Glioblastoma (GBM), WHO grade IV glioma, represents the majority of adult malignant primary brain tumors, with an incidence of 2-3 per 100,000 person-years. The survival for GBM has increased in the last decade but is still low with a median survival of 15-18 months. Recurrence after initial standard therapy, radiation therapy and chemotherapy with temozolomide, few options are available. Even with further therapy, median progression free survival at 6 months after first relapse (PFS-6) is only 15%. Similarly, anaplastic astrocytoma and anaplastic oligodendroglioma, grade III gliomas, once recurrent after radiation therapy and first-line chemotherapy, have identical therapeutic options and poor outcomes with PFS-6 of 31%. Temozolomide (TMZ) has a favorable side effect profile and is available orally, however, cytotoxicity occurs. Metronomic temozolomide at low doses on a continuous schedule, have demonstrated better survival in studies. This study will determine the recommended dose and the side effects of PCI-24781/Abexinostat with metronomic temozolomide.

开始日期2023-06-26

申办/合作机构

University of Nebraska

[+1]

NCT04498520

/ Withdrawn临床1期IIT

Phase I Trial of Abexinostat Combined With Palbociclib and Fulvestrant in Patients With Antiestrogen Refractory ER+, HER2- Breast Cancer and Gynecological Metastatic Tumors

This phase I trial investigates the side effects and best dose of abexinostat and palbociclib when given together with fulvestrant in treating patients with breast or gynecologic cancer. Abexinostat may prevent tumor cells from growing and multiplying and may kill tumor cells. Palbociclib may prevent or slow the growth of tumor cells when used with other anti-hormonal therapy. Estrogen can cause the growth of breast and gynecologic tumor cells. Fulvestrant may help fight breast or gynecologic cancer by blocking the use of estrogen by the tumor cells. Giving abexinostat, palbociclib, and fulvestrant may work better in treating patients with breast or gynecologic cancer.

开始日期2021-03-31

申办/合作机构

The University of California, San Francisco

[+2]

100 项与艾贝司他相关的临床结果

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100 项与艾贝司他相关的转化医学

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100 项与艾贝司他相关的专利（医药）

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项与艾贝司他相关的文献（医药）

2024-12-05·LEUKEMIA & LYMPHOMA

A phase 1 trial of abexinostat with ibrutinib in relapsed/refractory mantle cell lymphoma and non-germinal center diffuse large B cell lymphoma

Article

作者: Bantilan, Kurt S. ; Zelenetz, Andrew D. ; Zhu, Menglei ; Kumar, Anita ; Matasar, Matthew ; Joseph, Ashlee ; von Keudell, Gottfried ; Salles, Gilles ; Gurumurthi, Ashwath ; Biggar, Erin ; Castro, Ali ; Hamlin, Paul A.

In this phase 1 study, we hypothesized that the combination of the HDAC inhibitor, abexinostat, with ibrutinib would be safe and efficacious in relapsed and refractory MCL and non-germinal center (non-GCB) dLBCL.The main limitation of this study is the premature closure of the trial resulting in small patient numbers without the planned dose expansion cohort with targeted accrual of 34 patients.Furthermore, three MCL responders were unable to complete the full duration of therapy.The trial was terminated in late 2021 due to the evolving therapeutic landscape for relapsed MCL, such as a shift from ibrutinib to the use of 2nd generation BTK inhibitors and the approval of Brexucabtagene autoleucel CAR-T therapy in third-line therapy for MCL.

2024-12-01·Computational and structural biotechnology journal

Uncovering the potential of APOD as a biomarker in gastric cancer: A retrospective and multi-center study

Article

作者: Wang, Zisong ; Wang, Xuanyu ; Sun, Le ; Xu, Yihang ; Tian, Sufang ; Liu, Xiaoping ; Chen, Hongshan

Gastric cancer (GC) poses a significant health challenge worldwide, necessitating the identification of predictive biomarkers to improve prognosis. Dysregulated lipid metabolism is a well-recognized hallmark of tumorigenesis, prompting investigation into apolipoproteins (APOs). In this study, we focused on apolipoprotein D (APOD) following comprehensive analyses of APOs in pan-cancer. Utilizing data from the TCGA-STAD and GSE62254 cohorts, we elucidated associations between APOD expression and multiple facets of GC, including prognosis, tumor microenvironment (TME), cancer biomarkers, mutations, and immunotherapy response, and identified potential anti-GC drugs. Single-cell analyses and immunohistochemical staining confirmed APOD expression in fibroblasts within the GC microenvironment. Additionally, we independently validated the prognostic significance of APOD in the ZN-GC cohort. Our comprehensive analyses revealed that high APOD expression in GC patients was notably associated with unfavorable clinical outcomes, reduced microsatellite instability and tumor mutation burden, alterations in the TME, and diminished response to immunotherapy. These findings provide valuable insights into the potential prognostic and therapeutic implications of APOD in GC.

2024-11-01·JCO Precision Oncology

Updated Survival Follow-Up for Phase Ib Trial of the Histone Deacetylase Inhibitor Abexinostat With Pazopanib in Patients With Solid Tumor Malignancies

Article

作者: Aggarwal, Rahul R. ; Bergsland, Emily K. ; Chaudhuri, Sibapriya ; Tsang, Erica S. ; Thomas, Scott ; Rozie, Alexandrine ; Calabrese, Susan ; Grabowsky, Jennifer ; Pawlowska, Nela ; Dhawan, Mallika S. ; Munster, Pamela N.

PURPOSE:

Histone deacetylase (HDAC) inhibition downregulates hypoxia-inducible factor-1α and modulates multiple metabolomic pathways relevant in cancer. Here we report a potential novel biomarker to predict exceptional responders (>3 years) in patients receiving HDAC and vascular endothelial growth factor (VEGF) inhibition.

PATIENTS AND METHODS:

Patients with solid tumor malignancies were enrolled in this phase Ib trial of abexinostat (4/7 ×21 days) and pazopanib (28/28 days), with a dose expansion in renal cell carcinoma (RCC). Plasma was analyzed for metabolomics and peripheral blood mononuclear cells (PBMCs) for VEGF and HDAC2 expression levels.

RESULTS:

Fifty-one patients were enrolled: n = 36 patients in dose escalation and n = 15 in dose expansion. After the initial report in 2017, six patients had remained on study: four with RCC and one each with medullary thyroid and thymic neuroendocrine carcinoma. One patient with RCC remains on treatment for >11 years after progression on five systemic therapies. Overall, the median duration of therapy measured 5.6 (1-133) months. The median duration of therapy in exceptional responders measured 44.1 (39.8-133+) months. The median overall survival in patients with high PBMC HDAC2 expression versus low HDAC2 was 32.3 versus 9.2 months ( P = .004) for all patients and 43.3 versus 25.1 months for patients with RCC ( P = .09). Exceptional responders had lower kynurenine levels both pre- and post-treatment ( P = .002, P < .001, respectively). HDAC2 and kynurenine expression levels were inversely correlated ( P = .02).

CONCLUSION:

Abexinostat added to pazopanib shows extended tolerability and long-term responses and survival. PBMC HDAC2 levels, the abexinostat target, are relevant predictors of response. In addition, metabolomic assessment points to kynurenine as a predictor for exceptional response to combined VEGF plus HDAC inhibition.

项与艾贝司他相关的新闻（医药）

2025-07-08

·医药观澜

徐诺药业口服癌症新药「艾贝司他」拟纳入优先审评

7月7日，中国国家药监局药品审评中心（CDE）官网公示，徐诺药业申报的甲苯磺酸艾贝司他片拟纳入优先审评，拟用于既往接受过至少两种系统性治疗的复发或难治滤泡性淋巴瘤成年患者。公开资料显示，艾贝司他是一种新型有效的口服泛HDAC抑制剂。根据徐诺药业公开资料介绍，艾贝司他是一种新型有效的口服泛HDAC抑制剂，允许通过每日两次（BID）给药维持足够的药物浓度以发挥抗肿瘤活性。公开资料显示，表观遗传改变（包括CREBBP或EP300突变等）是滤泡性淋巴瘤的主要驱动因素，组蛋白脱乙酰酶（HDAC）抑制剂有可能抵消CREBBP或EP300突变导致的组蛋白乙酰化缺失。在2024年美国临床肿瘤学会（ASCO）年会上，徐诺药业公布了艾贝司他治疗滤泡性淋巴瘤中国注册2期临床主要终点首次分析数据。该研究旨在评估艾贝司他治疗复发/难治性滤泡性淋巴瘤患者的疗效和安全性。截至2023年12月15日，有90例患者的数据可分析。在82例具有12周可评估疗效的患者中，IRC评估的客观缓解率（ORR）为67.1%，包括12.2%的完全缓解（CR）。既往治疗大于3线的患者的ORR为69.0%。中位无进展生存期（PFS）为13.77个月，中位缓解持续时间（DoR）为13.96个月。中位总生存期（OS）数据尚未成熟，42个月OS率为74.3%。该项研究结论：艾贝司他单药80mg每日两次治疗耐受性良好，在多线治疗后复发/难治性滤泡性淋巴瘤患者中表现出显著的疗效。除了治疗滤泡性淋巴瘤，艾贝司他联合BTK抑制剂伊布替尼治疗套细胞淋巴瘤（MCL）的1期临床研究此前也已经取得优效研究成果，并发表于权威医学期刊Leukemia & Lymphoma。试验结果显示，艾贝司他与伊布替尼的联合治疗方案在复发性MCL患者中展现出了较好的治疗活性。最佳ORR高达86%，其中CR率达到了71%，这一数据优于既往伊布替尼单一疗法的表现。此外，联合治疗的DOR达到了19.6个月，显著延长了患者的PFS。相比之下，伊布替尼单药治疗的RAY3试验结果显示，ORR为77%，CR率为23%，中位PFS为15个月，联合疗法的优势明显。研究团队指出，联合疗法的疗效可能归功于两药之间的协同作用，它们从不同角度抑制了肿瘤细胞的生长和扩散，从而实现了更为彻底和持久的疾病控制。参考资料：[1]中国国家药监局药品审评中心（CDE）官网. Retrieved July 8, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c[2]2024 ASCO｜徐诺药业向全球发布艾贝司他治疗滤泡性淋巴瘤中国注册2期主要终点首次分析数据. Retrieved May 31 , 2024, from https://mp.weixin.qq.com/s/VnT8HFa00Heh7Q3bUpueMw[3]速递 | 世界知名杂志《Leukemia & Lymphoma》正式发布艾贝司他联合伊布替尼治疗套细胞淋巴瘤的优效研究成果. Retrieved Sep 26, 2024, from https://mp.weixin.qq.com/s/o6j1-sCUhJb9vFbZhRRyrg免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

ASCO会议优先审批临床2期临床结果申请上市

2025-07-07

·氨基观察

中国反制欧盟中高端医疗器械；君圣泰医药完成1.25亿港币配股融资

氨基观察-创新药组原创出品作者 | 黄恺地缘政治正在医疗器械领域引发新一轮激烈的风暴。由于欧盟持续出台措施，持续在公共采购领域对中国企业设置壁垒，中国不得不采取对等限制措施。7月6日，财政部发布《财政部关于在政府采购活动中对自欧盟进口的医疗器械采取相关措施的通知》。其中规定，采购预算金额4500万元人民币以上（约合533万欧元）的医疗器械时，确需采购进口产品的，在履行法定程序后，应当排除欧盟企业（不包括在华欧资企业）参与；对于参与的非欧盟企业，其提供的自欧盟进口的医疗器械占比不得超过项目合同总金额的50%。由于欧盟与中方均设定了约500万欧元单个项目预算的门槛，表明此次博弈主要聚焦于中高端产品领域。同时，中国商务部新闻发言人表示，中方措施只针对自欧盟进口医疗器械产品，在华欧资企业生产产品不受影响。药企正努力抓住融资窗口。7月7日，君圣泰医药发布公告，称已经完成配股融资1.25亿港元。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。/ 01 /市场速递1）4500万元以上项目欧盟械企被禁7月6日，财政部发布《财政部关于在政府采购活动中对自欧盟进口的医疗器械采取相关措施的通知》。其中规定，采购预算金额4500万元人民币以上（约合533万欧元）的医疗器械时，确需采购进口产品的，在履行法定程序后，应当排除欧盟企业（不包括在华欧资企业）参与；对于参与的非欧盟企业，其提供的自欧盟进口的医疗器械占比不得超过项目合同总金额的50%。/ 02 /医药动态1）徐诺药业艾贝司他拟纳入优先审评7月7日，CDE官网显示，徐诺药业的艾贝司他片拟纳入优先审评，用于治疗既往接受过至少两种系统性治疗的复发或难治滤泡性淋巴瘤成年患者。2）正大天晴HER2双抗ADC拟纳入突破性疗法7月7日，CDE网站显示，正大天晴的注射用TQB2102拟纳入突破性疗法，用于HER2阳性早期或局部晚期乳腺癌患者的新辅助治疗。3）星汉德生物乙肝TCR-T疗法获批临床7月7日，星汉德生物宣布，中国国家药品监督管理局药品审评中心（CDE）批准其乙肝病毒（HBV）特异性T细胞受体（TCR）工程化T细胞治疗——SCG101V新药1/2期临床试验（IND）申请，用于治疗慢性乙型肝炎。4）正大天晴HER2双抗启动首个Ⅲ期临床7月7日，正大天晴宣布，TQB2930登记了首个Ⅲ期临床试验，拟用于HER2（人类表皮生长因子受体2）阳性复发/转移性乳腺癌的治疗。/ 03 /资本信息1）君圣泰医药完成配股融资1.25亿港元7月7日，君圣泰医药发布公告，已经按每股2.21港元成功配售5655.5万股给至少六名独立承配人，合计融资1.25亿港元。/ 04 /海外药闻1）中外制药与Gero PTE达成2.2亿美元合作7月7日，罗氏控股的日本公司——中外制药与Gero PTE公司宣布，双方已签署联合研究与许可协议，致力于将Gero的AI驱动平台融入中外制药的研发战略，共同开发针对衰老相关疾病的新型疗法。这项合作中，中外制药将向Gero支付一笔未公开金额的预付款，并提供高达2.5亿美元的开发和销售里程碑款项。2）Apogee IL-13抗体药物APG777治疗中重度AD的2期试验数据优异7月7日，Apogee公布其潜在同类最佳抗IL-13抗体药物APG777治疗中重度特应性皮炎（AD）患者的2期APEX临床试验A部分16周积极数据。APEX A部分16周数据显示，APG777在各项终点均优于标准疗法，并呈现快速起效的瘙痒缓解和皮损改善，安全特征与同类药物一致。基于该消息，Apogee股价盘前大涨23%。PS：欢迎扫描下方二维码，添加氨基君微信号交流。

优先审批细胞疗法临床3期带量采购突破性疗法

2025-03-10

·PRNewswire

BAVENCIO Continues to Strengthen Its Position in the Immuno-Oncology Landscape | DelveInsight

With the rising adoption of checkpoint inhibitors and combination therapies, BAVENCIO's market growth is driven by expanding indications and strategic partnerships. However, competition from KEYTRUDA and TECENTRIQ poses challenges, making differentiation through combination strategies key to its success. LAS VEGAS, March 10, 2025 /PRNewswire/ -- DelveInsight's " BAVENCIO Market Size, Forecast, and Market Insight Report" highlights the details around BAVENCIO, a human IgG1 lambda monoclonal antibody that targets programmed death-ligand 1 (PD-L1). The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of BAVENCIO. 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]. Pfizer/Merck/EMD Sereno's BAVENCIO (avelumab) Overview BAVENCIO is a human antibody targeting programmed death ligand-1 (PD-L1). Preclinical studies have demonstrated its ability to activate both adaptive and innate immune responses. By inhibiting the interaction between PD-L1 and PD-1 receptors, BAVENCIO helps restore T cell-mediated antitumor immunity in preclinical models. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer formed a strategic partnership to jointly develop and commercialize BAVENCIO. In the U.S., BAVENCIO is approved for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-based chemotherapy. It is also indicated for patients with locally advanced or metastatic UC who experience disease progression during or after platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-based treatment. Additionally, BAVENCIO in combination with axitinib is approved in the U.S. for the first-line treatment of patients with advanced renal cell carcinoma. The FDA has also granted accelerated approval for BAVENCIO in the treatment of adults and pediatric patients (12 years and older) with metastatic Merkel cell carcinoma, based on tumor response rate and duration of response. Continued approval may depend on further clinical trials confirming its benefits. Currently, BAVENCIO is approved in 50 countries for at least one indication. Learn more about BAVENCIO projected market size for merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma @ BAVENCIO Market Potential Urothelial carcinoma is the most common cancer of the urinary system, arising from urothelial cells and primarily affecting individuals over the age of 50. It is more prevalent in males, with an incidence rate two to three times higher than in females. According to DelveInsight's analysis, approximately 41 million new cases of urothelial carcinoma were reported across the 7MM in 2023. The standard treatment primarily involves chemotherapy, particularly cisplatin-based regimens. For patients who do not respond to initial systemic therapy, immunotherapy—using agents such as atezolizumab and pembrolizumab—serves as a secondary option. In some cases, surgical interventions like nephroureterectomy are also performed. Approved treatment options for urothelial carcinoma include OPDIVO (nivolumab), PADCEV (enfortumab vedotin-ejfv), KEYTRUDA (pembrolizumab), and BAVENCIO (avelumab), among others. The urothelial carcinoma treatment market is projected to experience substantial growth, rising from USD 900 million in 2023 at a notable CAGR through 2034, driven by the introduction of innovative therapies currently in clinical trials. However, challenges such as treatment complications in elderly patients and dependence on blood transfusions may pose barriers to market expansion. Dive deep into an in-depth assessment of the Urothelial Carcinoma Market Merkel cell carcinoma is a rare and aggressive neuroendocrine skin cancer that originates from Merkel cells—specialized mechanoreceptors located at the dermo-epidermal junction responsible for touch sensation. According to DelveInsight's estimates, approximately 9,000 new cases of MCC were reported in the 7MM in 2023, with the United States accounting for 37% of these cases. Several approved treatments for MCC are currently available, primarily focusing on immune modulation. Notable therapies include BAVENCIO, a monoclonal antibody developed by Merck KGaA; KEYTRUDA (pembrolizumab), a PD-1 inhibitor from Merck; and ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor co-developed by Incyte Corporation and MacroGenics. DelveInsight's analysis estimates that the MCC treatment market in the 7MM was valued at approximately USD 411 million in 2023. Over the forecast period from 2024 to 2034, this market is expected to grow at a CAGR of 8.7%, driven by the introduction of innovative therapies. Discover more about the Merkel cell carcinoma market in detail @ Merkel Cell Carcinoma Market Report Renal cell carcinoma is the most prevalent form of kidney cancer, comprising approximately 90% of all cases. It ranks among the ten most common cancers worldwide. The prognosis for advanced RCC remains poor, with a five-year survival rate of around 11-12%. Research indicates that RCC accounts for the vast majority of kidney cancer cases. Over the past decade, the treatment landscape for advanced RCC has evolved significantly, driven by the introduction of novel therapies and advancements in surgical and ablative techniques. Treatment approaches have become increasingly personalized, with prognostic groups established to tailor interventions based on disease severity. For patients in good health with isolated metastases, surgical excision, radiotherapy, or ablative therapy may be recommended to postpone systemic treatment. Meanwhile, those ineligible for surgical removal may benefit from alternatives such as cryoablation, thermal ablation, or stereotactic ablative body radiation therapy. Additionally, targeted treatments like tyrosine kinase inhibitors (TKIs) and anti-VEGF antibodies have become essential in both first- and second-line therapy, offering effective management options for advanced RCC. The market outlook for advanced RCC appears promising, driven by ongoing innovations and the expansion of therapeutic options. As investigational treatments advance through clinical trials, they have the potential to significantly improve patient outcomes and address existing gaps in care. The competitive landscape is rapidly evolving, with developments in targeted therapies, immunotherapies, and combination treatments aiming to enhance survival rates and quality of life for patients with advanced RCC. For more insights on the evolving landscape of renal cell carcinoma, visit @ Advanced Renal Cell Carcinoma Market Emerging Competitors of BAVENCIO The urothelial carcinoma pipeline is highly dynamic, with promising new therapies in development, including IMFINZI + IMJUDO + SoC (AstraZeneca), Disitamab vedotin (Pfizer), Vactosertib + IMFINZI (MedPacto), TYRA-300 (Tyra Biosciences), LYTGOBI + KEYTRUDA (Taiho Oncology), UGN-104 (UroGen Pharma), and others. In the Merkel cell carcinoma space, the potential emerging competitors of BAVENCIO include IFx-2.0 (TuHURA Biosciences), NIDLEGY (L19-IL2/L19-TNF) (Philogen), ITI 3000 (Immunomic Therapeutics), PH 762 (Phio Pharmaceuticals/AgonOx), KT 253 (Kymera Therapeutics), MCLA 145 (Merus N.V.), and others. Key companies such as Exelixis/Bristol-Myers Squibb (Zanzalintinib (XL092) + Nivolumab), AstraZeneca/ HUTCHMED (Savolitinib + Durvalumab), Corvus Pharmaceuticals (Ciforadenant (CPI-444)), Xynomic Pharmaceuticals (Abexinostat), NiKang Therapeutics (NKT2152), and others are involved in developing drugs for advanced RCC. To know more about the number of competing drugs in development, visit @ BAVENCIO Market Positioning Compared to Other Drugs Key Milestones of BAVENCIO In January 2021, EMD Serono and Pfizer Inc. announced that the European Commission (EC) approved BAVENCIO as a monotherapy for first-line maintenance in adult patients with locally advanced or metastatic urothelial carcinoma who have remained progression-free after undergoing platinum-based chemotherapy. In December 2020, EMD Serono and Pfizer Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of BAVENCIO as a monotherapy for first-line maintenance in adult patients with locally advanced or metastatic urothelial carcinoma who have remained progression-free after undergoing platinum-based chemotherapy. In June 2020, EMD Serono and Pfizer Inc. announced that the FDA has approved the supplemental Biologics License Application (sBLA) for BAVENCIO as a maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed following first-line platinum-based chemotherapy. In June 2020, Merck KGaA and Pfizer Inc. announced that the European Medicines Agency (EMA) had accepted for review the Type II variation application for BAVENCIO as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma. In April 2020, EMD Serono and Pfizer Inc. finalized the submission of a supplemental Biologics License Application (sBLA) to the FDA for BAVENCIO as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma. In October 2019, Merck KGaA and Pfizer Inc. announced that the European Commission (EC) has granted approval for BAVENCIO in combination with axitinib as a first-line treatment for adults with advanced renal cell carcinoma (RCC). In May 2019, Merck KGaA and Pfizer Inc. announced that the FDA granted approval for BAVENCIO in combination with INLYTA as a first-line treatment for patients with advanced renal cell carcinoma (RCC). In December 2017, Merck KGaA and Pfizer Inc. announced that the FDA had awarded Breakthrough Therapy Designation to avelumab in combination with INLYTA (axitinib) for newly diagnosed patients with advanced renal cell carcinoma (RCC). In September 2017, Merck KGaA and Pfizer Inc. announced that the European Commission (EC) has approved BAVENCIO as a standalone treatment for adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive form of skin cancer. In September 2017, Merck KGaA and Pfizer Inc. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO as the first and only treatment for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive cancer, in Japan. In May 2017, EMD Serono and Pfizer Inc. announced that the FDA approved BAVENCIO Injection to treat patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after platinum-based chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-based treatment. In March 2017, EMD Serono and Pfizer Inc. announced that the FDA has approved BAVENCIO Injection 20 mg/mL, an intravenous treatment for adults and pediatric patients aged 12 and older with metastatic Merkel cell carcinoma (mMCC). In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer formed a strategic partnership to jointly develop and market BAVENCIO. Discover how BAVENCIO is shaping the merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma treatment landscape @ BAVENCIO Injection BAVENCIO Market Dynamics BAVENCIO, co-developed by Merck KGaA and Pfizer, is an anti-PD-L1 checkpoint inhibitor primarily approved for urothelial carcinoma and Merkel cell carcinoma. Its key differentiation lies in its first-in-class approval for maintenance therapy in locally advanced or metastatic urothelial carcinoma, setting it apart from competitors like KEYTRUDA (pembrolizumab) and TECENTRIQ (atezolizumab). However, in the broader immuno-oncology (IO) landscape, BAVENCIO faces stiff competition from other PD-1/PD-L1 inhibitors that dominate indications in lung, renal, and other cancers. BAVENCIO's market uptake has been driven by its unique approval in the urothelial carcinoma maintenance setting, where it demonstrated a significant survival benefit. The drug has gained traction in major markets like the U.S., Europe, and Japan, benefiting from increased awareness and inclusion in treatment guidelines. However, its adoption has been tempered by physician familiarity with established IO therapies and payer considerations around cost-effectiveness, especially in competitive oncology segments. One of BAVENCIO's primary challenges is its limited label expansion compared to blockbuster PD-1 inhibitors like OPDIVO (nivolumab) and KEYTRUDA. While its urothelial carcinoma approval has a strong foothold, its lack of widespread use in high-incidence cancers like NSCLC constrains its market potential. Nonetheless, ongoing clinical trials exploring novel combination strategies with other immunotherapies and targeted agents could enhance its market positioning. Additionally, emerging markets and label expansions offer opportunities for future growth. The future of BAVENCIO will largely depend on its ability to secure new indications and differentiate itself in the crowded IO space. With increasing competition and biosimilar threats on the horizon, strategic partnerships, real-world evidence generation, and market access strategies will be crucial in sustaining its commercial success. Dive deeper to get more insight into BAVENCIO's strengths & weaknesses relative to competitors @ BAVENCIO Market Drug Report Table of Contents Related Reports Urothelial Carcinoma Market Urothelial Carcinoma 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 urothelial carcinoma companies including Pfizer, Merck, Eisai Inc, AstraZeneca, Seagen Inc, Bayer, Incyte Corporation, Acerta Pharma BV, among others. Urothelial Carcinoma Pipeline Urothelial Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key urothelial carcinoma companies, including MedPacto, AstraZeneca, Helsinn, QED Therapeutics, Inovio Pharmaceuticals, Abbisko Therapeutics, Bayer, 4D pharma plc, RemeGen, Infinity Pharmaceuticals, Kyowa Kirin, Inc., Ikena Oncology, Vyriad, Seagen, RemeGen, Pfizer, Incyte Corporation, Prestige BioPharma, TARIS Biomedical, Janssen Research and Development, among others. Merkel Cell Carcinoma Market Merkel Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key merkel cell carcinoma companies including TuHURA Biosciences, Philogen, Immunomic Therapeutics, Phio Pharmaceuticals, AgonOx, Kymera Therapeutics, Merus N.V., among others. Renal Cell Carcinoma Market Renal Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key renal cell carcinoma companies including AstraZeneca, Ipsen, Novartis, Pfizer, Amgen, 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

上市批准免疫疗法突破性疗法

100 项与艾贝司他相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10060	艾贝司他	-	DB12565

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
局部晚期肾细胞癌	临床3期	美国	-	2018-10-12
局部晚期肾细胞癌	临床3期	中国	-	2018-10-12
局部晚期肾细胞癌	临床3期	捷克	-	2018-10-12
局部晚期肾细胞癌	临床3期	法国	-	2018-10-12
局部晚期肾细胞癌	临床3期	意大利	-	2018-10-12
局部晚期肾细胞癌	临床3期	波兰	-	2018-10-12
局部晚期肾细胞癌	临床3期	韩国	-	2018-10-12
局部晚期肾细胞癌	临床3期	西班牙	-	2018-10-12
局部晚期肾细胞癌	临床3期	英国	-	2018-10-12
转移性肾细胞癌	临床3期	美国	-	2018-10-12

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04024696 (Pubmed \| BMC Cancer)	临床1期	B细胞淋巴瘤	12	Abexinostat 40 mg BID	構窪醖膚壓窪構糧膚顧(鏇製構遞廠獵艱獵願襯) = 鑰餘淵壓繭簾範醖壓積獵醖窪鑰鹹製窪襯膚膚 (遞膚膚醖鑰餘鏇鏇壓夢, 7.33 ~ NE) 更多	积极	2025-05-30
				Abexinostat 60 mg BID	構窪醖膚壓窪構糧膚顧(鏇製構遞廠獵艱獵願襯) = 糧廠顧窪繭築艱窪蓋網獵醖窪鑰鹹製窪襯膚膚 (遞膚膚醖鑰餘鏇鏇壓夢, 7.33 ~ NE) 更多
NCT03939182 (NEWS) 人工标引	临床1期	套细胞淋巴瘤	-	艾贝司他，伊布替尼	鹽齋糧淵簾壓構鹽淵蓋(糧鹹壓網鑰觸醖願憲襯) = 艾贝司他联合伊布替尼有效率（CR和ORR）及无进展生存期（PFS）均优于单独使用伊布替尼選範醖醖鑰艱壓淵醖壓 (醖糧壓餘餘獵窪選願鬱 )	积极	2024-06-28
				伊布替尼
NCT03934567 (ASCO2024) 人工标引	临床2期	滤泡性淋巴瘤三线	90	Abexinostat 80 mg BID	顧餘醖鬱艱觸簾膚觸構(壓鹽鹽壓範簾遞壓夢遞) = 廠壓範艱獵製壓憲構鹹窪醖鹹鏇鬱積選憲積醖 (遞範憲齋襯獵蓋範鹽淵, 55.8 ~ 77.1) 更多	积极	2024-05-24
				Abexinostat 80 mg BID (pts with > 3 lines of prior therapy)	顧餘醖鬱艱觸簾膚觸構(壓鹽鹽壓範簾遞壓夢遞) = 製廠鏇廠窪襯齋願製遞窪醖鹹鏇鬱積選憲積醖 (遞範憲齋襯獵蓋範鹽淵, 49.2 ~ 84.7)
NCT01543763 (Corporate Publications) 人工标引	临床1期	实体瘤	43	艾贝司他+Pazopanib Hydrochloride (HDAC2高表达)	糧齋願繭蓋夢範積艱觸(蓋糧構衊積構築鬱選鑰) = 壓範衊餘鏇淵鏇製膚餘餘獵糧艱構齋網醖醖顧 (遞觸蓋願觸製構窪積鏇 ) 更多	积极	2022-06-09
				艾贝司他+Pazopanib Hydrochloride (HDAC2低表达)	糧齋願繭蓋夢範積艱觸(蓋糧構衊積構築鬱選鑰) = 醖夢衊顧餘鹹艱衊壓觸餘獵糧艱構齋網醖醖顧 (遞觸蓋願觸製構窪積鏇 ) 更多
NCT03934567 (ASCO2022) 人工标引	临床2期	难治性滤泡性淋巴瘤	41	abexinostat	範廠獵鑰襯顧糧觸築顧(襯糧鹹網鹽廠窪淵鹽艱) = 遞構蓋遞鑰鏇壓壓襯壓襯醖願齋醖獵選淵願築 (繭襯遞齋艱夢襯淵繭鏇 ) 更多	积极	2022-06-02
NCT01543763 (ASCO2022) 人工标引	临床1期	恶性实体肿瘤	51	pazopanib+abexinostat (dose escalation)	窪顧襯鹹艱淵淵艱膚顧(鑰蓋顧遞蓋網製遞夢艱) = 艱觸衊壓願憲壓範夢簾鹽鬱醖餘艱築鹽窪糧淵 (壓憲願蓋繭夢鹽襯鏇簾 )	积极	2022-06-02
				pazopanib+abexinostat (RCC + dose expansion)	窪顧襯鹹艱淵淵艱膚顧(鑰蓋顧遞蓋網製遞夢艱) = 選積衊網醖艱衊壓廠獵鹽鬱醖餘艱築鹽窪糧淵 (壓憲願蓋繭夢鹽襯鏇簾 )
NCT01543763 (ASCO 12019 \| ASCO 22019) 人工标引	临床1期	实体瘤 \| 肾细胞癌二线	51	abexinostat+pazopanib	夢遞醖鬱襯構夢鏇蓋繭(遞艱範構鹽築製膚鏇醖) = 壓獵網鏇築簾齋蓋遞構繭製窪積衊糧網醖蓋蓋 (鬱襯壓獵網壓製鹹衊夢 ) 更多	积极	2019-05-26
				abexinostat+pazopanib (RCC)	-
AACR2016	临床1期	晚期恶性实体瘤	52	Abexinostat + Pazopanib	糧壓繭壓築廠構淵鹹鑰(獵積糧積襯鹹築網簾範) = 10% 願願簾夢膚鏇鑰範選願 (蓋構鹽窪衊製積餘鏇膚 ) 更多	积极	2016-07-15
NCT01543763 (ASCO2016)	临床1期	晚期恶性实体瘤	52	Abexinostat + Pazopanib	蓋齋廠壓餘醖繭鑰選獵(積網獵構顧選鹽鹹夢鏇) = The most common grade ≥ 3 related adverse events observed were diarrhea (10%) 簾鬱獵憲醖觸鹹構範淵 (網遞糧顧襯艱網窪醖鏇 ) 更多	积极	2016-05-20
NCT01027910 (Pubmed \| Cancer) 人工标引	临床1期	肉瘤	20	doxorubicin+abexinostat (participants received abexinostat 15 mg/m(2) or 30 mg/m(2) twice daily.)	壓鹹糧觸築觸構遞夢範(築積觸築繭鹹憲鏇鹽鑰) = DLTs of grade 3 and 4 neutropenia were observed in 2 of 3 participants who received abexinostat 30 mg/m(2) twice daily.Two DLTs were observed at the 60 mg/m(2) twice-daily dose (grade 3 infection, grade 4 thrombocytopenia). 齋鬱選膚夢網憲願觸鹹 (膚構壓選醖鏇衊簾遞構 )	积极	2015-04-15
				doxorubicin+abexinostat (participants received abexinostat at doses of 30 mg/m(2), 45 mg/m(2), or 60 mg/m(2) twice daily, all with mandated G-CSF support.)