A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE PF-08046054/SGN-PDLlV VERSUS DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY-TREATED PROGRAMMED CELL DEATH LIGAND 1 (PD-Ll) POSITIVE NON-SMALL-CELL LUNG CANCER (NSCLC)

The purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC) with PD-L1 expression greater than or equal to 1% and had cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted treatment regimen(s) for participants with known actionable genomic alterations (AGAs). Participants in this study must have cancer that has spread through their body or can't be removed with surgery or treated with definitive radiation.
Participants will randomly (like a flip of the coin) be assigned to either the PF-08046054 treatment group or the docetaxel treatment group. Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle. Study participation may be up to 5 years if the participant's NSCLC is responding to treatment. The study team will see how each participant is doing with the study treatment during regular visits at the clinic.

开始日期2025-09-29

申办/合作机构

Pfizer Inc.

CTR20251788

/ Recruiting临床1期

一项在晚期实体瘤参与者中进行的PF-08046054/SGN-PDL1V I期研究

本研究将评估PF-08046054 作为单药治疗用于晚期实体恶性肿瘤参与者时以及作为联合治疗用于转移性或不可切除HNSCC 或NSCLC 参与者时的安全性、耐受性、PK和抗肿瘤活性。

开始日期2025-05-22

申办/合作机构

辉瑞投资有限公司

[+2]

NCT05208762

/ Recruiting临床1期

A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.
Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.

开始日期2022-10-25

申办/合作机构

Seagen, Inc.

100 项与 Fetrastobart vedotin 相关的临床结果

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100 项与 Fetrastobart vedotin 相关的转化医学

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100 项与 Fetrastobart vedotin 相关的专利（医药）

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项与 Fetrastobart vedotin 相关的文献（医药）

2025-12-31·mAbs

A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity

作者: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Velazquez, Roberto ; Simmons, Quincey ; Tschantz, William R. ; Sagar, Vivek ; Hainzl, Dominik ; Barzaghi-Rinaudo, Patrizia ; Korn, Joshua ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; Synan, Alyssa ; D’Alessio, Joseph A.

P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer.This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC).In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17.Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC.In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17.Overall, the preclin. data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-pos. cells.

2025-06-12·ACS Medicinal Chemistry Letters

Site-Selective Anti-PD-L1 Antibody–MMAE Conjugate for Enhanced NSCLC Therapy

Article

作者: Kwon, Se Jeong ; Son, Jinyoung ; Chung, Sang J.

Nonsmall cell lung cancer (NSCLC) presents significant therapeutic challenges, causing advancements in targeted therapies. We have developed a site-selective antibody-drug conjugate (ADC), durvalumab-monomethyl auristatin E (MMAE), with a drug-antibody ratio (DAR) of 4, specifically targeting programmed death-ligand 1 (PD-L1), aimed at enhancing NSCLC therapy. Utilizing the innovative AbClick Pro linker, this ADC ensures stable, site-specific conjugation of MMAE to durvalumab, preserving antibody functionality and integrity. In vivo studies demonstrate that durvalumab-MMAE achieves substantial tumor growth inhibition in NSCLC xenograft models, with an impressive tumor growth inhibition rate of over 60% at lower dosages without significant toxicity. These results, combined with a favorable pharmacokinetic profile featuring extended half-life and low clearance, highlight the potential of durvalumab-MMAE (DAR4) as a potent next-generation ADC for treating PD-L1-expressing cancers, offering a promising avenue for improved NSCLC patient outcomes.

2025-06-01·Pharmaceutical Fronts

Design, Development, and Antitumor Potential of CD228-Targeted Antibody–Drug Conjugates

作者: Xie, Liping ; Qiu, Haitao

Abstract:

Melanotransferrin (CD228) is a membrane glycoprotein involved in tumor growth and metastasis and is highly expressed in various solid tumors. Despite its tumor-specific nature, no antibody drugs targeting CD228 are currently available. This study aimed to develop a humanized CD228 monoclonal antibody and its antibody–drug conjugate (ADC) to evaluate in vitro cytotoxicity and in vivo antitumor efficacy against melanoma. In this work, mice were immunized with the extracellular domain of CD228, and specific antibodies were screened using hybridoma technology, followed by humanization. The humanized antibody was conjugated to monomethyl auristatin E (MMAE) with a citrulline–valine linker and purified by protein A chromatography. The drug–antibody ratio (DAR) and purity were analyzed using hydrophobic interaction chromatography and size-exclusion chromatography. CCK8 assay was performed to assess cytotoxicity against tumor cells, and antibody-dependent cell-mediated cytotoxicity (ADCC) was assessed using Jurkat cells. An A2058 melanoma xenograft model was used to examine in vivo efficacy. This work identified a humanized antibody, Ab-2F6A1, with high CD228 binding affinity, with EC50 values of 1.746 ng/mL (protein binding activity) and 83.8 ng/mL (cell binding activity). The ADC, Ab-2F6A1-VcMMAE, had an average DAR of 4.9026 and a purity of 98.24% and showed significant in vitro cytotoxicity against melanoma, breast, and colon cancer cells. Ab-2F6A1-VcMMAE has a stronger ADCC effect compared with the positive control (Ab-hI49-VcMMAE), and exhibited superior melanoma tumor inhibition in vivo. Given the above, a novel humanized anti-CD228 antibody and its ADC were successfully developed. The ADC demonstrated strong antigen binding, in vitro antitumor activity, ADCC effects, and superior in vivo melanoma inhibition, supporting CD228 as a promising therapeutic target.

项与 Fetrastobart vedotin 相关的新闻（医药）

2026-02-19

·ioncology

2026 ELCC｜摘要速递：驱动基因阴性晚期NSCLC免疫治疗进展

以PD-1/PD-L1抑制剂为代表的免疫检查点抑制剂（ICIs）联合化疗，已成为驱动基因阴性晚期非小细胞肺癌（NSCLC）的一线标准治疗方案，为患者带来显著生存获益。然而，其在临床实践中仍面临诸多挑战，包括治疗选择有限、疗效持续时间短及耐药机制复杂，导致整体预后仍不理想。为突破当前治疗瓶颈，亟需开发更具特异性、安全性与有效性的新型治疗策略。 2026年欧洲肺癌大会（ELCC 2026）将于2026年3月25日至28日在丹麦哥本哈根举行。近日，其官网公布了部分入选摘要信息，其中涵盖了驱动基因阴性晚期NSCLC领域的多项研究进展，涉及创新药物及联合策略、生物标志物探索及特殊人群精细化管理等。《肿瘤瞭望》现对相关研究信息进行整理，以飨读者。创新药物及治疗策略摘要号：3O 英文标题：Anti-Tumor Activity of Gotistobart Compared to Docetaxel in Patients with Metastatic Squamous Non-Small Cell Lung Cancer (sqNSCLC) Progressing on PD-(L)1 Inhibitors: Stage 1 PRESERVE-003 Phase 3 Trial 中文标题：Gotistobart对比多西他赛在PD-(L)1抑制剂治疗期间进展的转移性鳞状非小细胞肺癌患者中的抗肿瘤活性：PRESERVE-003 III期试验第1阶段讲者：Kai He（美国）摘要号：69P 英文标题：First-Line Pumitamig (PD-L1 × VEGF-A bsAb) Monotherapy in PD-L1+ Non-Squamous and Squamous Non-Small Cell Lung Cancer: Data From a Phase 1b/2a Trial in China 中文标题：中国1b/2a期研究——Pumitamig（PD-L1×VEGF-A双特异性抗体）单药一线治疗PD-L1阳性非鳞型和鳞型NSCLC的研究数据摘要号：80P 英文标题：A phase Ib/II study of second-line cadonilimab, anlotinib and docetaxel in patients with checkpoint inhibitor (CPI)-experienced advanced non-small cell lung cancer 中文标题：卡度尼利单抗联合安罗替尼和多西他赛二线治疗经免疫检查点抑制剂治疗的晚期NSCLC的1b/Ⅱ期研究摘要号：98P 英文标题：Nanoparticle polymeric micellar paclitaxel (pm-Pac), platinum, and sintilimab as first-line treatment for advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC): A Phase II study update 中文标题：pm-Pac联合铂类及信迪利单抗一线治疗晚期或转移性非鳞型NSCLC的Ⅱ期研究最新进展摘要号：102P 英文标题：Sustained Response and Long-Term Therapeutic Benefits Beyond Treatment Cessation in NSCLC Relapsed-Patients Treated with Ateganosine and ICI in the THIO-101 Trial 中文标题：THIO-101研究——Ateganosine联合免疫检查点抑制剂治疗复发NSCLC患者停药后的持续应答及长期治疗获益摘要号：105P 英文标题：Interim data on first-line (1L) nivolumab (N) + ipilimumab (I) with 2 cycles of platinum-based chemotherapy (C) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) from the German non-interventional study (NIS) FINN 中文标题：德国FINN非干预性研究中期数据：纳武利尤单抗联合伊匹木单抗加2周期铂类化疗一线治疗转移性NSCLC 摘要号：107P 英文标题：Health-related quality of life with ivonescimab versus pembrolizumab for PD-L1 positive, non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China 中文标题：来自中国的随机、双盲Ⅲ期HARMONi-2研究：依沃西单抗对比帕博利珠单抗治疗PD-L1阳性NSCLC的健康相关生活质量摘要号：109P 英文标题：Patient-Reported Outcomes With Acasunlimab Monotherapy and in Combination With Pembrolizumab: Results From a Phase 2 Study of PD-L1+ mNSCLC 中文标题：Acasunlimab单药及联合帕博利珠单抗治疗PD-L1阳性转移性NSCLC的Ⅱ期研究：患者报告结局摘要号：112P 英文标题：Safety of Valemetostat and Pembrolizumab in Advanced or Metastatic 1L NSCLC Without Actionable Genomic Alterations Expressing PD-L1 With TPS ≥ 50%: Interim Results From the Phase 1b Trial 中文标题：Ib期研究中期结果——Valemetostat联合帕博利珠单抗一线治疗PD-L1 TPS≥50%、无可靶向基因组改变的晚期/转移性NSCLC的安全性摘要号：113P 英文标题：Translational Analysis of Acasunlimab in Combination With Pembrolizumab in CPI-Treated Metastatic NSCLC 中文标题：Acasunlimab联合帕博利珠单抗治疗经免疫检查点抑制剂治疗的转移性NSCLC的转化性分析摘要号：148TiP 英文标题：A phase 3 trial of a PD-1/VEGF bispecific antibody (PF-08634404) vs pembrolizumab in combination with platinum-based chemotherapy in first-line for locally advanced or metastatic non-small cell lung cancer (Symbiotic-Lung-01) 中文标题：Symbiotic-Lung-01Ⅲ期研究：PD-1/VEGF双特异性抗体PF-08634404对比帕博利珠单抗分别联合铂类化疗一线治疗局部晚期或转移性NSCLC 摘要号：149TiP 英文标题：ROSETTA Lung-02: A Global Phase 2/3, Randomized, Open-Label Trial of Pumitamig, a PD-L1 × VEGF-A Bispecific Antibody, in Combination With Chemotherapy in Patients (pts) With First-Line Non-Small Cell Lung Cancer 中文标题：2/3期国际、随机、开放标签ROSETTA Lung-02研究：Pumitamig （PD-L1×VEGF-A双特异性抗体）联合化疗一线治疗NSCLC 摘要号：152TiP 英文标题：PADL1NK-005: A randomized phase 3 trial of PDL1V (PF-08046054) monotherapy vs docetaxel in patients with previously treated PD-L1-positive non-small cell lung cancer 中文标题：随机PADL1NK-005Ⅲ期研究——PDL1V（PF-08046054）单药对比多西他赛治疗经治的PD-L1阳性NSCLC 摘要号：169eP 英文标题：Self-oxygenating PROTAC Microneedles Overcome Immunotherapy Resistance in Non-Small Cell Lung Cancer 中文标题：自供氧PROTAC微针克服非小细胞肺癌免疫治疗耐药生物标志物探索与精准决策摘要号：500MO 英文标题：PD-L1 Blueprint AI: Validation of an AI-assisted PD-L1 scoring algorithm against original Blueprint Study data 中文标题：PD-L1 Blueprint AI——基于Blueprint原始研究数据验证AI辅助PD-L1评分算法讲者：Fred R. Hirsch（美国）摘要号：76P 英文标题：Impact of genomic alterations on clinical outcomes with first-line cemiplimab + chemotherapy for advanced NSCLC: An analysis from EMPOWER-Lung 3 中文标题：EMPOWER-Lung 3研究分析：基因组改变对cemiplimab联合化疗一线治疗晚期NSCLC临床结局的影响摘要号：79P 英文标题：RATIONALE-304: baseline tumour genomic alterations according to programmed death-ligand 1 (PD-L1) subgroups in nonsquamous non-small cell lung cancer (nsq-NSCLC) treated with first-line tislelizumab (TIS) plus chemotherapy (CT) vs CT alone 中文标题：RATIONALE-304研究：替雷利珠单抗联合化疗对比单纯化疗一线治疗非鳞型NSCLC时，不同PD-L1亚组的基线肿瘤基因组改变摘要号：81P 英文标题：AI-enabled platform for baseline plasma ctDNA whole-exome profiling to identify candidate biomarkers of immunotherapy outcomes in advanced driver-negative NSCLC 中文标题：基于人工智能的基线血浆ctDNA全外显子测序平台：筛选晚期驱动基因阴性NSCLC免疫治疗疗效的候选生物标志物摘要号：83P 英文标题：Comprehensive molecular profiling of tumor tissue and liquid biopsy in NSCLC patients treated with immune-checkpoint inhibitors 中文标题：免疫检查点抑制剂治疗的NSCLC患者的肿瘤组织和液体活检的综合分子谱分析摘要号：97P 英文标题：Multimodal AI Models Integrating Clinical and CT Imaging Data to Predict Survival Outcomes in Immunotherapy-Treated NSCLC: Results from the Multicentric APOLLO11 Study 中文标题：APOLLO11多中心研究：整合临床和CT影像数据的多模态人工智能模型预测NSCLC患者接受免疫治疗的生存结局摘要号：106P 英文标题：PLR-NIVO: A Novel AI-Assisted Prognostic Score in Nivolumab-Treated Metastatic NSCLC 中文标题：PLR-NIVO评分：纳武利尤单抗治疗转移性NSCLC的新型人工智能辅助预后评分摘要号：156eP 英文标题：Integrated Metabolomic and Tumor Microenvironment Profiling Identifies Predictive Biomarkers for Immunotherapy Response in Advanced NSCLC 中文标题：代谢组与肿瘤微环境整合分析鉴定晚期非小细胞肺癌免疫治疗疗效预测生物标志物摘要号：157eP 英文标题：A Multimodal Radio-Pathomics Model for Predicting Immunotherapy Response and Prognosis in Advanced Non-Small Cell Lung Cancer: A Multicenter Retrospective Study 中文标题：多模态放射组学-病理组学模型预测晚期非小细胞肺癌免疫治疗疗效与预后：一项多中心回顾性研究摘要号：164eP 英文标题：Clinical role of PD-L1 polymorphisms in PD-L1 overexpressing advanced NSCLC treated with first-line ICI monotherapy 中文标题：PD-L1基因多态性在PD-L1过表达晚期非小细胞肺癌一线免疫单药治疗中的临床作用摘要号：171eP 英文标题：Genome-Wide Association, Single-Cell, and Spatial Transcriptomics analyses revealed STK24-expressing positive epithelial cells in tumour progression and the immunotherapy response 中文标题：全基因组关联、单细胞及空间转录组学揭示STK24阳性上皮细胞在肿瘤进展与免疫治疗应答中的作用摘要号：158eP 英文标题：Prognostic Impact of the Pan-Immune-Inflammation Value in Advanced Non-Small Cell Lung Cancer Treated with First-Line Pembrolizumab: A Real-World Cohort Study 中文标题：泛免疫炎症指数对帕博利珠单抗一线治疗晚期非小细胞肺癌的预后价值：一项真实世界队列研究摘要号：159eP 英文标题：Prognostic Value of the Immune Checkpoint Inhibitor Score (IChIS) in Palliative Immunotherapy-Treated Non-Small Cell Lung Cancer: A Real-World Study 中文标题：免疫检查点抑制剂评分（IChIS）对姑息性免疫治疗非小细胞肺癌的预后价值：一项真实世界研究摘要号：160eP 英文标题：Exploring the prognostic value of the magnesium-immune prognostic score (MIPS) in metastatic non‑small cell lung cancer receiving Nivolumab 中文标题：镁-免疫预后评分（MIPS）对接受纳武利尤单抗治疗的转移性非小细胞肺癌的预后价值探索长生存与耐药突破摘要号：72P 英文标题：Cemiplimab monotherapy for first line advanced NSCLC patients with PD-L1 expression ≥50%: 6-y outcomes of EMPOWER-Lung 1 中文标题：EMPOWER-Lung 1研究6年随访结果：cemiplimab单药一线治疗PD-L1表达≥50%的晚期NSCLC患者摘要号：82P 英文标题：Clinical, immuno-phenotypic and transcriptomic determinants of primary resistance to chemo-immunotherapy (CT-IT) in patients with advanced non-small cell lung cancer (NSCLC) 中文标题：晚期NSCLC患者对化疗联合免疫治疗原发性耐药的临床、免疫表型和转录组学决定因素摘要号：88P 英文标题：First-line Serplulimab for Advanced Squamous Non-small Cell Lung Cancer: Updated Survival of the ASTRUM-004R Trial 中文标题：ASTRUM-004R研究更新生存数据：斯鲁利单抗单药一线治疗晚期肺鳞癌摘要号：150TiP 英文标题：A phase 1b/2 trial of a PD-1/VEGF bispecific antibody (PF-08634404) in combination with anticancer agents in first-line (1L) for advanced solid tumors (Symbiotic-Lung-20) 中文标题：1b/2期Symbiotic-Lung-20研究：PD-1/VEGF双特异性抗体PF-08634404联合抗肿瘤药物一线治疗晚期实体瘤摘要号：173eP 英文标题：BDNF-TrkB Signaling in CD8+ T Cells Drives Immune Evasion and Acquired Resistance to Anti-PD-1 Therapy 中文标题：CD8+T细胞中BDNF-TrkB信号通路介导免疫逃逸与抗PD-1治疗获得性耐药真实世界研究及临床管理摘要号：8MO 英文标题：Subcutaneous Versus Intravenous Toripalimab, in Combination with Chemotherapy, as a First-Line Treatment for Recurrent or Metastatic Non-Squamous (Nsq) Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase 3 Trial 中文标题：皮下注射对比静脉注射特瑞普利单抗联合化疗一线治疗复发或转移性非鳞状非小细胞肺癌：一项随机III期试验讲者：邬麟教授 (湖南省肿瘤医院) 摘要号：71P 英文标题：Budget impact analysis of cemiplimab for first line treatment of patients with metastatic non-small cell lung cancer and programmed cell death ligand 1 expression ≥ 50% in Germany 中文标题：cemiplimab一线治疗PD-L1表达≥50%的转移性NSCLC德国患者的预算影响分析摘要号：73P 英文标题：A Comparison of Tislelizumab (TIS) Plus Chemotherapy (CT) vs Programmed Cell Death Protein-1 (PD-1) Inhibitor Monotherapy in First-Line (1L) Non-Squamous (nsq) Non-Small Cell Lung Cancer (NSCLC) Patients (pts) With Programmed Cell-Death Ligand 1 (PD-L1) ≥50% 中文标题：替雷利珠单抗联合化疗对比PD-1抑制剂单药一线治疗PD-L1≥50%的非鳞型NSCLC患者的研究摘要号：77P 英文标题：Long-Term Outcomes of Brain Radiotherapy Combined With Camrelizumab and Platinum-Doublet Chemotherapy in Untreated Advanced Non-Small Cell Lung Cancer (NSCLC) with Brain Metastases: 3-Year Updated Results of the Phase 2 C-Brain Trial 中文标题：C-Brain Ⅱ期研究3年更新结果：颅脑放疗联合卡瑞利珠单抗及铂类双药化疗治疗初治伴脑转移晚期NSCLC的长期结局摘要号：78P 英文标题：Patient-reported outcomes (PROs) of cemiplimab plus chemotherapy in advanced non-small cell lung cancer (aNSCLC): A focus on age subgroups from EMPOWER-Lung 3 中文标题：EMPOWER-Lung 3研究：cemiplimab联合化疗治疗晚期NSCLC的患者报告结局——聚焦年龄亚组摘要号：91P 英文标题：High-Dose Consolidative Thoracic Radiotherapy after Favorable Response to First-Line Immune Checkpoint Inhibitors in Advanced NSCLC 中文标题：晚期NSCLC患者一线免疫检查点抑制剂治疗获良好应答后的大剂量巩固性胸部放疗摘要号：92P 英文标题：IMMUNOLung80 Outcomes of First-Line Immunotherapy in Octogenarians with Advanced NSCLC — A Multicentre Study 中文标题：IMMUNOLung80：八旬晚期非小细胞肺癌患者一线免疫治疗的结局 —— 一项多中心研究摘要号：100P 英文标题：Patient-Reported Outcomes-based symptom monitoring Among Patients Receiving Immunotherapy for Lung Cancer: A Randomized Controlled Trial 中文标题：基于患者报告结局的症状监测在肺癌免疫治疗患者中的应用：随机对照试验摘要号：110P 英文标题：Pembrolizumab vs atezolizumab as first-line treatment for advanced NSCLC with PD-L1-expression ≥50% 中文标题：帕博利珠单抗对比阿替利珠单抗一线治疗PD-L1表达≥50%的晚期NSCLC 摘要号：111P 英文标题：Proactive Management of Immune-related Hepatic Events in a Phase 2 Trial of Acasunlimab Plus Pembrolizumab in Patients With mNSCLC 中文标题：Acasunlimab联合帕博利珠单抗治疗转移性NSCLC的Ⅱ期研究中，免疫相关肝脏不良事件的主动管理策略摘要号：154eP 英文标题：Real-World Effectiveness and Resource Utilization of First-Line Pembrolizumab in NSCLC: A Retrospective Observational Study (MOSAICO Study) 中文标题：帕博利珠单抗一线治疗非小细胞肺癌的真实世界疗效与资源利用：一项回顾性观察研究（MOSAICO研究）摘要号：155eP 英文标题：Real-world effectiveness of first line nivolumab plus ipilimumab with chemotherapy in patients with non-small cell lung cancer with low PD-L1 tumor expression (Dutch NVALT-34 study) 中文标题：纳武利尤单抗联合伊匹木单抗及化疗一线治疗低PD-L1表达非小细胞肺癌的真实世界疗效（Dutch NVALT-34研究）摘要号：165eP 英文标题：Not Only Histology: The Role of Chemotherapy Backbone in Immunotherapy Outcomes in Advanced Lung Cancer - A Network Meta-Analysis 中文标题：不仅是组织学：化疗骨架在晚期肺癌免疫治疗疗效中的作用——一项网络荟萃分析摘要号：168eP 英文标题：Patient-reported outcomes for atezolizumab subcutaneous and intravenous: results from the Spanish population included in IMscin002 中文标题：阿替利珠单抗皮下注射与静脉注射的患者报告结局：IMscin002研究西班牙人群结果摘要号：176eP 英文标题：Impact of PD-L1 Status on the Development of Cutaneous Immune-Related Adverse Events in Non-Small Cell Lung Cancer Patients Receiving Immunotherapy 中文标题：PD-L1状态对接受免疫治疗的非小细胞肺癌患者皮肤免疫相关不良反应发生的影响摘要号：178eP 英文标题：PATIENTS WITH ADVANCED LUNG CANCER TREATED WITH CHEMO-ANTIPD1 AND CHEMO-ANTIPD1-ANTIANGIOGENIC IN THE FIRST LINE: EXPERIENCE IN OUR CENTRE 中文标题：化疗联合PD-1单抗、化疗联合PD-1单抗及抗血管生成一线治疗晚期肺癌：单中心经验排名不分先后，按照摘要类别划分；如有遗漏或任何问题，请后台留言内容来源：2026 ELCC官网 https://www.esmo.org/meeting-calendar/european-lung-cancer-congress-2026/programme （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床2期临床3期

2026-02-11

·谈医说药

2026年02月11日药品临床试验默示许可

序号受理号药品名称申请人名称适应症注册分类 1 CXSL2501018 HL08 华兰生物工程股份有限公司;华兰基因工程有限公司拟用于肥胖患者的体重控制。 1 2 JXSB2600012 PF-08046054 (注射用冻干粉针) Pfizer Inc. 本品适用于治疗既往接受过含铂化疗、接受或未接受过程序性死亡受体-1（PD-1）或程序性死亡配体1抑制剂（PD-L1）治疗的局部晚期不可切除或转移性非小细胞肺癌成年患者，这些患者经过市售的或经验证的方法检测确定其肿瘤表达PD-L1表达≥1%。 1 3 JXHB2500174 LOU064片 Novartis Pharma AG 中重度化脓性汗腺炎 1 4 JXHB2500173 LOU064片 Novartis Pharma AG 中重度化脓性汗腺炎 1 5 CXHL2501351 GEN-725片河南真实生物科技有限公司 GEN-725与PD-1单抗联合用于治疗晚期实体瘤 2.4 6 CXHL2501350 GEN-725片河南真实生物科技有限公司 GEN-725与PD-1单抗联合用于治疗晚期实体瘤 2.4 7 CXHL2501343 注射用西罗莫司（白蛋白结合型）石药集团中奇制药技术（石家庄）有限公司注射用西罗莫司（白蛋白结合型）联合SYS6023用于治疗不可切除的局部晚期或转移性乳腺癌。 2.4 8 CXSL2501062 托莱西单抗注射液信达生物制药（苏州）有限公司单药用于治疗非家族性高胆固醇血症和混合型血脂异常的成人患者。治疗用生物制品:2.2类 9 CXSL2501052 阿得贝利单抗注射液上海盛迪医药有限公司;苏州盛迪亚生物医药有限公司阿得贝利单抗联合化疗用于可切除的局部进展期胃癌或胃食管结合部癌 2.2 10 CXSL2501060 信迪利单抗注射液信达生物制药（苏州）有限公司 IBI310联合信迪利单抗和贝伐珠单抗伴或不伴化疗用于既往未接受过系统治疗的不可切除或转移性肝细胞癌的一线治疗。 2.2 11 CXSL2501057 贝伐珠单抗注射液信达生物制药（苏州）有限公司 IBI310联合信迪利单抗和贝伐珠单抗伴或不伴化疗用于既往未接受过系统治疗的不可切除或转移性肝细胞癌的一线治疗。 2.2 12 CXSL2501055 SYS6023 石药集团巨石生物制药有限公司 SYS6023联合用药用于治疗不可切除的局部晚期或转移性乳腺癌。 1 13 CXSL2501054 MRG006A 乐普生物科技股份有限公司本品联合免疫检查点抑制剂、靶向治疗药物用于晚期肝癌患者的治疗 1 14 CXSL2501063 IMM0306 宜明昂科生物医药技术（上海）股份有限公司 IgG4相关性疾病（IgG4-RD） 1 15 CXSL2501061 IBI310 信达生物医药科技（杭州）有限公司;信达生物制药（苏州）有限公司 IBI310联合信迪利单抗和贝伐珠单抗伴或不伴化疗用于既往未接受过系统治疗的不可切除或转移性肝细胞癌的一线治疗。 2.2 16 CXHB2500326 HRS-1893片山东盛迪医药有限公司 1.拟用于治疗肥厚型心肌病以及心肌肥厚导致的心力衰竭；2.拟用于治疗射血分数保留的心力衰竭。 1 17 CXHL2501348 JAB-23E73片北京加科思新药研发有限公司 JAB-23E73联合白蛋白结合型紫杉醇和吉西他滨治疗KRAS基因改变的转移性胰腺导管腺癌患者。 1 18 CXHL2501347 JAB-23E73片北京加科思新药研发有限公司 JAB-23E73联合白蛋白结合型紫杉醇和吉西他滨治疗KRAS基因改变的转移性胰腺导管腺癌患者。 1 19 CXHL2501346 JAB-23E73片北京加科思新药研发有限公司 JAB-23E73联合白蛋白结合型紫杉醇和吉西他滨治疗KRAS基因改变的转移性胰腺导管腺癌患者。 1 20 CXSL2501053 DXC006 杭州多禧生物科技有限公司小细胞肺癌 1 21 CXHL2501337 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 22 CXHL2501336 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 23 CXHL2501335 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 24 CXHL2501334 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 25 CXHL2501333 司美格鲁肽片杭州诺澳生物医药科技有限公司;江苏诺泰澳赛诺生物制药股份有限公司拟用于肥胖（BMI ≥ 30kg/m2）或超重（BMI ≥ 27kg/m2）且伴有至少一种体重相关合并症的成年患者体重管理 2.2 26 JXSB2500147 Litifilimab (BIIB059) Biogen Idec Research Limited 用于治疗正在接受非生物制剂标准疗法的成人活动期系统性红斑狼疮（SLE ）。有或无全身表现且抗疟药治疗反应不佳和/或不耐受的活动性亚急性皮肤型红斑狼疮（SCLE）和/或慢性皮肤型红斑狼疮（CCLE）。 1 27 CXHB2500325 CG2001 北京辰光医药科技有限公司;辰光（天津）制药有限公司本品用于男性雄激素性脱发患者的治疗。化学药品 28 JXHL2500387 Eloralintide注射液 Eli Lilly and Company 超重或肥胖患者的中重度阻塞性睡眠呼吸暂停 1 29 JXHL2500386 Eloralintide注射液 Eli Lilly and Company 超重或肥胖患者的中重度阻塞性睡眠呼吸暂停 1 30 JXHL2500385 Eloralintide注射液 Eli Lilly and Company 超重或肥胖患者的中重度阻塞性睡眠呼吸暂停 1 31 JXHL2500384 Eloralintide注射液 Eli Lilly and Company 超重或肥胖患者的中重度阻塞性睡眠呼吸暂停 1 32 JXHL2500383 Eloralintide注射液 Eli Lilly and Company 本品用于成年肥胖或者超重患者在饮食和运动基础上的长期体重管理。 1 33 JXHL2500382 Eloralintide注射液 Eli Lilly and Company 本品用于成年肥胖或者超重患者在饮食和运动基础上的长期体重管理。 1 34 JXHL2500381 Eloralintide注射液 Eli Lilly and Company 本品用于成年肥胖或者超重患者在饮食和运动基础上的长期体重管理。 1 35 JXHL2500380 Eloralintide注射液 Eli Lilly and Company 本品用于成年肥胖或者超重患者在饮食和运动基础上的长期体重管理。 1 36 JXHL2500377 Eloralintide注射液 Eli Lilly and Company 肥胖或超重合并膝骨关节炎疼痛 1 37 JXHL2500376 Eloralintide注射液 Eli Lilly and Company 肥胖或超重合并膝骨关节炎疼痛 1 38 JXHL2500375 Eloralintide注射液 Eli Lilly and Company 肥胖或超重合并膝骨关节炎疼痛 1 39 JXHL2500374 Eloralintide注射液 Eli Lilly and Company 肥胖或超重合并膝骨关节炎疼痛 1 40 CXSL2600068 BG-A3004注射液广州百济神州生物制药有限公司免疫介导性皮肤病 1 41 CXSL2501000 R01注射液杭州纽安津生物科技有限公司根治术后具高危复发风险的恶性实体瘤患者，主要包括胰腺癌、食管癌、肝细胞癌、胆道恶性肿瘤、胃癌以及结直肠癌等。 1 42 CXSL2501002 GKL-006注射液北京基因启明生物科技有限公司中重度银屑病 1 43 CXSL2500998 流感病毒裂解疫苗（高剂量）成大生物（本溪）有限公司;辽宁成大生物股份有限公司接种本疫苗后，可刺激机体产生抗流感病毒的免疫力。用于预防疫苗相关型别的流感病毒引起的流行性感冒。 3.2 44 CXSL2501188 OVV-01注射液上海荣瑞医药科技有限公司 OVV-01注射液静脉及瘤内给药联合治疗晚期实体瘤 1 45 CXSL2501187 OVV-01注射液（静脉）上海荣瑞医药科技有限公司 OVV-01注射液静脉及瘤内给药联合治疗晚期实体瘤 1 46 CXSB2500226 U16注射液上海优卡迪智造生命科技有限公司;上海优卡迪生物医药科技有限公司复发或难治性非霍奇金淋巴瘤治疗用生物制品

2026-02-10

·谈医说药

2026年02月10日药品临床试验默示许可

序号受理号药品名称申请人名称适应症注册分类 1 JXSB2600005 PF-08046054 (注射用冻干粉针) Seagen Inc. PF-08046054 单药或联合帕博利珠单抗或联合帕博利珠单抗和化疗，用于转移性或不可切除的晚期实体瘤（I期研究）。 1 2 CXSB2500242 替雷利珠单抗注射液（皮下注射）广州百济神州生物制药有限公司本品计划用于恶性肿瘤的治疗。 2.1 3 CYHL2500217 马来酸甲麦角新碱注射液成都倍特药业股份有限公司流产后出血；非哺乳期女性产后出血增加及子宫复旧不全。 3 4 CXSL2501044 注射用SHR-A2102 苏州盛迪亚生物医药有限公司;上海恒瑞医药有限公司本品联合阿得贝利单抗±SHR-8068，或联合阿美替尼用于非小细胞肺癌的治疗。 1 5 CXSL2501043 SHR-8068注射液苏州盛迪亚生物医药有限公司本品联合SHR-A2102和阿得贝利单抗用于非小细胞肺癌的治疗。 2.2 6 CXSL2501048 注射用SHR-A2102 苏州盛迪亚生物医药有限公司;上海恒瑞医药有限公司本品联合HS-10504片用于治疗晚期非小细胞肺癌。 1 7 CXSL2501046 注射用SHR-A2009 苏州盛迪亚生物医药有限公司本品联合HS-10504片用于治疗晚期非小细胞肺癌 1 8 CXSL2501047 注射用SHR-1826 苏州盛迪亚生物医药有限公司本品联合HS-10504片用于治疗晚期非小细胞肺癌。 1 9 CXSL2501049 注射用HS-20122 上海翰森生物医药科技有限公司;常州恒邦药业有限公司本品联合HS-10504片用于治疗晚期非小细胞肺癌 1 10 CXSL2501050 HS-20117注射液上海翰森生物医药科技有限公司;常州恒邦药业有限公司本品联合HS-10504片用于治疗晚期非小细胞肺癌 1 11 CXHL2501339 HS-10504片江苏豪森药业集团有限公司;上海翰森生物医药科技有限公司本品联合注射用SHR-A2102或联合注射用SHR-A2009或联合注射用HS-20122或联合HS-20117注射液或联合注射用SHR-1826用于治疗晚期非小细胞肺癌 1 12 CXHL2501338 HS-10504片江苏豪森药业集团有限公司;上海翰森生物医药科技有限公司本品联合注射用SHR-A2102或联合注射用SHR-A2009或联合注射用HS-20122或联合HS-20117注射液或联合注射用SHR-1826用于治疗晚期非小细胞肺癌 1 13 JXSL2500236 BI 764532 输注用浓缩粉末 Boehringer Ingelheim International GmbH 本品联合阿替利珠单抗、卡铂和依托泊苷用于治疗一线广泛期小细胞肺癌（ES-SCLC）成人患者。 1 14 CXSL2501042 注射用MK-1045 默沙东研发（中国）有限公司系统性红斑狼疮 1 15 CXSL2501041 注射用MK-1045 默沙东研发（中国）有限公司系统性红斑狼疮 1 16 CYHL2500216 异硫蓝注射液湖南华纳大药厂股份有限公司;广东星昊药业有限公司淋巴示踪：异硫蓝注射液皮下给药后，通过注射区域渗透以示踪淋巴管。对于下述情形进行淋巴造影：原发性或继发性肿瘤淋巴结引流区，以及治疗方式引起的淋巴结反应。四肢原发性和继发性淋巴水肿；乳糜尿，乳糜腹水或乳糜胸。 3 17 JXSL2500232 Cevostamab Genentech, Inc. 系统性红斑狼疮（伴有或不伴有活动性狼疮性肾炎） 1 18 JXHL2500379 AZD9574 AstraZeneca AB AZD8205联合AZD9574联合或不联合AZD2936用于治疗晚期或转移性实体恶性肿瘤。 1 19 JXHL2500378 AZD9574 AstraZeneca AB AZD8205联合AZD9574联合或不联合AZD2936用于治疗晚期或转移性实体恶性肿瘤。 1 20 CXSL2501025 AK139注射液中山康方生物医药有限公司慢性自发性荨麻疹 1 21 CXSL2501022 AK139注射液中山康方生物医药有限公司过敏性鼻炎 1

申请上市抗体药物偶联物临床1期临床结果临床申请

100 项与 Fetrastobart vedotin 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
转移性非小细胞肺癌	临床3期	美国	Pfizer Inc.	2025-09-29
转移性非小细胞肺癌	临床3期	中国	Pfizer Inc.	2025-09-29
转移性非小细胞肺癌	临床3期	日本	Pfizer Inc.	2025-09-29
转移性非小细胞肺癌	临床3期	澳大利亚	Pfizer Inc.	2025-09-29
转移性非小细胞肺癌	临床3期	加拿大	Pfizer Inc.	2025-09-29
转移性非小细胞肺癌	临床3期	以色列	Pfizer Inc.	2025-09-29
转移性非小细胞肺癌	临床3期	波兰	Pfizer Inc.	2025-09-29
转移性非小细胞肺癌	临床3期	韩国	Pfizer Inc.	2025-09-29
转移性非小细胞肺癌	临床3期	西班牙	Pfizer Inc.	2025-09-29
转移性非小细胞肺癌	临床3期	中国台湾	Pfizer Inc.	2025-09-29

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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


NCT05208762 (C5851001, ESMO2025)	临床1期	非小细胞肺癌	45	PDL1V 1.5 mg/kg	範齋壓願壓艱積範範積(選獵鏇範鹽壓築觸構遞) = 25.3% 衊衊構網襯製積淵壓糧 (積製築簾積醖壓壓製壓 ) 更多	积极	2025-10-17
				PDL1V 1.5 mg/kg (TPS ≥1%)
NCT05208762 (NEWS) 人工标引	临床1期	头颈部鳞状细胞癌	-	SGN-PDL1V 1.75mg/kg	鹽鬱選廠壓艱窪夢獵觸(糧鑰觸獵窪淵獵製觸鹽) = 顧餘鹽醖築鏇鏇鑰憲構鏇製襯顧願鹹淵鬱餘製 (膚顧齋齋繭膚膚製膚鬱 )	积极	2025-07-11
NCT05208762 (C5851001, ASCO2025) 人工标引	临床1期	复发性非鳞状非小细胞肺癌 \| 复发性非小细胞肺癌	-	PDL1V	觸獵網蓋鹽憲窪淵鑰餘(積簾膚夢積蓋鏇齋築觸) = 構鏇顧廠憲膚廠餘淵襯蓋醖鑰鏇鬱淵膚膚鹽醖 (淵獵廠範築範衊夢鏇齋 ) 更多	积极	2025-05-23
				PDL1V (NSCLC)	觸獵網蓋鹽憲窪淵鑰餘(積簾膚夢積蓋鏇齋築觸) = 壓膚鑰廠蓋願選鹹衊繭蓋醖鑰鏇鬱淵膚膚鹽醖 (淵獵廠範築範衊夢鏇齋 ) 更多
NCT05208762 (SGN-PDL1V-001, ESMO2024) 人工标引	临床1期	PD-L1阳性实体瘤 PD-L1 Expression	55	SGN-PDL1V	積膚鹹蓋選製製鬱糧鹽(願艱網網範憲衊醖願憲) = 淵簾選鹽簾蓋願蓋窪鬱鏇選鹽製廠艱廠膚淵廠 (襯製艱襯壓艱願襯窪襯 ) 更多	积极	2024-09-13