附属二院肿瘤学科主任、教研室主任 I期临床试验病房主任辽宁省特聘教授、辽宁省百千万人才百人层次中国临床肿瘤学会常务理事中国抗癌协会乳腺肿瘤整合康复专业委员会副主任委员中国临床肿瘤学会乳腺癌专家委员会常务委员中国抗癌协会乳腺癌专业委员会常务委员辽宁省医学会肿瘤分会副主任委员辽宁省抗癌协会乳腺癌专业委员会副主任委员大连市医学会肿瘤分会主任委员张蓝心医生大连医科大学附属第二医院住院医师、临床医学博士获得“石力绽放，乳此美好”中青年医师病例演讲大赛辽宁省冠军研究方向：乳腺癌耐药、转移 2021年参加ESMO大会壁报交流展示，研究成果同步收录于Annals of Oncology杂志于2022年、2023年ASCO大会发表研究论文2篇，并同步收录于Journal of Clinical Oncology杂志第一作者发表SCI论文3篇，累计影响因子18.6分 ▌参考文献： [1]. Matteo Lambertini, Amir Sonnenblick, Elisa Agostinetto, et al. Association Between Risk-Reducing Surgeries and Survival in Young BRCA Carriers with Breast Cancer: Results from an International Cohort Study. 2024 SABCS GS1-08. [2]. Judy Garber, et al. OlympiA: A phase 3, Multicenter, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib after (Neo)Adjuvant Chemotherapy in Patients w/ Germline BRCA1 & BRCA2 Pathogenic Variants & High-Risk HER2-Negative Primary Breast Cancer: Longer Term Follow. 2024 SABCS GS1-09. [3]. Erica Mayer, et al. TBCRC 056: A Phase II Study of Neoadjuvant Niraparib with Dostarlimab for Patients with BRCA- or PALB2-Mutated Breast Cancer: Results From the ER+/HER2- Cohort. 2024 SABCS RF3-01. 精彩推荐 1 星海曼月刊丨李曼教授团队：静观HR+晚期乳腺癌PI3Ki、AKTi发展，前瞻PAM通路抑制剂耐药机制（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果免疫疗法临床2期

2024-12-18

·贝壳社

全球畅销肿瘤药揭秘

▲点击图片，了解详情作者：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. 关于贝壳社贝壳社是国内领先的医健创新创业服务平台，为医健创业者提供全路径创业服务。通过产业空间运营、创业教育、投资孵化、数字化赋能、企业价值增长等服务体系，给医健创业企业提供产业空间、人才战略培养、投融资、产业生态资源、数字化转型等服务。同时，贝壳社布局澳洲，帮助国内生物医药企业加速走向海外；成立“泰格-泰珑-贝壳社企业经营服务中心”为企业成长提供全生命周期的增值服务，提高企业运营效率，加快企业成长发展。我们深度链接政府、科研院所、临床机构、投资机构、第三方服务商、CXO等行业资源，致力于赋能医疗健康创业公司成长，推动创新技术造福人类生命健康。往期推荐 1 百亿大药，难逃“内卷”魔咒 2 破局！国内首款CD19 ADC药物获批上市 _ 3 国产「十亿美元分子」并不遥远 _ *声明：本文仅为作者观点，不构成任何投资建议，且非治疗方案推荐。投稿请添加小助手：bioclub666

免疫疗法专利到期上市批准

2024-12-18

·drugs

San Antonio Breast Cancer Symposium, Dec. 10 to 13

The annual San Antonio Breast Cancer Symposium was held from Dec. 10 to 13 in San Antonio. Attendees included medical oncologists, radiation oncologists, researchers, and other health care professionals. The conference highlighted recent advances in the risk, diagnosis, treatment, and prevention of breast cancer, and presentations focused on emerging treatments in hard-to-treat patient populations, including patients with metastatic breast cancer. As part of the BIG 2-04 MRC SUPREMO phase 3 clinical trial, Ian Kunkler, M.B., B.Chir., of the University of Edinburgh in the United Kingdom, and colleagues found that chest wall irradiation may be omitted among patients with intermediate-risk breast cancer who have undergone mastectomy. For the study, patients were randomly assigned to receive chest wall irradiation after mastectomy or to omit chest wall irradiation after mastectomy. The researchers found that postmastectomy radiotherapy to the chest wall among women with one to three positive axillary nodes after an axillary clearance or negative on an axillary clearance, axillary node sample, or sentinel node biopsy was not associated with an improvement in 10-year overall survival. The investigators also found that postmastectomy radiotherapy reduced chest wall recurrence by less than 2 percent at 10 years. Furthermore, the approach did not have an impact on metastasis-free survival. "Postmastectomy radiotherapy National Institute for Health and Care Excellence guidelines currently recommend radiotherapy in women with one to three positive nodes after mastectomy," Kunkler said. "So, our results should change guidelines and practice internationally." Press Release As part of the phase 3 COMET study, Ann Partridge, M.D., M.P.H., of the Dana-Farber Cancer Institute and Harvard Medical School in Boston, and colleagues found that active monitoring is a reasonable approach for the management of patients with grade 1 or 2, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative low-risk ductal carcinoma in situ (DCIS), with no evidence of a higher incidence of microinvasive or invasive disease. For the study, patients were randomly assigned to either undergo active monitoring or receive guideline-concordant care consisting of surgery with or without adjuvant radiation. During a two-year period, the authors assessed quality of life, anxiety, depression, worries about DCIS, and symptom trajectories via surveys that employed validated quality-of-life measures. Patients filled out surveys prior to randomization, at six months, at one year, and after two years. The researchers found that the overall lived experience of women randomly assigned to active monitoring was similar to that of those selected to follow the current guideline for care, which is surgery with or without radiation. During the two years of follow-up, health-related quality of life, anxiety, depression, worry, and symptom trajectories were comparable regardless of the treatment received. "If longer-term follow-up supports the safety of active management from a cancer outcome standpoint, this approach could be considered as an option for women with this condition," Partridge said. "It is critical that we understand how women feel when they are living with an active-monitoring approach and how it impacts their overall quality of life, psychosocial health, worries about DCIS, anxiety and depression, and other related symptoms. These data are reassuring in that respect." Press Release In the multicenter, double-blind OlympiA study, Judy E. Garber, M.D., of the Dana-Farber Cancer Institute in Boston, and colleagues provided further support for the benefits of olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, among patients with high-risk, HER2-negative breast cancer with germline mutations in BRCA1 or BRCA2 . The authors randomly assigned 1,836 patients with BRCA -positive, HER2-negative breast cancer (1:1) to receive either olaparib or placebo for one year following completion of chemotherapy, surgery, and radiation. The researchers found that after a median follow-up of 6.1 years, patients with high-risk, BRCA -positive breast cancer who received olaparib after standard treatment continued to have better survival outcomes than those who received placebo. The continued demonstration of the efficacy of olaparib in breast cancer patients who carry pathogenic variants in BRCA1/2 makes it important to identify these individuals when they begin their treatment, the authors noted. "The ongoing data from the OlympiA trial are reassuring in the observations of persistent and increasing benefits in the follow-up phases, improving not only recurrence, but also overall survival. Benefits are demonstrated in both triple-negative breast cancer as well as hormone receptor-positive tumors, despite the shortened follow-up and smaller numbers in the estrogen receptor-positive group," Garber said. "These data also highlight the safety of olaparib and, therefore, the possibility of moving PARP inhibitors to the treatment of BRCA -associated breast cancers that are lower risk." The study was supported by AstraZeneca and Merck, the manufacturers of olaparib. Press Release SABCS: Chest Wall Irradiation Does Not Impact Survival in Breast Cancer MONDAY, Dec. 16, 2024 -- For patients with intermediate-risk breast cancer, chest wall irradiation after mastectomy does not influence 10-year overall survival, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Risk-Reducing Surgery Improves Outcomes in Young Breast Cancer Patients With BRCA Mutations MONDAY, Dec. 16, 2024 -- Risk-reducing mastectomy and salpingo-oophorectomy are both associated with significant improvements in outcomes among young BRCA carriers with breast cancer, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Adding Camrelizumab to Neoadjuvant Chemo Beneficial in TNBC FRIDAY, Dec. 13, 2024 -- The addition of camrelizumab to neoadjuvant chemotherapy improves pathological complete response for patients with early or locally advanced triple-negative breast cancer, according to a study published online Dec. 13 in the Journal of the American Medical Association to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Active Monitoring Noninferior to Guideline Care for Ductal Carcinoma in Situ FRIDAY, Dec. 13, 2024 -- For patients with ductal carcinoma in situ, active monitoring is noninferior to guideline-concordant care that involves surgery with or without adjuvant radiation, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Omission of Axillary Staging Noninferior for Node-Negative Breast Cancer FRIDAY, Dec. 13, 2024 -- Omission of surgical axillary staging is noninferior to sentinel lymph-node biopsy for patients with clinically node-negative, T1 or T2 invasive breast cancer, according to a study published online Dec. 12 in the New England Journal of Medicine to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Imlunestrant Tied to Improved PFS for ER-Positive, HER2-Negative Breast Cancer With ESR1 Mutations THURSDAY, Dec. 12, 2024 -- For patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer, imlunestrant leads to significantly longer progression-free survival among those with ESR1 mutations, according to a study published online Dec. 11 in the New England Journal of Medicine to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

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KEGG	Wiki	ATC	Drug Bank
D09730	奥拉帕利	L01XX46	DB09074

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适应症	国家/地区	公司	日期
晚期子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	挪威	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	挪威	AstraZeneca AB	2024-08-15
BRCA突变阳性乳腺癌	日本	AstraZeneca KK	2022-08-24
HRD 阳性卵巢癌	美国	AstraZeneca Pharmaceuticals LP	2020-05-19
HRR 基因突变去势抵抗性前列腺癌	美国	AstraZeneca Pharmaceuticals LP	2020-05-19
胚系BRCA突变胰腺癌	美国	AstraZeneca Pharmaceuticals LP	2019-12-27
胰腺癌	韩国	AstraZeneca Pharmaceuticals LP	2019-10-29
前列腺癌	韩国	AstraZeneca Pharmaceuticals LP	2019-10-29
复发性HER2阴性乳腺癌	日本	MSD KK	2018-07-02
复发性HER2阴性乳腺癌	日本	AstraZeneca KK	2018-07-02
转移性胰腺腺癌	澳大利亚	AstraZeneca Pty Ltd.	2018-05-23
乳腺癌	加拿大	AstraZeneca Canada, Inc.	2016-04-29
卵巢癌	加拿大	AstraZeneca Canada, Inc.	2016-04-29
转移性腺癌	欧盟	AstraZeneca AB	2014-12-16

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适应症	最高研发状态	国家/地区	公司	日期
去势抵抗性前列腺癌	申请上市	美国	AstraZeneca PLC	2022-08-17
子宫内膜癌	临床3期	法国	AstraZeneca PLC	2024-06-26
卵巢浆液性腺癌	临床3期	美国	Novartis Pharmaceuticals Corp.	2021-07-02
卵巢浆液性腺癌	临床3期	中国	Novartis Pharmaceuticals Corp.	2021-07-02
卵巢浆液性腺癌	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2021-07-02
卵巢浆液性腺癌	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2021-07-02
卵巢浆液性腺癌	临床3期	奥地利	Novartis Pharmaceuticals Corp.	2021-07-02
卵巢浆液性腺癌	临床3期	比利时	Novartis Pharmaceuticals Corp.	2021-07-02
卵巢浆液性腺癌	临床3期	巴西	Novartis Pharmaceuticals Corp.	2021-07-02
卵巢浆液性腺癌	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2021-07-02

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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


NCT04306367 (CTgov)	临床2期	晚期胆管癌	14	Olaparib+pembrolizumab	願遞顧蓋積窪鏇繭壓鬱(窪憲築遞艱醖築選鑰鹹) = 窪築糧襯醖鑰積構糧選鏇願選廠遞鹹鹹膚構願 (淵積積衊觸遞繭網鹽餘, 憲鏇糧艱網遞範觸餘廠 ~ 壓淵願範鹽襯鬱夢簾憲) 更多	-	2024-12-17
NCT02477644 (PAOLA-1/ENGOT-ov25, Pubmed \| Oncologist)	临床3期	卵巢癌维持	806	Olaparib plus Bevacizumab	構選網艱糧積網範鬱鏇(鑰繭齋願網繭襯夢積襯) = mean Global Health Status and cognitive functioning seemed better with olaparib than bevacizumab alone 艱範憲鏇鏇餘獵觸醖鬱 (衊積鑰觸鹹窪齋網製艱 )	积极	2024-12-14
				Placebo
NCT02032823 (OlympiA, BusinessWire) 人工标引	临床3期	早期乳腺癌辅助 BRCA2 Mutation (Germline) \| BRCA1 Mutation (Germline)	-	LYNPARZA	構鏇選衊顧選餘製鑰餘(鹽醖築糧憲鬱顧糧觸醖) = 範憲範膚夢鑰窪憲夢廠壓艱醖鬱襯壓獵窪艱製 (淵簾繭襯糧網膚獵窪鹹 ) 更多	积极	2024-12-11
				Placebo	構鏇選衊顧選餘製鑰餘(鹽醖築糧憲鬱顧糧觸醖) = 築遞積窪構獵糧壓餘鬱壓艱醖鬱襯壓獵窪艱製 (淵簾繭襯糧網膚獵窪鹹 ) 更多
NCT03740165 (KEYLYNK-001, Company_Website) 人工标引	临床3期	卵巢上皮癌一线 BRCA non-mutated	-	KEYTRUDA+ LYNPARZA	網範觸糧襯糧簾築壓鏇(顧選顧網膚醖觸築醖蓋) = met its primary endpoint of progression-free survival. 憲觸選襯襯夢積積艱齋 (範襯築簾淵鑰願鬱壓蓋 ) 达到更多	积极	2024-12-09
				KEYTRUDA+ Placebo
NCT03367689 (NOBROLA, Pubmed \| Breast)	临床2期	homologous recombination deficiency	114	Olaparib	艱簾積積願構淵鑰構網(製製鹹窪蓋艱築製齋選) = 淵遞觸鹹蓋選鹹衊獵廠鹹夢襯壓鹹範窪夢糧獵 (鹹憲夢製鏇遞齋齋網簾, 11.8 ~ 88.2)	积极	2024-12-01
NCT03976362 (KEYLYNK-008 \| MK-7339-008, CTgov)	临床3期	鳞状非小细胞肺癌	851	Pembro+Olaparib (Pembro + Olaparib (Maintenance Phase))	網鏇糧鑰遞觸範願鹽遞(鑰鹽膚窪夢製簾遞廠鏇) = 鬱壓夢醖鹽壓膚範選夢網醖鹹膚衊夢鏇繭夢鬱 (襯淵範鏇窪獵齋蓋餘鏇, 選鑰醖糧鏇醖鹽襯鹹獵 ~ 鬱積壓夢窪構廠艱淵遞) 更多	-	2024-11-06
				Placebo (Pembro + Placebo (Maintenance Phase))	網鏇糧鑰遞觸範願鹽遞(鑰鹽膚窪夢製簾遞廠鏇) = 餘衊繭遞醖簾鹽鹹襯積網醖鹹膚衊夢鏇繭夢鬱 (襯淵範鏇窪獵齋蓋餘鏇, 蓋膚餘壓廠憲鹽觸選壓 ~ 範鹽窪選鬱鑰鏇窪觸艱) 更多
NCT02511795 (Pubmed) 人工标引	临床1期	实体瘤 \| 小细胞肺癌	130	Adavosertib+olaparib (refractory solid tumor + part A)	窪糧糧壓衊窪構鏇繭蓋(艱鏇簾憲製觸築顧積廠) = 鬱膚艱膚簾鏇鬱糧範顧齋選壓構獵選憲範鑰窪 (淵蓋餘醖糧夢憲願觸鏇 ) 更多	积极	2024-11-01
				Adavosertib + olaparib (platinum-sensitive extensive-stage or relapsed small-cell lung cancer + part B)	窪糧糧壓衊窪構鏇繭蓋(艱鏇簾憲製觸築顧積廠) = 餘遞醖壓願憲衊鏇淵壓齋選壓構獵選憲範鑰窪 (淵蓋餘醖糧夢憲願觸鏇 ) 更多
NCT02477644 (PAOLA-1/ENGOT-ov25, Pubmed \| Ann Oncol)	临床3期	卵巢癌维持 PARP inhibitor	806	Olaparib plus bevacizumab	淵繭願築鑰餘觸繭壓齋(憲簾願衊淵窪壓夢製範) = 製鏇鏇膚淵襯遞淵繭鬱繭簾壓憲繭膚觸選廠製 (鑰鹹夢鏇齋壓醖糧遞顧 )	积极	2024-11-01
				Platinum-based chemotherapy with PARP inhibitor rechallenge	淵繭願築鑰餘觸繭壓齋(憲簾願衊淵窪壓夢製範) = 蓋夢鬱鑰膚窪餘壓鑰餘繭簾壓憲繭膚觸選廠製 (鑰鹹夢鏇齋壓醖糧遞顧 )
NCT03047135 (Pubmed \| JAMA Oncol)	临床2期	非转移性前列腺癌 HRR alteration \| BRCA2 alterations	51	Olaparib 300 mg	鹽簾糧艱憲鏇鏇鏇鑰遞(廠鹹衊夢憲襯選醖齋鹽) = 衊網製膚鏇廠鏇選衊衊觸襯衊構壓網壓築窪廠 (醖鬱顧窪選繭醖鹽網鬱 )	积极	2024-10-01