Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK 3β) Inhibitor, Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma

9-ING-41 is a small molecule potent selective GSK-3β inhibitor with antitumor activity. This study investigates 9-ING-41 in combination with carboplatin chemotherapy in patients with incurable, recurrent or metastatic salivary gland carcinomas (SGC). Patients with advanced SGC (including all histologic subtypes and adenoid cystic carcinoma [ACC]) will receive 9-ING-41 intravenously (IV) along with carboplatin IV at standard dosing together on Day 1, and 9-ING-41 alone on Day 4 of a 21-day cycle. Participants will be enrolled to two histologic cohorts: Cohort 1 will be comprised of those with ACC, and Cohort 2 will include patients with non-ACC SGC (or all other salivary gland cancer histologies). Treatment will continue until progression of disease, death, or discontinuation of therapy for any reason.

开始日期2030-12-18

申办/合作机构

Actuate Therapeutics, Inc.

NCT05403723

/ Suspended临床1期IIT

A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination with Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer

This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC).

开始日期2025-12-31

申办/合作机构

University of Maryland Baltimore

[+1]

NCT06291064

/ Not yet recruiting临床2期IIT

TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy (TARMAC)

The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC).
All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis.

开始日期2025-11-01

申办/合作机构

The University of Chicago

100 项与卡铂相关的临床结果

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100 项与卡铂相关的转化医学

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100 项与卡铂相关的专利（医药）

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27,745

项与卡铂相关的文献（医药）

2025-12-31·NMC case report journal

A Primary Spinal Intramedullary Mixed Germ Cell Tumor: A Case Report and Literature Review

Article

作者: SHIMAUCHI-OHTAKI, Hiroya ; HORIGUCHI, Keishi ; HIRATO, Junko ; NAKATA, Satoshi ; HONDA, Fumiaki ; YOKOO, Hideaki ; OYA, Soichi ; GOTO, Yuta ; TOMOMASA, Ran ; NAKAMURA, Shunsuke

Central nervous system germ cell tumors are rare and account for 2% to 3% of all central nervous system tumors in Japan. Here, we report an extremely rare case of a primary spinal intramedullary mixed germ cell tumor. A 33-year-old man presented with a chief report of dysuria and numbness in the right lower extremity. Magnetic resonance imaging revealed a mass lesion on the left side of the intramedullary spinal cord at the Th10-11 vertebral body level with hyperintensity on T2-weighted images, isointensity on T1-weighted images, and uniform contrast in gadolinium. Cerebrospinal fluid examination revealed a few atypical cells. Although tumor removal using the posterior median sulcus approach was attempted, only a biopsy was performed because intraoperative rapid pathology suggested a possible diagnosis of germinoma. Permanent pathology revealed a mixed germ cell tumor (mainly comprising a germinoma with a yolk sac tumor). Postoperatively, cerebrospinal irradiation and 8 courses of the carboplatin and etoposide regimen were administered. No recurrence or new lesions were observed on magnetic resonance imaging at 94 months postoperatively. Our extensive literature search found only 4 cases of a mixed germ cell tumor of primary intramedullary origin in the spinal cord. Most spinal germ cell tumors described in the literature are either germinomas or mature teratomas; however, mixed germ cell tumors can also occur, albeit infrequently. Although additional cases need to be accumulated, our case suggests that yolk sac elements in spinal mixed germ cell tumors might not be directly associated with poor life expectancy.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare

Article

作者: Bernauer, Mark ; Roth, Joshua A. ; Dorman, Stephanie ; Kratochvil, David

BACKGROUND:

Biosimilars to originator bevacizumab (Avastin), such as bevacizumab-bvzr (Zirabev), can deliver substantial savings and/or expanded access to biologic therapy for patients with metastatic colorectal (mCRC) and non-squamous non-small cell lung cancer (mNSCLC). The objective of this study is to explore the cost-efficiency and budget-neutral expanded access of bevacizumab-bvzr in mCRC and mNSCLC in Medicare.

METHODS:

We developed a Medicare payer perspective simulation model of patients treated for mCRC and mNSCLC to estimate cost-savings from converting bevacizumab (originator) to bevacizumab-bvzr or alternative biosimilars such as bevacizumab-awwb, -maly, and -abcd. The target patient population receiving annual first-line systemic therapy was calculated using Medicare enrollment data, SEER cancer incidence rates in patients age ≥65, and an assumption that 39.3% and 77.2% of new diagnoses receive systemic therapy for mCRC and mNSCLC respectively based on recent evidence. 76.0% of systemically treated mCRC patients and 11.4% of incident mNSCLC patients were expected to be treated with bevacizumab-based regimens based on recent evidence. Costs were derived from the 2024 Average Sales Price (ASP). Results include per-patient per-month (PPPM) cost savings (vs. originator), total monthly savings in the cohort, and number needed to convert (NNC) to biosimilar to fund the treatment of an additional 100 patients.

RESULTS:

PPPM savings from conversion to bevacizumab-bvzr were $4,205 in mCRC and $8,410 in mNSCLC. In 100% conversion scenarios, full cohort monthly savings were $27,664,432 in mCRC (n = 6,579) and $32,319,323 in mNSCLC (n = 3,843), respectively. At 100% conversion, monthly savings from biosimilar conversion could fund up to 13,887 additional mCRC patient-months of treatment with bevacizumab-bvzr + FOLFOX, and up to 8,959 additional mNSCLC patient-months of treatment with bevacizumab-bvzr + paclitaxel + carboplatin. In mCRC and mNSCLC the biosimilar NNC from the originator was 47 and 43, respectively. The biosimilar NNC from other biosimilars ranged from 60-4,564 and 55-4,422 for mCRC and NSCLC, respectively.

CONCLUSION:

In the first cost-efficiency and expanded access study of biosimilar bevacizumab in mCRC and mNSCLC, we find that bevacizumab-bvzr-based regimens can result in substantial cost savings relative to originator-based first line treatment in Medicare. These cost savings could be reinvested to treat a substantial number of additional patients with mCRC or mNSCLC, or fund other costs of care in Medicare, on a budget-neutral basis.

2025-12-01·CHILDS NERVOUS SYSTEM

Holocord intramedullary pilocytic astrocytoma mimicking holocord spinal abscess: a case report and literature review

Review

作者: Erguven, Merve ; Dolen, Duygu ; Sabanci, Pulat Akin ; Gulsever, Cafer Ikbal ; Unverengil, Gokcen

PURPOSE:

This report aims to present a case of a child with holocord pilocytic astrocytoma and review the existing literature to provide insights into current management strategies.

CASE PRESENTATION:

An 11-month-old patient presented with progressive quadriplegia and was initially diagnosed with a spinal abscess. MRI revealed a heterogeneously enhancing cystic intramedullary lesion extending from the cervicomedullary region to the conus medullaris. The patient underwent an emergent T10-L1 total laminectomy and midline myelotomy for presumed abscess drainage. Intraoperative findings, however, were inconsistent with an abscess, suggesting a neoplastic process. Postoperative MRI indicated persistent spinal cord compression and histopathological examination showed no leukocytes or microorganisms. A second surgery the following day extended the laminectomy to T3, achieving gross total resection. Pathology confirmed a grade I pilocytic astrocytoma. Given the patient's age, chemotherapy with vincristine and carboplatin was initiated, as radiotherapy was unsuitable. Early physical therapy was commenced, resulting in significant neurological improvement to 4/5 muscle strength in all extremities according to the Medical Research Council (MRC) scale in the first year. Chemotherapy was discontinued due to systemic complications. At the 1-year follow-up, MRI demonstrated no tumor recurrence.

CONCLUSION:

The management of holocord pilocytic astrocytomas presents significant challenges, particularly in pediatric patients. While surgical resection remains the cornerstone of treatment, the role of chemotherapy requires further investigation. This case underscores the necessity of a multidisciplinary approach and highlights the potential for favorable outcomes with appropriate intervention.

1,980

项与卡铂相关的新闻（医药）

11 小时之前

·贝壳社

新靶点双抗，打出核爆

瞪羚社/ Jerry.Z 近日，Merus公布了其EGFR/LGR5双抗联用K药在头颈鳞癌的临床数据，数据披露后导致其股价大涨。这款双抗，俨然有成为头颈鳞癌治疗领域的Best in class的势头，而或许更为重要的，是LGR5这个靶点的想象力，愈发丰满了起来。01LGR5靶点LGR5这个靶点全称为富含亮氨酸重复序列的G蛋白受体5，由LGR5基因翻译，其具体蛋白质结构如图所示。LGR5 在多种组织中表达，例如肌肉、胎盘、脊髓和脑，特别是作为某些组织中成体干细胞的生物标志物。那么该靶点又跟癌症有什么关系呢？这个奥秘在于wnt通路之中。我们之前的文章中有提到，wnt通路与细胞的不正常生长和增殖是密切相关的，而LGR5靶蛋白质就是该通路之中的一员。具体来说，LGR5与癌症的关系可以概括为以下几点：1）LGR5通过与其配体R-spondin结合来调节经典Wnt信号强度。2）LGR5增强Wnt/β-catenin信号通路，从而刺激癌症干细胞增殖和自我更新。3）目前已证实LGR5通过激活Wnt/β-catenin 信号通路促进乳腺癌细胞中的癌细胞迁移、肿瘤形成和上皮间质转化。此外，据报道LGR5高表达与患者生存期较短呈正相关，详情可以参考文献《LGR5 is a marker of poor prognosis in glioblastoma and is required for survival of brain cancer stem-like cells》。那么说了这么多，人们对于该靶点的探索如何呢？该靶点直接跳过了单抗时代，没有人去开发相应的单抗产品，而直接进入了双抗时代，而First in class就是我们刚才提到的Merus的管线。此外，该靶点还用来开发CAR-T疗法用来治疗实体瘤。国外深耕于此的公司是Carina Biotech，目前相应头像CNA3103正处于临床I/II期研究阶段，预期2027年到达临床终点。它在CAR-T领域的探索，对于二级市场来说还是太过早期。因此，我们主要还是关注Merus双抗的表现吧。02PetosemtamabMerus的EGFR/LGR5双抗名为Petosemtamab，其独特设计为：抗体ADCC效应得到了增强。它的立项应该算非常早期了，临床试验开始的时候才2018年。在2021年上，它公布了在结直肠癌适应症上的临床I期剂量递增数据。患者基线上，接受奥沙利铂、伊立替康和氟嘧啶类药物以及EGFR单抗（如果RASwt）治疗后病情进展的转移性CRC患者，患者先前治疗中位线数达到了4（1-10）。33 名患者接受了11个剂量水平（5至1500 毫克，固定剂量）的治疗。最后结果之上，30名患者中17名无或低基线肿瘤EGFR 表达（0-1+ IHC），22 名患者中18名未观察到sEGFR水平升高（< 4 ng/mL）。当然，这个结果现在来看或许说明不了什么，并且之后Merus也把结肠癌适应症放在了稍后推进的位置，而是优先推进头颈鳞癌适应症。那么之后的临床数据呢？2024年，MCLA-158和帕博利珠单抗一线联用治疗头颈鳞癌的数据发布。目前复盘来看，选择该双抗去头颈鳞癌适应症大概率是因为它的另一个靶点EGFR的原因：EGFR是头颈鳞癌重要的致癌驱动因子。通过I期剂量爬坡，确定了II期临床最佳的剂量为1500mg Q2W，最后结果来看，在10例可评估疗效的患者中，有1例确认完全缓解，12例部分缓解，其中3例未确认部分缓解，相当于ORR率达到了67%，cORR率达到了50%，小样本数据来看，极其惊艳。并且从下方的患者PD-L1 CPS表达来看，两名缓解程度最好的患者PD-L1 CPS表达率并不高，并且从整体图像来看，该药物的疗效与PD-L1 CPS表达似乎相关效应不算太明显。这是个非常好的信号，意味着未来在治疗人群上可以得到进一步扩大。而在单药后线治疗头颈鳞癌的数据来看，也很不错。在受试者达到75的中型样本量的情况下，ORR达到了36%。不仅如此，该药还探索了在MET外显子14（METex14）突变的NSCLC适应症上的情况，应答率达到了53%（8/15 cPR）。而这次的ASCO大会，算是Merus彻底的爆发。今年ASCO会议上，Merus公布了Petosemtamab与帕博利珠单抗联合用药治疗一线头颈鳞癌的更新数据。共有43名患者接受了评估，结果显示，cORR达到了惊人的63%(27/43)，其中有6名患者实现CR，21名患者实现PR，对于PD-L1 CPS>20的患者，ORR达到73%(19/26)，mPFS为9个月，而在12个月的OS率则为79%。但安全性方面，不良反应率或许稍高，三级以上的TRAE达到了44%；而目前这个中位OS率，基本可以奠定它成为Best in class的霸主。03头颈鳞癌情况头颈鳞癌目前情况如何？根据2024CSCO头颈癌指南，一线RIR头颈癌(远处转移)治疗的1级推荐方案为帕博利珠单抗+卡铂/顺铂+5-FU，基于3期临床KEYNOTE-048试验结果。KEYNOTE-048纳入882名无法通过局部治疗治愈且未经过系统治疗的复发/转移性(R/M)HNSCC患者，患者将随机分配接受帕博利珠单抗(P，n=301)、帕博利珠单抗+化疗(P+C，n=281)或西妥昔单抗(EGFR单抗，以下简称E，n=300)治疗。疗效表格如下，帕博利珠单抗在单独给药时，在CPS大于20的人群下产生了显著的优势，中位OS达到了14.9个月，HR达到了0.61。而在CPS大于1的人群之中，mOS稍低，为12.3个月，HR达到了0.74，算是赶在了疗效差异化的边缘，但是我们似乎可以看到一个很有意思的地方，就是在无进展生存期来看，帕博利珠单抗明显相比西妥昔单抗要更短。这是个很有意思的地方，也是K药目前在头颈鳞癌治疗的瑕疵所在。至于这个瑕疵是否可以靠着Petosemtamab去弥补，是非常值得期待的事情。（图源：华创新药）但总而言之，一方面Petosemtamab也已经进入到了三期临床阶段，针对一线治疗和后线治疗头颈鳞癌，大有颠覆这个市场的雄心。另一方面，其它双抗也在这个领域想要有所进展，毕竟头颈鳞癌是EGFR密切相关的癌症，和EGFR相关的多抗都会想办法来试一下，例如Bicara的EGFR/TGF-β双抗目前也注册了一线治疗头颈鳞癌的三期试验，此外还有国内百利天恒的SI-B001，以及HER3的ADC等。结语：总体而言，目前Petosemtamab还是非常富有想象力的一条管线，它在头颈鳞癌崭露了自己的价值，但不可否认的是，其它做了EGFR双抗相关的biotech也会在这个赛道上发力，因此这个赛道还是呈现出越来越卷的形态的，也希冀Petosemtamab能够在III期临床拿到惊艳的OS结果。往期推荐1医健企业前沿动态2医健行业BD/出海/投融资洞察___*声明：本稿件为转载，仅用于分享，不代表本公众号立场，如涉及版权等问题，请尽快联系我们，我们将第一时间更正或删除，谢谢！

细胞疗法免疫疗法临床1期抗体药物偶联物

20 小时之前

·医药魔方

药械合作的“来时路”：一款创新药物的伴随诊断极致布局

2025年2月，强生公司的埃万妥单抗注射液（锐珂®）（Amivantamab, Rybrevant®）在中国获批上市：与卡铂和培美曲塞联合给药，用于经检测确认携带EGFR 20号外显子插入（exon20ins）突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。4月底，埃万妥单抗的第二个适应症在华获批：联合卡铂和培美曲塞，治疗携带EGFR exon19del或L858R，经EGFR-TKI治疗进展的晚期非鳞状NSCLC患者。同年的4月、5月，埃万妥单抗的两款原研伴随诊断（组织和血浆）依次获得NMPA批准。而这两个用途，均搭载于制造业单项冠军企业艾德生物的同一款产品——人类10基因突变联合检测试剂盒（可逆末端终止测序法）。这款试剂盒，曾在2018年首次通过NMPA创新医疗器械审查通道获批上市：作为治疗肺癌和肠癌关键靶向药物的伴随诊断，已经服务中国临床七个年头。本次获批是增加了EGFR exon20ins的CDx标签，以及第二个全新用途——血浆检测。埃万妥单抗何许人也埃万妥单抗是一款双特异性抗体，可以同时靶向结合EGFR和MET的胞外域，施加双重抗癌机制：它阻断配体结合，诱导EGFR和MET降解，从而阻扰其信号传递；它亦可通过免疫效应细胞，靶向杀伤肿瘤细胞。如此高效的作用机制，造就了埃万妥单抗优异的治疗效果——NCCN指南关于埃万妥单抗的用药推荐：1类推荐——联合卡铂和培美曲塞，一线治疗EGFR exon20ins晚期的NSCLC（非鳞癌）患者；1类推荐——联合拉泽替尼（lazertinib），一线治疗携带EGFR exon19del/L858R的NSCLC患者；1类推荐——联合化疗，后续治疗经奥希替尼治疗进展、携带EGFR exon19del/L858R的晚期NSCLC患者；2A类推荐——后续治疗经铂类化疗进展、携带EGFR exon20ins的NSCLC患者。自从2021年FDA首次批准上市后，埃万妥单抗一路高歌猛进，从单药到组合，从一线到后线，从罕见靶点（EGFR exon20ins）到常见靶点（EGFR 19del/L858R），每一项研究都蕴藏着“敢教日月换新天”的期许和能量。伴随诊断——“优等生”的晋级之路在创新药物全球商业化的进程中，每项新适应症的获批，都会增加广泛的适用人群；而每治疗一名患者，便肩负了一份承诺，一份责任。强生作为全球药企，对药物/诊断的协同布局可谓追求到了极致：纵观埃万妥单抗的成长过程，在全球主要的区域市场，强生都为其搭建了药物与CDx产品的生态系统，以应对各国独特的法规要求，采用最高的标准来确认适用的患者人群，从而确保治疗获益的稳定输出。在美国、日本、中国，埃万妥单抗为了有效定位患者，采用了两种最有效的技术路径：收集肿瘤组织（FFPE）和血浆（plasma）样本，使用在本国获批上市的伴随诊断试剂盒进行分子检测，获得EGFR基因的exon20ins突变结果，从而确认患者是否可以接受治疗。因此，强生在每个国家的市场，通过合作开发的方式，分别布局了“组织+血浆”至少两款CDx产品。尤其是在日本，由于实行的是药物-诊断-医保强绑定的临床应用模式，强生也为药物补充了区域性诊断策略：对于联用EGFR-TKI的适应症，需要识别EGFR常见突变（exon19del和L858R），强生选择了在日本NSCLC临床市占率颇高的产品——艾德生物的人类肺癌11基因（PCR）试剂盒（AmoyDx® Pan Lung Cancer PCR Panel）合作申报伴随诊断[1]，可谓将诊断合规做到极致。伴随诊断——创新药生态的重要一环对于CDx的系统性布局，强生并不是独家：各家跨国药企，为创新抗肿瘤药物，都搭建了完整的生态；专注于生物标志物的高水准诊断产品，正是创新药物生态搭建的支柱。与原研CDx的协同开发，是靶向机制药物上市的必备条件，也是嵌入创新药生命周期的“护身锦囊”。在机遇与风险并存、规则与认知震荡上升的当下，坚守科学本质的“笨办法”，往往才是唯一的捷径。以血浆检测为例，我们穷举在美国获批上市的伴随诊断（液体活检）产品清单，不难看出，肺癌、肠癌、乳腺癌、前列腺癌这些瘤种，已经有成熟的血浆检测临床共识，血浆CDx是药物上市的必选项；而跨国药企的畅销药物，大多都承载了血浆CDx的开发使命。这些创新的CDx产品，开发难度大，而一旦成功上市，却能有效地拓宽适用人群，是药物大规模推广的公认前提。FDA批准的血浆伴随诊断一览（更新至2025年4月）中国伴随诊断，生态正在成长自从2018年，NMPA开始按照“伴随诊断（CDx）”的标准，审批靶向药物相关的IVD产品以来，药物开发者、诊断开发者们，便与监管部门一道展开了执着的探索。尤其是创新药，与CDx的协同开发、共同上市，是产品合规应用的必备保障，也是临床循证的必经之路。过去几年，中国的原研CDx产品的数量已经有了可喜的积累，然而药物/诊断的获批节奏普遍难以同步：上市时间相差一年已经算是乐观情况；更有甚者，药物上市前承诺过的原研CDx计划，挣扎多年无法落实、苦苦找人接盘的也大有人在，此中过程不可谓不艰苦。创新药与CDx的上市时间差，导致标准诊断方法的可及性困难——这使得患者接受的治疗决策，经常暴露在丛林般的信息来源中；而对于靶向驱动的抗肿瘤治疗来说，CDx的缺失，给临床应用蒙上了一层难以预测的合规风险。道虽远，行则将至回到开篇，一款创新药、两款原研伴随诊断、三个月内在国内相继上市——这个协同节奏之紧凑，令人眼前一亮。一家国际顶级药企，一个伴随诊断龙头，强生与艾德交出的这份答卷，实乃在中国药监体系的监督与激励下，药械合作的一次优秀示范。艾德生物的这款NGS试剂盒，适用于两个适应症（肺癌和结直肠癌）的10个临床决策基因：EGFR、ALK、ROS1、RET、KRAS、NRAS、PIK3CA、BRAF、HER2和MET。随着“肿瘤组织+血浆”EGFR exon20ins伴随诊断标签的入列，这款产品将继续作为中国肿瘤CDx的前哨，探索药物与器械协同上市、临床获益模式的新边界。我们也能看到，未来会有更多如强生一样的企业：作为敬畏科学、敢于突破的实践者，加码中国创新药生态的先行者，选择志向相投的合作者，搭建出属于自己的行业丰碑。Copyright © 2025 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

上市批准诊断试剂

2025-05-27

·PRNewswire

AbbVie Features New Data Across Difficult-to-Treat Solid Tumors and Blood Cancers at ASCO 2025, Highlighting Breadth and Depth of its Oncology Portfolio

- Key oral presentations highlight new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) including telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced non-small cell lung cancer (NSCLC), ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN). NORTH CHICAGO, Ill., May 27, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers. "The data we're presenting at this year's ASCO reflect the breadth and depth of our oncology pipeline and our unwavering commitment to research that could transform outcomes for patients facing cancer," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These presentations underscore our leadership in driving scientific innovation to address some of the most pressing unmet needs in oncology today by leveraging our innovative platforms such as ADCs." An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase: Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study (NCT05029882).1 Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%.1 High ORR was observed regardless of c-Met protein expression levels.1 At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR).1 The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%).1 Additional data with 4 months follow-up will be presented at ASCO. Temab-A is also being evaluated in multiple ongoing clinical trials including a Phase 1/2 Study (NCT06772623) in first-line NSCLC without actionable genomic alterations in combination with budigalimab (AbbVie's investigational programmed cell death 1 inhibitor), a Phase 2 study (NCT06107413) in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid and bevacizumab, and a Phase 3 study (NCT06614192) as monotherapy in patients with c-Met overexpressing refractory metastatic CRC. "The anti-tumor activity of Temab-A in patients with pre-treated, advanced EGFR-mutated non-squamous NSCLC is encouraging and supports further exploration of this novel ADC in this setting," said Ross Camidge, M.D., Ph.D, University of Colorado Cancer Center, United States and principal investigator of the trial. "Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated with poor prognosis." Additional oral presentations will highlight new safety and efficacy data for ABBV-706, a SEZ6-directed ADC with a Top1i payload, and pivekimab sunirine (PVEK), a novel ADC designed to target CD123: In a Phase 1 open-label study of ABBV-706 monotherapy, 64 patients with high-grade neuroendocrine neoplasms (NENs), a diverse group of rare and aggressive solid tumors, received ABBV-706 monotherapy IV at 1.3–3.5 mg/kg once every 3 weeks.2,3 The entire cohort had an ORR of 31.3%, and a median DoR of 5.6 months.2 The most common grade ≥3 TEAEs (cumulative across all dose levels), were anemia (45%), neutropenia (33%), and thrombocytopenia (21%).2 Additional data will be presented at ASCO. This ongoing study (NCT05599984) is evaluating ABBV-706 as monotherapy, or in combination with budigalimab, carboplatin, or cisplatin, in patients with advanced solid tumors expressing SEZ6, including small-cell lung cancer, NENs and high-grade Central Nervous System tumors. Results from the open-label, multicenter Phase 1b/2 CADENZA trial (NCT03386513) of PVEK monotherapy in patients with previously untreated or relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive and rare type of blood cancer, demonstrated clinical benefit.4,5 The results show that among 33 untreated patients, the primary endpoint of composite complete response (CCR) rate, defined as CR + clinical CR (CR with minimal skin abnormality), was 70% (95% CI, 51.3-84.4) with a median duration of CCR of 9.8 months. ORR was 85%.4 In the 51 patients with R/R BPDCN, the CCR rate was 14% with a median duration of CCR of 9.2 months. ORR was 35%.4 Among all the 84 patients enrolled, the most common grade ≥3 TEAEs were peripheral edema (12%).4 TEAEs led to discontinuation in 9% and 7% of patients with first-line and R/R BPDCN, respectively. 4 Additional data will be presented at ASCO. PVEK is also being evaluated in a Phase 1/2 study (NCT04086264) in R/R and newly diagnosed acute myeloid leukemia. "Over the past few years, we've significantly expanded our ADC portfolio to investigate a broad range of solid tumors and blood cancers, reflecting our deep commitment to transforming cancer care through targeted therapies and biomarker driven approaches," said Daejin Abidoye, M.D., vice president, therapeutic area head of solid tumors, AbbVie. "These results highlight the potential of our investigational medicines to offer a meaningful clinical benefit in multiple difficult-to-treat cancers, where current treatment options are limited." Further information on AbbVie clinical trials is available at . Additional details on key presentations at ASCO are available below and the full ASCO Annual Meeting 2025 abstracts are available here. Telisotuzumab adizutecan, ABBV-706, pivekimab sunirine, etentamig, livmoniplimab, budigalimab, ABBV-291 and ABBV-969 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. Venetoclax, ibrutinib, epcoritamab, telisotuzumab vedotin are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. EPKINLY ®/TEPKINLY ® (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. VENCLEXTA®/VENCLYXTO® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. IMBRUVICA® (ibrutinib) is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) Please see full Prescribing Information for EPKINLY® (epcoritamab-bysp) Please see full Prescribing Information for IMBRUVICA® (ibrutinib) Please see full Prescribing Information for VENCLEXTA® (venetoclax tablets) About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Camidge R, Raimbourg J, Lee Y-G, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate, in Patients With Advanced EGFR Mutated Non-Squamous NSCLC: Results From a Phase 1 Study. Abstract 8512 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cooper A, Chandana S, Furqan M, et al. Safety and efficacy of ABBV-706, a seizure-related homolog protein (SEZ6)- targeting antibody-drug conjugate, in high-grade neuroendocrine neoplasms. Abstract 105 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Sultana Q, Kar J, Verma A, et al. A Comprehensive Review on Neuroendocrine Neoplasms: Presentation, Pathophysiology and Management. J Clin Med. 2023 Aug 5;12(15):5138. doi: 10.3390/jcm12155138. Pemmaraju N, Marconi G, Montesinos P, et al. Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study. Abstract 6502 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cazzato G, Capuzzolo M, Bellitti E, et al. Blastic Plasmocytoid Dendritic Cell Neoplasm (BPDCN): Clinical Features and Histopathology with a Therapeutic Overview. Hematol Rep 2023;15(4):696-706 doi: 10.3390/hematolrep15040070. Contacts: SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果ASCO会议临床1期抗体药物偶联物临床2期

100 项与卡铂相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01363	卡铂	L01XA02	DB00958

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
子宫内膜癌	日本	Clinigen KK	2024-06-24
乳腺癌	日本	Clinigen KK	2011-11-25
乳腺癌	日本	Bristol-Myers Squibb KK	2011-11-25
尤文肉瘤	日本	Clinigen KK	2005-09-15
尤文肉瘤	日本	Bristol-Myers Squibb KK	2005-09-15
肝母细胞瘤	日本	Bristol-Myers Squibb KK	2005-09-15
肝母细胞瘤	日本	Clinigen KK	2005-09-15
神经母细胞瘤	日本	Clinigen KK	2005-09-15
神经母细胞瘤	日本	Bristol-Myers Squibb KK	2005-09-15
视网膜母细胞瘤	日本	Bristol-Myers Squibb KK	2005-09-15
视网膜母细胞瘤	日本	Clinigen KK	2005-09-15
肾母细胞瘤	日本	Bristol-Myers Squibb KK	2005-09-15
肾母细胞瘤	日本	Clinigen KK	2005-09-15
非小细胞肺癌	日本	Clinigen KK	2000-07-27
非小细胞肺癌	日本	Bristol-Myers Squibb KK	2000-07-27
头颈部鳞状细胞癌	中国	Bristol-Myers Squibb Srl	1997-07-28
头颈部肿瘤	日本	Bristol-Myers Squibb KK	1990-03-30
头颈部肿瘤	日本	Clinigen KK	1990-03-30
淋巴瘤	日本	Bristol-Myers Squibb KK	1990-03-30
淋巴瘤	日本	Clinigen KK	1990-03-30

未上市

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
多形性胶质母细胞瘤	临床3期	美国	CarThera SAS	2024-01-29
多形性胶质母细胞瘤	临床3期	奥地利	CarThera SAS	2024-01-29
多形性胶质母细胞瘤	临床3期	比利时	CarThera SAS	2024-01-29
多形性胶质母细胞瘤	临床3期	法国	CarThera SAS	2024-01-29
多形性胶质母细胞瘤	临床3期	德国	CarThera SAS	2024-01-29
多形性胶质母细胞瘤	临床3期	意大利	CarThera SAS	2024-01-29
多形性胶质母细胞瘤	临床3期	荷兰	CarThera SAS	2024-01-29
多形性胶质母细胞瘤	临床3期	西班牙	CarThera SAS	2024-01-29
多形性胶质母细胞瘤	临床3期	瑞士	CarThera SAS	2024-01-29
复发性胶质母细胞瘤	临床3期	美国	CarThera SAS	2024-01-29

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临床结果

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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


NCT03416153 (CTgov)	临床2期	口咽部鳞状细胞癌 \| 口咽肿瘤	91	Radiation Therapy+Carboplatin+Paclitaxel (Standard Treatment)	夢遞醖觸窪襯願選構蓋 = 網觸鏇憲願壓鬱繭鹽鹹構獵鑰淵廠繭醖鹽網積 (範夢網觸鹹簾膚鏇糧鑰, 簾積廠齋襯壓鹹獵窪廠 ~ 範壓構築鹽齋觸艱壓鏇) 更多	-	2025-05-22
				Radiation Therapy+Carboplatin+Paclitaxel (De-escalation Treatment)	夢遞醖觸窪襯願選構蓋 = 積窪鏇蓋簾鹹觸繭選夢構獵鑰淵廠繭醖鹽網積 (範夢網觸鹹簾膚鏇糧鑰, 構觸憲鏇餘選蓋餘壓糧 ~ 膚積遞簾膚遞鏇鹹鏇襯) 更多
NCT03944915 (DEPEND, CTgov)	临床2期	乳头状瘤病毒感染 \| HPV相关鳞状细胞癌 \| 局部晚期头颈部鳞状细胞癌	35	Nivolumab+Carboplatin+Paclitaxel (Standard Chemotherapy)	積鏇壓壓選願觸鑰構壓 = 窪鬱觸淵夢窪遞鏇顧鏇製鑰鹹遞糧鑰襯鹹願鑰 (壓衊夢願衊糧夢夢範蓋, 網願淵蓋遞簾築夢願醖 ~ 簾夢獵鬱鏇繭膚築鹹壓) 更多	-	2025-05-11
				Radiation+Filgrastim Injection+Paclitaxel+Hydroxyurea Pill+cisplatin+5-fluorouracil (De-escalated Chemotherapy)	積鏇壓壓選願觸鑰構壓 = 齋廠範製願選鑰網獵積製鑰鹹遞糧鑰襯鹹願鑰 (壓衊夢願衊糧夢夢範蓋, 壓鹹鹽獵壓壓糧遞齋獵 ~ 鹽鹽餘窪壓餘構鹽鹹顧) 更多
NCT04967417 (PHOEBS, CTgov)	临床2期	非小细胞肺癌 \| 转移性非小细胞肺癌 \| 脑转移瘤	13	Carboplatin+Pembrolizumab+Pemetrexed (Non-squamous Cell Carcinoma)	襯壓獵衊鏇鹽範糧願製(鏇範鹽壓積夢築糧願製) = 網獵鏇簾鬱鏇襯願窪積襯獵齋選淵醖積顧壓繭 (淵壓鑰齋膚獵鑰鬱顧鹹, 艱壓製醖淵鏇壓獵鏇壓 ~ 糧遞壓構餘膚獵鏇觸鹹) 更多	-	2025-05-09
				Carboplatin+Paclitaxel+Pembrolizumab (Squamous Cell Carcinoma)	襯壓獵衊鏇鹽範糧願製(鏇範鹽壓積夢築糧願製) = 糧觸築顧製鏇繭膚夢網襯獵齋選淵醖積顧壓繭 (淵壓鑰齋膚獵鑰鬱顧鹹, 獵觸醖蓋醖餘衊繭餘獵 ~ 糧顧齋衊築積構鹽蓋窪) 更多
NCT03107182 (OPTIMA II \| OPTIMA-II, CTgov)	临床2期	头颈部鳞状细胞癌 \| HPV阳性的口咽鳞状细胞癌 \| HPV相关鳞状细胞癌 ... 更多	72	Adjuvant RT+Nivolumab (Single Modality De-escalation Arm (SDA))	築築齋衊鏇觸鑰鏇遞鹹 = 遞築顧齋製淵願蓋醖繭蓋築淵獵醖夢獵鹹憲糧 (網艱鹹選獵糧憲淵築壓, 選艱齋網鹹壓繭構襯鹽 ~ 壓夢膚願積積簾觸艱鏇) 更多	-	2025-05-06
				Chemoradiotherapy+Nivolumab+Paclitaxel+Hydroxyurea+cisplatin+Famotidine+Diphenhydramine+Dexamethasone+5-FU (Intermediate De-escalation Arm (IDA))	築築齋衊鏇觸鑰鏇遞鹹 = 觸襯壓醖構鑰網積醖膚蓋築淵獵醖夢獵鹹憲糧 (網艱鹹選獵糧憲淵築壓, 遞齋窪廠繭憲網選淵鹽 ~ 夢築築糧淵襯壓壓壓窪) 更多
NCT04512430 (CTgov)	临床2期	非小细胞肺癌	4	Carboplatin+Pemetrexed+Atezolizumab+Bevacizumab	醖選醖醖窪餘製憲糧鏇 = 壓鏇蓋鏇淵憲鹹餘艱窪築醖餘衊憲簾製壓憲艱 (範醖憲醖積膚膚窪蓋窪, 獵鑰糧願獵淵觸築鑰鏇 ~ 廠簾壓願觸鑰壓鏇齋夢) 更多	-	2025-04-02
NCT00513786 (CTgov)	临床2期	晚期子宫内膜癌	38	Carboplatin+Paclitaxel+bevacizumab	觸壓齋繭選築廠觸願簾(艱鬱膚繭範膚獵繭鑰鹹) = 齋鑰鏇鑰壓壓繭夢鏇膚選醖願構構築衊廠獵鑰 (廠願醖鏇壓積淵選壓襯, 遞衊積顧構繭範蓋窪簾 ~ 夢鹹窪範淵築鏇壓願製) 更多	-	2025-03-28
NCT04158141 (CTgov)	临床3期	恶性胸膜间皮瘤	16	Pleurectomy+Carboplatin+Pemetrexed+Cisplatin+Pemetrexed Disodium (Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment))	繭簾積網選夢鹹鏇糧範 = 鹹觸醖衊獵範壓繭製鬱糧餘鹽淵鏇廠製繭襯獵 (遞窪獵鬱觸衊簾夢繭鑰, 齋築選繭醖繭築鹽齋遞 ~ 願範積餘鹽夢築窪襯窪) 更多	-	2025-02-19
				Intensity-Modulated Radiation Therapy+Carboplatin+Pemetrexed+Cisplatin+Pemetrexed Disodium (Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS))	繭簾積網選夢鹹鏇糧範 = 鑰襯鬱鏇衊獵構憲齋簾糧餘鹽淵鏇廠製繭襯獵 (遞窪獵鬱觸衊簾夢繭鑰, 憲鑰齋憲鬱鹽鏇衊醖鹽 ~ 壓築蓋襯壓積鏇鬱願遞) 更多
NCT03980925 (GETNE T1913, CTgov)	临床2期	胃肠道神经内分泌肿瘤 \| 胃肠胰神经内分泌肿瘤	37	Nivolumab+Etoposide+Carboplatin	觸鬱蓋廠襯蓋鹹獵積繭 = 選鏇簾鏇齋顧簾壓範糧範憲餘簾蓋憲鹹繭窪築 (齋選範淵鏇糧製鹹構窪, 夢淵範餘獵積膚鏇製鹹 ~ 網選餘餘顧簾淵夢廠觸) 更多	-	2025-01-13
NCT04923776 (CTgov)	临床2期	广泛期小细胞肺癌	2	Stereotactic Body Radiation Therapy (SBRT)+Etoposide+Carboplatin+Atezolizumab	鹹鹹糧鹹範鏇繭繭構夢(壓衊夢憲衊糧積夢壓蓋) = 夢鬱壓夢製積夢鑰願選齋積窪齋醖餘願簾願選 (餘觸廠願艱窪觸衊觸製, 餘選製選選衊窪蓋鹽選 ~ 艱淵遞簾淵獵範衊憲積) 更多	-	2024-12-30
NCT05786430 (LUCAS, ESMO_ASIA2024) 人工标引	临床2期	EGFR突变的非小细胞肺癌 EGFR Mutation	54	Lazertinib + Pemetrexed + Carboplatin	窪遞構選築鏇繭窪選繭(獵獵繭獵襯顧糧壓壓窪) = 壓壓鑰構築蓋膚艱積觸壓艱襯鬱選醖淵憲壓廠 (觸簾繭鹽餘鬱廠壓簾襯, 5.16 ~ 9.56) 更多	积极	2024-12-07