JCOG2507: A Phase III Randomized Controlled Trial Comparing Osimertinib plus Carboplatin plus Pemetrexed with Amivantamab plus Lazertinib for EGFR-Mutant Advanced Non-Squamous Non-Small Cell Lung Cancer (APEX)

开始日期2026-07-30

申办/合作机构-

NCT07586202

/ Recruiting临床2期

A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer

The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes, including EGFR.

开始日期2026-07-28

申办/合作机构

Janssen Research & Development LLC

NCT07507188

/ Not yet recruiting临床2期IIT

Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, Locally Advanced or Metastatic/Recurrent Non-Small Cell Lung Cancer (INSTAR Study)

* In this study, we hypothesized that immune engagement by amivantamab will enhance antitumor efficacy by modulating the immune microenvironment in combination with lazertinib in patients with untreated EGFR-mutant NSCLC or with chemotherapy (carboplatin plus pemetrexed) after progression with 3rd generation (3G) EGFR TKI.
* The primary objective of this study is to examine the patients' tumors for immunomodulatory effects of amivantamab-based regimens.
* In a phase 2, two cohort clinical trial, treatment naïve patients with EGFR-mutant NSCLC will be treated with amivantamab SC plus oral lazertinib (Cohort 1, n=30) or patients with EGFR-mutant NSCLC progressed on or after 3G EGFR TKI treated with amivantamab SC plus chemotherapy (Cohort 2, n=30).

开始日期2026-04-06

申办/合作机构

Yonsei University

100 项与埃万妥单抗相关的临床结果

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100 项与埃万妥单抗相关的转化医学

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100 项与埃万妥单抗相关的专利（医药）

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307

项与埃万妥单抗相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost comparison of osimertinib plus platinum-pemetrexed versus amivantamab plus lazertinib for the first-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer

Article

作者: Hearmon, Natalie ; Upton, Elysia ; Procter, Emily ; Nieva, Jorge J. ; Rattigan-Brown, Yanique ; Freeman, Harry ; Lopes, Gilberto de Lima ; Karia, Pritesh

OBJECTIVES:

Novel first-line (1L) combination regimens offer improved efficacy for patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) versus the standard of care, but their costs have not been comprehensively evaluated. Total and differential costs of 1L osimertinib plus platinum-pemetrexed, intravenous (IV) amivantamab plus lazertinib, and subcutaneous (SC) amivantamab plus lazertinib were estimated from a United States (US) payer perspective.

METHODS:

A cost of care model was developed to assess treatment acquisition, administration, disease management, and adverse event (AE) management costs for osimertinib plus platinum-pemetrexed versus IV and SC amivantamab plus lazertinib for patients with EGFRm NSCLC. A one-year time horizon was chosen to allow for direct treatment comparison; a one-year treatment duration was assumed for treat-to-progression regimen components.

RESULTS:

The total first-year cost per-patient for osimertinib plus platinum-pemetrexed (all-payer perspective: $172,600; private perspective: $253,529; Medicare perspective: $84,926) was over twofold lower than for IV amivantamab plus lazertinib (all-payer perspective: $418,176; private perspective: $618,240; Medicare perspective: $201,441) and for SC amivantamab plus lazertinib (all-payer perspective: $419,718; private perspective: $621,166; Medicare perspective: $201,482). This translated to per-patient cost savings of $245,577; $364,711; and $116,514 for osimertinib plus platinum-pemetrexed versus IV amivantamab plus lazertinib and $247,118; $367,637; and $116,555 versus SC amivantamab plus lazertinib for the all-payer, private, and Medicare perspectives, respectively.

LIMITATIONS:

Limited data availability necessitated cost conversions across payer perspectives and assumptions for select inputs, including specific concomitant medication durations. Additionally, as any payer-negotiated discounts for treatment are confidential, model treatment acquisition costs reflected list prices. These data limitations contributed to uncertainty surrounding model inputs.

CONCLUSIONS:

From a US payer perspective, osimertinib plus platinum-pemetrexed was associated with substantially lower overall costs compared with IV and SC amivantamab plus lazertinib for the 1L treatment of patients with EGFRm locally advanced or metastatic NSCLC.

2026-09-01·ORAL ONCOLOGY

Intravenous amivantamab after cetuximab failure in recurrent or metastatic head and neck squamous cell carcinoma: a single-centre retrospective real-world cohort study

Article

作者: Lin, Fengjuan ; Xue, Liqiong ; Guo, Ye ; Tang, Wenbo ; Zhou, Jiuli ; Zhao, Wei

BACKGROUND:

Patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who exhaust platinum, immune checkpoint inhibitors (ICIs), and cetuximab lack standard options. The OrigAMI-4 trial showed subcutaneous amivantamab activity in anti-EGFR-naïve patients; real-world intravenous (IV) amivantamab data after cetuximab failure are absent.

METHODS:

We retrospectively analysed consecutive R/M HNSCC patients treated with IV amivantamab monotherapy (November 2024-July 2025) after progression on standard therapies. Response was assessed per RECIST 1.1; toxicity per CTCAE v5.0.

RESULTS:

Twenty patients were included (median age 54 years; 70.0% male; median four prior systemic lines). All received prior platinum and ICIs; 18 (90.0%) progressed on cetuximab. At a median follow-up of 6.8 months, confirmed ORR was 30.0% (6/20; 95% CI 11.9-54.3) ; DCR at first reassessment (6 weeks) was 80.0% (16/20; 95% CI 56.3-94.3) and confirmed DCR at 12 weeks was 45.0% (9/20; 95% CI 23.1-68.5). Median PFS was 3.0 months (95% CI 2.3 to not reached) and median OS 9.7 months (95% CI 6.8 to not reached). The most frequent treatment-related adverse events were hypoalbuminaemia (90.0%), rash (70.0%), and infusion-related reactions (45.0%; all grade 1-2); two patients had grade 3 events, none discontinued treatment.

CONCLUSION:

In this small retrospective cohort, IV amivantamab showed antitumour activity in heavily pretreated, cetuximab-exposed R/M HNSCC, with a 30% confirmed ORR, 45% confirmed 12-week DCR, 9.7-month median OS, and no treatment discontinuations for toxicity. These data suggest that dual EGFR-MET targeting may retain clinical utility after anti-EGFR failure, and support prospective evaluation with biomarker stratification.

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.

1,608

项与埃万妥单抗相关的新闻（医药）

23 小时之前

·BiG生物创新社

MNC的AB面：砍掉不确定，买入确定性

7月中下旬，诺华、阿斯利康、强生和勃林格殷格翰（BI）等八家MNC陆续披露半年报。整体来看，全球医药市场仍由创新药大单品放量和中后期管线接续支撑，但不同企业的增长质量与业绩预期进一步分化，资本市场反馈也随之拉开差距。更值得关注的是，MNC的研发与资本配置逻辑正在从“以管线数量分散风险”转向“以资本回报筛选资产”。专利悬崖与内部研发效率下降共同放大了增长压力，也使临床确定性和商业兑现能力成为资产定价的核心。 01 低质量研发扩张周期结束 2026年，延续近三十年的全球药物研发管线扩张周期出现了拐点。据Citeline发布的《2026年医药研发年度回顾》显示，截至2026年1月，全球在研药物数量由上一年的23,875个下降至22,940个，降幅为3.9%。这是近三十年来全球研发管线规模首次收缩。过去，MNC习惯通过庞大的项目数量分散风险。只要候选药物足够多，即便单个项目成功率不高，最终也可能跑出几个重磅产品。然而，在当前研发成本持续攀升的背景下，行业已不再愿意为低确定性项目买单。越来越多企业选择及时止损，避免后期更高昂的失败成本。表1.2026上半年8大MNC削减管线情况数据来源：公开资料整理阿斯利康是其中的典型代表。2026年上半年，公司共终止13条管线，覆盖肿瘤、自免、心血管等多个治疗领域，且涉及从Ⅰ期到Ⅲ期的不同开发阶段（表1）。值得注意的是，同一天阿斯利康移除了两款自研ADC管线：EGFR/cMET双特异性ADC AZD9592和CLDN18.2 ADC AZD4360分别因为PK/PD不佳、疗效不足被终止。而从中国引进的CLDN18.2 ADC CMG901的III期达到双主要终点，管理层给出峰值销售30至50亿美元的预期。自研CLDN18.2 ADC AZD4360因疗效终止，同一天中国引进的同靶点ADC CMG901拿到了III期阳性。这说明在ADC这个高度依赖工程经验的领域，外部采购已成为阿斯利康填补管线的既定策略。罗氏的调整同样集中在缺乏足够验证的项目。据罗氏2026H1财报显示，其共有七款新药被移出管线。仅7月9日，罗氏便终止两款亨廷顿病反义寡核苷酸候选药物的临床开发。其中，与Ionis合作开发的tominersen在II期GENERATION HD2试验中，虽达到安全性和生物标志物终点，但经过16个月治疗，患者的功能、认知和运动能力均未获得实质改善。另一款候选药物RG6496则因动物模型提示长期重复给药可能存在安全隐患，在Ⅰ期首次人体试验阶段即被叫停。对罗氏而言，及时砍掉长期投入却缺乏临床兑现能力的低效管线是主动止损。面对神经退行性疾病高投入、高失败率的现实，能够动态调整赛道、集中资源于优势领域，正是其穿越周期的核心能力。除此之外，GSK、BMS和强生等MNC也作出了类似的战略取舍（表1）。因此，MNC所谓的研发降本是重新计算项目的预期回报。当一项资产的成功概率、商业价值和剩余开发成本不再匹配时，继续推进本身就是一种低效率的资本配置。从这个角度看，全球管线数量的首次收缩是低质量研发扩张周期的结束，MNC的研发模式将由“拼管线数量”转向“重资产质量”。 02 资源向确定性资产集中在清理低潜力项目的同时，MNC正在将资源集中到能够支撑当期业绩、同时具备适应症拓展或全球放量空间的大单品上（表2）。表2. 2026H1年MNC制药收入排名数据来源：官网信息整理 2026 H1，诺华净销售额为275.21亿美元，同比下降2%，核心营业收入下降7%。但肿瘤业务收入达到85.36亿美元，同比增长34%，成为表现最强的业务板块。其中，Kisqali上半年销售额达到32.11亿美元，同比增长48%，并在第一季度超过礼来阿贝西利，成为全球销售额最高的CDK4/6抑制剂。早期乳腺癌和转移性乳腺癌两大市场共同推动放量。其临床基础也为增长提供支撑。紧随其后接力的是放射配体疗法Pluvicto，该产品上半年销售额12.93亿美元，同比增长55%，主要由转移性去势抵抗性前列腺癌市场需求推动。也是在通过技术平台、生产供应链和临床开发能力，提高后来者复制与追赶的难度。与此同时，Kesimpta、Cosentyx和Leqvio等产品在不同治疗领域形成接力。在多款大单品的共同驱动下，诺华在Q2单季销售额达到144.08亿美元，同比增长1%，成功扭转一季度颓势。 BI的增长确定性更为直观。2026 H1，公司总营收达到183.49亿美元，同比增长16.2%；人用药品业务收入153.1亿美元，同比增长20.1%。其中，仅Jardiance（恩格列净）一款产品便贡献66亿美元收入，仍是公司最主要的增长动力。但BI并非只依赖一款成熟产品。2025年获批的肺纤维化药物Jascayd（那米司特）和HER2突变非小细胞肺癌药物Hernexeos（宗艾替尼）已经开始商业化。与此同时，GLP-1R/GCGR双激动剂Survodutide进入Ⅲ期并取得积极数据，公司还启动了三项肿瘤Ⅲ期研究。从Jardiance的持续放量到Jascayd和Hernexeos两款新药进入商业化，再到多项Ⅲ期资产推进，BI正在将单一产品的增长优势转化为更具延续性的业绩支撑。强生也不例外，2026年上半年，强生创新制药业务收入318.10亿美元，同比增长9.4%，其中肿瘤业务增长19.9%。Darzalex收入达到81.71亿美元，增长20.6%；Carvykti增长55.1%至12.54亿美元；Tecvayli、Talvey和Rybrevant三款双抗合计收入13.34亿美元。自身免疫领域的Tremfya增长70.6%，神经科学产品Spravato增长43.2%。尽管这些产品覆盖不同技术平台，但它们都已经越过早期概念验证，进入适应症拓展和商业放量阶段。正是由于核心产品增长具备较高可见度，强生将全年营收指引从1003亿至1013亿美元上调至1008亿至1014亿美元。赛诺菲、罗氏和GSK财报中也能看到类似的资源集中趋势（表2）。由此来看，MNC正在形成清晰的三层增长结构，最上层是当期贡献现金流的大单品，中层是刚上市或正在拓展适应症的新产品，底层则是距离注册较近的Ⅲ期资产。对于无法进入这三层结构、又缺乏明显技术差异化的项目，其继续留在管线中的价值正在迅速下降。 03 研发竞争资本化管线收缩和资产聚焦的背后，是日益迫近的专利悬崖。据Evaluate Pharma数据显示，2027年至2028年间，预计将有年销售额超过1800亿美元的药物失去专利保护，约占全球药品市场的12%。这意味着，MNC需要在非常有限的时间窗口内，找到足以填补千亿美元收入缺口的新产品。压力已经反映在财报中。强生的Stelara在2025年迎来生物类似药竞争后，国际市场销售额在2025年一年内下降近33%。另一款自免产品Simponi的美国化合物专利已经于2024年到期，目前也有生物类似药处于开发阶段。诺华的Entresto已经失去美国市场独占权，多家仿制药获得FDA批准；该产品同时进入美国首轮医保谈判，谈判价格降幅达到53%，并于今年生效。对诺华而言，即使Kisqali、Kesimpta和Pluvicto仍在高速增长，也必须尽快完成新旧产品切换。罗氏面对的是更长周期的HER2产品迭代压力。Herceptin之后，Perjeta和Kadcyla接过了收入贡献，但Kadcyla的核心专利已在欧美部分地区到期，同时受到Enhertu扩张的挤压。2026年上半年，Kadcyla销售额同比下降6%。Perjeta也进入生物类似药竞争窗口，罗氏因此通过固定剂量皮下注射制剂Phesgo改善给药便利性，试图延长产品生命周期。 GSK的核心HIV产品Dovato将在2028年面临专利到期。公司一方面要从2024年314亿英镑收入增长至2031年超过400亿英镑，另一方面必须在Dovato收入承压前建立新的增长支柱。对GSK而言，这是一场产品周期与研发周期之间的赛跑。然而，专利悬崖压力之外，MNC内部研发管线收益率持续走低，据摩根士丹利报告显示，MNC内部研发管线收益率不足5%，难以支撑公司市值和净资产收益率，相比之下，MNC通过BD与并购合作快速填补产品线缺口，这种“借力”策略比完全自主研发更加高效和经济。以GSK为例。2026年上半年，GSK研发投入为51.58亿英镑（约69.38亿美元），同时启动“Accelerate Growth”成本节约计划，目标到2029年实现每年19亿英镑（约25.56亿美元）节约。节省下来的资源将用于后期管线，公司预计2026年启动超过20项Ⅲ期研究。与此同时，GSK以约106亿美元完成对Nuvalent的收购，获得zidesamtinib和neladalkib等晚期肺癌资产。这一系列动作并非简单削减研发，而是通过压缩低回报成本，将更多资金投向成功概率更高项目上。由此，MNC的研发竞争开始呈现明显的资本化特征。研发预算的边际增量越来越多地流向BD和并购。面对专利悬崖与内部研发效率下降的双重压力，MNC愿意为更高的临床确定性和更清晰的商业前景的资产支付溢价。写在最后 2026年上半年的MNC的财报折射出全球药企资本配置方式的深刻变化：高质量资产因临床确定性与时间价值而愈发昂贵，缺乏差异化的普通项目则可能同时失去融资和交易机会。增长焦虑并未削弱MNC的下注意愿，反而推动资本加速向确定性资产集中，并由此催生出越来越显著的“确定性溢价”。参考资料 [1]https://www.citeline.com/en/rd26 [2]国信证券、中信建投、东吴证券研报 [3]各企业财报，各种公开资料等近期活动第12届 BiG IMPACT年会10月23-24日将在上海张江正式启幕，本次年会汇聚哈佛院士、RA Capital等全球顶级产学研投力量，打造中国创新对话世界的稀缺跨境平台；早鸟6折优惠截至8月31日，点击报名锁定国际前沿盛宴！时间及地点：10月23-24日（周五-周六）上海-张江希尔顿；规模：800-1000人报名入口 ▼ 参会通道 VIP 门票：3000 元 / 人；含：全部论坛 + 闭门会 + 23 日晚宴 + 24 日午餐会议门票：1000元/人；含：10月23-24日公开会议 * 以上付费门票 8月31日前可享早鸟价 6折优惠会员 / 特邀通道：免费；审核制（限 BiG 会员 / 特邀 / 往届 speaker），权益同VIP门票院校 / 临床通道：免费；审核制（仅含10月23-24公开会议，不含午餐及晚宴）共建Biomedical创新生态圈！如何加入BiG会员？

财报临床3期

2026-07-31

·Healthcare Digital

Johnson & Johnson and Firefly: Targeting KRAS-Driven Cancers

Johnson & Johnson has built one of the industry's most diversified oncology portfolios. Credit: National Cancer Institute / Unsplash Johnson & Johnson is hoping it can improve treatment outcomes for one of oncology’s toughest challenges after confirming the acquisition of Firefly Bio KRAS mutations occur in roughly one in five human cancers , making them among the most common oncogenic drivers. The mutations multiply rapidly, making them challenging to treat, and are particularly common in pancreatic cancer sufferers, where the vast majority of tumours contain a KRAS mutation. After completing its acquisition of Firefly Bio, a preclinical biotechnology company developing targeted protein degradation cancer therapies, Johnson & Johnson is hoping Firefly's degrader antibody conjugate (DAC) technology can improve treatment outcomes for one of oncology's most difficult molecular targets. Using its proprietary FireLink DAC platform, Firefly aims to selectively deliver protein degraders to cancer cells, initially targeting KRAS-driven solid tumours. A new approach to KRAS treatment John Reed, Executive Vice President of Pharmaceuticals and R&D at Johnson & Johnson Innovative Medicine, believes the acquisition will deliver more meaningful and lasting treatment options for patients battling KRAS-driven cancer. On LinkedIn following the acquisition’s confirmation, he writes, “Despite recent advances, improvements in treatments for KRAS-driven cancers are still needed, with the aim of reducing toxicities and prolonging the durability of responses. John Reed, Executive Vice President of Pharmaceuticals and R&D at Johnson & Johnson Innovative Medicine. Credit: Johnson & Johnson By delivering a highly selective KRAS protein degrader directly into tumour cells, the DAC platform is designed to target degrader molecules where they are needed, while preserving healthy tissues – potentially overcoming key limitations associated with existing untargeted approaches.” Why are KRAS-driven cancers so difficult to treat? For decades, KRAS was considered "undruggable" because: The protein has a very smooth surface with few places for drugs to bind. It binds its natural fuel molecule (GTP) extremely tightly. It naturally cycles rapidly between active and inactive states, making it difficult for drugs to bind effectively. Until recently, treatment options have largely been limited to chemotherapy, immunotherapy and therapies targeting pathways downstream of KRAS. A diverse oncology portfolio Johnson & Johnson has built one of the industry's most diversified oncology portfolios, spanning conventional biologics, cell therapies and next-generation targeted treatment platforms. It includes established multiple myeloma treatments Darzalex and Carvykti, alongside newer medicines such as Rybrevant, Talvey and Tecvayli. Firefly marks the company's latest investment in next-generation oncology technologies. Prior to the Firefly acquisition, Johnson & Johnson’s most recent oncology deal was the US$3.05bn purchase of clinical-stage biotech firm Halda Therapeutics in December 2025, which expanded its presence in solid tumours through Halda's RIPTAC platform. Jennifer Taubert, Executive Vice President and Worldwide Chairman of Johnson & Johnson Innovative Medicine. Credit: Johnson & Johnson. Speaking at the time of the Halda Therapeutics acquisition, Jennifer Taubert, Executive Vice President and Worldwide Chairman at Johnson & Johnson Innovative Medicine, says, “This strategic milestone underscores our commitment to redefining cancer treatment with breakthrough science and transformative medicines. “We are excited to formally welcome the talented Halda team to Johnson & Johnson and look forward to working together to achieve our shared goal of eliminating cancer.” Acquiring biotech firms before clinical maturity Firefly Bio is the latest example of a growing trend in pharmaceutical M&A, with major drugmakers increasingly acquiring early-stage platform companies to secure access to emerging modalities such as protein degradation, antibody-drug conjugates and radiopharmaceuticals that could underpin the next generation of precision oncology treatments. Given the high costs associated with clinical-stage, low-risk oncology assets, such as GSK’s US$10.6bn acquisition of Nuvalent , purchasing a comparatively inexpensive early-stage platform capable of generating multiple future therapies represents an attractive long-term investment for healthcare’s biggest players. Company portals Johnson & Johnson Executives Jennifer Taubert Executive Vice President, Worldwide Chairman and Innovative Medicine John Reed Executive Vice President, Innovative Medicine, Research & Development

并购免疫疗法

2026-07-30

·药明康德

强生双特异性抗体疗法获优先审评资格；治疗白癜风，辉瑞小分子抑制剂3期临床结果积极…… | 产业新闻

强生双特异性抗体疗法获优先审评资格强生公司（Johnson & Johnson）今日宣布，美国FDA已授予全人源EGFR/MET靶向双特异性抗体Rybrevant Faspro（amivantamab和hyaluronidase）皮下注射制剂的补充生物制品许可申请（sBLA）优先审评资格，该疗法拟用于治疗复发性或转移性头颈部鳞状细胞癌（HNSCC）成人患者。如获批准，该疗法将为接受含铂化疗及PD-1或PD-L1抑制剂治疗后疾病进展的患者提供一种新的治疗选择。 FDA授予优先审评资格的决定基于关键性1b/2期OrigAMI-4研究的结果。研究显示，接受Rybrevant Faspro单药治疗的患者中，经确认的客观缓解率为42%，其中超过三分之一的缓解者达到完全缓解。该研究排除了由人乳头瘤病毒（HPV）引起的口咽鳞状细胞癌患者，以及既往接受过抗EGFR治疗的患者。相关研究结果已在2026年美国临床肿瘤学会（ASCO）年会上公布，并同期发表于Journal of Clinical Oncology。治疗白癜风，辉瑞小分子抑制剂3期临床结果积极辉瑞公司（Pfizer）今日宣布，两项评估Litfulo（ritlecitinib）治疗活动期及稳定期非节段型白癜风（NSV）患者的3期临床试验取得积极顶线结果。TRANQUILLO研究纳入年龄为12岁及以上的患者，而TRANQUILLO 2研究仅纳入成人患者。在两项研究中，Litfulo的50 mg和100 mg剂量组在面部和全身白癜风面积评分指数（VASI）共同主要终点方面均较安慰剂组实现显著且具有临床意义的改善。基于这些结果，辉瑞计划在全球提交Litfulo的监管申请。在两项研究中，与安慰剂组相比，接受Litfulo治疗的患者在第52周达到面部白癜风面积评分指数较基线改善≥75%（F-VASI75）和全身白癜风面积评分指数较基线改善≥50%（T-VASI50）的比例均显著更高。Litfulo治疗NSV的安全性特征与其治疗斑秃时已确立的安全性特征一致，未观察到新的安全性信号。总体而言，各治疗组发生治疗伴发不良事件（TEAE）的患者比例相似。 Litfulo是一款口服JAK3和TEC家族激酶抑制剂，目前正在开发用于治疗非节段型白癜风。通过靶向参与该疾病发生发展的关键免疫信号通路，Litfulo被认为可以调节导致黑色素细胞破坏的免疫细胞活性。开发体内CAR-T疗法，强生达成研发合作由Flagship Pioneering创立、致力于开发新型RNA药物的Sail Biomedicines日前宣布，与强生公司达成一项战略合作，旨在推进创新型体内嵌合抗原受体T细胞（CAR-T）疗法的开发。这些疗法有望改善免疫介导性疾病患者的治疗结局。此次合作将结合Sail利用其专有Endless RNA（eRNA）和靶向纳米颗粒平台开展的AI驱动产品设计，以及强生公司在药物开发、生产和商业化方面的能力。双方将推进Sail在自身免疫性疾病领域的体内CAR-T项目，同时推进其他项目，利用Sail的产品开发引擎构建体内CAR-T药物组合，旨在通过重置免疫系统实现持久的疾病缓解。 Sail的平台整合了eRNA技术、靶向纳米颗粒递送技术和AI驱动设计能力，以优化候选药物的治疗性能。该公司专注于利用该平台开发治疗免疫介导性疾病的体内CAR-T药物，目标是将CAR-T细胞疗法的潜在治愈能力带给更多患者。根据协议条款，强生公司将支付7.85亿美元的初始款项，其中包括4.65亿美元的股权投资；如达到特定开发里程碑，还将支付1.4亿美元。若强生公司决定行使收购Sail的独家选择权，还将额外支付25.8亿美元。参考资料： [1] Sail Biomedicines Announces Strategic Collaboration to Develop New Class of Medicines for In Vivo CAR-T. Retrieved July 30, 2026, from https://www.globenewswire.com/news-release/2026/07/30/3335802/0/en/relation-announces-expanded-collaboration-with-gsk.html [2] Pfizer Announces Positive Topline Phase 3 Results for LITFULO in Patients with Nonsegmental Vitiligo. Retrieved July 30, 2026, from https://www.businesswire.com/news/home/20260730163060/en/Pfizer-Announces-Positive-Topline-Phase-3-Results-for-LITFULO-in-Patients-with-Nonsegmental-Vitiligo [3] Johnson & Johnson's RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer. Retrieved July 30, 2026, from https://www.prnewswire.com/news-releases/johnson--johnsons-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-receives-us-fda-priority-review-as-potential-first-in-class-egfr--and-met-targeted-subcutaneous-treatment-for-advanced-head-and-neck-cancer-302838985.html 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新……

100 项与埃万妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	埃万妥单抗	L01	-

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
EGFR阳性非小细胞肺癌	日本	Janssen Pharmaceutical KK	2025-03-27
EGFR 外显子 19 缺失突变型非小细胞肺癌	美国	Janssen Biotech, Inc.	2024-08-19
EGFR外显子21替代突变非小细胞肺癌	美国	Janssen Biotech, Inc.	2024-08-19
非小细胞肺癌	加拿大	Janssen, Inc.	2022-03-30
EGFR 20号外显子插入突变非小细胞肺癌	美国	Janssen Biotech, Inc.	2021-05-21

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
EGFR突变的非小细胞肺癌	申请上市	中国	Cilag AG	2024-01-26
EGFR突变的非小细胞肺癌	申请上市	中国	Janssen-Cilag International NV	2024-01-26
EGFR突变的非小细胞肺癌	申请上市	中国	上海强生制药有限公司	2024-01-26
复发性头颈部鳞状细胞癌	临床3期	美国	Janssen Research & Development LLC	2025-12-03
复发性头颈部鳞状细胞癌	临床3期	中国	Janssen Research & Development LLC	2025-12-03
复发性头颈部鳞状细胞癌	临床3期	日本	Janssen Research & Development LLC	2025-12-03
复发性头颈部鳞状细胞癌	临床3期	澳大利亚	Janssen Research & Development LLC	2025-12-03
复发性头颈部鳞状细胞癌	临床3期	奥地利	Janssen Research & Development LLC	2025-12-03
复发性头颈部鳞状细胞癌	临床3期	比利时	Janssen Research & Development LLC	2025-12-03
复发性头颈部鳞状细胞癌	临床3期	巴西	Janssen Research & Development LLC	2025-12-03

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临床结果

适应症

分期

评价

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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


NCT05379595 (OrigAMI-1, Pubmed \| J Clin Oncol)	临床1/2期	RAS/BRAF基因野生型结直肠癌三线 RAS / BRAF / EGFR ectodomain wild-type \| ERBB2/HER2 amplification	94	Amivantamab (cohort A)	築顧築鬱鑰醖繭膚蓋齋(蓋蓋鑰簾淵齋遞積廠選) = 艱遞夢壓餘窪積顧鹽鏇鑰鏇膚糧製醖製繭願遞 (鏇艱鑰窪網築淵顧餘鑰 ) 更多	积极	2026-06-10
				Amivantamab (cohort B)	築顧築鬱鑰醖繭膚蓋齋(蓋蓋鑰簾淵齋遞積廠選) = 選夢簾獵積醖簾襯鬱廠鑰鏇膚糧製醖製繭願遞 (鏇艱鑰窪網築淵顧餘鑰 ) 更多
NCT04077463 (CHRYSALIS-2, ASCO2026)	临床1期	EGFR突变的非小细胞肺癌一线 EGFR mutations	49	Amivantamab plus lazertinib	觸鬱鑰簾膚鬱鏇簾襯遞(築簾積廠膚淵製艱獵膚) = 齋糧築膚網鹹遞壓窪遞襯願鹽餘淵遞衊窪繭鹽 (簾醖網積遞憲鑰獵遞淵, 27.7 ~ NE) 更多	积极	2026-05-29
ASCO2026	N/A	EGFR阳性非小细胞肺癌二线	22	Amivantamab monotherapy	齋鏇鏇積壓齋鏇構淵夢(獵膚構餘糧蓋餘鑰製淵) = 艱鹹製襯廠蓋遞襯積簾鹽築繭築膚繭顧選遞壓 (鹹醖艱壓簾糧廠繭膚顧, 36.1 ~ 80.9) 更多	积极	2026-05-29
				Amivantamab monotherapy (classical EGFR)	齋鏇鏇積壓齋鏇構淵夢(獵膚構餘糧蓋餘鑰製淵) = 願鑰壓製遞襯餘獵襯壓鹽築繭築膚繭顧選遞壓 (鹹醖艱壓簾糧廠繭膚顧 ) 更多
NCT05379595 (OrigAMI‑1, ASCO2026)	临床1/2期	RAS/BRAF基因野生型结直肠癌 RAS/BRAF wild-type	73	Amivantamab (CMS2)	壓築鏇鹹網壓夢艱糧鏇(積範餘觸鹽願壓鹽蓋鏇) = 積選鏇壓糧構積壓願淵蓋醖獵選鹹鑰願築築蓋 (遞鑰蓋顧鹹範簾觸繭繭 ) 更多	积极	2026-05-29
				Amivantamab (CMS4)	壓築鏇鹹網壓夢艱糧鏇(積範餘觸鹽願壓鹽蓋鏇) = 獵積壓選願糧夢鹽繭構蓋醖獵選鹹鑰願築築蓋 (遞鑰蓋顧鹹範簾觸繭繭 ) 更多
ASCO2026	N/A	非小细胞肺癌二线 EGFR-mutant	4,909	Platinum-pemetrexed chemotherapy (Chemo)	鏇淵鹹夢願獵壓襯衊淵(積鹽夢淵齋獵鹽壓廠鏇): HR = 1.92 更多	积极	2026-05-29
				immunotherapy +Chemo (IC)
NCT06385080 (OrigAMI-4, ASCO2026)	临床1/2期	复发性头颈部鳞状细胞癌	102	Amivantamab	衊簾獵鹹窪顧遞鑰齋蓋(齋齋蓋鏇壓鑰襯繭夢願) = 襯憲艱願積夢獵餘築簾顧積選範膚襯膚醖憲構 (製鹹艱獵廠襯築範顧餘, 37 ~ 57) 更多	积极	2026-05-29
ASCO2026	N/A	-	15	oral doxycyclinetopical clindamycinl corticosteroids + oral doxycyclinetopical clindamycin + oral doxycyclinetopical clindamycin	夢繭鏇醖鹽齋齋醖淵獵(襯艱鑰壓齋襯憲鹽膚鹹) = 遞憲壓醖範膚憲網襯簾醖繭襯憲構鏇網顧鏇膚 (襯鹹鑰壓鏇艱醖網簾鹹 ) 更多	积极	2026-05-29
NCT06667076 (COPERNICUS, ASCO2026)	临床2期	EGFR突变的非小细胞肺癌一线 EGFR-mutated	190	SC amivantamab + lazertinib	醖壓鏇糧齋衊願壓壓夢(簾窪顧蓋襯選鹽獵鹽蓋) = 憲襯齋衊淵淵鬱齋廠鏇膚鹽鏇鏇網鏇壓願淵餘 (襯選鏇網積鬱顧淵鏇鑰 ) 更多	积极	2026-05-29
WJOG17323L (ASCO2026)	临床2期	EGFR突变的非小细胞肺癌一线 EGFR mutations	70	Amivantamab + lazertinib (advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve)	夢鑰構夢廠範衊觸壓膚(蓋憲選醖獵壓衊顧鹹構) = 憲願範衊簾繭繭範鏇壓窪壓鏇憲鹹觸淵廠選願 (齋齋願齋範簾繭醖壓鹽 ) 更多	积极	2026-05-29
				Afatinib (advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve)	夢鑰構夢廠範衊觸壓膚(蓋憲選醖獵壓衊顧鹹構) = 願齋襯淵積簾遞獵鏇襯窪壓鏇憲鹹觸淵廠選願 (齋齋願齋範簾繭醖壓鹽 ) 更多
NCT05074940 (Phase 2 clinical trial, CTgov)	临床2期	腺样囊性癌 \| 唾液腺肿瘤	21	Amivantamab	遞鏇糧製衊繭齋憲鹹窪 = 廠範觸糧廠齋膚鹽壓窪築願廠衊餘鹽選憲構願 (遞鹹餘襯顧願選廠選鬱, 夢獵艱願壓醖窪遞築繭 ~ 憲膚築蓋積網醖壓鏇鑰) 更多	-	2026-05-08