A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma

Urothelial carcinoma (UC) is the ninth most common cancer type worldwide. While the treatment of front-line metastatic urothelial carcinoma (mUC) has improved, there remains a high unmet need for effective therapies for participants who have recurrent disease and disease that has progressed after frontline treatment. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab.
Livmoniplimab is an investigational drug being developed for the treatment of mUC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at one of 2 different doses) in combination with budigalimab (another investigational drug), or either docetaxel, paclitaxel, or gemcitabine (based on investigator's choice). Approximately 150 adult participants will be enrolled in the study across 56 sites worldwide.
In arm 1, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab. In arm 2, participants will receive IV infused livmoniplimab (dose B) in combination with IV infused budigalimab. In arm 3 (control), participants will receive the investigator's choice: IV infused or injected docetaxel; IV infused or injected paclitaxel; or IV infused gemcitabine. The estimated duration of the study is up to approximately 3.5 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

开始日期2025-01-20

申办/合作机构

AbbVie, Inc.

NCT06487559

/ Recruiting临床1期

A Phase 1b Study to Evaluate the Safety and Pharmacokinetics of Livmoniplimab in Combination With Budigalimab in Chinese Subjects With Locally Advanced or Metastatic Child-Pugh A Hepatocellular Carcinoma Who Have Progressed After a First-Line Regimen That Includes an Immune Checkpoint Inhibitor

Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to assess adverse events and how livmoniplimab in combination with budigalimab moves through the body in adult Chinese participants with Locally Advanced or metastatic Child-Pugh A Hepatocellular Carcinoma (HCC).
Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 2 stages to this study. Stage 1 is a safety run-in. There are 2 treatment arms in stage 1 and participants will receive escalating doses of Livmoniplimab in combination with budigalimab (fixed dose). Stage 2 is dose expansion. There are 2 treatment arms in stage 2 and participants will receive Livmoniplimab in combination with budigalimab in multiple doses. Approximately 20 adult participants will be enrolled in the study across 15 sites in China.
In part 1 (dose escalation), participants will be intravenously infused with escalating doses of livmoniplimab in combination with budigalimab every 3 weeks. In part 2 (dose expansion), participants will be intravenously infused with livmoniplimab in combination with budigalimab in multiple doses every 3 weeks. The estimated duration of the study is up to 2 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

开始日期2024-09-11

申办/合作机构

AbbVie, Inc.

NCT06236438

/ Active, not recruiting临床2/3期

A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Non-Squamous Non-Small Cell Lung Cancer (NSCLC) remains a leading cause of cancer mortality worldwide, with poor survival prospects for metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab plus chemotherapy versus pembrolizumab plus chemotherapy in participants with untreated metastatic non-squamous non-small cell lung cancer.
Livmoniplimab is an investigational drug being developed for the treatment of NSCLC. There are 2 stages to this study. In Stage 1, there are 4 treatment arms. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug) + chemotherapy, budigalimab +chemotherapy, or pembrolizumab +chemotherapy. In Stage 2, there are 2 treatments arms. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab +chemotherapy or placebo in combination with pembrolizumab +chemotherapy. Chemotherapy consists of IV Infused pemetrexed + IV infused cisplatin or IV infused or injected carboplatin. Approximately 840 adult participants will be enrolled in the study across 200 sites worldwide.
Stage 1: In cohort 1, participants will receive intravenously (IV) infused livmoniplimab (dose A)+ IV infused budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + IV Infused pemetrexed. In cohort 2, participants will receive livmoniplimab (dose B) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In cohort 3, participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed . In cohort 4, participants will receive IV Infused pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. Stage 2: In arm 1, participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In arm 2, participants will receive IV Infused placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. The estimated study duration is 55 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

开始日期2024-04-10

申办/合作机构

AbbVie, Inc.

100 项与 Livmoniplimab 相关的临床结果

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100 项与 Livmoniplimab 相关的转化医学

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100 项与 Livmoniplimab 相关的专利（医药）

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项与 Livmoniplimab 相关的文献（医药）

Frontiers in Oncology

First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ß1 complex, as monotherapy and in combination with the anti–PD-1 antibody budigalimab in patients with advanced solid tumors

Article

作者: Blaney, Martha ; Shimizu, Toshio ; Graham, Michelle ; Sahtout, Mohammad ; Miller, Kathy D. ; Stoll, Brian ; LoRusso, Patricia ; Kongpachith, Sarah ; Tolcher, Anthony ; Golan, Talia ; Patel, Maulik ; Powderly, John ; Miller, Kathy D ; Tribouley, Catherine ; Leibman, Rachel ; Abdul Razak, Albiruni ; Kao, Steven

Background:

Transforming growth factor (TGF)-ß1 is a pleiotropic cytokine that can promote tumor growth and suppress antitumor immune responses. Latent TGF-ß1 associates with glycoprotein-A repetition predominant (GARP) on the surface of regulatory T cells prior to its activation and release. Livmoniplimab is a monoclonal antibody (mAb) that binds the GARP:TGF-ß1 complex to inhibit activation and release of TGF-ß1. It is in clinical development in combination with budigalimab, an anti-programmed cell death protein 1 Fc-modified mAb. The first-in-human, phase 1, dose-escalation results are presented herein (ClinicalTrials.gov: NCT03821935).

Methods:

The dose-escalation phase enrolled adult patients with advanced solid tumors. Patients received escalating doses of livmoniplimab ranging from 3mg to 1500mg, once every 2 weeks (Q2W), as monotherapy or in combination with a 500mg fixed dose of budigalimab Q4W. The primary objective of the dose escalation was to determine the recommended phase 2 dose. Secondary objectives were to assess safety and pharmacokinetics (PK), and exploratory objectives included evaluating preliminary efficacy.

Results:

Fifty-seven patients enrolled in the dose escalation: 23 in monotherapy cohorts and 34 in combination therapy cohorts. Dose-limiting toxicities were limited, no maximum tolerated dose was reached, and the maximum administered dose of 1500mg was selected for dose expansion. The most common adverse events reported in monotherapy-treated patients were fatigue, anemia, and nausea, and those in combination therapy-treated patients were pruritus, fatigue, nausea, and anemia. Livmoniplimab exhibited dose-proportional PK, and peripheral blood biomarker data demonstrated saturation of the GARP:TGF-ß1 complex on platelets at livmoniplimab doses within the linear PK range. No objective tumor responses were observed in the monotherapy dose escalation. However, the objective response rate was 15% in the combination dose escalation, with a median response duration of 8.4 months.

Conclusion:

Livmoniplimab was well-tolerated as monotherapy and in combination with budigalimab in the dose-escalation phase. Encouraging preliminary efficacy was demonstrated in the combination dose escalation in heavily pretreated patients, supporting further development of this novel drug combination in patients with advanced solid tumors.

Frontiers in Oncology

Corrigendum: First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP: TGF-ß1 complex, as monotherapy and in combination with the anti–PD-1 antibody budigalimab in patients with advanced solid tumors

作者: Graham, Michelle ; Shimizu, Toshio ; Blaney, Martha ; Sahtout, Mohammad ; Stoll, Brian ; LoRusso, Patricia ; Kongpachith, Sarah ; Golan, Talia ; Tolcher, Anthony ; Patel, Maulik ; Powderly, John ; Miller, Kathy D ; Tribouley, Catherine ; Leibman, Rachel ; Abdul Razak, Albiruni ; Kao, Steven

[This corrects the article DOI: 10.3389/fonc.2024.1376551.].

项与 Livmoniplimab 相关的新闻（医药）

2025-05-27

·PRNewswire

AbbVie Features New Data Across Difficult-to-Treat Solid Tumors and Blood Cancers at ASCO 2025, Highlighting Breadth and Depth of its Oncology Portfolio

- Key oral presentations highlight new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) including telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced non-small cell lung cancer (NSCLC), ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN). NORTH CHICAGO, Ill., May 27, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers. "The data we're presenting at this year's ASCO reflect the breadth and depth of our oncology pipeline and our unwavering commitment to research that could transform outcomes for patients facing cancer," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These presentations underscore our leadership in driving scientific innovation to address some of the most pressing unmet needs in oncology today by leveraging our innovative platforms such as ADCs." An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase: Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study (NCT05029882).1 Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%.1 High ORR was observed regardless of c-Met protein expression levels.1 At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR).1 The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%).1 Additional data with 4 months follow-up will be presented at ASCO. Temab-A is also being evaluated in multiple ongoing clinical trials including a Phase 1/2 Study (NCT06772623) in first-line NSCLC without actionable genomic alterations in combination with budigalimab (AbbVie's investigational programmed cell death 1 inhibitor), a Phase 2 study (NCT06107413) in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid and bevacizumab, and a Phase 3 study (NCT06614192) as monotherapy in patients with c-Met overexpressing refractory metastatic CRC. "The anti-tumor activity of Temab-A in patients with pre-treated, advanced EGFR-mutated non-squamous NSCLC is encouraging and supports further exploration of this novel ADC in this setting," said Ross Camidge, M.D., Ph.D, University of Colorado Cancer Center, United States and principal investigator of the trial. "Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated with poor prognosis." Additional oral presentations will highlight new safety and efficacy data for ABBV-706, a SEZ6-directed ADC with a Top1i payload, and pivekimab sunirine (PVEK), a novel ADC designed to target CD123: In a Phase 1 open-label study of ABBV-706 monotherapy, 64 patients with high-grade neuroendocrine neoplasms (NENs), a diverse group of rare and aggressive solid tumors, received ABBV-706 monotherapy IV at 1.3–3.5 mg/kg once every 3 weeks.2,3 The entire cohort had an ORR of 31.3%, and a median DoR of 5.6 months.2 The most common grade ≥3 TEAEs (cumulative across all dose levels), were anemia (45%), neutropenia (33%), and thrombocytopenia (21%).2 Additional data will be presented at ASCO. This ongoing study (NCT05599984) is evaluating ABBV-706 as monotherapy, or in combination with budigalimab, carboplatin, or cisplatin, in patients with advanced solid tumors expressing SEZ6, including small-cell lung cancer, NENs and high-grade Central Nervous System tumors. Results from the open-label, multicenter Phase 1b/2 CADENZA trial (NCT03386513) of PVEK monotherapy in patients with previously untreated or relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive and rare type of blood cancer, demonstrated clinical benefit.4,5 The results show that among 33 untreated patients, the primary endpoint of composite complete response (CCR) rate, defined as CR + clinical CR (CR with minimal skin abnormality), was 70% (95% CI, 51.3-84.4) with a median duration of CCR of 9.8 months. ORR was 85%.4 In the 51 patients with R/R BPDCN, the CCR rate was 14% with a median duration of CCR of 9.2 months. ORR was 35%.4 Among all the 84 patients enrolled, the most common grade ≥3 TEAEs were peripheral edema (12%).4 TEAEs led to discontinuation in 9% and 7% of patients with first-line and R/R BPDCN, respectively. 4 Additional data will be presented at ASCO. PVEK is also being evaluated in a Phase 1/2 study (NCT04086264) in R/R and newly diagnosed acute myeloid leukemia. "Over the past few years, we've significantly expanded our ADC portfolio to investigate a broad range of solid tumors and blood cancers, reflecting our deep commitment to transforming cancer care through targeted therapies and biomarker driven approaches," said Daejin Abidoye, M.D., vice president, therapeutic area head of solid tumors, AbbVie. "These results highlight the potential of our investigational medicines to offer a meaningful clinical benefit in multiple difficult-to-treat cancers, where current treatment options are limited." Further information on AbbVie clinical trials is available at . Additional details on key presentations at ASCO are available below and the full ASCO Annual Meeting 2025 abstracts are available here. Telisotuzumab adizutecan, ABBV-706, pivekimab sunirine, etentamig, livmoniplimab, budigalimab, ABBV-291 and ABBV-969 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. Venetoclax, ibrutinib, epcoritamab, telisotuzumab vedotin are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. EPKINLY ®/TEPKINLY ® (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. VENCLEXTA®/VENCLYXTO® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. IMBRUVICA® (ibrutinib) is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) Please see full Prescribing Information for EPKINLY® (epcoritamab-bysp) Please see full Prescribing Information for IMBRUVICA® (ibrutinib) Please see full Prescribing Information for VENCLEXTA® (venetoclax tablets) About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Camidge R, Raimbourg J, Lee Y-G, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate, in Patients With Advanced EGFR Mutated Non-Squamous NSCLC: Results From a Phase 1 Study. Abstract 8512 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cooper A, Chandana S, Furqan M, et al. Safety and efficacy of ABBV-706, a seizure-related homolog protein (SEZ6)- targeting antibody-drug conjugate, in high-grade neuroendocrine neoplasms. Abstract 105 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Sultana Q, Kar J, Verma A, et al. A Comprehensive Review on Neuroendocrine Neoplasms: Presentation, Pathophysiology and Management. J Clin Med. 2023 Aug 5;12(15):5138. doi: 10.3390/jcm12155138. Pemmaraju N, Marconi G, Montesinos P, et al. Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study. Abstract 6502 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cazzato G, Capuzzolo M, Bellitti E, et al. Blastic Plasmocytoid Dendritic Cell Neoplasm (BPDCN): Clinical Features and Histopathology with a Therapeutic Overview. Hematol Rep 2023;15(4):696-706 doi: 10.3390/hematolrep15040070. Contacts: SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果ASCO会议临床1期抗体药物偶联物临床2期

2025-05-16

·小药说药

肿瘤免疫治疗中的免疫抑制性细胞因子

-01-引言癌细胞表观遗传学和生长动力学的改变导致细胞外分泌多种细胞因子，这些细胞因子控制免疫细胞的活性，使其有利于肿瘤生长。其中，免疫调节细胞因子的分泌是招募免疫抑制细胞的主要因素。肿瘤微环境中的免疫调节细胞因子招募其他免疫抑制细胞，并负责效应免疫细胞的表型和功能转换，使其支持肿瘤的发展。表型转换的免疫细胞进一步提高免疫抑制细胞因子的水平，并使肿瘤环境抵抗抗肿瘤免疫细胞的活性。其中MDSCs、TAMs、Treg和Breg细胞是调节性细胞因子的主要来源。在广泛的免疫抑制细胞因子中，IL-10、TGF-β、IL-4和IL-35在多种癌症的肿瘤环境中占主导地位，主要负责免疫抑制。这些细胞因子改变先天性和适应性免疫细胞的命运，并调节癌细胞的生长和增殖能力。同时，免疫抑制细胞因子也改变了幼稚免疫细胞的表观基因组和转录网络，有利于免疫抑制细胞谱系的形成。此外，这些细胞因子可以直接作用于细胞毒性CD8+T细胞或自然杀伤（NK）细胞，并抑制其效应器功能和增殖。-02-一、IL-10IL-10是一种多功能的免疫抑制细胞因子，具有免疫调节和血管生成功能。IL-10由癌细胞和几种免疫细胞分泌，包括髓系和淋巴细胞。已有证据表明IL-10具有促进肿瘤和抑制肿瘤的双重功能。一方面，IL-10通过下调癌细胞和APC上的MHC表达来抑制细胞毒性T细胞活化，从而阻止抗原特异性T细胞识别癌细胞。另一方面，高剂量的IL-10可增强CD8+T细胞的增殖及其细胞毒性活性。某些炎性细胞因子和条件可能会促进组织损伤和肿瘤发生，IL-10可以抑制这些炎症状态，从而防止随后的肿瘤发生。最近的研究表明，基于西妥昔单抗的IL-10融合蛋白（CmAb-IL10）通过阻止树突状细胞介导的肿瘤浸润性CD8+T细胞凋亡，显示出强大的抗肿瘤作用。CmAb-IL10与免疫检查点阻断剂的联合应用显示，晚期肿瘤小鼠的抗肿瘤免疫力得到明显改善。因此，有必要根据具体癌症类型和患者亚群的具体情况，通过抑制或促进IL-10通路来评估潜在的治疗干预。-03- 二、TGF-βTGF-β作为一种免疫抑制细胞因子，通过不同的机制对免疫应答产生广泛的抑制作用。TGF-β降低Th1、Th2细胞和细胞毒性T淋巴细胞（CTL）的分化和功能，所有这些都提供重要的抗肿瘤反应。此外，TGF-β还通过调节Treg细胞的数量和功能，增强免疫耐受和肿瘤逃避。TGF-β通过抑制或刺激细胞增殖来调节免疫细胞的命运，从而影响胸腺和外周T细胞的发育。TGF-β在TME中起着双重作用，这是由于肿瘤发展的不同阶段和基因改变背景决定的。在早期肿瘤中，TGF-β途径可诱导细胞凋亡并抑制包括癌细胞在内的细胞增殖。矛盾的是，在晚期，它通过调节基因组不稳定性、EMT、新生血管生成、免疫逃避和转移，具有促肿瘤作用。当促肿瘤功能压倒细胞中TGF-β信号的抗肿瘤作用时，它将以一致的方式作为肿瘤促进剂发挥作用。尽管有许多因素增加了TGF-β信号转导的复杂性，但在肿瘤治疗中TGF-β信号靶向药物显示出了强大的活性。这些特异性或非特异性药物包括靶向TGF-β受体的小分子、反义寡核苷酸、疫苗、中和抗体以及受体IgG-Fc融合蛋白。Galunsertib（LY2157299）是第一个进入临床试验的小分子阻断剂，它抑制TGF-βRI激酶。在一项1/2期临床试验中，与安慰剂吉西他滨相比，Galunisertib联合吉西他滨治疗PAC患者的OS明显改善。TEW-7197是另一种TGF-βRI激酶抑制剂。GC-1008（fresolimumab）是一种能中和TGF-β所有亚型的人源单克隆抗体。M7824（Bintrafusp-alfa）是一种由抗PD-L1的抗体和TGF-βRII分子的胞外段组成的双功能分子，可以“捕获”在TME中的TGF-β。ABBV-151影响TGF-β主动释放的复杂过程是另一种治疗干预手段。抗GARP抗体ABBV-151阻断其与LAP的结合显著减缓乳腺癌细胞系的肺转移。Belagenpumatucel-L（Lucanix）是一种治疗性、基因修饰的异基因肿瘤细胞疫苗，用于NSCLC，抑制TGF-β2 mRNA的产生。虽然针对NSCLC的3期试验没有达到预定的临床终点，但额外的分析表明在患者亚群中取得了令人鼓舞的结果，在一线化疗结束后12周内随机使用Lucanix治疗的患者中，观察到OS的显著增加。Trabedersen（ap12009）是TGF-β2基因mRNA区域的反义互补物，通过下调TGF-β2 mRNA发挥抑制作用。在一项2期研究中，与标准化疗治疗相比，使用10 mM trabedersen治疗的复发/难治性晚期胶质瘤患者的2年生存率更高。-04-三、IL-4IL-4主要作用于Th2细胞的谱系特异性分化和体液免疫反应的调节。除嗜碱性粒细胞和肥大细胞外，IL-4主要由Th2细胞通过自分泌信号分泌。IL-4在肿瘤微环境中发挥着多种作用，并具有免疫抑制和抗肿瘤活性。研究表明，在结肠癌和乳腺癌小鼠模型中，阻断IL-4可减少特定肿瘤微环境中免疫抑制M2表型和MDSCs的生成，并改善肿瘤特异性CD8+T细胞反应。此外，阻断IL-4可提高抗OX40免疫治疗的反应性。在非小细胞肺癌小鼠模型中进行的类似研究表明，阻断IL-4可通过肿瘤抗原特异性树突状细胞增加IL-12的生成，从而增强效应T细胞的浸润和增殖，并减轻肿瘤负担。此外，在间变性甲状腺癌（ATC）小鼠模型中，IL-4的缺失可增强抗肿瘤免疫和总体存活率，且无任何明显毒性。研究表明，IL-4是一个新的治疗靶点，阻断可以减少肿瘤诱导的免疫抑制，提高传统癌症治疗的疗效。因此，与其他免疫抑制性细胞因子类似，IL-4是肿瘤发生和转移的关键调节因子，可能单独或与当前有效治疗癌症患者的治疗方案相结合，是一个有吸引力的免疫治疗靶点。-05-四、IL-35与IL-10、TGF-β和IL-4相比，IL-35是一种异二聚体且相对较新发现的细胞因子，属于IL-12家族细胞因子，由p35和EBi3亚单位组成。IL-35已被证明在良性和恶性肿瘤的发展中发挥重要作用，包括肝细胞癌、晚期乳腺癌、胰腺导管腺癌、非小细胞肺癌和前列腺癌。此前，已有研究证明IL-35主要由Tregs产生，近年来，肿瘤细胞中IL-35的表达逐渐得到证实。在体内，IL-35通过增强其他细胞因子的分泌，如IL-6和G-CSF（粒细胞集落刺激因子），促进肿瘤生长、进展和转移。IL-35还抑制多种细胞因子，包括IFN-γ，以实现促肿瘤效应。积累的数据表明，IL-35可以参与TME中恶性肿瘤细胞与周围免疫细胞之间的相互作用，诱导免疫抑制环境并限制有效抗肿瘤免疫反应的参与。随着多种IL-35+免疫细胞类型如M1 TAM和DC的发现和分离，目前的证据表明，肿瘤源性IL-35广泛参与不同细胞环境的促肿瘤特性，可能是通过抑制肿瘤浸润淋巴细胞（TIL）浸润和效应细胞增殖。总的来说，恶性肿瘤细胞以及周围基质细胞产生的IL-35有助于肿瘤微环境内的免疫抑制，从而支持肿瘤的持续生长和转移。-06-结语细胞因子在决定肿瘤发生命运的肿瘤免疫微环境中起着至关重要的作用。这些免疫抑制细胞因子限制抗肿瘤免疫细胞的增殖和效应功能，改变其可塑性，并将其转化为抑制表型。由于受限制的渗透或缺乏效应免疫细胞，导致免疫检查点抑制剂无法发挥最佳效果。因此，靶向或消耗这些细胞因子具有显著的临床益处。几种细胞因子在肿瘤发生中发挥免疫抑制作用，具体取决于肿瘤类型和肿瘤免疫环境。最近的多项研究显示，IL-10、TGF-β、IL-4和IL-35，这些细胞因子在限制抗肿瘤免疫和肿瘤生长进展中发挥重要作用。阻断IL-10、TGF-β、IL-4和IL-35等免疫抑制性细胞因子可能在使肿瘤对常规和免疫疗法敏感方面发挥显著的效果，从而激活抗肿瘤免疫，并控制肿瘤发生。参考资料：1.Tumorpromoting roles of IL-10, TGF-β, IL-4, and IL-35: Its implications in cancerimmunotherapy. SAGE Open Med. 2022; 10: 20503121211069012.2. Roles ofTGF-β signaling pathway in tumor microenvirionment andcancer therapy. Int Immunopharmacol. 2020 Oct 21;89(Pt B):107101.3. IL-35 Regulatesthe Function of Immune Cells in Tumor Microenvironment. Front Immunol. 2021;12: 683332.公众号内回复“ADC”或扫描下方图片中的二维码免费下载《抗体偶联药物：从基础到临床》的PDF格式电子书！公众号已建立“小药说药专业交流群”微信行业交流群以及读者交流群，扫描下方小编二维码加入，入行业群请主动告知姓名、工作单位和职务。

免疫疗法

2025-03-06

·PRNewswire

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. 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上市批准免疫疗法优先审批

100 项与 Livmoniplimab 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
转移性非鳞状非小细胞肺癌	临床3期	美国	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	日本	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	澳大利亚	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	比利时	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	智利	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	法国	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	以色列	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	荷兰	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	西班牙	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	中国台湾	AbbVie, Inc.	2024-04-10

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临床结果

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分期

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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


NCT03821935 (NCT03821935, Pubmed \| Front Oncol)	临床1期	晚期恶性实体瘤 GARP:TGF-ß1 complex	-	Livmoniplimab	夢獵簾艱齋窪製壓構餘(醖窪範餘衊範夢壓選壓) = 積壓觸觸獵獵餘積製鑰網鬱構鬱築鬱醖鹽鏇醖 (餘鬱糧範築鹹鑰網膚範 )	积极	2024-10-29
NCT03821935 (NCT03821935, Pubmed \| Front Oncol)	临床1期	晚期恶性实体瘤 GARP:TGF-ß1 complex	-	Budigalimab	積蓋壓窪餘糧襯製構衊(構積鬱鬱膚壓糧齋淵廠) = 鹽糧膚網醖襯築鹹膚製築蓋淵簾糧淵積糧鏇網 (積製衊壓鬱鏇鏇鹽蓋簾 ) 更多	积极	2024-10-29
NCT03821935 (ASCO2024)	临床1期	实体瘤 \| 尿路上皮癌 TGF-β1 \| GARP:TGF-β1 complex	200	Livmoniplimab 1500 mg + Budigalimab 500 mg	壓鏇網餘鹹鏇膚廠鏇遞(鑰願糧網鬱鏇鏇獵蓋築) = 製繭範網網製鹽餘襯餘衊蓋構觸餘鬱衊鏇淵齋 (襯壓糧膚餘選壓築齋遞, 12.9 ~ 39.5) 更多	积极	2024-05-24
NCT03821935 (AACR2024) 人工标引	临床1期	卵巢颗粒细胞瘤	57	Livmoniplimab + Budigalimab	顧網顧窪憲壓觸憲繭願(膚餘餘壓鑰艱簾憲遞鬱) = 積鏇淵鬱築醖範淵憲艱製構糧範積艱艱選獵膚 (築鹽選糧簾艱構衊構簾 ) 更多	积极	2024-04-05
NCT03821935 (ASCO_GU2024) 人工标引	临床1期	尿路上皮癌	48	Livmoniplimab + budigalimab	鏇築構廠願餘餘遞餘簾(築積鏇簾鑰憲鏇選選鬱) = 襯積齋壓鑰鹽蓋齋蓋齋簾艱網鹹鑰蓋觸齋憲簾 (範鬱構製鑰鏇廠蓋憲獵, 12.9 ~ 39.5) 更多	积极	2024-01-25