A Randomized, Open-label, Phase 3 Trial of Petosemtamab in Combination With mFOLFOX6 or FOLFIRI Versus Cetuximab in Combination With mFOLFOX6 or FOLFIRI as First-line Treatment for Participants With RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer

The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer located on the left side of the colon that cannot be safely removed by surgery or has spread to other parts of the body.
Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or standard-of-care cetuximab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo.
The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

开始日期2026-08-11

申办/合作机构

Genmab A/S

NCT07353957

/ Withdrawn临床2期

A Phase 2 Study to Investigate the Safety and Efficacy of Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer in Combination With Pembrolizumab as First-Line Treatment

The study will test the efficacy and safety of petosemtamab in combination with Pembrolizumab in first line patients with squamous non-small cell lung cancer and non-squamous non-small cell lung cancer.

开始日期2026-03-27

申办/合作机构

Merus NV

JPRN-jRCT2031240724

/ Active, not recruiting临床3期

A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab Vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma

开始日期2025-02-28

申办/合作机构-

100 项与 Petosemtamab 相关的临床结果

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100 项与 Petosemtamab 相关的转化医学

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100 项与 Petosemtamab 相关的专利（医药）

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项与 Petosemtamab 相关的文献（医药）

2026-12-31·mAbs

Antibodies to watch in 2026

Review

作者: Pinto, Kieran ; Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Reichert, Janice M. ; Chenoweth, Alicia ; Hsu, Yu-Shin

The Antibodies to Watch article series provides annual updates on commercial late-stage clinical development, regulatory review, and marketing approvals of antibody therapeutics. Since the first article was published in 2010, the late-stage pipeline has grown from 26 antibody therapeutics to over 200, while during the same time numerous molecules in late-stage studies either transitioned to regulatory review and were approved or were terminated. In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab. As antibody therapeutics development is a global enterprise, we also discuss trends in annual first approvals granted to antibody therapeutics in any country since 2010, stratified by the antibody's country of origin, documenting the notable increases in the total number of first approvals and those approved first in China. Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by their therapeutic area, mechanism of action, format, and country of origin. Our data show that the development and approval period were typically ~6 years, but on average this period was shorter for China-originated products.

2026-08-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Immunotherapeutic strategies in HPV-positive and HPV-negative recurrent/metastatic oropharyngeal squamous cell carcinoma: From PD-1 blockade to EGFR-directed bispecifics and therapeutic HPV vaccines

Review

作者: Del Mastro, Lucia ; Gili, Riccardo ; Di Bello, Armando ; Caterino, Marianna ; Cassano, Alessandra ; Bassolino, Antonio ; Fasano, Morena ; Polidori, Sara ; Falcicchia, Renato ; Tortora, Giampaolo

Oropharyngeal squamous cell carcinoma (OPSCC) comprises two biologically distinct entities, HPV-positive and HPV-negative disease, which differ in etiology, immune microenvironment, molecular drivers, and clinical behavior. This narrative review summarizes current evidence on immunotherapeutic strategies in OPSCC, focusing on subtype-specific biological rationale and emerging treatment approaches. A literature search of PubMed/MEDLINE, Embase, Cochrane Library, ClinicalTrials.gov, and major oncology meeting abstracts was conducted for studies published from January 2000 to February 2026. PD-1/PD-L1 inhibitors represent the current standard of care in recurrent/metastatic disease, with HPV-positive tumors generally showing more favorable outcomes, likely reflecting a more inflamed and antigen-rich tumor microenvironment. However, HPV status remains primarily a prognostic rather than a validated predictive biomarker for checkpoint inhibitor benefit. In contrast, HPV-negative OPSCC is more frequently characterized by immune exclusion, EGFR dependence, hypoxia, and activation of MET/HGF and TGF-β pathways, supporting the development of EGFR-centered and bifunctional strategies to overcome resistance. Emerging agents such as ficerafusp alfa, petosemtamab, and amivantamab have demonstrated promising early clinical activity, particularly in biomarker-enriched or post-immunotherapy settings. In HPV-positive disease, therapeutic vaccines targeting E6/E7 oncoproteins have shown encouraging immunogenicity and preliminary antitumor activity, especially when combined with PD-1 blockade. Overall, the immunotherapeutic landscape of OPSCC is evolving toward a biomarker-driven framework integrating viral status, immune contexture and pathway activation to enable more precise and personalized treatment strategies.

2026-05-01·CURRENT OPINION IN ONCOLOGY

Recent highlights and breakthroughs in immunotherapy for head and neck cancers

Review

作者: Vuille, Joanna A ; Szturz, Petr

Purpose of review:

This review highlights recent advances in immunotherapy for head and neck oncology, focusing on pivotal studies, both early-stage and late-stage, published or presented in 2025.

Recent findings:

Noteworthy results were reported with immune checkpoint inhibitors in mucosal squamous cell carcinoma of the head and neck (SCCHN) (KEYNOTE-689 and NIVOPOSTOP trials evaluating pembrolizumab and nivolumab, respectively, in the perioperative setting); in nasopharyngeal carcinoma (DIPPER and DIAMOND trials evaluating camrelizumab and toripalimab, respectively, in the curative setting with radiotherapy, and tagitanlimab in recurrent and/or metastatic disease); in cutaneous squamous cell carcinoma of the head and neck region (C-POST trial in the adjuvant setting and the combination of avelumab with cetuximab in the palliative setting); and in BRAF V600E-mutated anaplastic thyroid carcinoma (pembrolizumab with dabrafenib and trametinib). Passive immunotherapy targeting tumor-associated antigens also showed encouraging activity in R/M-SCCHN (petosemtamab, ficerafusp-alfa, amivantamab, enfortumab vedotin) and in heavily pretreated R/M nasopharyngeal carcinoma (antibody-drug conjugates becotatug vedotin and izalontamab brengitecan [iza-bren]).

Summary:

Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors.

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项与 Petosemtamab 相关的新闻（医药）

2026-08-06

·ir.genmab.com

Genmab Announces Financial Results for the First Half of 2026

August 6, 2026 Copenhagen, Denmark; Interim Report for the Six Months Ended June 30, 2026 Highlights Genmab announced positive Phase 3 results for epcoritamab plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), demonstrating statistically significant improvement in progression-free survival Genmab revenue increased 25% compared to the first six months of 2025, to $2,051 million Genmab 2026 financial guidance updated “The second quarter of 2026 delivered clinical progress for our late-stage portfolio. Epcoritamab continued to demonstrate its potential as a core therapy across the spectrum of B-cell malignancies, with strong data across multiple treatment settings and patient populations. At the same time, new data further support the development of Rina-S® (rinatabart sesutecan) in combination in advanced ovarian cancer. Together, these results reflect our continued commitment to delivering meaningful advances for patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Financial Performance First Half of 2026 Revenue was $2,051 million for the first six months of 2026 compared to $1,640 million for the first six months of 2025. The increase of $411 million, or 25%, was primarily driven by higher DARZALEX® and Kesimpta® royalties and higher EPKINLY® net product sales. Royalty revenue was $1,708 million in the first six months of 2026 compared to $1,378 million in the first six months of 2025, an increase of $330 million, or 24%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta. Net sales of DARZALEX by J&J were $8,171 million in the first six months of 2026 compared to $6,776 million in the first six months of 2025, an increase of $1,395 million or 21%. Global net sales of EPKINLY/TEPKINLY® were $312 million in the first six months of 2026 compared to $211 million in the first six months of 2025, an increase of $101 million or 48%. Cost of product sales were $149 million for the first six months of 2026 compared to $99 million for the first six months of 2025. The increase of $50 million, or 51%, was primarily driven by the profit-sharing amounts payable to AbbVie related to EPKINLY sales. Adjusted operating expenses, excluding Acquisition and integration related charges, were $1,270 million for the first six months of 2026 compared to $993 million for the first six months of 2025. The increase of $277 million, or 28%, was primarily driven by investment in our product pipeline, including the advancement of Rina-S and petosemtamab, and our global commercialization capabilities in preparation for their anticipated launches. Acquisition and integration related charges related to the integration of Merus were $77 million in the first six months of 2026. Amortization of acquired intangible assets was $24 million for the first six months of 2026 compared to $6 million for the first six months of 2025. The increase of $18 million, was primarily driven by the amortization of the Merus technology platform. Operating profit was $555 million in the first six months of 2026 compared to $548 million in the first six months of 2025. Adjusted operating profit, which excludes Acquisition and integration related charges and Amortization of acquired intangible assets, was $656 million in the first six months of 2026 compared to $554 million in the first six months of 2025. Outlook Genmab is updating its revenue, adjusted operating expenses and adjusted operating profit guidance for 2026. The improved guidance is driven by higher total royalty revenues from DARZALEX and net sales of EPKINLY. 2026 FULL YEAR OUTLOOK 1 Net product sales/Collaboration revenue consists of EPKINLY net product sales in the U.S. and Japan, and Tivdak® ex-U.S. net product sales plus Genmab's share of U.S. gross profits. 2 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $90 million and 2) amortization of intangible assets acquired through acquisitions of $47 million. 3 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $65 million and 2) amortization of intangible assets acquired through acquisitions of $45 million. Non-IFRS Financial Measures Our Adjusted operating expenses and Adjusted operating profit excludes acquisition and integration related charges and amortization of acquired intangible assets. These charges were recognized in prior periods and will likely reoccur in future periods. These items are excluded from operating expenses and operating profit because the Company believes they neither relate to the ordinary course of the Company's business nor reflect the Company's underlying business performance. Non-IFRS information is intended to portray the results of our baseline performance, supplement or enhance management's, analysts' and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with IFRS and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure. Conference Call Genmab will hold a conference call to discuss the results for the first six months of 2026 today, Thursday, August 6, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: https://register-conf.media-server.com/register/BId9cf2ff8aa3c489ca2ad2007d64a1964. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations. Contact Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs T: +1 609 524 0065; E: mmp@genmab.com Andrew Carlsen, Vice President, Head of Investor Relations T: +45 3377 9558; E: acn@genmab.com The Interim Report contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in the Interim Report nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®; HexElect®; KYSO®, RAINFOL™, ProfoundBio™ and Rina-S® are trademarks of ProfoundBio, U.S., Co. and Genmab (Suzhou) Co., Ltd. Tivdak® is a trademark of Seagen Inc.; EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.; Biclonics® and BIZENGRI® are registered trademarks of Merus N.V. Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®, RYBREVANT®, RYBREVANT FASPRO™,TECVAYLI® and TALVEY® are trademarks of Johnson & Johnson; TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC. Download the full Interim Report for the First Half of 2026 on attachment or at www.genmab.com/investor-relations CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/S Carl Jacobsens Vej 30 2500 Valby Denmark Attachment 060826_CA34_Genmab Interim Report H1 2026

财报临床结果临床3期

2026-08-05

·万象类器官

【Science】NAMs 从辅助工具到核心支点，类器官如何重塑下一代药物研发核心标准

类器官带来的不是实验工具的简单替换，而是全链条临床前评价逻辑革新，依托全球监管支持、三类成熟模型与多技术融合，逐步消解人与动物间的转化壁垒。背景数十年来，药物开发行业高度依赖动物模型开展临床前评价。动物实验虽为药物药效、安全性研究提供了重要支撑，但仅能近似模拟人体生理、代谢与免疫反应，无法完整复现人体真实生物学特征。这一先天局限，让整个药物研发管线长期陷入周期漫长、成本高昂、预测准确度不足的困境：数据显示，超过90%在临床前研究中展现潜力的化合物，最终都无法通过人体临床试验寡核苷酸药物、抗体-药物偶联物、靶向蛋白降解剂等新型治疗模态的出现，进一步拉大了动物与人体间的转化鸿沟。这类新药靶向的分子靶点、信号通路，大多在动物体内缺失或不具备等效功能，传统动物模型已经难以解答当下新药研发核心关注的药效与安全问题。文章说了什么 2026年，斯坦福大学 Joseph C. Wu 团队在国际顶级期刊《Science》发表重磅综述，系统性评价 NAMs（New Approach Methodologies, 新方法学）替代方案。在整套体系中，落地成果最丰富、临床转化价值最高的核心支柱，正是类器官（Organoids）。凭借三维自组装结构，类器官能够复刻人体器官的空间架构、细胞异质性与真实病理特征，为打破 "体外模型 → 临床疗效" 的转化魔咒提供了全新路径。政策“全面放行”：类器官数据可直接用于新药申报 Part.1 以往阻碍类器官商业化的最大痛点——缺乏官方审评效力，如今已被全球监管政策逐步打通：美国《FDA现代化法案2.0》（2022）与3.0（2025）明确规定：人源细胞模型、类器官、器官芯片数据，可作为非临床证据链的重要组成部分提交审评，不再强制要求动物实验作为临床研究的先决条件。 ICH 与 OECD 已出台标准化体外实验指南，将人iPSC来源心肌细胞纳入心脏安全性评价国际标准（E14/S7B框架），肝脏、气道类器官的标准化规范也在推进中。 2025年美国 NIH 投入8700万美元，成立标准化类器官建模中心（SOM Center），初期聚焦肝、肺、心、肠四种类器官，从细胞质控、培养流程到功能验证建立统一标准，着力解决长期困扰行业的"批次差异大、重复性差"问题。英国政府2025年11月发布《动物替代路线图战略》，明确2025至2030年为过渡期，逐步淘汰科研动物使用，优先扶持人源3D模型替代毒性试验（图-1）。如今，类器官已从实验室研究工具逐步升级为具备监管效力的标准化药物评价平台。图-1 三大类器官体系，精准适配不同疾病领域研发需求 Part.2 综述将类器官完整划分为三大体系，各有明确的应用场景和不可替代的临床价值：成体干细胞来源类器官：复刻成熟组织原生特征直接取材人体活检组织（肠道、皮肤、肝脏等），无需重编程，天然保留器官区域功能与表观遗传记忆。这类类器官适合慢性炎症性疾病（如炎症性肠病）及环境相关肝病的药物评价。局限在于无法构建脑、心肌等不具备活跃增殖干细胞的组织。 iPSC诱导多能干细胞类器官：遗传病与罕见病的理想模型通过体细胞重编程获得干细胞，定向分化成心脏、脑、视网膜、肝脏等组织，完整保留患者全部基因突变。囊性纤维化患者气道类器官已用于精准预测CFTR靶向药的临床疗效；渐冻症研究则借助iPSC类器官筛选出罗匹尼罗（Ropinirole），实现老药新用拓展。该路径无胚胎伦理争议、可无限传代，是单基因遗传病和罕见病领域目前最接近理想的体外模型。患者来源肿瘤类器官（PDTO）：肿瘤新药开发的关键平台直接取自手术或活检肿瘤样本，1:1 复刻患者肿瘤的病理结构、基因突变谱与微环境特征。综述重点提及的 MCLA-158（Petosemtamab），是全球首个通过实体瘤类器官筛选进入临床的候选药物。该双特异性抗体靶向EGFR和LGR5，从靶点验证到临床前开发均以结肠癌类器官为模型，目前处于II期临床阶段。此外，肝癌、肺癌、儿童肾癌PDTO的药敏结果，已有研究显示与患者真实临床响应高度匹配，可在临床前阶段提前区分有效人群，降低后期试验失败风险。类器官的核心优势：补足传统模型的系统性缺陷 Part.3 类器官的核心竞争力源自其对人体组织特征的直接复现能力。在结构层面，二维细胞培养缺乏分层结构与间质互作，动物模型则受限于物种间的基因调控差异。类器官通过自组装形成多层细胞结构，完整保留器官特有的细胞亚型分布与胞间信号通路。以肠道类器官为例，其包含吸收细胞、杯状细胞、干细胞及免疫细胞，再现了真实肠上皮微环境。在疾病适配性层面，三类高难度疾病领域尤其受益于类器官技术：衰老与环境相关慢病（如慢阻肺、肝纤维化）中，成体来源类器官保留了长期外界刺激带来的表观遗传损伤；先天遗传病方面，iPSC类器官自带致病突变，可追踪发育早期病变，这是动物模型无法覆盖的场景；实体肿瘤领域，PDTO保留了患者全部突变背景，解决了小鼠异种移植瘤模型中微环境不兼容的固有缺陷。在研发链条覆盖层面，从靶点发现与验证、高通量先导化合物筛选，到"培养皿临床试验"阶段的个体化药敏预测，类器官可在各环节发挥功能。多技术协同融合升级：类器官、器官芯片与计算模型一体化发展 Part.4 静态类器官受限于氧气和营养物质的扩散能力，存在缺氧核心和培养周期受限等问题。微流控芯片的引入改善了物质交换条件，使长期灌流培养和实时监测成为可能。将肝、心、肠、肿瘤类器官集成至同一微流控回路，则能够初步模拟药物吸收、分布、代谢和排泄的全身过程。 AI 在这一技术链条中的角色也在不断深化。生成式AI在分子设计层面已有实例验证 —— 综述提及的TNIK抑制剂（针对特发性肺纤维化），由AI完成生成与优化，在18个月内推进至II期临床，展示了计算驱动型研发的速度优势。主动学习框架则进一步构建了"设计-验证-优化"的闭环，Cellarity的DrugReflector平台整合超过100万组转录组扰动数据，通过迭代实验将活性分子命中率较随机筛选提升17倍，候选化合物CLY-124已进入I期临床。综述提出的四步研发路线中，类器官是每一环节的核心实验载体：闭环实验室中AI设计分子经类器官验证后迭代优化；系统性安全评价中多器官类器官芯片用于评估全身毒副作用；培养皿临床试验中成规模的PDTO库支持体外模拟人群给药；数字孪生则基于类器官输出的人体特异性参数构建个体化治疗仿真模型（图-2）。图-2 未来十年展望：动物实验从"必选项"走向"补充项" Part.5 《Science》综述给出了明确的趋势判断：未来十年，以类器官为核心的人源NAMs模型将逐步成为新药申报的核心证据来源，动物实验将从刚性必选项退居为补充对照工具。这一转型意味着三重结构性变化：因临床后期失败导致的巨额研发损失有望大幅缩减，筛选周期相应缩短；罕见遗传病、人特异性肿瘤、呼吸道疾病等长期受困于"无动物模型可用"的研发瓶颈将获得突破性工具支撑；"一患者一类器官"的个体化药敏测试路径为精准医疗提供了体外验证平台。小结这篇《Science》综述的核心价值，是建立起以类器官为核心支撑的全新药物评价体系。作为整套人源化研发方案的核心载体，类器官能够高保真复现人体组织特有的病理与生理特征，搭配全球持续放宽的审评政策，再结合微流控、人工智能技术形成协同链路，有效消解物种差异带来的研发转化壁垒，适配各类新型靶向药、罕见病药物与肿瘤新药的研发需求。如今类器官技术已经完成从实验室走向应用的初步探索，想要真正重塑行业沿用多年的临床前研发逻辑，搭建全行业通用标准、推进系统化产业工程将是下一阶段的核心重心。参考文献： Wu X, Wu MA, Zou J, Kleinstreuer N, Wu JC. Reimagining human-centric drug development with new approach methodologies. Science. 2026 Apr 23;392(6796):371-378. doi: 10.1126/science.aeb0045. Epub 2026 Apr 16. PMID: 41990130; PMCID: PMC13155199.

2026-07-26

·CMJ1887

类器官赋能新药研发：监管规则与行业发展前景

在过去的十年中，与类器官相关的研究进入了黄金时代，这标志着生物医学的重大转变。类器官已广泛应用于工业部门，并获得了监管机构的认可。但是，在这种快速扩张中，缺乏对类器官相关法规和依据类器官获得新药临床试验申请（investigational new drugs，IND）审批的药物的概述。本文就类器官相关法规和IND审批的研究进展，以及类器官前景和局限性进行全面的综述。类器官发展历程类器官是一种利用干细胞（包括多能干细胞和组织特异性成体干细胞等）或祖细胞，在体外三维培养体系中形成的、具有类似体内相应器官的结构和部分功能的微型组织或器官模型。 2009年，Hans Clevers实验室开发出了首个肠道类器官，标志着基于类器官的疾病建模的开端。2011年，人类多能干细胞和原代成体干细胞都被用于培育肠道类器官，同年，培养出了源自胚胎干细胞的视网膜类器官。2012年，培养出了源自人类多能干细胞的视网膜类器官。2013年，研究取得的进展包括从人类多能干细胞中培育出脑、肝、肾和胰腺类器官。在随后的几年里，前列腺和肺类器官（2014年）以及乳腺、输卵管和海马体类器官（2015年）相继被开发出来。2020年，研究人员成功培育出了蛇毒腺类器官，次年，软骨肉瘤类器官被诱导生成。到2022年，由人类多能干细胞培育出了毛发皮肤类器官，到2023年，具有转录多样性和特征的腹侧丘脑类器官从人类胚胎干细胞（hESC）中衍生出来。截至目前，已经成功建立了食道、视网膜、大脑、肾脏、肝脏、前列腺、乳腺和角膜的类器官模型，以及食管癌和脑胶质瘤的类器官模型。类器官模型的相关法规新药研发周期漫长和成本高昂确实极大地限制着药物开发进程，类器官具有与临床关联度更高、实验周期短、费用较低等特点，随着法规的变化，类器官和器官芯片可能会改变新药研发现状。在2010年，美国食品药品监督管理局（FDA）与美国国立卫生研究院（NIH）等机构共同合作开启 “组织芯片药物筛选计划”，旨在开发出一套模拟人体器官的芯片，建立起更准确、更有效的药物筛选模型，减少药物研发过程中对动物实验的依赖，提高药物研发的成功率，降低研发成本和风险。FDA Modernization Act 2.0 法案的通过，允许药物开发者在适当情况下使用包括类器官在内的替代方法进行临床前试验，不再强制要求进行动物试验，为类器官在药物研发等领域的应用开辟了道路，提供了政策层面的支持。欧洲药品管理局（EMA）《关于监管接受 3R（替代、减少、优化）测试方法原则的指南》建立可应用于监管用途的提交途径，也适用于类器官等技术。2021年，国家药品监督管理局药品审评中心（CDE）发布了鼓励使用二维或三维组织模型、类器官模型等创新仿生模型技术方面研发的相关指导。2024年，CDE 发布《模型引导的罕见病药物研发技术指导原则（征求意见稿）》强调由于罕见病的特殊性，要充分挖掘和利用一切可利用的数据，非临床研究数据来源包括基因、分子、细胞、类器官、器官芯片、动物研究数据等，明确了类器官数据在罕见病药物研发中的地位。使用类器官申报IND的药物的进展 2022年，赛诺菲和器官芯片公司Hesperos合作进行的新药SAR445088试验获FDA批准，成为全球首个完全基于“类器官芯片”研究获得临床前数据进入临床试验的新药。同年，北京循生生物医学研究有限公司通过类器官高通量平台获得的产品AVL-201临床试验的申请已受理。2023年，Merus公司通过人源类器官样本库筛选出的MCLA-158获得FDA批准临床试验，目前处于临床2期。同年，恒瑞医药HRS-1893片获批开展临床试验；北京艺妙神州医药科技有限公司自研的新一代抗肿瘤药物IM83使用类器官数据获IND；齐鲁制药开发的双特异性抗体肿瘤I类新药注射用QLF3108获得临床许可，目标适应证为晚期实体瘤。2024年，君赛生物通过类器官免疫共培养平台开发的基因修饰TIL细胞药物GC203的临床试验的申请已受理。类器官模型展望和挑战由于类器官本身的特点，其对药物筛选、验证及优化等具有重要作用，为药物研发带来了新的机遇和变革。同时，利用患者自身的细胞培养类器官，可以建立个性化的疾病模型，用于测试不同药物对患者个体的疗效，为患者制定个性化的治疗方案。此外，类器官具有一定的自我组织和分化能力，可为再生医学研究提供新的思路。随着社会的发展，传染病的频率和类型正在增加，类器官在急性传染病的研究、防治等方面具有独特的价值，可用于快速筛选治疗急性传染病的药物等。尽管类器官具有巨大潜力，但目前仍存在一些挑战，如类器官的标准化培养、模型的复杂性和伦理道德等问题。综上，在相关法规支持下，类器官模型能够帮助突破基于传统药物检测模型的局限性，加快药物测试，提高临床前安全性和功效评估的精度，从而减轻患者的风险并降低药物开发成本。尽管当前仍存在技术与临床挑战，但随着相关研究的进步，类器官在药物开发及个性化治疗等领域潜力巨大。作|者|介|绍通信作者：张玉柱就职于台州市中心医院（台州学院附属医院）肿瘤外科，硕士研究生导师。从事甲乳外科临床工作及肿瘤类器官相关分子药理学的研究。以第一作者在Journal of Clinical Oncology, Cancer Letters, Molecular Therapy - Nucleic Acids, Chinese Medical Journal, European Journal of Medicinal Chemistry上发表论文。近年来主持国家自然科学基金项目、中央本级重大增减支项目子课题、浙江省自然科学基金公益项目、浙江省省医药卫生科技项目多项。 END 供稿｜张玉柱编辑｜郝秀原、周思含初审｜高婷终审｜魏佩芳点击下方“阅读原文”查看全文

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100 项与 Petosemtamab 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
RAS/BRAF基因野生型结直肠癌	临床3期	美国	Genmab A/S	2026-08-11
复发性头颈部鳞状细胞癌	临床3期	美国	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	日本	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	阿根廷	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	澳大利亚	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	比利时	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	巴西	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	加拿大	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	智利	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	克罗地亚	-	2024-09-25

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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


NCT07353957 (MCLA-158-CL04, ASCO2026)	临床2期	转移性非小细胞肺癌一线 PD-L1 high	80	Petosemtamab plus pembrolizumab (PD-L1 high (TPS ≥50%) + metastatic non-small cell lung cancer)	齋鬱築繭顧鏇鬱艱簾網(蓋構襯壓遞襯鏇襯齋鏇) = 壓鹹選遞鬱醖窪廠壓鏇鬱廠獵齋構鏇窪積鏇網 (獵醖鑰醖簾顧選鹹選襯 )	积极	2026-05-29
Company_Website 人工标引	临床2期	微卫星稳定型结直肠癌 Microsatellite Stable (MSS) \| BRAF Gene Mutation Negative \| KRAS Gene Mutation Negative \| ... 更多	54	Petosemtamab + FOLFOX/FOLFIRI (1L treatment)	襯廠蓋簾鏇鬱壓選網糧(築糧艱鹹願襯積齋餘繭) = 鹽醖鑰膚廠壓夢淵獵壓廠餘壓壓觸齋製醖顧鏇 (壓衊積網獵衊簾壓積範 ) 更多	积极	2025-10-24
				Petosemtamab + FOLFOX/FOLFIRI (2L treatment)	襯廠蓋簾鏇鬱壓選網糧(築糧艱鹹願襯積齋餘繭) = 構繭簾積構醖選膚鹹繭廠餘壓壓觸齋製醖顧鏇 (壓衊積網獵衊簾壓積範 ) 更多
NCT03526835 (LiGeR-HN1, ASCO2025)	临床2期	食管癌 \| 晚期恶性实体瘤 \| 头颈部鳞状细胞癌 ... 一线 PD-L1+ 更多	45	Petosemtamab 1500 mg	憲鹹夢網襯築餘觸鬱壓(艱鹹壓遞積鏇選鑰艱襯) = 製顧憲襯齋積鏇淵遞獵窪構鏇願襯製簾觸憲觸 (夢積構築艱製觸願夢廠 ) 更多	积极	2025-05-30
NCT03526835 (NEWS) 人工标引	临床1/2期	头颈部鳞状细胞癌一线 PD-L1 Positive	43	petosemtamab + Keytruda	積願觸顧獵餘鬱範餘鑰(齋鏇淵膚獵蓋廠鏇齋衊) = 觸鏇鏇壓鑰積襯窪鏇獵獵遞鏇願廠憲選鏇簾製 (選襯鏇獵餘構鬱糧範糧 ) 更多	积极	2025-05-28
				Keytruda (历史数据)	積願觸顧獵餘鬱範餘鑰(齋鏇淵膚獵蓋廠鏇齋衊) = 繭範簾鏇顧願範淵積築獵遞鏇願廠憲選鏇簾製 (選襯鏇獵餘構鬱糧範糧 )
Company_Website 人工标引	临床1/2期	PD-L1阳性头颈部鳞状细胞癌三线 PD-L1 Expression	82	Petosemtamab 1500 mg Q2W	觸鏇顧願觸窪鬱淵餘遞(齋鏇製獵鏇衊構網獵網) = 繭願範襯憲餘製夢憲網築膚憲獵網遞繭構簾艱 (餘鏇製鹹鹹憲鬱襯願選, 27–46) 更多	积极	2024-12-07
				Petosemtamab 1100 mg Q2W	觸鏇顧願觸窪鬱淵餘遞(齋鏇製獵鏇衊構網獵網) = 鏇積衊繭製壓膚網衊獵築膚憲獵網遞繭構簾艱 (餘鏇製鹹鹹憲鬱襯願選, 8–35) 更多
NCT03526835 (ESMO_ASIA2024) 人工标引	临床1/2期	头颈部鳞状细胞癌二线	54	Petosemtamab 1500 mg (single-arm cohort)	壓鏇鏇襯築鏇夢構網願(廠醖網夢衊築憲鏇艱遞) = 糧淵積淵蓋鏇繭憲醖蓋鹽糧蓋鏇淵繭繭選淵糧 (獵壓廠鬱獵醖餘壓築觸 ) 更多	积极	2024-12-07
				Petosemtamab 1500 mg (dose-comparison cohort)	壓鏇鏇襯築鏇夢構網願(廠醖網夢衊築憲鏇艱遞) = 鹽選積廠顧範齋襯糧獵鹽糧蓋鏇淵繭繭選淵糧 (獵壓廠鬱獵醖餘壓築觸 )
NCT03526835 (GlobeNewswire) 人工标引	临床2期	头颈部鳞状细胞癌二线	54	Petosemtamab 1500 mg	願膚築艱鏇鬱膚鹽構願(鑰繭淵淵製醖鹽積襯餘) = 網膚醖淵鑰衊鏇簾廠顧齋衊鹹襯廠繭廠鹹淵鹽 (艱顧糧廠齋衊製醖糧餘 ) 更多	积极	2024-12-01
				Petosemtamab 1100 mg	衊鏇鬱繭鹽餘獵衊製積(範憲襯醖遞壓遞製繭壓) = 築衊顧憲願鬱餘衊齋蓋艱繭鬱鑰廠繭製製鬱糧 (鑰構壓顧簾積簾齋觸願 )
NCT03526835 (phase 2 study, ASCO2024) 人工标引	临床2期	头颈部鳞状细胞癌一线	26	Petosemtamab/Pembrolizumab	醖廠觸範鏇願網繭範蓋(遞衊願繭衊簾築廠壓膚) = 糧鏇齋齋鑰窪製壓選襯獵顧鹹製醖蓋鏇廠築鬱 (窪選醖壓壓顧製壓顧夢 ) 更多	积极	2024-05-24
NCT03526835 (AACR2023) 人工标引	临床1/2期	食管腺癌 \| 胃腺癌三线 EGFR Expression	-	Petosemtamab 1500 mg	襯窪簾選鏇製鏇艱積製(製齋齋夢糧襯醖構鏇壓) = the most frequent AEs regardless of causality (all grades/G3-4) were rash (33%/0%), hypotension (26%/6%), dyspnea (26%/4%), nausea (26%/1%), dermatitis acneiform (24%/1%), blood magnesium decreased (19%/5%), erythema (19%/0%), diarrhea (19%/0%); IRRs (composite term) were reported in 74%/21% of pts, mostly at the first infusion, and all resolved. 製鏇顧簾憲獵蓋醖艱蓋 (蓋鹽憲齋糧衊獵蓋鹽淵 )	积极	2023-04-14
AACR2023 人工标引	N/A	晚期头颈部鳞状细胞癌	49	MCLA-158	糧廠膚膚選壓醖選網衊(憲蓋積襯簾窪夢繭願製) = 艱選艱範構願顧觸構網網鏇鏇襯鬱餘糧糧齋範 (壓艱糧觸鬱製願遞夢選 ) 更多	积极	2023-04-14