Data from Phase 3 MANEUVER study demonstrating significant improvements in physical function and symptoms in patients with tenosynovial giant cell tumor (TGCT) treated with pimicotinib, to be featured in oral presentation

来自第3期MANEUVER研究的数据表明，使用pimicotinib治疗腱鞘巨细胞瘤（TGCT）的患者在身体功能和症状方面取得了显著改善，这些数据将在口头报告中展示。

Latest results for potential first-in-class anti-CEACAM5 ADC precemtabart tocentecan (M9140) highlight strong rationale for further development in colorectal cancer (CRC)

潜在的首个抗CEACAM5 ADC药物precemtabart tocentecan（M9140）的最新结果凸显了其在结直肠癌（CRC）中进一步开发的强有力理由。

Merck, a leading science and technology company, today announced the presentation of new oncology data across more than 12 tumor types at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 to June 4 in Chicago. The presentations include the Phase 3 MANEUVER data for potentially best-in-class pimicotinib in the treatment of the rare tumor TGCT, as well as data from both company- and investigator-sponsored studies highlighting the company’s focus on advancing differentiated molecules to tackle some of the most challenging cancers..

默克，一家领先的科技公司，今天宣布在2025年5月31日至6月4日于芝加哥举行的美国临床肿瘤学会（ASCO）年会上，展示涵盖12种以上肿瘤类型的新肿瘤学数据。这些展示包括pimicotinib治疗罕见肿瘤TGCT的三期MANEUVER研究数据，该药物可能成为同类最佳；同时还包括由公司及研究者发起的研究数据，突显了公司专注于推进差异化分子以应对一些最具挑战性的癌症。

“The new clinical data we are presenting at ASCO showcase our dedication to advancing innovative therapies for a wide range of diseases—spanning from common cancers to rare non-malignant neoplasms,” said Victoria Zazulina, M.D., Head of Development Unit, Oncology, for the Healthcare business of Merck.

“我们在ASCO展示的新的临床数据彰显了我们致力于推动从常见癌症到罕见非恶性肿瘤等广泛疾病的创新疗法，”默克医疗保健业务肿瘤学开发部门负责人维多利亚·扎祖利纳医学博士表示。

“From encouraging early data for our lead antibody-drug conjugate, precemtabart tocentecan, in patients with advanced CRC, to new Phase 2 findings and real-world evidence that reinforce the value of BAVENCIO first-line maintenance as a treatment option for advanced bladder cancer, to detailed Phase 3 results for pimicotinib in tenosynovial giant cell tumor, we are working to advance treatments that provide hope to patients and their families.”.

“从我们领先的抗体药物偶联物precemtabart tocentecan在晚期结直肠癌患者中的令人鼓舞的早期数据，到新的二期研究结果和真实世界证据进一步证实了BAVENCIO一线维持治疗作为晚期膀胱癌治疗选择的价值，再到pimicotinib在腱鞘巨细胞瘤中的详细三期研究结果，我们正努力推进为患者及其家属带来希望的治疗方法。”

Highlights of the company’s data include:

公司数据的亮点包括：

First presentation of Phase 3 MANEUVER data for pimicotinib in the treatment of TGCT (Abstract 11500)

pimicotinib治疗腱鞘巨细胞瘤（TGCT）的3期MANEUVER试验数据首次展示（摘要11500）

Detailed results from Part 1 of the Phase 3 MANEUVER study of pimicotinib in the treatment of patients with TGCT, conducted by Abbisko Therapeutics Co., Ltd., will be presented for the first time during the Sarcoma Oral Abstract Session on June 1, at 9:57 a.m. CST. In the trial, pimicotinib significantly improved objective response rate versus placebo, the primary endpoint, as well as all key secondary endpoints, and was well-tolerated.

由和誉生物制药有限公司开展的针对腱鞘巨细胞瘤（TGCT）患者的pimicotinib三期MANEUVER研究第一部分的详细结果，将于6月1日上午9点57分（中国标准时间）在肉瘤口头报告专场首次公布。试验中，pimicotinib相较于安慰剂，在主要终点客观缓解率以及所有关键次要终点上均显著改善，并且耐受性良好。

Pimicotinib is being developed by Abbisko Therapeutics; Merck holds the rights to commercialize pimicotinib worldwide..

Pimicotinib正在由Abbisko Therapeutics开发；Merck拥有在全球范围内商业化pimicotinib的权利。

Latest data for potentially first-in-class precemtabart tocentecan (Abstracts 3038 & TPS3165)

潜在的首个同类药物precemtabart tocentecan的最新数据（摘要3038和TPS3165）

The company continues to progress the clinical investigation of its lead antibody-drug conjugate (ADC), precemtabart tocentecan. New findings from the Phase 1 PROCEADE-CRC 01 study include data from the dose-optimization part in 60 irinotecan-refractory metastatic CRC patients (3L+) demonstrating encouraging efficacy at doses of 2.4mg/kg and 2.8mg/kg every 3 weeks (Q3W) and a predictable and manageable safety profile.

公司继续推进其领先的抗体药物偶联物（ADC）precemtabart tocentecan的临床研究。1期PROCEADE-CRC 01研究的新发现包括在60名对伊立替康耐药的转移性结直肠癌患者（3线及以上）中进行的剂量优化部分的数据，结果显示每3周（Q3W）2.4mg/kg和2.8mg/kg的剂量下疗效令人鼓舞，并且具有可预测和可控的安全性。

These data, which showed a higher ORR and similar safety at the 2.8 mg/kg dose, support the rationale for selecting this as the recommended dose for further development in CRC and other solid tumors, including those cancer types being investigated in the ongoing Phase 1b/2 PROCEADE-PanTumor study (NCT06710132).

这些数据显示，在2.8 mg/kg剂量下，客观缓解率（ORR）更高且安全性相似，支持了选择该剂量作为推荐剂量，用于结直肠癌（CRC）及其他实体瘤的进一步开发，包括正在进行的1b/2期PROCEADE-PanTumor研究（NCT06710132）中正在调查的那些癌症类型。

More mature data for PROCEADE-CRC-01 and details on the design for the PROCEADE-PanTumor study investigating precemtabart tocentecan in patients with locally advanced/metastatic non-small cell lung, gastric, gastroesophageal junction or pancreatic cancer will be presented at the congress..

PROCEADE-CRC-01 的更成熟数据以及关于 PROCEADE-PanTumor 研究设计的详细信息，该研究针对局部晚期/转移性非小细胞肺癌、胃癌、胃食管交界处癌或胰腺癌患者使用 precemtabart tocentecan，将在大会上展示。

New findings further building on the benefit from BAVENCIO

新发现进一步证明了BAVENCIO的益处

®

®

(avelumab) in the first-line maintenance setting in advanced bladder cancer (Abstracts 4501, e16561, e23275, 9543)

在晚期膀胱癌的一线维持治疗中（摘要编号：4501、e16561、e23275、9543）使用阿维鲁单抗（avelumab）

Interim results from the Phase 2 JAVELIN Bladder Medley trial will be presented, focusing on the efficacy of BAVENCIO in combination with the anti-Trop-2 ADC sacituzumab govitecan (Trodelvy

JAVELIN Bladder Medley 2期试验的中期结果将被公布，重点是BAVENCIO与抗Trop-2 ADC sacituzumab govitecan（Trodelvy）联合使用的疗效。

®

®

, Gilead Sciences) for patients with advanced urothelial carcinoma (UC) who are progression-free after first-line platinum-containing chemotherapy. When used in the maintenance setting, the combination therapy significantly improved progression-free survival (PFS) versus BAVENCIO alone (HR 0.49 [95% CI, 0.31-0.76]); median PFS was 11.17 months versus 3.75 months, respectively.

，Gilead Sciences）用于一线含铂化疗后无进展的晚期尿路上皮癌（UC）患者。在维持治疗中使用时，联合疗法相比单独使用BAVENCIO显著改善了无进展生存期（PFS）（HR 0.49 [95% CI, 0.31-0.76]）；中位PFS分别为11.17个月和3.75个月。

Overall survival (OS) data were immature at the time of analysis. Treatment-related adverse events were more frequent in the combination group (97.3%) compared with BAVENCIO monotherapy (63.9%)..

在分析时，总生存期（OS）数据尚不成熟。与BAVENCIO单药治疗（63.9%）相比，联合治疗组的治疗相关不良事件更为频繁（97.3%）。

The company also will present real-world evidence that reinforces the clinical trial findings from the Phase 3 JAVELIN Bladder 100 study of BAVENCIO as a first-line maintenance therapy in patients with locally advanced/metastatic UC. The data highlight the effectiveness and safety of BAVENCIO in routine clinical practice and heterogenous populations as well as the importance of personalized treatment decision-making..

该公司还将提供真实世界证据，以加强BAVENCIO作为局部晚期/转移性尿路上皮癌（UC）患者一线维持治疗的3期JAVELIN Bladder 100研究的临床试验结果。这些数据突显了BAVENCIO在常规临床实践和异质人群中的有效性和安全性，以及个性化治疗决策的重要性。

New research reinforcing the role of ERBITUX

新研究加强了ERBITUX的作用

®

®

(cetuximab) in colorectal cancer (Abstracts 3513, LBA3500)

（西妥昔单抗）在结直肠癌中的应用（摘要3513，LBA3500）

Investigator-sponsored research continues to reinforce ERBITUX as the backbone of treatment in CRC, including a rapid oral presentation on the final analysis of the FIRE-4 study evaluating the efficacy of cetuximab re-challenge in patients with RASwt mCRC. The study demonstrated greater overall response rate (ORR) in the ERBITUX-containing experimental arm versus physicians’ choice of treatment (11.9% vs 28.9%) and numerically higher OS and PFS.

研究人员发起的研究继续巩固ERBITUX作为结直肠癌（CRC）治疗的基石地位，其中包括关于FIRE-4研究最终分析的快速口头报告，该研究评估了西妥昔单抗再挑战在RAS野生型（RASwt）转移性结直肠癌（mCRC）患者中的疗效。研究表明，与医生选择的治疗方案相比，含ERBITUX的实验组总体缓解率（ORR）更高（11.9% vs 28.9%），总生存期（OS）和无进展生存期（PFS）也呈现数值上的提升。

Additional data from Pfizer’s Phase 3 BREAKWATER trial, evaluating the clinical efficacy of the combination of mFOLFOX6, encorafenib and ERBITUX in metastatic .

辉瑞的III期BREAKWATER试验的更多数据，评估了mFOLFOX6、encorafenib和ERBITUX联合治疗在转移性中的临床疗效。

BRAF V600E

BRAF V600E

-mutant CRC, will be featured in the Cancers of the Colon, Rectum, and Anus session. Merck holds the marketing rights to Erbitux globally, outside of the US and Canada.

-突变型CRC，将出现在结肠、直肠和肛门癌症会议中。默克公司在全球范围内持有Erbitux的营销权，美国和加拿大除外。

Select Merck-related abstracts accepted for the ASCO 2025 Annual Meeting include (all times in CDT):

选择与默克相关的、已被接受的ASCO 2025年会摘要包括（所有时间均为CDT）：

Title

标题

Lead Author

主要作者

Abstract

摘要

Session Information

会话信息

Pimicotinib

帕米考替尼

Pimicotinib in tenosynovial giant cell tumor (TGCT): Efficacy, safety and patient-reported outcomes of Phase 3 MANEUVER study

Pimicotinib治疗腱鞘巨细胞瘤（TGCT）：3期MANEUVER研究的有效性、安全性和患者报告结果

Niu X

牛 X

11500

11500

Session Title:

会议标题：

Sarcoma

肉瘤

Date:

日期：

Sunday, June 1, 2025

2025年6月1日，星期日

Session Time:

会话时间：

9:45 AM – 12:45 PM

上午9点45分 - 下午12点45分

Presentation Time:

演示时间：

9:45 AM – 9:57 AM

上午9点45分 - 上午9点57分

Location:

位置：

S100a

S100a

Precemtabart tocentecan (M9140)

普雷塞姆塔巴特·托森特卡恩 (M9140)

Precemtabart tocentecan (M9140), an anti-CEACAM5 ADC with exatecan payload, in patients with metastatic colorectal cancer (mCRC): Results from the dose optimization of the phase 1 PROCEADE CRC-01 study

Precemtabart tocentecan（M9140），一种携带艾沙替康载荷的抗CEACAM5抗体药物偶联物（ADC），用于治疗转移性结直肠癌（mCRC）患者：来自1期PROCEADE CRC-01研究剂量优化的结果

Kopetz S

科佩茨 S

3038

3038

Session Title:

会议标题：

Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

发展治疗学——分子靶向药物和肿瘤生物学

Session Title:

会议标题：

Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

发展治疗学——分子靶向药物与肿瘤生物学

Date:

日期：

Monday, June 2, 2025

2025年6月2日，星期一

Session Time:

会话时间：

1:30 PM – 4:30 PM

下午1:30 - 下午4:30

Location:

位置：

Hall A

大厅A

BAVENCIO

巴文西奥

®

®

(avelumab)

(阿维鲁单抗)

Avelumab + sacituzumab govitecan (SG) vs avelumab monotherapy as first-line (1L) maintenance treatment in patients (pts) with advanced urothelial carcinoma (aUC): Interim analysis from the JAVELIN Bladder Medley phase 2 trial

Avelumab联合Sacituzumab Govitecan（SG）与Avelumab单药作为晚期尿路上皮癌（aUC）患者的一线（1L）维持治疗：JAVELIN Bladder Medley 2期试验的中期分析

Hoffman-Censit J

霍夫曼-森西特 J

4501

4501

Session Title:

会议标题：

Genitourinary Cancer—Kidney and Bladder

泌尿生殖系统癌症——肾和膀胱

Date:

日期：

Sunday, June 1, 2025

2025年6月1日，星期日

Session Time:

会话时间：

9:45 AM – 12:45 PM

上午9点45分 - 下午12点45分

Presentation Time:

演示时间：

9:57 AM – 10:09 AM

上午9点57分 - 上午10点09分

Location:

位置：

Hall D2

D2大厅

Differences in patient (pt) characteristics and therapy choice across treatment (tx) groups in locally advanced or metastatic urothelial cancer (la/mUC) in the US: A survey on unmet patient needs

美国局部晚期或转移性尿路上皮癌（la/mUC）患者（pt）在治疗（tx）组间的特征及治疗选择差异：一项关于未满足患者需求的调查

Milloy N

米洛伊 N

e16561

e16561

Session Title:

会议标题：

Publication Only: Genitourinary Cancer—Kidney and Bladder

仅出版：泌尿生殖系统癌症——肾与膀胱

Management and outcomes of rash, peripheral neuropathy (PN), and hyperglycemia (HG) during first-line (1L) treatment (tx) of locally advanced/metastatic urothelial cancer (la/mUC) in a real-world setting

在真实世界环境中，局部晚期/转移性尿路上皮癌（la/mUC）一线治疗（1L）期间对皮疹、周围神经病变（PN）和高血糖（HG）的管理及结果

Nizam A

尼扎姆 A

e23275

e23275

Session Title:

会议标题：

Publication Only: Quality Care/Health Services Research

仅出版：质量护理/健康服务研究

Real-world safety and effectiveness of avelumab in immune-compromised (IC) and non-IC patients with Merkel cell carcinoma (MCC): Results from a prospective German registry (MCC-TRIM)

Avelumab在免疫功能受损（IC）和非IC的默克尔细胞癌（MCC）患者中的真实世界安全性和有效性：来自德国前瞻性登记研究（MCC-TRIM）的结果

Becker J

贝克尔 J

9543

9543

Session Title:

会议标题：

Publication Only: Genitourinary Cancer—Kidney and Bladder

仅出版：泌尿生殖系统癌症——肾与膀胱

ERBITUX

ERBITUX

®

®

(cetuximab)

（西妥昔单抗）

FIRE-4 (AIO KRK-0114): Randomized study evaluating the efficacy of cetuximab re-challenge in patients with metastatic RAS wild-type colorectal cancer responding to first-line treatment with FOLFIRI plus cetuximab

FIRE-4 (AIO KRK-0114)：评估西妥昔单抗再挑战在转移性RAS野生型结直肠癌患者中疗效的随机研究，这些患者对一线FOLFIRI加西妥昔单抗治疗有响应。

Weiss L

怀斯 L

3513

3513

Session Title:

会议标题：

Gastrointestinal Cancer—Colorectal and Anal

胃肠道癌症——结直肠和肛门

Date:

日期：

Sunday, June 1, 2025

2025年6月1日，星期日

Session Time:

会话时间：

11:30 AM – 1:00 PM

上午11点30分至下午1点

Presentation Time:

演示时间：

11:36 AM – 11:42 AM

上午11点36分 - 上午11点42分

Location:

位置：

Hall D1

D1大厅

First-line encorafenib + cetuximab + mFOLFOX6 in BRAF V600E-mutant metastatic colorectal cancer (BREAKWATER): Progression-free survival and updated overall survival analyses

恩科拉非尼 + 西妥昔单抗 + mFOLFOX6 一线治疗BRAF V600E突变转移性结直肠癌（BREAKWATER）：无进展生存期和更新的总生存期分析

Elez E

埃莱兹 E

LBA3500

LBA3500

Session Title:

会议标题：

Oral Abstract Session C: Cancers of the Colon, Rectum, and Anus

口头摘要会议C：结肠、直肠和肛门癌症

Date:

日期：

Friday, May 30, 2025

2025年5月30日，星期五

Session Time:

会话时间：

2:45 PM-5:45 PM

下午2点45分至下午5点45分

Presentation Time:

演示时间：

2:45 PM – 2:57 PM

下午2点45分 - 下午2点57分

Location:

位置：

Arie Crown Theater

阿里皇冠剧院

Advancing the Future of Cancer Care

推进癌症治疗的未来

At Merck, we strive every day to improve the futures of people living with cancer. Building on our 350-year global heritage as pharma pioneers, we are focusing our most promising science to target cancer’s deepest vulnerabilities, pursuing differentiated molecules to strike cancer at its core. By developing new therapies that can help advance cancer care, we are determined to create a world where more cancer patients will become cancer survivors.

在默克，我们每天都在努力改善癌症患者的生活前景。基于我们作为制药先锋350年的全球传统，我们正集中最前沿的科学力量，针对癌症最深层的脆弱点，开发独特的分子以直击癌症核心。通过研发能够推动癌症治疗的新疗法，我们决心创造一个让更多癌症患者成为癌症幸存者的世界。

Learn more at .

了解更多，请访问。

www.merckgroup.com.

www.merckgroup.com.

About Pimicotinib (ABSK021)

关于Pimicotinib (ABSK021)

Pimicotinib (ABSK021), which is being developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib has been granted breakthrough therapy designation (BTD) for the treatment of inoperable TGCT by China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA).

和誉医药开发的Pimicotinib（ABSK021）是一种新型的、口服给药的、高选择性和强效的小分子CSF-1R抑制剂。Pimicotinib已获得中国国家药品监督管理局（NMPA）和美国食品药品监督管理局（FDA）授予的用于治疗不可手术的腱鞘巨细胞瘤（TGCT）突破性疗法认定（BTD），以及欧洲药品管理局（EMA）授予的优先药物（PRIME）资格。

Merck holds .

默克持有。

worldwide commercialization rights for pimicotinib

pimicotinib的全球商业化权利

.

。

About precemtabart tocentecan (M9140)

关于Precemtabart Tocentecan（M9140）

Precemtabart tocentecan (previously known as M9140) is an investigational anti-CEACAM5 antibody-drug conjugate (ADC). Leveraging the company’s novel linker-payload technology, precemtabart tocentecan is the first CEACAM5 ADC with an exatecan payload, a potent topoisomerase inhibitor (TOP1i), which has been rationally designed for stability in circulation and superior cancer cell killing activity.

Precemtabart tocentecan（之前称为 M9140）是一种研究性的抗 CEACAM5 抗体药物偶联物 (ADC)。利用公司新颖的连接子-有效载荷技术，precemtabart tocentecan 是首个携带 exatecan 有效载荷的 CEACAM5 ADC，exatecan 是一种强效的拓扑异构酶抑制剂 (TOP1i)，经过合理设计以确保在血液循环中的稳定性以及卓越的癌细胞杀伤活性。

Beyond the direct effect on the target cell, precemtabart tocentecan has been shown in preclinical research to induce tumor cell death through a bystander effect permeating the cell membrane to neighboring cells, inducing apoptosis (cell death). This bystander effect within the tumor microenvironment may enhance efficacy, particularly in tumors with heterogenous CEACAM5 expression.

除了对靶细胞的直接作用外，临床前研究显示，precemtabart tocentecan 能够通过旁观者效应诱导肿瘤细胞死亡，这种效应可以穿透细胞膜影响邻近细胞，引发细胞凋亡（细胞死亡）。在肿瘤微环境中的这种旁观者效应可能会增强疗效，尤其是在具有异质性 CEACAM5 表达的肿瘤中。

Precemtabart tocentecan is currently being evaluated across tumor types with CEACAM5 expression and a high unmet need, including metastatic colorectal cancer (mCRC), gastric cancer (GC), non-small cell lung cancer (NSCLC), and pancreatic ductal adenocarcinoma (PDAC)..

Precemtabart tocentecan 正在针对具有CEACAM5表达和高度未满足需求的肿瘤类型进行评估，包括转移性结直肠癌（mCRC）、胃癌（GC）、非小细胞肺癌（NSCLC）和胰腺导管腺癌（PDAC）。

About BAVENCIO

关于BAVENCIO

®

®

(avelumab)

(阿维鲁单抗)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models..

BAVENCIO是一种人源化的抗程序性死亡配体-1（PD-L1）抗体。在临床前模型中，BAVENCIO已被证明能够激活适应性免疫和先天性免疫功能。通过阻断PD-L1与PD-1受体的相互作用，BAVENCIO在临床前模型中显示出能够解除对T细胞介导的抗肿瘤免疫反应的抑制作用。

BAVENCIO Approved Indications

BAVENCIO获批适应症

BAVENCIO

巴文西奥

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(avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy..

（avelumab）在美国适用于局部晚期或转移性尿路上皮癌（UC）患者的维持治疗，这些患者在一线含铂化疗期间未出现疾病进展。BAVENCIO还适用于在含铂化疗期间或之后出现疾病进展的局部晚期或转移性UC患者，或在使用含铂化疗进行新辅助或辅助治疗后12个月内出现疾病进展的患者。

BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

BAVENCIO联合阿昔替尼在美国被批准用于晚期肾细胞癌（RCC）患者的一线治疗。

In the US, BAVENCIO is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).

在美国，BAVENCIO 适用于治疗 12 岁及以上患有转移性默克尔细胞癌 (MCC) 的成人和儿童患者。

BAVENCIO is currently approved for at least one indication for patients in more than 50 countries.

BAVENCIO目前已在50多个国家获得至少一项适应症的批准。

BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)

根据欧盟产品特性摘要 (SmPC) 的 BAVENCIO 安全性概况

The special warnings and precautions for use for BAVENCIO monotherapy include infusion-related reactions, as well as immune-related adverse reactions that include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrinopathies, nephritis and renal dysfunction, and other immune-related adverse reactions.

BAVENCIO单药治疗的特殊警告和注意事项包括与输液相关的反应，以及免疫相关的不良反应，包括肺炎和肝炎（包括致命病例）、结肠炎、胰腺炎（包括致命病例）、心肌炎（包括致命病例）、内分泌疾病、肾炎和肾功能障碍，以及其他免疫相关的不良反应。

The special warnings and precautions for use for BAVENCIO in combination with axitinib include hepatotoxicity..

BAVENCIO与阿昔替尼联合使用时的特殊警告和注意事项包括肝毒性。

The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia..

在实体瘤患者中，使用BAVENCIO单药治疗最常见的不良反应包括疲劳、恶心、腹泻、食欲减退、便秘、输液相关反应、体重减轻和呕吐。而BAVENCIO与阿昔替尼联合使用时最常见的不良反应包括腹泻、高血压、疲劳、恶心、发声困难、食欲减退、甲状腺功能减退、咳嗽、头痛、呼吸困难和关节痛。

About ERBITUX

关于ERBITUX

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(cetuximab)

（西妥昔单抗）

ERBITUX

ERBITUX

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is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX

是一种针对表皮生长因子受体（EGFR）的IgG1单克隆抗体。作为一种单克隆抗体，ERBITUX的作用机制

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is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites.

与标准的非选择性化疗不同，它专门针对并结合EGFR。这种结合抑制了受体的激活及其后续的信号传导途径，从而减少肿瘤细胞对正常组织的侵袭以及肿瘤向新部位的扩散。

It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on .

它还被认为可以抑制肿瘤细胞修复化疗和放疗造成的损伤的能力，并抑制肿瘤内部新血管的形成，这似乎会全面抑制肿瘤的生长。基于 。

in vitro

体外

evidence, ERBITUX

证据，ERBITUX

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also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).

同时靶向细胞毒性免疫效应细胞朝向表达EGFR的肿瘤细胞（抗体依赖性细胞介导的细胞毒作用[ADCC]）。

ERBITUX

ERBITUX

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has already obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX

已经在100多个国家获得了用于治疗RAS野生型转移性结直肠癌以及头颈部鳞状细胞癌的市场授权。默克公司获得了ERBITUX的销售权。

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, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.

，ImClone有限责任公司的注册商标，在美国和加拿大以外地区，1998年从Eli Lilly and Company的全资子公司ImClone LLC获得。