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.

NCT07065630

/ Not yet recruiting临床2期IIT

A Phase II Study of Volrustomig, Paclitaxel, and Carboplatin Followed by Response-Adaptive Treatment in Untreated Locoregional HPV-Negative Head and Neck Cancer

The purpose of this study is to assess the objective response rate following neoadjuvant therapy with volrustomig, paclitaxel, and carboplatin in previously untreated human papillomavirus (HPV)-negative locally advanced head and neck squamous cell carcinoma
.

开始日期2026-01-17

申办/合作机构

The University of Chicago

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

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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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25,138

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.

2025-12-31·Future Science OA

Immune checkpoint inhibitors or targeted therapy by mismatch repair status in endometrial cancer: a meta-analysis

Review

作者: Zeng, Ting ; Zhao, Jing ; Shu, Chuqiang ; Tang, Yi ; Chen, Yan ; Huang, Kui ; Zhang, Pu

OBJECTIVE:

This study evaluated the benefits of immune checkpoint inhibitors (ICIs) and/or targeted therapies in mismatch repair-deficient (dMMR) and mismatch repair-proficient (pMMR) patients with advanced or recurrent endometrial cancer (EC) via network meta-analysis.

METHODS:

English databases were searched from inception through January 2025. Randomized controlled trials (RCTs) assessing the efficacy and safety of related therapies for patients with EC stratified by MMR status were included. The main evaluation indicators included progression-free survival (PFS), overall survival (OS), the objective response rate (ORR), and severe adverse events (SAEs).

RESULTS:

Ten studies were included in the analysis. The results indicated that in the dMMR population, ICIs provide superior survival benefits. Among these, Dostarlimab combined with carboplatin and paclitaxel (CP) had the highest PFS and OS rates. For the pMMR population, Selinexor + CP offers significant benefits over CP alone, although OS outcome data are limited. In pMMR patients with prior chemotherapy, the lenvatinib + pembrolizumab strategy may provide additional PFS benefits relative to chemotherapy treatment.

CONCLUSIONS:

ICIs offered advantages for the dMMR population, whereas selinexor could provide survival benefits for the pMMR population. For pMMR patients who have received prior chemotherapy, the lenvatinib plus pembrolizumab strategy shows promise.

2,261

项与卡铂相关的新闻（医药）

2025-09-19

·ioncology

收官！遇见 WCLC・每日精粹｜《肿瘤瞭望》速递六大关键亮点，纵览全球肺癌诊疗新视野

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标” 由国际肺癌研究协会（IASLC）主办的2025年世界肺癌大会（WCLC2025）于2025年9月9日在西班牙巴塞罗那圆满闭幕。作为肺癌及其他胸部恶性肿瘤领域全球领先的多学科肿瘤学盛会，本次大会吸引了来自世界各地的众多专家学者参会，围绕肺癌及其他胸部恶性肿瘤的前沿诊疗进展展开了深入探讨。大会特设“Highlights of the Day”专场，旨在回顾当日领域重磅研究进展，为全球肺癌领域研究者提供了聚焦当日核心进展的高效途径，以便快速捕捉研究动态、同步前沿认知。在会议现场，《肿瘤瞭望》特邀“小细胞肺癌、间皮瘤和胸腺恶性肿瘤的进展”领域“Highlights of the Day”专场汇报波兰格但斯克医科大学Rafal Dziadziuszko教授接受专访，回顾WCLC小细胞肺癌、间皮瘤和胸腺恶性肿瘤领域重磅研究进展，特此整理，以飨读者。纵览前沿：小细胞肺癌与间皮瘤新进展专家简介 Rafal Dziadziuszko 教授波兰格但斯克医科大学肿瘤与放射治疗科主任欧洲放射肿瘤学会（ESRO）、国际肺癌研究协会（IASLC）、欧洲肿瘤内科学会（ESMO）、欧洲癌症研究与治疗组织 - 肺癌组（EORTC –LCG）、美国临床肿瘤学会（ASCO）成员 Journal of Thoracic Oncology杂志副主编肿瘤瞭望您在本次WCLC大会“HOD02-Highlights of the Day-Monday Abstracts“专场上总结了小细胞肺癌、间皮瘤和胸腺恶性肿瘤相关研究进展，请您介绍一下主要发现？ Rafal Dziadziuszko教授首先，今年间皮瘤的相关内容覆盖得非常全面。第一项研究回顾了纳入间皮瘤TNM分期系统的三个大型数据集的分子及组织病理学分类（摘要号：OA12.01）。这使我们得以了解当前基于不同分子分层的患者预后情况，这些分子分型包括BAP1缺失、NF2突变、p53突变及其他突变。值得关注的是，在这个包含550多名患者的大型数据集中，经基因组分析和免疫组化验证，BAP1缺失均为良好预后因素。而NF2突变、p53突变及其他分子改变均为不良预后因素，这意味着存在这些改变的患者预后更差。第二项研究是一项III期临床试验，该试验在4-6个周期的卡铂联合培美曲塞化疗基础上加入了帕博利珠单抗（摘要号：OA12.02）。帕博利珠单抗组患者表现出更优的预后，且这种获益主要来自非上皮样组织学类型的患者，这与间皮瘤领域的其他研究结果一致。在所有患者群体中，试验组的中位总生存期（OS）为17个月，而对照组为16个月。有趣的是，BAP1缺失在此研究中再次成为良好预后因素，但不能预测患者是否能从帕博利珠单抗治疗中获益。该研究还评估了MTAP缺失，结果显示其为不良预后因素，且同样无法预测患者能否从加用帕博利珠单抗的治疗方案中获益。接下来的一项研究聚焦于在美加机构合作网络中的专科中心接受手术治疗的局限期弥漫性胸膜间皮瘤（DPM）患者群体（摘要号：OA12.03）。该研究包含两组患者：一组接受纳武利尤单抗单药治疗，另一组接受三个周期的纳武利尤单抗联合伊匹木单抗治疗，随后进行手术，术后再接受化疗或放疗等治疗，之后继续进行免疫治疗。接受纳武利尤单抗单药治疗的患者，中位无事件生存期（mEFS）约为9个月，总生存期（OS）为19个月。相比之下，接受纳武利尤单抗联合伊匹木单抗治疗的患者，mEFS为19个月，总生存期（OS）仍未达到。这些预后结果颇具前景，但目前的早期数据尚不足以支持在实际临床实践中采用这种新辅助治疗方案。小细胞肺癌领域，我重点介绍了一项Ib期临床试验，该试验评估了Tarlatamab联合阿替利珠单抗或度伐利尤单抗作为维持治疗的效果（摘要号：OA13.01）。试验对象为已接受4-6个周期化免联合治疗方案（即阿替利珠单抗或度伐利尤单抗联合铂类化疗）的患者。结果显示，Tarlatamab联合PD-L1抑制剂的治疗方案具有安全性，仅出现少数几例细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICAN）病例，且未出现剂量限制性毒性（DLTs）。总生存期（OS）数据十分令人鼓舞：12个月总生存率超过80%，这一数值高于接受一线化免联合治疗方案治疗患者的12个月总生存率。目前，该研究正推进至一线治疗阶段，另一项评估Tarlatamab联合策略的临床试验也已启动。这些试验旨在明确加用这种靶向DLL3的药物是否能改善小细胞肺癌患者的预后。 Prof. Rafal Dziadziuszko: First, mesothelioma was covered very nicely this year. We reviewed the molecular and histopathological classification of three large datasets included in the TNM classification of mesothelioma(ABSTRACT No. OA12.01). This gave us the current knowledge of outcomes for patients stratified by different molecular alterations: namely BAP1 loss, NF2 mutations, p53 mutations, and others. Interestingly, BAP1 loss was a prognostic factor in this large dataset that included more than 550 patients, confirmed both by genomic analysis and immuno-histochemistry. Unsurprisingly, other alterations, NF2, p53, and others were poor prognostic factors, meaning patients with these alterations had worse outcomes. The second study I’d like to summarize is a phase 3 trial that added pembrolizumab to 4–6 cycles of carboplatin plus pemetrexed chemotherapy(ABSTRACT No. OA12.02). The pembrolizumab group showed superior outcomes, and this benefit was mainly driven by patients with non-epithelioid histology,this was in line with other observations in mesothelioma. In the overall patient population, median overall survival (OS) was 17 months in the experimental group versus 16 months in the control group. Interestingly, BAP1 loss was again a positive prognostic factor here but not predictive of benefit from pembrolizumab. MTAP loss was also evaluated in this study, which was a negative prognostic factor and not predictive of benefit from adding pembrolizumab either. The next study focuses on a selected group of patients eligible for surgery at specialized centers in a US-Canadian institutional network(ABSTRACT No. OA12.03). The study included two groups: one received nivolumab monotherapy, and the other received nivolumab plus ipilimumab for three cycles, followed by surgery and then post-surgical treatment, either chemotherapy or radiation, followed by immunotherapy. Patients who received nivolumab alone had a mEFS of approximately 9 months and an OS of 19 months. In contrast, patients who received nivolumab plus ipilimumab (nivolumab + ipi) had a mEFS of 19 months and OS is not reached. These outcomes are promising, though early data don’t yet provide sufficient evidence to support neoadjuvant treatment in real-world clinical practice.Turning to small cell lung cancer, I’d like to highlight a phase 1b study evaluating Tarlatamab plus either atezolizumab or durvalumab as maintenance therapy(ABSTRACT No. OA13.01). In the setting of patients who received 4–6 cycles of chemo-immunotherapy (either atezolizumab or durvalumab plus platinum-based chemotherapy). The trial showed that the combination of Tarlatamab plus PD-L1 inhibitors was safe, with only a few cases of CRS and ICAN toxicity issues, and no dose-limiting toxicities (DLTs). The OS data were very encouraging: 12-month OS (counted from the start of treatment) exceeded 80%, which is higher than the typical 12-month OS for patients treated upfront with chemo-immunotherapy.This study is now progressing to first-line treatment, and another trial—evaluating tarlatamab given concomitantly with chemo-immunotherapy is also launching. These trials aim to determine whether adding this DLL3-targeting agent will improve outcomes for small cell lung cancer patients. 肿瘤瞭望请您分享下您的团队重点关注的研究方向？ Rafal Dziadziuszko教授我在波兰格但斯克医科大学负责I期临床试验项目的患者管理工作，目前我们正在开展多项针对不同靶点创新药物研究。我对DLL3抑制剂的疗效尤为关注，其中，Obrixtamig的I期临床试验数据颇具前景。此外，针对小细胞肺癌和非小细胞肺癌，另一类新兴的全身治疗手段是双特异性抗体，例如靶向VEGF联合PD-1/PD-L1的双特异性抗体等，我们的项目中已纳入多款此类分子药物，期望它们能成为治疗这两种类型肺癌的下一代全身治疗方案。 Prof. Rafal Dziadziuszko: I oversee patients in our phase 1 program at the Medical University of Gdansk, where we’re currently testing a number of different molecules. I’m particularly interested in the efficacy of other DLL3 inhibitors—among them, Obrixtamig has very promising phase 1 data. Another emerging wave of systemic therapies for both small cell and non-small cell lung cancer is bispecific antibodies that target VEGF plus either PD-1 or PD-L1. We have several of these molecules in our program, and we’re hopeful they will become the next generation of systemic therapies for both types of lung cancer. 巅峰盛会，精粹尽览 2025 年世界肺癌大会（WCLC2025）作为全球肺癌及胸部恶性肿瘤领域的顶级学术盛会，汇聚了各国顶尖专家学者的智慧与成果，堪称一场推动诊疗进步的 “思想盛宴”。大会期间，《肿瘤瞭望》“遇见 WCLC·每日精粹”栏目以专业视角全程深度追踪，凭借实时、精准的报道，为全球肺癌领域工作者搭建起高效的资讯传递桥梁，不仅第一时间送达大会前沿动态，更助力未能亲临现场的同仁穿透复杂数据表象，精准捕捉诊疗突破的核心逻辑与发展脉络。接下来，小编凝练六大核心亮点，与您一起重温这场兼具科学深度与人文温度的肺癌诊疗革新之旅，解码全球肺癌防治事业的前行方向。 tips：点击如下各图片，即可查看原文内容亮点一：盛会启幕，锚定肺癌防治的全球协作新坐标遇见WCLC｜盛会刚刚启幕！白春学教授、杨达伟教授深度解析肺癌早筛早诊的中国突破与全球贡献 👇点击图片即可查看原文 2025年9月6日，2025年世界肺癌大会（WCLC 2025）开幕式全体会议盛大召开，本场会议以“通过社会进步变革肺癌防治”为主题，为全球肺癌防治领域的交流协作与创新发展拉开崭新序幕。《肿瘤瞭望》直击现场，第一时间速递开幕式热点！ 👇点击图片即可查看原文与此同时，《肿瘤瞭望》特邀复旦大学附属中山医院白春学教授、杨达伟教授围绕“肺癌早筛早诊：中国突破、技术赋能与全球经验分享”展开探讨。 2025WCLC大会主席Noemí Reguart教授解读会议亮点——以巴塞罗那为新起点，开启IASLC抗击胸部肿瘤新五十年 👇点击图片即可查看原文作为肺癌及其他胸部恶性肿瘤领域全球领先的多学科肿瘤学盛会，本次大会吸引了来自世界各地的众多专家学者参会，围绕肺癌及其他胸部恶性肿瘤的前沿诊疗进展展开了深入探讨。会议现场，《肿瘤瞭望》特邀大会主席、西班牙巴塞罗那医院Noemí Reguart教授接受解读会议议程设置及研究成果相关亮点。亮点二：IASLC主席换届授旗仪式，开启中国引领全球肺癌诊疗的新纪元遇见WCLC·巅峰对话｜周彩存教授接任IASLC主席！与卸任主席Paul Van Schil教授共话肺癌诊疗前沿与全球协作新蓝图 👇点击图片即可查看原文 2025年9月8日，2025WCLC第二场主席研讨会期间，备受瞩目的IASLC主席换届授旗仪式正式举行，比利时安特卫普大学医院Paul Van Schil教授圆满完成任期，正式卸任IASLC主席一职。Paul Van Schil教授将象征IASLC学术使命与引领责任的旗帜，郑重交予同济大学附属东方医院的周彩存教授。这一交接不仅是IASLC学术传承的关键节点，更标志着协会正式开启由中国专家领衔、携手全球同仁共促胸部肿瘤诊疗事业进步的全新篇章。《肿瘤瞭望》特邀国际肺癌研究协会（IASLC）卸任主席、比利时安特卫普大学医院Paul Van Schil教授与新任主席、同济大学附属东方医院周彩存教授立足东西方临床实践的差异，深入探讨肺癌领域从诊疗策略到创新技术的前沿图景与实践方向。亮点三：“中国专场”IASLC-CSCO-CAALC联合会议——以原创成果引领肺癌诊疗新声遇见WCLC·圆桌讨论会｜从基础研究到临床转化——吴一龙教授、周清教授、刘思阳教授共探肺癌诊疗新路径，助力患者长生存 👇点击图片即可查看原文本届WCLC“中国专场”，主题为“肺癌治疗的全球视角：携手应对现实世界挑战”。从跟随者、参与者到引领者，中国肺癌学者在国际舞台上的话语权日益提升。会议现场，《肿瘤瞭望》特邀IASLC-CSCO-CAALC联合会议专场主席广东省人民医院吴一龙教授及团队周清教授、刘思阳教授围绕“肺癌诊疗前沿：机制、策略、转化与未来展望”展开探讨。亮点四：Highlights of the Day——每日精粹，前沿速递遇见WCLC·每日精粹｜聚焦肺癌免疫治疗前沿——回顾2025 WCLC关键突破与未竟之路 👇点击图片即可查看原文《肿瘤瞭望》特邀“免疫治疗”领域“Highlights of the Day”专场汇报者罗马Regina Elena国家癌症研究所Federico Cappuzzo教授回顾WCLC免疫治疗领域重磅研究进展。遇见WCLC·每日精粹丨Martin Reck盘点2025 WCLC重要研究 👇点击图片即可查看原文《肿瘤瞭望》特邀“Highlights of the Day - Sunday Abstracts”专场的点评专家、德国 Grosshansdor 肺科医院Martin Reck教授对2025 WCLC重要研究予以点评。遇见WCLC·每日精粹｜杨泮池教授：亚洲非吸烟女性肺癌负担沉重，早期筛查策略亟需变革 👇点击图片即可查看原文《肿瘤瞭望》特邀“肺癌筛查”领域“Highlights of the Day”专场汇报者中国台湾大学医学院杨泮池教授回顾WCLC肺癌筛查领域重磅研究进展。遇见WCLC·每日精粹｜Christian Rolfo教授评述肺癌风险因素与肿瘤生物学新发现 👇点击图片即可查看原文《肿瘤瞭望》特邀“肺癌风险因素及肿瘤生物学”领域“Highlights of the Day”专场汇报者俄亥俄州立大学癌症医学中心詹姆斯癌症医院Christian Rolfo教授回顾WCLC该领域重磅研究进展。亮点五：2025 WCLC“中国之声”——以原创技术与临床突破定义“精准诊疗”新高度遇见WCLC·现场热评｜方文涛教授详解第9版TNM分期在胸腺恶性肿瘤领域的变革与展望 👇点击图片即可查看原文本届大会特设专场，以“新TNM分期对胸腺恶性肿瘤治疗的意义”为主题进行了深入探讨。《肿瘤瞭望》特邀同济大学附属东方医院方文涛教授围绕第九版TNM分期系统的更新要点、临床实践意义及未来发展方向等关键议题进行权威解读。 2025WCLC 研究者说｜郑静教授分享肺癌骨转移免疫治疗新视角与大会热点追踪 👇点击图片即可查看原文本届大会，浙江大学附属第一医院周建娅教授团队开展的一项题为“骨转移对晚期非小细胞肺癌（NSCLC）一线免疫治疗疗效的影响”的前瞻性真实世界研究成果入选，《肿瘤瞭望》有幸邀请到浙江大学附属第一医院郑静教授结合其团队最新研究成果，深入剖析肺癌骨转移对免疫治疗疗效的影响及其临床应对策略，系统阐述多学科协作在骨转移综合管理中的核心价值。 2025WCLC 研究者说｜任胜祥教授深度解析复合式冷热消融技术在肺癌领域的临床价值与未来展望 👇点击图片即可查看原文在本届大会，来自上海市肺科医院任胜祥教授团队一项探索“肺癌患者接受复合式冷热消融技术治疗的安全性和有效性”研究成果入选，《肿瘤瞭望》特邀该研究主要研究者任胜祥教授接受专访，分享该研究主要成果。遇见WCLC·现场热评｜支修益教授：控烟与早筛双轨并进，为肺癌防控按下“加速键” 👇点击图片即可查看原文在大会现场，《肿瘤瞭望》有幸邀请到中国控烟与健康协会副会长、全国控烟与肺癌防治协作组组长、首都医科大学宣武医院胸外科首席专家支修益教授进行专访。支教授就全球控烟策略与国际肺癌筛查新趋势、电子烟面临的危害与挑战，以及我国控烟与肺癌一、二级预防策略等重要议题，进行了深度剖析与权威解读。 2025WCLC 研究者说｜围手术期免疫治疗方案显OS优势，岳东升教授解读可切除NSCLC治疗争议与未来探索方向 👇点击图片即可查看原文本届大会，由天津医科大学肿瘤医院岳东升教授团队主持开展的RATIONALE-315研究公布了最终分析结果，《肿瘤瞭望》特邀岳东升教授解读该项研究成果、分享围手术期免疫治疗领域热议话题。遇2025WCLC 研究者说｜张扬教授解读磨玻璃为主型肺腺癌淋巴结清扫从“系统性扫荡”到“选择性清除”的精准外科突破 👇点击图片即可查看原文本届大会，来自复旦大学附属肿瘤医院张扬教授分享了探索磨玻璃为主型肺腺癌患者不进行与进行系统性纵隔淋巴结清扫非劣效性随机对照研究结果，《肿瘤瞭望》特邀张扬教授解读该项研究成果与肺癌精准外科新方向。 2025WCLC 研究者说丨ADC还是TKI？方文峰教授解读HER2靶向治疗前沿议题 👇点击图片即可查看原文本届大会，来自中山大学肿瘤防治中心方文峰教授分享了靶向HER2的ADC药物TQB2102治疗HER2异常非小细胞肺癌（NSCLC）的疗效与安全性结果。《肿瘤瞭望》特邀方文峰教授解读该项研究成果，分享ADC领域的前沿进展。 2025WCLC 研究者说丨ADC联合EGFR-TKI突破疗效平台期，周斐教授分享局晚期/转移性NSCLC创新策略探索新进展 👇点击图片即可查看原文本届大会，来自同济大学附属东方医院周斐教授分享了Iza-Bren（BL-B01D1）联合奥希替尼治疗EGFR突变阳性局部晚期或转移性非小细胞肺癌患者Ⅱ期研究结果，《肿瘤瞭望》特邀周斐教授解读该项研究成果。亮点六：2025 WCLC圆满闭幕，以全球协作开启“肺癌可控可治”新征程 2025WCLC 圆满闭幕｜2026 相约首尔再启新程！韩宝惠教授深度解析肺癌免疫治疗关键问题与 KRAS 突变治疗新选择 👇点击图片即可查看原文 2025年9月9日，2025年世界肺癌大会（WCLC 2025）在西班牙巴塞罗那圆满闭幕。在为期四天的会议中，全球肺癌领域的顶尖专家学者与临床医生共聚一堂，围绕肺癌及其他胸部恶性肿瘤的基础研究、临床诊疗、多学科协作与转化医学等关键议题开展了深入而富有成效的交流。 👇点击图片即可查看原文与此同时，《肿瘤瞭望》特邀上海市胸科医院韩宝惠教授基于2025 WCLC免疫治疗相关最新研究进展，分享肺癌免疫治疗现状、耐药应对策略与创新方向。 2025 WCLC不仅是一场学术盛会，更是全球肺癌领域“凝聚共识、协同行动”的起点。《肿瘤瞭望》2025“遇见WCLC”栏目圆满收官，感谢所有肺癌领域工作者及关注肺癌诊疗领域的读者们的支持，《肿瘤瞭望》将继续陪伴您，持续提供专业、深入、及时的肿瘤领域前沿信息，与您携手共进，迎接肺癌防控事业更加光明的未来。 2026年韩国首尔，让我们共同期待肺癌诊疗的下一次“范式革新”！（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。

放射疗法临床3期

2025-09-17

·BioSpace

Choosing China: Akeso’s $3M Beginnings and the Rise of China’s Biotech Sector

Akeso CEO Michelle Xia, who worked in the lab during the biotech’s initial stages after founding. Courtesy Akeso From a small team of researchers and skipped salaries, CEO Michelle Xia has steered Akeso to become one of the most exciting companies in the industry today. When Akeso was starting out some 13 years ago, the leadership team had $3 million and a bold goal to move China’s drug industry toward innovation. “When Akeso was first established, China’s biopharmaceutical industry was still in its infancy,” CEO Michelle Xia told BioSpace in an email interview. “To put it simply, very few were engaged in innovative drug discovery at that time; the sector was overwhelmingly dominated by generics. Against this backdrop, pursuing innovative drug development required tremendous effort.” As Xia tells it, China during the early 2010s had no “mature ecosystem for innovation.” The local industry amounted to companies that made generic versions of drugs that had already launched in Western countries years earlier. Over the years, however, Akeso has grown explosively to become one of the leading faces of an ascendant Chinese biotech industry. Today, the company is worth more than $15 billion—a far cry from the $3 million angel fundraising that kicked things off for Xia and her team. In large part, Akeso’s recent worldwide renown is thanks to its partnership with California-based Summit Therapeutics, which in December 2022 paid $500 million upfront plus up to $5 billion in potential milestones to partner with the rising Chinese star. At the heart of this partnership is ivonescimab, an asset that in the past year has not only arrested the attention of the biopharma industry but has also come to symbolize an emerging approach to cancer. Ivonescimab is a bispecific antibody that targets two key cancer pathways. It blocks PD-1 signaling, preventing cancer cells from evading the immune system, and inhibits the VEGF cascade, which tumors use to create new blood vessels to supply nutrients and oxygen, supporting unchecked growth. In September last year, Akeso and Summit announced that ivonescimab bested Merck’s Keytruda, a cornerstone cancer therapy, in a Phase III study of non-small cell lung cancer (NSCLC). That clinical win cemented Akeso as a serious global contender, but Xia insists that the biotech is much more than ivonescimab and a signal of China’s biotech boom. Akeso’s beginnings may have been humble, but Xia’s dreams for the company are big. A ‘Natural’ Choice When Xia returned to China in 2008, striking out on her own was never part of the plan. A biochemistry graduate of Sun Yat-sen University, Xia had spent more than two decades away from home. She had picked up postgraduate degrees from Newcastle University and Glasgow University in the U.K. before finding her way to the United States in 1996 to focus on cancer immunotherapy at the University of Louisville. Akeso CEO Michelle Xia/ Courtesy Akeso Eventually, Xia decided to leave the confines of academia and test her mettle in industry. She went through a couple of companies—Bayer among them, as a senior scientist in 2006—before settling down at Crown Bioscience, a contract research organization focused on oncology and immuno-oncology. There, she climbed the ranks until 2008, when Crown decided to open a subsidiary in China. With Xia’s help, Crown marked the Asian giant’s “first-ever comprehensive outsourced collaboration” for antibody drug development with a global pharma company, she said. Aside from allowing her to flex her executive skills, Xia’s return to China opened up her eyes—not just to the biomedical needs of the domestic market, but also to its promise. “My return to China represented a significant transition in my career,” she said. “It provided me with valuable insights into the landscape of innovative drug development and clinical needs in the Chinese market.” Even so, Xia didn’t exactly expect to become the CEO of her own biotech. “Before returning to China, I hadn’t seriously considered launching my own venture,” she said. But the experience with Crown made her realize that China could be a world leader in drug discovery. “Choosing China felt natural,” Xia said. “We saw tremendous unmet needs and opportunities.” Taking inspiration from the name of the Greek goddess of healing, Xia and three other co-founders launched Akeso in 2012, confident in their abilities. “Each of us had already gained substantial international experience in our respective fields,” Xia said, which helped provide a “solid foundation” for their new venture. Yet Akeso’s early days proved to be a struggle. China’s biopharma industry at the time was “still in its infancy,” Xia said. Talent and capital were wanting, and infrastructure was poor. Patients were severely underserved, with treatments lagging decades behind other countries. There was little confidence in what they were trying to do, too. Doctors, investors and regulators were all skeptical, Xia told BioSpace . “We had to work tirelessly to earn the trust of physicians and key stakeholders,” she said. “Every idea was new, and nothing came easily.” Xia and her team rented out a small office space, hired a handful of researchers and, when needed, went without salary for a couple of months. The origins of Akeso were a far cry from the cushy, well-resourced corporations that they were used to. Thirteen years later, Xia’s gamble has paid off. From its unpolished beginnings in the 2010s, China’s biotech sector has grown rapidly and systematically. At the heart of this transformation is a change in the country’s regulatory regime; the government after 2015 updated drug regulations to meet international standards, giving drugmakers the chance to play on the global stage. Over the years, private equity and venture capital in China likewise gained momentum, providing companies that all-important financial bloodline with which to run their operations. It hasn’t all been smooth—other biotech companies operating in China have told BioSpace that the region has experienced a similar drop in financing in recent years as companies in America. This has pushed them to seek licensing agreements with multinational corporations. But according to Xia, the Chinese biotech sector provides a “conducive ecosystem for biopharma innovation .” The talent pool has grown and the country’s capital market system has matured. China’s size is also an advantage, with a large patient population to power clinical trials and a market hungry for novel and effective therapies. “These elements contribute to rich clinical resources essential for drug development,” Xia said. China has a “sizable market with strong demand, efficient capital utilization, and clinical outcomes as well as regulatory reviews that meet the rigorous requirements of markets such as the United States and Europe.” Looking back on Akeso’s journey, Xia is glad she stuck with it. “Every bit of that perseverance has been worth it,” she said. The 2.0 Era Like the rapid and major evolution of the Chinese biotech industry, Akeso’s business and pipeline have grown from a domestic view to a global mindset. There’s ivonescimab, of course, which in April won Chinese approval as a first-line treatment in patients with PD-L1-positive NSCLC. Over in the U.S., though, the treatment has run into issues after missing the overall survival target in a global Phase III study, an outcome that the FDA had deemed crucial for an approval. Even so, ivonescimab is the first-ever PD-1/VEGF therapy to reach the market. Summit intends to Biologics License Application for the drug and to push forward with ivonescimab’s Phase III development. The biotech is running HARMONi-3 and HARMONi-7 , which are pitting the bispecific against Keytruda. The studies are expected to complete in 2028 and 2029, respectively. Xia wants it known, however, that Akeso is much more than ivonescimab. In June, cadonilimab became what she characterized as “the world’s first cancer immunotherapy bispecific antibody” when China’s health authority approved the drug—and included it for insurance coverage—for patients with cervical cancer. Like ivonescimab, the drug targets two key cancer markers, PD-1 and CTLA-4, both of which allow tumors to evade the immune response. These two are “foundational assets” for Akeso, according to Xia, emblematic of the company’s growth strategy of pushing immuno-oncology “into the 2.0 era.” Akeso is the only biopharma player so far to have two approved immuno-oncology bispecifics, Xia pointed out. Akeso also has a single U.S.-approved product in penpulimab, indicated in a combo with cisplatin or carboplatin and gemcitabine as a first-line option for recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. The approval, granted in April this year , also allowed the use of penpulimab monotherapy in patients who had progressed on or after platinum chemotherapy. Following in the footsteps of these pipeline leaders is AK146D1, a bispecific antibody-drug conjugate (ADC)—a molecule that can simultaneously target two cancer markers while also carrying a toxic payload. The asset, according to Xia, is being studied both in China and abroad, testing its therapeutic potential in advanced cancers. Other pipeline assets include bispecific antibodies targeting PD-1/LAG-3 and TIGIT/ TGFβ, as well as what Xia calls “dual-payload” ADCs. Of course, partnerships remain top-of-mind for Akeso, though Xia wouldn’t provide specifics. “We consistently adopt an open approach to seek more international collaborations,” she said. And while Akeso is currently putting much of its energy into cancer, the company is also leveraging its bispecific technology in other therapeutic areas like autoimmune and neurodegenerative diseases. In February, Chinese regulators accepted the investigational new drug application for AK139, which Xia said is “the world’s first IL-4R/ST2 bispecific antibody” to enter the clinic. It’s being tested in respiratory and skin conditions. Farther into the future, Xia revealed that Akeso also wants to break out of the bispecific space and explore other modalities, such as mRNA and siRNA therapies, as well as cell and gene editing. “We aim to become a globally influential pharmaceutical innovator,” Xia said.

上市批准临床3期免疫疗法

2025-09-15

·复宏汉霖

复宏汉霖H药汉斯状®实体瘤领域4项研究入选CSCO 2025口头报告

2025年9月15日，复宏汉霖（2696.HK）宣布，公司自主研发的创新型抗PD-1单抗H药汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）肺癌和其他实体肿瘤领域4项研究最新结果以口头报告的形式在第28届中国临床肿瘤学会（CSCO）学术年会上发布。其中，斯鲁利单抗联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）的国际多中心III期ASTRUM-005研究结束分析的亚洲人群最新数据结果，在本次CSCO大会上以口头报告的形式首次发布。 H药汉斯状®是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国、英国、德国、印度、印度尼西亚、新加坡等近40个国家和地区获批上市, 覆盖全球近半数人口。聚焦肺癌和消化道肿瘤等高发实体肿瘤，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，截至目前，H药已获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、食管鳞状细胞癌（ESCC）和非鳞状非小细胞肺癌（nsNSCLC）。此外，复宏汉霖在全球同步开展10余项以H药为核心的免疫联合疗法临床研究，于中国、美国、日本、土耳其、波兰、格鲁吉亚等国家和地区累计入组逾5100人。相关研究显示，斯鲁利单抗具有更强的PD-1内吞作用，减少T细胞表面留存的PD-1受体数目[1]，带来更快、更强的免疫激活效应。此外，斯鲁利单抗能够减少PD-1对免疫共刺激分子CD28的募集，从而减少磷酸化酶SHP2对CD28的去磷酸化作用，更大程度保留CD28传递的信号[2-4]，因此，斯鲁利单抗进一步提高了信号通路下游AKT蛋白的活性[5]，促进T细胞的持续、稳健活化。肺癌一线全覆盖，亚洲人群获益再验证据国家癌症中心发布的最新数据，2022年肺癌新发病例数达106.06万，死亡例数为73.3万，居各类癌症之首[6]。全球首个获批一线治疗小细胞肺癌的抗PD-1单抗H药汉斯状®目前已全面覆盖肺癌一线治疗，除已获批的三项肺癌适应症，同时正在全球范围内积极推动一项H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的国际多中心III期临床试验。 ASTRUM-005研究是一项随机、双盲、国际多中心的III期临床试验，旨在研究斯鲁利单抗对比安慰剂分别联合化疗一线治疗ES-SCLC的疗效和安全性。该研究结果于2022年ASCO年会上首次发布，并于2022年9月登顶全球四大顶级医学期刊之一的《美国医学会杂志》（JAMA）。ASTRUM-005全人群的研究结束（end-of-study）分析结果于ASCO 2025大会上首次发布，四年OS率达21.9%。本次CSCO大会上首次以口头报告的形式首次发布亚洲人群的研究结束分析结果，结果显示，中位随访时间43.6个月时，在亚洲人群中，斯鲁利单抗联合化疗的OS、PFS、ORR和DOR结果中显示出一致的临床获益，相较于单纯化疗展现了更明显的抗肿瘤活性——斯鲁利单抗组中位OS达到15.8个月，较化疗组提高4.7个月，4年OS率达到22.4%，为同类药物已报道数据中最高，研究结束分析的结果进一步支持斯鲁利单抗联合化疗作为ES-SCLC患者的一线疗法。另一项入选大会口头报告的ASTRUM-005R研究是截至目前中国ES-SCLC领域样本量最大的真实世界研究，纳入的635例患者中位rwPFS为8.2个月，中位OS为17.2个月。该研究证实了斯鲁利单抗一线治疗ES-SCLC良好的疗效和安全性，验证了ASTRUM-005研究结果，为斯鲁利单抗联合化疗一线治疗ES-SCLC补充有力证据。 ASTRUM-005：斯鲁利单抗或安慰剂联合化疗一线治疗广泛期小细胞肺癌的国际多中心、随机、双盲III期研究——亚洲人群数据结果：截至2024年5月7日数据截止时，亚洲患者的中位随访时间为43.6个月。所有401例随机分组的亚洲患者均被纳入有效性和安全性分析。两组基线人口统计学和疾病特征均衡。其中斯鲁利单抗组患者262例，接收斯鲁利单抗联合卡铂与依托泊苷治疗；安慰剂组患者139例，接受安慰剂联合卡铂与依托泊苷治疗。在总体人群中，斯鲁利单抗联合化疗较安慰剂组中位总生存期（OS）明显延长，亚洲亚组与总体人群获益趋势一致。亚洲患者中，斯鲁利单抗组中位OS为15.8个月（95% 置信区间[CI]：13.3–17.9），安慰剂组为11.1个月（95% CI：10.0–12.9），风险比（HR）为0.61（95% CI：0.48–0.76，p < 0.001），斯鲁利单抗组较化疗组中位OS延长4.7个月。斯鲁利单抗组4年OS率远高于安慰剂组（22.4% vs. 8.4%）。独立影像评估委员会（IRRC）评估的中位无进展生存期（PFS）在斯鲁利单抗组为6.1个月（95% CI：5.5–8.2），安慰剂组为4.3个月（95% CI：4.2–4.4），HR = 0.47（95% CI：0.37–0.60，p < 0.001）。基于研究者评估与基于IRRC评估的PFS分析结果一致，均显示斯鲁利单抗组的持续获益。亚组分析显示，在不同年龄、性别、种族、ECOG评分、吸烟史、转移状态及PD-L1表达等预设亚组中，斯鲁利单抗组均显示出一致的OS和PFS获益。基于IRRC评估，斯鲁利单抗组确认的客观缓解率为71.8%，安慰剂组为58.3%；两组中位缓解持续时间分别为7.0个月和3.2个月（HR = 0.47，p < 0.001）。安全性特征与既往报告一致，未发现新的安全性信号。结论：该研究结束分析的结果证明斯鲁利单抗联合卡铂与依托泊苷一线治疗可为ES-SCLC亚洲患者带来长期生存获益，进一步支持斯鲁利单抗联合化疗作为ES-SCLC患者的一线疗法。 ASTRUM-005R：斯鲁利单抗一线治疗广泛期小细胞肺癌的全国多中心真实世界研究结果：研究共纳入635例患者进行分析，中位随访时间14.9个月。630例可评估患者中，7例达到完全缓解，428例达到部分缓解，ORR为69.0%。中位rwPFS为8.2个月（95% CI：7.4-9.2)；中位OS为17.2个月（95% CI：15.4-19.8)。无脑转移的患者的中位rwPFS数值高于伴脑转移的患者（8.3个月 vs. 7.4个月，p=0.431),无肝转移患者的中位rwPFS数值高于伴肝转移的患者（9.3个月 vs. 6.4个月，p＜0.001）。AE发生率为36.7%，其中3级AEs为12.8%，78例患者（12.3%）因不良反应导致治疗中断，3例患者（0.5%）发生了与不良反应相关的死亡。斯鲁利单抗相关不良事件发生率为20.5%，主要为1-2级（16.7%），未发现新的安全性信号。结论：这项全国最大样本量的ES-SCLC真实世界研究证实了斯鲁利单抗一线治疗ES-SCLC良好的疗效和安全性，验证了ASTRUM-005研究结果，为斯鲁利单抗联合化疗一线治疗ES-SCLC补充有力证据。持续探索实体瘤肿瘤的治疗潜力公司亦持续深化H药在更多实体肿瘤领域的临床探索，积极推进H药联合化疗用于新辅助/辅助治疗胃癌III期临床研究以及H药联合贝伐珠单抗联合化疗用于一线治疗转移性结直肠癌（mCRC）患者的国际多中心III期临床研究（ASTRUM-015）。在本次CSCO大会上，2项探索H药在实体肿瘤领域的IIT研究最新数据以口头报告的形式发布。一种新型“R-ISV-RO”技术治疗晚期实体瘤的探索性临床研究结果： “R-ISV-RO”是一种将立体定向放疗（SBRT）与肿瘤内注射TLR7激动剂（R837）和OX40激动剂（RO）联合PD-1抑制剂的瘤内疫苗注射，用于激活局部和全身抗肿瘤免疫的新型实体瘤治疗技术。本研究共纳入30例患者。注射病灶的3个月客观缓解率（ORR）为32.0%，疾病控制率（DCR）达96%；6个月ORR为47.4%。12例患者出现远隔效应。注射病灶的中位无进展生存期（PFS）为6.1个月，中位总生存期（OS）为14.2个月。亚组分析显示，骨与软组织肉瘤患者的中位至治疗失败时间（mTTP）显著延长至8.1个月，而其他肿瘤类型患者仅为2.8个月（p<0.001）。R-ISV-RO治疗方案耐受性良好，仅10%患者出现3级及以上不良事件。流式细胞术检测提示T细胞介导的免疫激活与更佳临床结局相关，表明其在介导R-ISV-RO诱导的抗肿瘤免疫中起关键作用。肿瘤微环境（TME）分析为全身免疫应答激活提供了证据，而代谢组学分析则揭示了治疗诱导的代谢重塑。结论：在这项探索性试验中，R-ISV-RO疗法对注射病灶及远隔病灶均展现出令人鼓舞的疗效，尤其对肉瘤患者效果显著。治疗后还观察到系统性免疫应答及代谢重塑现象。呋喹替尼联合斯鲁利单抗一线治疗转移性或不可切除的非透明肾细胞癌的疗效与安全性——一项单臂、多中心的II期临床研究结果：截至2025年7月31日，一共入组36例转移性或不可切除的非透明肾细胞癌（nccRCC）患者，接受呋喹替尼联合斯鲁利单抗的一线治疗，中位PFS随访时间是9.3个月（95%CI 7.4个月vs. 14个月），中位PFS暂未达到，9个月PFS率为87.3%。35例患者疗效可评估，最佳缓解：1例完全缓解（CR），16例部分缓解（PR），17例疾病稳定（SD），1例疾病进展（PD）。客观缓解率（ORR）为48.6%（95% CI 32.0%，65.1%），疾病控制率（DCR）为97.1%（95%CI 85.1%，99.9%）。快速进展（定义为入组后4个月内进展）的3例患者（2例乳头状肾细胞癌+1例嫌色细胞癌）均具有肉瘤样特征。未发生导致死亡的≥3级治疗期间出现的不良事件（TEAEs）。结论：目前研究数据表明，呋喹替尼联合斯鲁利单抗作为一线治疗方案，在转移性或不可切除的非透明细胞肾细胞癌中取得了令人鼓舞的疗效，且安全性表现良好。【参考文献】 [1] Issafras H, et al. Structural basis of HLX10 PD-1 receptor recognition, a promising anti-PD-1 antibody clinical candidate for cancer immunotherapy. PLoS One. 2021;16(12):e0257972. [2] Hui E, et al. T cell costimulatory receptor CD28 is a primary target for PD-1-mediated inhibition. Science. 2017;355(6332):1428-1433. [3] Patsoukis N, et al. Interaction of SHP-2 SH2 domains with PD-1 ITSM induces PD-1 dimerization and SHP-2 activation. Commun Biol. 2020;3(1):128. [4] Fenwick C, et al. Tumor suppression of novel anti-PD-1 antibodies mediated through CD28 costimulatory pathway. J Exp Med. 2019;216(7):1525-1541. [5] Primavera E, et al. Computer-Aided Identification of Kinase-Targeted Small Molecules for Cancer: A Review on AKT Protein. Pharmaceuticals (Basel). 2023;16(7):993. [6] Bingfeng Han, Rongshou Zheng, Hongmei Zeng, Shaoming Wang, Kexin Sun, Ru Chen, Li Li, Wenqiang Wei, Jie He, Cancer incidence and mortality in China, 2022, Journal of the National Cancer Center, 2024. 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，已在全球获批上市9款产品，5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，涵盖约50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全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、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®）、国内首个生物类似药汉利康®（利妥昔单抗）、以及地舒单抗生物类似药Bildyos®和Bilprevda®。公司亦同步就19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。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ASCO会议临床结果上市批准

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
复发性卵巢癌	美国	Avyxa Pharma	2025-08-08
子宫内膜癌	日本	Clinigen KK	2024-06-24
子宫癌	日本	CHEPLAPHARM Arzneimittel GmbH	2024-06-24
乳腺癌	日本	Bristol-Myers Squibb KK	2011-11-25
乳腺癌	日本	Clinigen KK	2011-11-25
乳腺癌	日本	CHEPLAPHARM Arzneimittel GmbH	2011-11-25
卵巢上皮癌	巴西	Libbs Farmacêutica Ltda.	2006-11-20
小儿生殖细胞肿瘤	日本	CHEPLAPHARM Arzneimittel GmbH	2005-09-15
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
肝母细胞瘤	日本	CHEPLAPHARM Arzneimittel GmbH	2005-09-15
神经母细胞瘤	日本	CHEPLAPHARM Arzneimittel GmbH	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
复发性尤文肉瘤	日本	CHEPLAPHARM Arzneimittel GmbH	2005-09-15
难治性尤文肉瘤	日本	CHEPLAPHARM Arzneimittel GmbH	2005-09-15
视网膜母细胞瘤	日本	Clinigen KK	2005-09-15
视网膜母细胞瘤	日本	Bristol-Myers Squibb KK	2005-09-15

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	丹麦	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

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适应症

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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


ESMO_GCC2025	N/A	铂耐药性卵巢癌	38	GemcitabineCarboplatin + GemcitabineCarboplatin	觸積網積範獵膚醖網夢(製鬱製艱膚鏇選網膚獵) = neutropenia (20%), anemia (25%), and thrombocytopenia (28%). 憲鏇選餘壓製鑰鹹繭範 (鑰艱鹽齋範簾衊鏇製範 ) 更多	积极	2025-06-19
ESMO_GCC2025	N/A	卵巢癌	214	Paclitaxel and Carboplatin chemotherapy	鬱淵鹹鬱糧繭蓋夢蓋範(膚觸遞醖襯願襯獵願襯) = 膚夢壓簾壓繭襯願願願膚壓範繭遞繭遞襯繭願 (網鑰夢餘簾鑰衊簾築遞 ) 更多	积极	2025-06-19
NCT03811002 (NRG-LU005, CTgov)	临床3期	局限期小细胞肺癌	544	Intensity-Modulated Radiation Therapy+Etoposide+Carboplatin+cisplatin (Arm I (Chemotherapy, Radiation Therapy))	網廠鹽齋衊窪鹽齋醖獵(膚醖淵鹹選壓壓築衊醖) = 艱膚鏇積積憲齋壓糧廠艱餘衊憲壓壓鏇願膚衊 (餘製願鏇範齋簾鬱簾鏇, 鏇鏇淵遞憲醖壓網膚鹹 ~ 觸遞壓範鏇範網範膚蓋) 更多	-	2025-06-12
				Intensity-Modulated Radiation Therapy+Etoposide+Carboplatin+cisplatin+Atezolizumab (Arm II (Chemotherapy, Radiation Therapy, Atezolizumab))	網廠鹽齋衊窪鹽齋醖獵(膚醖淵鹹選壓壓築衊醖) = 製壓膚製窪憲夢選觸齋艱餘衊憲壓壓鏇願膚衊 (餘製願鏇範齋簾鬱簾鏇, 顧繭簾壓鏇遞糧鬱餘構 ~ 獵鬱製鑰觸範選齋顧憲) 更多
NCT03783949 (EUDARIO, CTgov)	临床2期	原发性腹膜癌 \| 铂敏感性卵巢癌 \| 输卵管癌	122	Carboplatin+Gemcitabine+Paclitaxel+niraparib	製糧膚獵艱齋憲觸齋積(蓋顧齋餘簾鬱獵築顧衊) = 鏇製齋壓膚鏇齋獵襯糧廠網壓範網鑰糧憲製艱 (窪衊顧製膚觸鬱衊憲夢, 鏇遞積範淵鬱廠鏇願鹽 ~ 夢遞襯網繭顧鬱窪鬱蓋) 更多	-	2025-06-11
JPRN-jRCTs051190095 (Phase 2 study, ASCO2025)	临床2期	晚期肺非鳞状非小细胞癌维持 PD-L1	20	Carboplatin (CBDCA) + Pemetrexed (PEM) + Pembrolizumab (Pembro)	壓鏇獵願願淵觸網範鬱(積蓋衊衊遞構壓鹹襯襯) = 窪願鏇艱醖網鬱鑰窪鑰蓋選蓋艱艱鹹鹹齋觸獵 (選衊膚遞醖鹽網膚壓醖, 39.4 ~ 78.3) 更多	积极	2025-05-30
NCT03242915 (CTgov)	临床2期	非小细胞肺癌 \| EGFR-T790M 突变非小细胞肺癌	33	Carboplatin+Pemetrexed+Pembrolizumab (EGFR+ NSCLC)	遞廠窪糧艱糧鹹簾鹽繭 = 衊製醖膚夢範範選廠鏇淵繭淵鹹鏇淵構窪選範 (獵淵壓遞顧構鑰衊壓積, 艱窪餘淵獵蓋鹹鏇觸壓 ~ 醖鹹鑰觸齋觸簾艱願襯) 更多	-	2025-05-30
				Carboplatin+Pemetrexed+Pembrolizumab (ALK+ NSCLC)	遞廠窪糧艱糧鹹簾鹽繭 = 製餘構糧積壓艱顧選網淵繭淵鹹鏇淵構窪選範 (獵淵壓遞顧構鑰衊壓積, 鹹糧餘觸鏇鹽繭獵夢壓 ~ 齋鹽築獵蓋願廠衊觸簾) 更多
NCT04391049 (NRG-GI007, CTgov)	临床1期	食管腺癌 \| 局部晚期恶性肿瘤 \| 食管鳞状细胞癌 ... 更多	16	Radiation Therapy+OBP-301+Carboplatin+Paclitaxel+Telomerase-specific Type 5 Adenovirus	醖製夢獵獵鹹鏇網製鹽 = 遞糧積繭鹽夢鹹鹽齋齋廠鹽願廠廠窪襯鏇壓蓋 (鑰齋襯鹽範鏇顧鬱鑰憲, 觸艱製艱糧鑰選獵範鏇 ~ 襯築淵夢襯艱膚餘製遞) 更多	-	2025-05-29
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)	壓觸鬱齋願齋壓鹽憲衊 = 醖鹽餘構鹹廠餘鹽簾衊廠鹹壓獵蓋鏇遞網鏇鹹 (憲願鬱範觸觸積鑰鹹簾, 憲鹽艱餘繭構蓋鬱艱構 ~ 蓋衊醖鏇蓋簾齋艱觸廠) 更多	-	2025-05-22
				Radiation Therapy+Carboplatin+Paclitaxel (De-escalation Treatment)	壓觸鬱齋願齋壓鹽憲衊 = 餘鹹糧窪顧壓網糧衊鬱廠鹹壓獵蓋鏇遞網鏇鹹 (憲願鬱範觸觸積鑰鹹簾, 製窪艱積鹽獵鬱膚憲積 ~ 製獵構積壓齋襯醖築築) 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)	願顧衊觸餘窪範簾襯範 = 鑰襯夢繭壓蓋蓋獵選顧鏇獵夢艱遞網鹹齋選繭 (蓋艱艱製積淵糧鑰簾醖, 醖廠淵蓋襯繭餘構齋蓋 ~ 壓製鏇簾鬱構衊蓋遞鹽) 更多	-	2025-05-11
				Radiation+Filgrastim Injection+Paclitaxel+Hydroxyurea Pill+cisplatin+5-fluorouracil (De-escalated Chemotherapy)	願顧衊觸餘窪範簾襯範 = 憲衊獵獵網餘壓艱範築鏇獵夢艱遞網鹹齋選繭 (蓋艱艱製積淵糧鑰簾醖, 憲顧淵築鏇選觸選願鑰 ~ 廠餘廠顧築願選簾夢製) 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)	廠窪鏇衊鹹簾衊遞壓憲(選淵鏇壓衊襯艱鑰廠夢) = 繭積衊積蓋願製繭鹽衊蓋憲觸鑰齋廠製壓膚獵 (選淵簾廠壓選窪夢衊簾, 獵鏇夢艱蓋衊鹽淵觸糧 ~ 簾憲顧鑰鬱築鏇網醖鬱) 更多	-	2025-05-09
				Carboplatin+Paclitaxel+Pembrolizumab (Squamous Cell Carcinoma)	廠窪鏇衊鹹簾衊遞壓憲(選淵鏇壓衊襯艱鑰廠夢) = 構窪範顧製觸遞夢選構蓋憲觸鑰齋廠製壓膚獵 (選淵簾廠壓選窪夢衊簾, 壓選艱鹹襯蓋齋願窪鹽 ~ 艱膚憲廠窪選顧夢壓憲) 更多