An Open-label, Single-arm, Multicenter Phase II Study to Evaluate the Efficacy of Amivantamab in Combination With FOLFIRI as a Second-line Treatment in Patients With RAS/BRAF Wild-type Advanced Colorectal Cancer Progressing on Prior Anti-EGFR Based Treatment.

This trial is a multicenter, single arm study of efficacy of amivantamab in combination with FOLFIRI in RAS/BRAF wild-type advanced colorectal cancer patients progressed prior treatment including oxaliplatin based chemotherapy. This trial will be conducted by Severance Hospital that is responsible for the project management of the trial. Patient recruitment will take at 3 institutions.
Participants will be treated for up to 24 cycles (approximately 2 years) after initiation of treatment with intravenous 1050mg(BW<80kg) or 1400mg(BW≥80kg) of amivantamab every 4 weeks in combination with FOLFIRI. FOLFIRI includes folic acid, 5-FU and irinotecan. FOLFIRI will be administered intravenously with folic acid 400 mg/m², 5-FU 2400 mg/m², and irinotecan 180 mg/m² every 2 weeks. This study will use ORR based on RECIST 1.1 criteria as the primary endpoint and the tumor assessment will be done every 8 weeks. Secondary endpoints are DCR, PFS, OS, and safeties. Exploratory biomarkers in tumor tissue and ctDNA in blood will be investigated in both pre-treatment and post-treatment periods.

开始日期2025-05-01

申办/合作机构

Yonsei University

ChiCTR2500100101

/ Suspended临床2期IIT

Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Standard of Care Therapeutic Agents in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

开始日期2025-04-14

申办/合作机构

上海市东方医院

NCT06816992

/ Recruiting临床1期

Phase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC

The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.

开始日期2025-02-27

申办/合作机构

Oric Pharmaceuticals, Inc.

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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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176

项与埃万妥单抗相关的文献（医药）

2025-12-01·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

作者: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

2025-05-01·LUNG CANCER

A cost-effectiveness analysis of amivantamab plus lazertinib versus osimertinib in the treatment of US and Chinese patients with EGFR-mutated advanced non-small cell lung cancer

Article

作者: Li, Qiu ; Qin, Yi ; Wu, Qiuji

BACKGROUND:

The combination of amivantamab and lazertinib (AL) has demonstrated clinically significant efficacy in patients with previously untreated EGFR-mutated advanced non-small cell lung cancer (NSCLC). However, its economic value relative to the standard therapy, osimertinib, remains unclear. This study evaluates the cost-effectiveness of AL regimen compared with osimertinib in US and Chinese healthcare settings.

METHODS:

A partitioned survival model, comprising progression-free survival (PFS), post-progression, and death states, was developed using a Markov model. Clinical data were obtained from the recent Phase III MARIPOSA trial. Direct medical costs (including drug acquisition, administration, and adverse event management) were obtained from US and Chinese healthcare system data, public databases, and the literature. Health-state utilities were sourced from the literature. Incremental cost-effectiveness ratios (ICERs) were calculated based on quality-adjusted life years (QALYs). Threshold analysis was performed to identify pricing strategies at specified willingness-to-pay (WTP) thresholds. Model robustness was assessed through sensitivity and scenario analyses, and additional subgroup analyses performed.

RESULTS:

In the base case analysis, the average costs of AL and osimertinib regimen were $1,030,524.3 (China: $234,270.87) and $466,922.0 (China: $20,075.35), respectively, and the QALYs achieved were 4.08 (China: 3.66) and 2.60 (China: 2.66), respectively. The ICERs for AL compared with osimertinib in the US and China were $563,602.3 and $214,195.51, respectively. Based on the respective WTP thresholds in the US and China, the AL regimen did not represent a cost-effective option. Sensitivity, scenario, and subgroup analyses confirmed the robustness of these findings.

CONCLUSIONS:

Although AL regimen prolongs QALYs compared with osimertinib, it may not meet cost-effectiveness thresholds given current US pricing and simulated Chinese prices. These findings emphasize the need to consider policy implications and future pricing strategies.

2025-04-01·Journal of the National Comprehensive Cancer Network

Chemotherapy-Based Combination Regimens for Advanced EGFR-Mutant NSCLC After EGFR-TKI Failure: A Network Meta-Analysis

Article

作者: Liao, Jun ; Zhang, Li ; Zhang, Ya-Xiong ; Zhuang, Wei-Tao ; Li, Meng-Di ; Pang, Lan-Lan ; Chen, Zi-Hong ; Fang, Wen-Feng

Background: Traditional chemotherapy provides restricted benefits for advanced EGFR-mutant non–small cell lung cancer (NSCLC) after failure of EGFR-tyrosine kinase inhibitors (EGFR-TKIs), necessitating the combined treatment. However, it remains controversial which is the optimal regimen. Methods: Eligible randomized controlled trials (RCTs) comparing various platinum-based chemotherapy (Chemo) regimens in patients with EGFR-mutated NSCLC who experienced disease progression on EGFR-TKIs were included. A Bayesian random-effects network meta-analysis was performed. Progression-free survival (PFS) was analyzed using the logarithm of hazard ratio (HR) and its standard error, whereas objective response rate (ORR) and treatment-related adverse events (TRAEs) were analyzed using odds ratio (OR) and 95% confidence intervals. Results: A total of 9 RCTs involving 2,534 patients with EGFR-TKI resistance, published between 2022 and 2024, were included in the meta-analysis. The analyzed regimens were summarized into 5 arms: platinum-based doublet chemotherapy (“Chemo”); immunotherapy + chemotherapy (“Chemo_IO”); bevacizumab + chemotherapy (“Chemo_Bev”), immunotherapy combined with bevacizumab (or bispecific antibody against PD-1/PD-L1 and VEGF) + chemotherapy (“Chemo_anti–PD-1/PD-L1_anti-VEGF”), and amivantamab + chemotherapy (“Chemo_Ami”). Compared with “Chemo,” both “Chemo_Ami” and “Chemo_anti–PD-1/PD-L1_anti-VEGF” significantly prolonged PFS (HR, 0.48 [95% CI, 0.32–0.71] and HR, 0.51 [95% CI, 0.41–0.62], respectively) and improved ORR (OR, 3.13 [95% CI, 1.64–5.96] and OR, 2.17 [95% CI, 1.51–3.11], respectively). “Chemo_Bev” also significantly reduced the risk of progression (HR, 0.66 [95% CI, 0.45–0.98]). In contrast, “Chemo_IO” failed to improve ORR (OR, 1.25 [95% CI, 0.89–1.81]) and provided a modest PFS benefit (HR, 0.78 [95% CI, 0.64–0.95) compared with “Chemo.” Furthermore, compared with “Chemo_IO,” both “Chemo_Ami” and “Chemo_anti–PD-1/PD-L1_anti-VEGF” significantly prolonged PFS (HR, 0.62 [95% CI, 0.39–0.95] and HR, 0.65 [95% CI, 0.52–0.81], respectively) and improved ORR (OR, 2.51 [95% CI, 1.17–5.14] and OR, 1.73 [95% CI, 1.13–2.60], respectively). No statistically significant difference in PFS was observed among “Chemo_Ami,” “Chemo_anti–PD-1/PD-L1_anti-VEGF,” and “Chemo_Bev.” Additionally, “Chemo_Ami” was associated with a significantly higher incidence of grade 3–5 TRAEs (OR, 3.71 [95% CI, 1.08–12.7]) compared with “Chemo,” whereas no significant differences in TRAEs were observed among the other regimens. Conclusions: Antiangiogenic agents may create a therapeutic window for immunotherapy in advanced NSCLC after progression on prior EGFR-TKI treatment. Based on their superior efficacy, “Chemo_anti–PD-1/PD-L1_anti-VEGF” and “Chemo_Ami” are recommended as preferred treatment options for patients who experienced disease progression on EGFR-TKIs. Our study highlights and updated therapeutic approach for advanced EGFR-mutant NSCLC.

656

项与埃万妥单抗相关的新闻（医药）

2025-04-16

·GBIHealth

强生2025Q1业绩表现强劲，预计将因关税损失4亿美元；美国对药品启动232调查

企业动态No.1 / 4.93亿美元！默沙东获得Cyprumed口服肽递送平台非独占全球权益2025年4月15日，德国Cyprumed公司宣布，与默沙东（NYSE：MRK）签署一项非独占许可及选择权协议，利用Cyprumed的创新药物递送技术开发MSD的肽类口服制剂。根据协议条款，MSD获得了Cyprumed口服肽递送平台的非独占全球权利，用于若干未公开的目标。协议还授予MSD独家许可Cyprumed技术用于个别目标的选择权。如果合作开发的产品获得批准，Cyprumed将有资格获得高达4.93亿美元的预付款、开发、监管和净销售里程碑款项。如果MSD行使独家许可选择权，Cyprumed可能会获得额外付款。根据协议，MSD将负责利用Cyprumed递送技术开发产品的研究、开发、制造和商业化。->点击文末阅读原文，解锁完整双语新闻No.2 / 强生2025Q1业绩表现强劲，预计将因关税损失4亿美元美国强生公司（纽约证券交易所代码：JNJ）近日公布2025年第一季度财报，集团收入（按固定汇率计算，下同）达219亿美元，同比增长4.2%。按业务划分，创新制药业务收入增长4.2%，达138.7亿美元；医疗科技业务收入同比增长4.1%，至80.2亿美元。从地区表现来看，美国市场收入增长5.9%，达123亿美元；欧洲市场增长2.2%，至51.1亿美元；美国以外的西半球市场大幅增长9.2%，达11.7亿美元；而亚太及非洲市场微降0.6%，收入为33.1亿美元。从增长驱动力来看，强生的核心肿瘤产品包括：多发性骨髓瘤药物兆珂（达雷妥尤单抗）、前列腺癌药物安森珂（阿帕他胺）、同样用于治疗多发性骨髓瘤的CAR-T细胞疗法卡卫荻（西达基奥仑赛），以及肺癌药物锐珂（埃万妥单抗）。在免疫学领域，银屑病药物特诺雅（古塞奇尤单抗）和类风湿性关节炎药物欣普尼（戈利木单抗）表现突出；而在神经领域，抑郁症药物速开朗（艾司氯胺酮）成为主要增长点。兆珂以32.4亿美元的销售额成为最畅销药物，同比增长22.5%。值得关注的是，从传奇生物授权引进的卡卫荻表现亮眼，本季度销售额达3.69亿美元，较2024年第一季度的1.57亿美元大幅增长。2025年1月，强生宣布以146亿美元收购美国生物制药公司Intra-Cellular Therapies（纳斯达克股票代码：ITCI）。通过此次收购，强生获得了已在美国获批治疗双相抑郁症的Caplyta（卢美哌隆），以及Intra-Cellular的神经系统疾病研发管线。该交易于2025年4月初正式完成，强生随即上调了全年业绩指引：预计营运收入将达到920亿美元，同比增长3.8%，较此前913亿美元和3%增幅的预测有所提升。强生CEO谈关税问题：税收政策比关税“更有效”值得注意的是，强生在新闻稿中特别指出，全年收入指引已将关税对集团业务的影响考虑在内。在财报电话会议上，公司高管就关税问题展开讨论，重点分析了关税对医疗科技业务造成的冲击，并警示若关税政策延伸至药品领域可能引发的市场混乱。强生首席财务官约瑟夫·沃尔克（Joseph Wolk）指出，当前“主要针对医疗科技产品的关税”预计将在2025年造成4亿美元的负面影响。沃尔克特别强调，这一数字“已包含《美墨加协定》（USMCA）中未豁免的墨西哥和加拿大进口关税”。此外，美国钢铁和铝关税也产生了一定程度的影响。但影响销往中国市场美国产品的“中国关税及中方反制关税”，“在这4亿美元的总影响中，可能是占比最大的部分”。沃尔克指出，强生基本无法通过提高产品价格来缓解关税影响，他强调：“我们在价格调整上的空间非常有限——医疗科技业务方面已有合同协议约束”，并表示若关税扩大到药品领域，操作空间将更小。沃尔克透露，这4亿美元的负面影响已计入资产负债表中的商品成本项，实质上将由公司直接承担利润损失：“（这4亿美元）将体现在库存账目中，并通过未来损益表逐步消化”。强生首席执行官杜安卿（Joaquin Duato）特别强调，近期将关税扩大至药品领域的威胁可能导致“供应链中断进而引发药品短缺”。他直言不讳地指出，关税政策不如税收政策改革有效：“若要在美国本土提升医疗科技和药品制造能力，最有效的解决方案不是关税，而是税收政策。”杜安卿指出，“自特朗普总统2017年税改以来，美国医疗科技和制药领域的生产投资显著增长”。强生已于2025年3月宣布计划未来四年内在美国投资550亿美元，包括建设四个生产基地。杜安卿预计，项目完成后“在美国使用的所有先进药物基本上都将实现本土生产”。->点击文末阅读原文，解锁完整双语新闻行业政策No.1 / 卫健委印发家庭医生签约基本服务包清单，可为慢病患者提供长期处方近日，国家卫健委印发《家庭医生签约基本服务包清单（试行）》（简称《清单》），提出一般人群及9类重点人群基本服务包内容以及服务要求，供各地在开展签约服务时参考使用。《清单》针对一般人群设置了健康档案管理、健康咨询、体重管理、门诊转诊等服务项目。针对65岁及以上老年人，特设中医药健康管理、上门随访（80岁及以上）、失能照护、用药指导等服务。对于高血压、糖尿病、慢阻肺等慢病患者，家庭医生可按需提供长期处方服务（4～12周）。针对精神障碍患者、肺结核患者、孕产妇、儿童及残疾人等其他重点人群，也设置了相应的服务项目。卫健委要求各地以《清单》为基础，结合基层服务能力和签约群众需求，进一步明确本地签约服务包内容。鼓励各地建立签约服务项目库，由签约居民根据自身需求“点单”选择服务内容。签约居民应根据人群类型选择一种适宜服务包进行签约，符合多种人群类型的，可优先确定一种人群服务包，同时适当补充其他服务内容，规范提供服务。->点击阅读原文，解锁完整双语新闻No.2 / 美国商务部启动232条款药品调查在美国总统特朗普近期表态拟对制药行业加征关税后，美国商务部（DoC）发布公告表示已于2025年4月1日启动“232条款”调查药品及原料药进口对国家安全的影响，并就调查结果公开征求意见。商务部公告显示，调查的核心目标之一是判定“是否有必要通过关税或配额来保障国家安全”。此外，美国商务部还针对半导体行业另行启动了“232条款调查”。“232条款调查”指美国商务部根据1962年《贸易扩展法》第232条款规定的授权，对特定产品进口是否对美国国家安全造成威胁进行立案调查。通常，商务部长会在270天内公布调查结果。援引《232条款》可使总统无需经国会批准即对产品加征关税或实施其他贸易限制，该条款现已成为特朗普政府的常用政策工具，例如2018年特朗普就曾据此对进口钢铁和铝产品加征关税。根据该公告，本次药品调查将重点关注“成品仿制药与非专利药、应急医疗产品、原料药及关键起始物料等核心原料，以及相关衍生产品”。此次调查的其他对象还包括：评估美国市场对药品及原料药的当前及预期需求量；评估美国本土药品及原料药产能对其国内需求的满足程度；评估外国供应链在满足美国药品需求中的作用；评估外国政府补贴及掠夺性贸易行为对美国医药行业竞争力的影响；评估因外国不公平贸易行为及政府扶持的产能过剩导致的药品价格人为压低对经济的影响；研判外国实施药品出口限制的可能性，包括其将药品供应管控武器化的能力；研判提升美国本土药品及原料药产能以降低进口依赖度的可行性。->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ xujingou@baidu.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

细胞疗法免疫疗法财报并购引进/卖出

2025-04-16

·BiG生物创新社

翰森制药的肺癌药物拼图

作者｜Bio-three前文笔者已经提及的非小细胞肺癌（EGFR突变非小细胞肺癌进入排列“组合时代”），以及小细胞肺癌（小议小细胞肺癌三大热门靶点：B7H3、DLL3、TROP2），共同组成的肺癌领域是全球癌症中最大的健康挑战，也是全球肿瘤药物最大的市场，各家药企兵家必争之地。肺癌领域是中国乃至全球癌症中最大的健康挑战作为首个国产的EGFR-TKI抑制剂，翰森制药开发的阿美替尼目前已经收获三项适应症，2023年销售额为37.38亿元，虽然2024年并未公布具体销售值，但外界预测其销售额峰值未来有望突破80亿元，成为国产非小细胞肺癌领域的第一大超级单品，同时还在和多款药物进行联用及迭代药物开发。小细胞肺癌领域近年来才逐步取得突破，超级单品仍在酝酿开发中。2023年，GSK葛兰素史克以1.85亿美元首付款，及最多15.25亿美元的成功里程碑付款，引进了翰森制药的B7-H3 ADC药物HS-20093海外权益。HS-20093几乎同一时间和第一三共的B7H3 ADC药物，启动了小细胞肺癌的关键三期临床，未来同样具有全球超级单品的潜力。翰森制药肺癌相关创新药物的开发矩阵此外加上翰森制药从普米斯引进的EGFR/c-Met双抗，以及多款小分子和ADC药物的开发，翰森制药基于超级单品的支撑，目前已经在非小细胞肺癌和小细胞肺癌领域建立12条管线，组成了广泛的创新产品研发矩阵，未来有望奠定国内肺癌领域的霸主地位。 01 非小细胞肺癌：依托超级单品，强势布局迭代及协同药物2015年，阿斯利康开发的奥希替尼，作为全球首个第三代EGFR-TKI靶向治疗药物获批上市，2024年全球销售额达到65.80亿美元，是非小细胞肺癌领域当之无愧的王者。翰森制药开发的阿美替尼在奥希替尼的基础上，通过环丙基取代甲基进行了结构改进，一方面避免了非选择性代谢物的产生，同时也更易突破血脑屏障，对脑转移患者仍然有效。奥希替尼和阿美替尼结构对比（J Thorac Oncol. 2021 May;16(5):740-763.）2020年3月，阿美替尼首次获批用于既往经EGFR-TKI治疗进展，且T790M突变阳性的局部晚期或转移性NSCLC患者；2021年12月，获批用于具有EGFR外显子19缺失或外显子21(L858R)置换突变阳性的局部晚期或转移性NSCLC成人患者的一线治疗。2025年3月，阿美替尼再次获批用于含铂根治性放化疗后未出现疾病进展的不可切除的局部晚期EGFR外显子19缺失或外显子21(L858R)置换突变的NSCLC患者的治疗。三期临床POLESTAR研究数据显示，阿美替尼组的中位无进展生存期（PFS）达到30.4个月，安慰剂组则为3.8个月（风险比HR=0.200），显著改善了这一患者人群的生存状态。阿美替尼的POLESTAR三期临床结果（2024 WCLC）目前阿美替尼的前两项适应症已成功续约纳入最新版国家医保目录，未来进一步显著放量。然而目前已经有六款本土EGFR-TKIs抑制剂已经获批上市，未来竞争将进一步升级，但翰森已经做好了多款下一代药物开发的应对策略。EGFR-TKIs使用后大约15%-19%的非小细胞肺癌患者，会出现c-MET扩增的耐药，其成为EGFR-TKIs耐药最大的障碍。翰森开发的c-MET抑制剂HS-10241，对于c-MET靶点的高度选择性和抑制性。目前HS-10241正在和阿美替尼开展一项三期联合治疗试验，未来有望进一步拓展阿美替尼的应用。除了小分子布局c-Met，翰森还对EGFR和c-Met进行了大分子布局。2022年，翰森以总价14.68亿元从普米斯生物，引进了一款EGFR/c-MET双特异性抗体HS-20117/PM1080，其是一款去岩藻糖非对称1+1结构IgG-like的全人源抗体。EGFR/c-MET双特异性抗体HS-20117/PM1080（2023 AACR）通过对于EGFR，c-MET两端亲和力的优化和选择，HS-20117/PM1080在体外表现出对于EGFR/c-MET双阳性肿瘤细胞的偏向性结合，从而可能减少潜在的针对EGFR单阳性细胞的毒性，强生的同款双抗药物Amivantamab已经获批三项EGFR突变的非小细胞肺癌适应症。更值得关注的是，近期公布的PCT专利（WO2025067492）中，通过阿美替尼和EGFR/c-MET双抗HS-20117的联用，在含有EGFR19外显子缺失突变的非小细胞肺癌 PC-9细胞系来源裸小鼠皮下异种移植瘤模型中，两者表现出良好的协同抗肿瘤作用，目前两者正在进行一项1b期联合治疗试验，未来值得期待。阿美替尼和EGFR/c-MET双抗HS-20117的协同作用（WO2025067492）近期召开的2025年ELCC欧洲肺癌大会上，强生也更新了其EGFR/c-Met双抗药物Amivantamab，联合第三代ERFR TKI药物lazertinib，对比奥希替尼一线治疗EGFR突变的非小细胞肺癌临床MARIPOSA中的长期临床数据。数据显示，Amivantamab+lazertinib组的中位OS仍未达到，而奥希替尼的中位OS为36.7个月，当前的HR值为0.75，未来有望在对照组的基础上延长12个月的生存期，有望创造全球最长的突变的非小细胞肺癌OS数据，显著改变EGFR突变的非小细胞肺癌的一线治疗格局，这也为翰森的阿美替尼和EGFR/c-MET双抗联用树立了标杆。刚刚公布2025第一季度财报，强生预测Amivantamab+lazertinib两者总计的销售峰值，有望在2028年达到近50亿美元。强生Amivantamab+lazertinib联用三期临床MARIPOSA（2025 ELCC）此外翰森制药也对EGFR/c-Met双抗进行了升级，2024年3月14日，翰森制药宣布，在2022年首次合作的基础上，进一步扩大同普米斯战略合作关系。普米斯将许可翰森制药使用普米斯自主研发的抗EGFR/cMet双特异抗体HS-20117/PM1080用于开发ADC产品。2025年4月2日，翰森医药在CDE药物临床试验登记与信息公示平台网站上，登记了一项或为EGFR/c-Met双抗ADC药物HS-20122，在包括非小细胞肺癌的多种晚期实体瘤患者中，启动一项I期临床研究CTR20251230，其也成为再一款进入临床阶段的EGFR/c-Met双抗ADC（EGFR突变非小细胞肺癌进入排列“组合时代”），未来有望和内部多款产品产生协同作用。HS-20122临床试验信息登记信息（CDE）立足于阿美替尼的开发经验，翰森也了选择深耕迭代EGFR-TKI。两款针对EGFR C797S突变的第四代抑制剂HS-10375和HS-10504已先后进入临床阶段，有望进一步解决三代EGFR-TKI耐药难题。另一款针对EGFR外显子20插入（ex20ins）突变的HS-10376向公认难治的肺癌亚型发起挑战，传统EGFR-TKI、化疗和免疫疗法对携带此类突变的NSCLC疗效都较有限。此外，RET抑制剂HS-10365和KRAS G12C抑制剂HS-10370分别瞄准肺癌的不同突变亚型。初步的疗效数据显露了这两款小分子抑制剂的锋芒。在30例RET融合阳性晚期NSCLC患者中，HS-10365的客观缓解率（ORR）为70.0%。在41例KRAS G12C突变晚期NSCLC患者中，HS-10370的ORR为51.2%。此外，KRAS G12D抑制剂HS-10529刚刚获批临床。 02 小细胞肺癌：B7H3突破在即，BD催化全球化布局除了非小细胞肺癌中的强势布局，翰森在小细胞肺癌中也进行了广泛布局。B7-H3 ADC的ADC药物HS-20093和第一三共的药物DS-7300a（ifinatamab deruxtecan，I-DXd）的结构较为相似，HS-20093采用相同的连接子GGFG，毒素方面依托于恒瑞开发的拓扑异构酶抑制剂毒素SHR-9265，在DXd酰胺基α位同样引入环丙基形成自主毒素，两者DAR值为4。第一三共DXd和翰森SHR-9265结构比较（Mol Cancer Ther 2024;23:606–18）2024年世界肺癌大会WCLC会议期间，翰森更新了HS-20093在小细胞肺癌患者中的初步临床数据。52例可评估患者中，8.0 mg/kg和10 mg/kg两个剂量下的响应率分别为61.3%和50.0%。中位PFS分别为5.9个月和7.3个月（未成熟）。HS-20093小细胞肺癌临床数据更新（2024 WCLC，GSK官网）安全性特征与既往报告一致，最常见的3级（≥10%）治疗相关不良事件为中性粒细胞减少、白细胞减少、淋巴细胞减少、血小板减少和贫血。根据以上有效性和安全性的结果，翰森几乎和第一三共在同一时间启动了B7-H3 ADC，在小细胞肺癌中的三期临床，并选择了差异化的8 mg/kg Q3W剂量进行试验，相关临床结果值得期待，同时基于BD交易将催化其全球化进程加快，有望进一步开拓海外市场。除了HS-20093，近期翰森制药又一款代号为HS-20108的药物，获得小细胞肺癌及神经内分泌肿瘤等在内的多种晚期实体瘤的临床试验默许，根据其药物形式，推测为一款SEZ6的ADC药物，其也可能是国内首款进入临床的SEZ6 ADC药物。翰森制药HS-20108获得临床试验默许2024年ASCO会议上，艾伯维公布了其SEZ6 ADC药物ABBV-706的早期临床数据，在小细胞肺癌亚组中客观缓解率达到60.9%。翰森的SEZ6 ADC药物同样在小细胞肺癌H69模型中，表现出良好的抗肿瘤效果，有望为小细胞肺癌患者带来差异性的治疗方案。翰森制药SEZ6 ADC小细胞肺癌临床前数据（WO2024230742）小结显然翰森制药基于大小分子的结合的方式，多种药物构成了肺癌领域的产品矩阵，并且多款药物基于研发进度的先后秩序，形成了良好的产品开发梯队，相关产品有望连续进入商业化阶段，不断扩展该领域的优势。然而当前百花齐发的创新药开发阶段，谁也没法将超级单品进行一一布局，随着更多创新产品的强势崛起，对于其肺癌版图的完整性，翰森显然还需要进一步布局。例如翰森在没有PD-1/L1产品的情况下，基于PD-1（L1）/VEGF双抗的强势崛起，目前在PD-L1高表达的一线非小细胞肺癌，以及三代EGFR耐药的二线治疗中均表现出显著疗效，同时在小细胞肺癌中的化疗联合一\二线治疗中也有惊艳表现，翰森或有必要通过BD交易的方式进行相关布局。此外，虽然翰森管线中有一款TROP2 ADC药物HS-20105，2023年就开始了临床，但是一直显示的状态为尚未招募。考虑到科伦的TROP-2 ADC药物SKB264目前已经在EGFR突变的三线非小细胞肺癌中已经获批，同时在二线及一线治疗中也有布局，在PD-L1表达的非小细胞肺癌中也有布局，甚至还扩展到了辅助治疗阶段，未来也有望成为非小肺癌领域的重磅药物，翰森有必要采用联用或其它方式加速开发。科伦TROP-2 ADC药物SKB264开发状态（科伦官网）同样在小细胞肺癌领域，虽然目前的格局还不甚明朗，翰森可借助恒瑞PD-L1抗体阿得贝利进行联用配合，但是考虑到多个下一代药物的冲击，翰森也有必要布局一款安进已经获批上市的DLL-3/CD3双抗，进行差异化的靶点布局，同时未来有望在一二线取得突破。综上所述，基于超级大单品的快速放量，以及重磅创新的产品的快速推进，翰森未来有望在肺癌领域形成超百亿的产品矩阵，同时也期待其进一步加速创新，完善产品拼图，造福更多的患者。共建Biomedical创新生态圈！如何加入BiG会员？

临床3期引进/卖出抗体药物偶联物医药出海上市批准

2025-04-15

·GlobeNewswire-Health Care

LiveWorld Releases First-Ever AI Brand Reputation Index for Leading Pharmaceutical Brands

Study Highlights Critical Influence of AI-Driven Reputation on Pharma Market Leaders and New EntrantsCAMPBELL, Calif. and NEW YORK, April 15, 2025 (GLOBE NEWSWIRE) -- LiveWorld, Inc. (OTC Markets: LVWD), a pioneer in social-first digital engagement and integrated human-AI solutions, today released its inaugural AI Brand Reputation Index, providing unprecedented insight into how artificial intelligence shapes the perceptions of 50 leading pharmaceutical brands. The comprehensive study identifies key reputation drivers, revealing crucial implications for market leaders and emerging therapies alike. "As healthcare professionals, patients, and caregivers increasingly rely on AI-driven platforms for information, pharmaceutical brands must understand and actively manage their AI-driven reputations," said Peter Friedman, LiveWorld Chairman and CEO. "This index gives companies actionable insights to strategically enhance their brand positioning and ensure long-term success." Key Findings from the Report Include: Market Leaders Confirmed: Brands with high consumer familiarity and proven efficacy, such as Dupixent, and Keytruda, demonstrated robust AI reputations, driven by clinical effectiveness and healthcare professional trust.Advertising Not the Only Driver: Vertex Pharmaceuticals' Trikafta topped the rankings despite limited advertising, showcasing the power of clinical efficacy, healthcare provider endorsement, and authentic patient advocacy in building AI-driven brand perception.Challenges for New Therapies: Emerging drugs like Leqvio and Rybrevant struggle with AI visibility, highlighting immediate opportunities for strategic content marketing.Safety Perceptions Persist: Products with perceived safety concerns, such as Remicade and Xeljanz, face significant hurdles in AI-driven reputation, underscoring the lasting impact of safety profiles.Accessibility Matters: Brands recognized for affordability and patient-friendly access, including Farxiga and Jardiance, enjoyed enhanced AI-driven sentiment. The study utilizes LiveWorld’s proprietary AI framework assessing seven weighted reputation factors across prominent large language models (LLMs) including ChatGPT (GPT-4), Perplexity, and Grok. These factors encompassed efficacy, safety, healthcare professional trust, consumer sentiment, digital visibility, affordability, and patient loyalty. Based on the rankings, the study recommends strategic approaches for pharma companies to build up their brand reputation starting with investing in AI-powered brand monitoring and continuous reputation management. "AI-driven reputation management is no longer optional—it is a strategic imperative," added Friedman. "Brands that proactively engage with their AI presence will significantly outperform their competition." Helpful Links: LiveWorld AI Brand Reputation Index for Pharma Top 50 BrandsBrands interested in requesting a customized AI brand reputation report for their brand with competitive comparisons may contact us here. About LiveWorld LiveWorld is a social-first digital agency and software company that unlocks the full potential of social media to transform customer relationships through integrated compliance, engagement, and insight solutions. We provide brand marketers bold creative rooted in strategy that captivates and resonates, social moderation and engagement that activates interactions, software that enriches customer experiences, and compliance that enables and accelerates digital programs. With over 28 years of making connections, we leverage our social media DNA to deliver emotion-driven behavior change through digital campaigns with a human touch. LiveWorld clients include the number one brands in pharmaceuticals, healthcare, and financial-travel services. LiveWorld is headquartered in Campbell, California, with an additional office in New York City. Learn more at www.liveworld.com and @LiveWorld. LiveWorld ContactPR Contact:Matthew HammerLiveWorldmhammer@liveworld.com(737) 212-9739

100 项与埃万妥单抗相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	埃万妥单抗	L01	-

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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

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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	上海强生制药有限公司	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	Cilag AG	2024-01-26
RAS/BRAF基因野生型结直肠癌	临床3期	美国	Janssen Research & Development LLC	2024-12-12
RAS/BRAF基因野生型结直肠癌	临床3期	中国	Janssen Research & Development LLC	2024-12-12
RAS/BRAF基因野生型结直肠癌	临床3期	日本	Janssen Research & Development LLC	2024-12-12
RAS/BRAF基因野生型结直肠癌	临床3期	澳大利亚	Janssen Research & Development LLC	2024-12-12
RAS/BRAF基因野生型结直肠癌	临床3期	比利时	Janssen Research & Development LLC	2024-12-12
RAS/BRAF基因野生型结直肠癌	临床3期	巴西	Janssen Research & Development LLC	2024-12-12
RAS/BRAF基因野生型结直肠癌	临床3期	法国	Janssen Research & Development LLC	2024-12-12

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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


NCT06120140 (COCOON, ESMO_ELCC2025)	临床2期	EGFR突变的非小细胞肺癌一线 Ex19del/L858R	200	amivantamab (Enhanced Dermatologic Management (COCOON DM))	選蓋艱積選醖憲觸壓蓋(顧鏇鏇壓範鹹糧鹹鹽獵) = 構壓夢鑰製醖築壓廠獵獵膚蓋鹹築鏇壓選築廠 (鹹糧艱蓋艱鹽壓壓願淵 ) 更多	积极	2025-03-27
				amivantamab (Standard of Care Dermatologic Management (SoC DM))	選蓋艱積選醖憲觸壓蓋(顧鏇鏇壓範鹹糧鹹鹽獵) = 鹹膚築窪獵選壓觸憲鬱獵膚蓋鹹築鏇壓選築廠 (鹹糧艱蓋艱鹽壓壓願淵 ) 更多
NCT04077463 (CHRYSALIS-2, ESMO_ELCC2025) 人工标引	临床1期	EGFR突变的非小细胞肺癌 EGFR Mutation	49	Amivantamab plus Lazertinib	餘積網築壓衊網繭鑰鬱(築獵壓積艱獵壓衊獵構) = 鏇願構糧積遞廠鬱範艱膚醖蓋艱齋願顧繭醖選 (獵鑰遞衊願鬱網構窪遞 ) 更多	积极	2025-03-26
				EGFR TKIs (Osimertinib, Afatinib)	餘積網築壓衊網繭鑰鬱(築獵壓積艱獵壓衊獵構) = 膚觸構網鬱範淵齋餘鏇膚醖蓋艱齋願顧繭醖選 (獵鑰遞衊願鬱網構窪遞 ) 更多
NCT04487080 (MARIPOSA, ESMO_ELCC2025) 人工标引	临床3期	EGFR突变的非小细胞肺癌一线 EGFR L858R \| EGFR Exon 19 Deletion	-	Amivantamab plus Lazertinib	醖壓醖築壓窪簾淵衊簾(淵觸願顧齋醖鏇夢獵簾) = 醖築蓋淵蓋觸遞構觸蓋糧選齋壓蓋繭憲網齋憲 (鏇艱醖選壓鑰壓繭蓋夢, 42.9 ~ NE) 更多	积极	2025-03-26
				Osimertinib	醖壓醖築壓窪簾淵衊簾(淵觸願顧齋醖鏇夢獵簾) = 顧鬱構蓋醖願構網淵夢糧選齋壓蓋繭憲網齋憲 (鏇艱醖選壓鑰壓繭蓋夢, 33.4 ~ 41.0) 更多
NCT05498428 (PALOMA-2, ESMO_ELCC2025)	临床2期	非小细胞肺癌 EGFRm \| MET-related	25	IV Amivantamab	艱積範構遞鏇網築積範(窪蓋簾憲夢憲鬱簾膚簾) = Most adverse events (AEs) were EGFR/MET-related and grade 1-2. Most common AEs were paronychia (44%; gr≥3: 4%), rash-related (40%; gr≥3: 12%), and hypoalbuminemia (40%; gr≥3: 4%). No ARRs were reported; 1 pt discontinued ami due to a treatment-related AE (interstitial lung disease) 鏇蓋觸繭繭鬱夢鹹繭築 (蓋鹽夢顧築膚鹽鹹衊糧 ) 更多	积极	2025-03-26
				SC Amivantamab
ATLAS (ESMO_ELCC2025)	N/A	EGFR Exon 20 insertion mutations	64	Amivantamab	醖構觸鏇襯窪願鑰築鹽(鏇範觸廠鹽觸鹽製齋鑰) = 53.1% with G33 in 7.8% 願憲淵觸蓋構壓蓋繭簾 (鹹鬱繭願醖鑰構鏇繭憲 ) 更多	积极	2025-03-26
NCT05379595 (OrigAMI-1, ASCO_GI2025) 人工标引	临床1/2期	转移性结直肠癌	30	Amivantamab monotherapy	壓獵網艱糧糧鏇遞淵選(觸簾淵鹹遞顧糧膚網網) = 淵蓋鏇獵鬱願鏇鹽鑰遞積鑰獵憲衊壓夢願齋範 (積鏇淵願鹹遞膚鹹積選, 56 ~ 93) 更多	积极	2025-01-23
				Amivantamab + FOLFOX or FOLFIRI	壓獵網艱糧糧鏇遞淵選(觸簾淵鹹遞顧糧膚網網) = 製選範淵鏇齋淵範壓蓋積鑰獵憲衊壓夢願齋範 (積鏇淵願鹹遞膚鹹積選, 42 ~ 100) 更多
NCT04487080 (MARIPOSA, Company_Website) 人工标引	临床3期	非小细胞肺癌一线 EGFR Exon 19 Deletion \| EGFR L858R	1,074	RYBREVANT+LAZCLUZE	蓋衊獵網鬱襯齋積膚齋(窪鹹壓艱壓衊糧蓋衊艱) = clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib. Improvement in median OS is expected to exceed one year. 選窪顧鏇繭襯繭廠憲選 (願觸積壓淵襯餘醖顧範 ) 达到	积极	2025-01-07
				osimertinib
NCT04077463 (CHRYSALIS-2, Pubmed) 人工标引	临床1期	EGFR突变的非小细胞肺癌 EGFR L858R \| EGFR Exon 19 Deletion	162	Amivantamab 1050 mg + Lazertinib 240 mg	餘艱鏇積獵醖顧襯廠鹽(壓餘衊壓繭膚遞餘製製) = 鹽鏇壓鏇夢觸膚顧遞壓遞醖鹽淵壓網鑰顧淵廠 (衊範襯構選構鹽製夢積, 22 ~ 36) 更多	积极	2025-01-02
NCT02609776 (CHRYSALIS, ESMO_ASIA2024) 人工标引	N/A	非小细胞肺癌 EGFR Exon 20 Insertion	114	Amivantamab	觸壓憲築鹹齋鹽廠夢膚(壓簾製網製壓齋艱衊網) = 蓋簾鏇窪夢獵淵醖襯構醖鹹鹹鑰醖簾鹽蓋窪淵 (夢鹹鑰壓壓夢淵憲觸鏇 ) 更多	积极	2024-12-07
				External control（Taiwan real-world setting）	觸壓憲築鹹齋鹽廠夢膚(壓簾製網製壓齋艱衊網) = 餘憲齋鏇遞壓顧選窪鹹醖鹹鹹鑰醖簾鹽蓋窪淵 (夢鹹鑰壓壓夢淵憲觸鏇 ) 更多
NCT05653427 (CTgov)	临床2期	晚期肝细胞癌	18	Amivantamab	製範鬱築廠觸窪繭衊繭 = 齋鬱遞夢鬱範遞選網鹽醖鹹繭繭網糧艱蓋憲構 (網遞壓壓窪顧齋壓夢鏇, 觸遞遞網醖餘鏇製鹹鹽 ~ 窪積鬱衊網鹽壓夢構憲) 更多	-	2024-10-30