TACTI-004, a Double-Blinded, Randomized Phase 3 Trial in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Receiving Eftilagimod Alfa (MHC Class II Agonist) in Combination with Pembrolizumab (PD-1 Antagonist) and Chemotherapy.

The purpose of this study is to compare eftilagimod alfa (efti) in combination with pembrolizumab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) among adults with metastatic non-small cell lung cancer (NSCLC).
Participants will receive either efti plus standard treatment (pembrolizumab and platinum doublet chemotherapy) or placebo plus standard treatment and will be treated for up to 2 years.

开始日期2025-03-01

申办/合作机构

Immutep SAS

[+1]

NCT06128863 / Recruiting临床2期IIT

Phase II, Single-arm Clinical Trial Evaluating Efficacy and Safety of Pembrolizumab in Combination with a Soluble LAG-3 Protein, Eftilagimod Alpha, and Radiotherapy in Neoadjuvant Treatment of Patients with Soft Tissue Sarcomas (EFTISARC-NEO)

This is a phase II single-arm single-stage study evaluating efficacy and safety of pembrolizumab in combination with a soluble LAG-3 protein, eftilagimod alpha (Efti) and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas. This study will determine the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the combination treatment.

开始日期2023-07-17

申办/合作机构

Maria Sklodowska-Curie National Research Institute of Oncology

[+1]

NCT04252768 / Withdrawn临床1期

AIPAC-002 (Active Immunotherapy PAClitaxel-002): A Multicentre, Phase Ib Study to Test a New Schedule of Eftilagimod Alpha (a Soluble LAG-3 Protein) as Adjunctive to Weekly Paclitaxel in Hormone Receptor-positive Metastatic Breast Carcinoma Patients

This is a multicentre, multinational Phase Ib study in female HR+ MBC patients not receiving Her2-targeted therapy. Treatment consists of a chemo-immunotherapy phase followed by a maintenance phase. The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 80 mg/m2 paclitaxel intravenously on Day 1, 8 and 15 and 30 mg efti subcutaneously on Day 1 and 15 in a 28-day (4-week) cycle. Efti will always be given after paclitaxel. The maintenance phase comprises 6 visits with 4 weekly intervals; during each such visit 30 mg efti is given subcutaneously as monotherapy. A total of 24 subjects will be enrolled into the study. The primary goal of the study is safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day in contrast to subsequent days as in the AIPAC trial.

开始日期2023-06-01

申办/合作机构

Immutep SAS

100 项与重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep) 相关的临床结果

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100 项与重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep) 相关的转化医学

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100 项与重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep) 相关的专利（医药）

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项与重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep) 相关的文献（医药）

2024-11-01·JTO clinical and research reports

Eftilagimod Alpha (a Soluble LAG-3 Protein) Combined With Pembrolizumab in Second-Line Metastatic NSCLC Refractory to Anti–Programmed Cell Death Protein 1/Programmed Death-Ligand 1-Based Therapy: Final Results from a Phase 2 Study

Article

作者: Roxburgh, Patricia ; Krebs, Matthew G. ; Majem, Margarita ; Clay, Tim ; Mueller, Christian ; Andres, B. ; Doger, Bernard ; Krebs, Matthew G ; Triebel, F. ; Doger, B. ; Forster, Martin ; Triebel, Frédéric ; Majem, M. ; Forster, M. ; Iams, W. ; Clay, T. ; Bajaj, P. ; Iams, Wade ; Perera, Suvini ; Peguero, J. ; Mueller, C. ; Bajaj, Pawan ; Barba, Andres ; Krebs, M.G. ; Roxburgh, P. ; Perera, S. ; Peguero, Julio

Introduction:

Eftilagimod alpha (efti), a soluble lymphocyte activation gene-3 protein, triggers antigen-presenting cell and T-cell (CD4⁺ and CD8⁺) activation and helps overcome resistance to programmed cell death protein 1 or programmed cell death-ligand 1 (PD-(L)1) inhibitors. We assessed efti plus pembrolizumab in second-line anti-PD-(L)1-refractory metastatic patients with NSCLC.

Methods:

After confirmed progression on anti-PD-(L)1-based first-line therapy, patients received efti (30 mg subcutaneously every 2 weeks for eight 3-week cycles and then every 3 weeks for up to 54 weeks) plus pembrolizumab (200 mg intravenously every 3 weeks for up to 105 weeks). The primary endpoint was the objective response rate by modified Response Evaluation Criteria in Solid Tumors version 1.1 for immune-based therapies. Secondary endpoints included disease control rate, progression-free survival, overall survival (OS), and tolerability. Exploratory endpoints included tumor growth kinetics and predefined subgroup analyses. Programmed cell death-ligand 1 tumor proportion score was assessed centrally.

Results:

Thirty-six patients were enrolled from April 2019 to August 2021 using Simon's two-stage design. Most patients (81.8%) had low or negative (<50%) PD-(L)1 tumor proportion score. First-line therapy was anti-PD-(L)1-based for all patients, combined with chemotherapy for 66.7%. The confirmed objective response and disease control rates were 8.3% and 33.3%. The median progression-free survival was 2.1 months and the median OS was 9.9 months. Patients exhibiting high PD-(L)1 expression or acquired resistance to PD-(L)1 inhibitors revealed superior response and survival outcomes, and OS was closely correlated with disease control. No treatment-emergent adverse event led to permanent discontinuation of study treatment.

Conclusions:

Efti plus pembrolizumab was well-tolerated and revealed signs of antitumor activity in patients with NSCLC resistant to PD-(L)1 inhibitors, warranting further investigation. Trial registration number: NCT03625323.

2024-09-03·CLINICAL CANCER RESEARCH

Eftilagimod Alpha (Soluble LAG3 Protein) Combined with Pembrolizumab as Second-Line Therapy for Patients with Metastatic Head and Neck Squamous Cell Carcinoma

Article

作者: Patel, Grisma ; Pousa, Antonio L. ; Roxburgh, Patricia ; Bajaj, Pawan ; Brignone, Chrystelle ; Mueller, Christian ; Krebs, Matthew ; Doger, Bernard ; Forster, Martin ; Triebel, Frederic ; Peguero, Julio ; Brana, Irene ; Carcereny, Enric

Abstract:

Purpose::

Eftilagimod alpha (efti), a soluble LAG3 protein, activates antigen-presenting cells (APC) and downstream T cells. TACTI-002 (part C) evaluated whether combining efti with pembrolizumab led to strong antitumor responses in patients with second-line recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) while demonstrating good tolerability.

Patients and Methods::

In this multinational phase II trial using Simon’s two-stage design, patients who were PD-L(1)-naïve with R/M HNSCC who had failed first-line platinum-based therapy, unselected for PD-L1, received intravenous pembrolizumab (200 mg, once every 2 weeks) combined with subcutaneous efti (30 mg once every 2 weeks for 24 weeks and once every 3 weeks thereafter). The primary endpoint was objective response rate per RECIST 1.1 modified for immune-based therapy by investigator assessment. Additional endpoints included duration of response, progression-free survival, overall survival, and tolerability. Pharmacodynamic effects (absolute lymphocyte count) and Th1 cytokine biomarkers (IFNγ/CXCL10)] were evaluated in liquid biopsies.

Results::

Between March 2019 and January 2021, 39 patients were enrolled; 37 were evaluated for response. All patients received prior chemotherapy, and 40.5% were pretreated with cetuximab; 53.1% of patients had PD-L1 combined positive score <20. With a median follow-up of 38.8 months, the objective response rate was 29.7%, including 13.5% complete responders. The median duration of response was not reached. Rapid and sustained absolute lymphocyte count increase was observed in patients who had an objective response. Th1 biomarkers increased sustainably after first treatment. No unexpected safety signals were observed.

Conclusions::

Efti plus pembrolizumab was safe and showed encouraging antitumor activity and pharmacodynamic effects in patients with second-line head and neck squamous cell carcinoma (HNSCC), thus supporting further evaluation of this combination in earlier treatment lines.

2024-02-01·Clinical cancer research : an official journal of the American Association for Cancer Research

Paclitaxel plus Eftilagimod Alpha, a Soluble LAG-3 Protein, in Metastatic, HR+ Breast Cancer: Results from AIPAC, a Randomized, Placebo Controlled Phase IIb Trial

Article

作者: Perjesi, Luca ; Dalenc, Florence ; Pápai, Zsuzsanna ; Brignone, Chrystelle ; Duhoux, Francois P. ; Armstrong, Anne ; Kuemmel, Sherko ; Marme, Frederik ; Jager, Agnes ; Dirix, Luc ; Cuypere, Eveline ; Triebel, Frederic ; Schröder, Carolina P. ; Wildiers, Hans ; Mueller, Christian ; Vuylsteke, Peter ; Menke-van der Houven van Oordt, Catharina Willemien ; Chan, Steve ; Huober, Jens ; Brain, Etienne

Abstract:

Purpose::

Eftilagimod alpha (efti), a soluble lymphocyte activation gene (LAG-3) protein and MHC class II agonist, enhances innate and adaptive immunity. Active Immunotherapy PAClitaxel (AIPAC) evaluated safety and efficacy of efti plus paclitaxel in patients with predominantly endocrine-resistant, hormone receptor–positive, HER2-negative metastatic breast cancer (ET-resistant HR+ HER2− MBC).

Patients and Methods::

Women with HR+ HER2– MBC were randomized 1:1 to weekly intravenous paclitaxel (80 mg/m2) and subcutaneous efti (30 mg) or placebo every 2 weeks for six 4-week cycles, then monthly subcutaneous efti (30 mg) or placebo maintenance. Primary endpoint was progression-free survival (PFS) by blinded independent central review. Secondary endpoints included overall survival (OS), safety/tolerability, pharmacokinetics/pharmacodynamics, and quality of life. Exploratory endpoints included cellular biomarkers.

Results::

114 patients received efti and 112 patients received placebo. Median age was 60 years (91.6% visceral disease, 84.1% ET-resistant, 44.2% with previous CDK4/6 inhibitor treatment). Median PFS at 7.3 months was similar for efti and placebo. Median OS was not significantly improved for efti (20.4 vs. 17.5 months; HR, 0.88; P = 0.197) but became significant for predefined exploratory subgroups. EORTC QLQC30-B23 global health status was sustained for efti but deteriorated for placebo. Efti increased absolute lymphocyte, monocyte and secondary target cell (CD4, CD8) counts, plasma IFNγ and CXCL10 levels.

Conclusions::

Although the primary endpoint, PFS, was not met, AIPAC confirmed expected pharmacodynamic effects and demonstrated excellent safety profile for efti. OS was not significantly improved globally (2.9-month difference), but was significantly improved in exploratory biomarker subgroups, warranting further studies to clarify efti's role in patients with ET-resistant HER2− MBC.

173

项与重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep) 相关的新闻（医药）

2024-12-16

·GlobeNewswire-Health Care

Immutep and Monash University Announce First Publication Detailing How Human LAG-3 Binds to MHC Class II

Findings published in Science Immunology resolve how human LAG-3 binds to its main ligand providing a better foundation for development of blocking LAG-3 therapeutics, including Immutep’s anti-LAG-3 small molecule programData also supports eftilagimod alfa’s (efti) preferential binding to a subset of MHC Class II molecules on antigen-presenting cells leading to their activation SYDNEY, AUSTRALIA, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces new findings published in Science Immunology that resolve how human lymphocyte activation gene 3 (LAG-3) binds to its main ligand MHC Class II (MHC-II), also known as HLA Class II (HLA-II) in humans. The publication is the first to show the crystal structure of a human LAG-3/HLA-II complex and provides a better foundation for development of blocking LAG-3 therapeutics, including Immutep’s anti-LAG-3 small molecule program. Under the oversight of Professor Jamie Rossjohn FAA FRS, at Monash University’s Biomedicine Discovery Institute (BDI), and in collaboration with Immutep, this breakthrough is an exemplar of the importance of industry-academia alliances. The LAG-3 immune control mechanism is the exclusive focus of Immutep across both cancer and autoimmunity and a clinically validated target of deep interest throughout the academic, medical, and industry sectors. Dr. Jan Petersen, first author of the study, said: “The way the PD-1 and CTLA-4 immune checkpoint molecules bind to their respective ligands has been resolved for many years. However, the resolution of the interface between another important checkpoint molecule, LAG-3, and its main ligands, HLA-II molecules, has remained elusive. Solved using data collected at the Australian Synchrotron, a structure of a LAG-3/HLA-II complex provides a structural foundation to harness rationally for future development of antibodies and small molecule therapeutics designed to block LAG-3 activity.” Dr. Frédéric Triebel, Immutep’s CSO, added: “It is thrilling to be able to see and analyze the interactions taking place at the interface between the soluble homodimeric LAG-3 protein and its main ligand. We now better understand how efti uniquely acts as an MHC-II agonist by preferentially binding to a subset of MHC-II molecules clustered in lipid raft microdomains on the surface of antigen-presenting cells. These findings add to the strong foundation of our work with Professor Rossjohn and his team to develop a deeper understanding of the structure and function of the LAG-3 immune control mechanism, particularly as it relates to our anti-LAG-3 small molecule program.” The Crystal Structure of the Human LAG-3–HLA-DR1–Peptide Complex publication details how LAG-3 engages two HLA-II molecules (see Figure 1). The data in the publication supports efti’s (soluble LAG-3) preferential binding to a subset of MHC-II molecules on antigen-presenting cells leading to their activation. Figure 1: Human LAG-3 homodimer (with domains D1, D2, D3 and D4) binding to two separate HLA-II (MHC-II) molecules on the surface of an antigen-presenting cell (APC), imposing a distinct 38° offset angle. This figure has been modified from the original Figure 1c of Petersen et al to aid visualisation. About the Monash Biomedicine Discovery InstituteCommitted to making the discoveries that will relieve the future burden of disease, the Monash Biomedicine Discovery Institute (BDI) at Monash University brings together more than 120 internationally-renowned research teams. Spanning seven discovery programs across Cancer, Cardiovascular Disease, Development and Stem Cells, Infection, Immunity, Metabolism, Diabetes and Obesity, and Neuroscience, Monash BDI is one of the largest biomedical research institutes in Australia. Our researchers are supported by world-class technology and infrastructure, and partner with industry, clinicians and researchers internationally to enhance lives through discovery. About ImmutepImmutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com. Australian Investors/Media:Catherine Strong, Sodali & Co+61 (0)406 759 268; catherine.strong@sodali.com U.S. Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; chris.basta@immutep.com ABN: 90 009 237 889

免疫疗法AACR会议

2024-12-12

·GlobeNewswire-Health Care

Immutep Reports Promising New Data in Head and Neck Cancer at ESMO Immuno-Oncology 2024

Data shows strong overall survival, progression-free survival, and durability from novel combination of efti in combination with pembrolizumab in difficult-to-treat head and neck cancer patients with PD-L1 CPS <1Positively, median overall survival (OS) has not yet been reached and the 12-month OS rate is 67%, both well above historical controlsComplete response rate increases to 12.9% and 16.1%, according to RECIST 1.1 and iRECIST, respectivelyTreatment continues to be well tolerated SYDNEY, AUSTRALIA, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces positive clinical results from Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. This study evaluates eftilagimod alpha (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in first line recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with negative PD-L1 expression. The new promising data presented by Martin Forster, M.D., Ph.D., at the ESMO Immuno-Oncology (IO) Annual Congress 2024 includes strong overall survival, progression-free survival, and durability. This adds to the high response rates and favourable safety data previously reported on 12 July 2024. Prof. Martin Forster of the UCL Cancer Institute and University College London Hospital NHS Foundation Trust, London, UK, and TACTI-003 Investigator, stated, “The new survival and durability data, coupled with increasing complete responses, build on the strong response rates already established with this novel IO combination in head and neck squamous cell cancers with PD-L1 CPS <1. This difficult-to-treat disease places a high burden on patients who unfortunately have very limited treatment options that all include chemotherapy. Collectively, these impressive results build on the potential promise of efti to improve patient outcomes and expand populations that respond to anti-PD-1.” Results Data as of the 31 October 2024 cut-off date in evaluable 1L HNSCC patients (N=31) whose tumours express PD-L1 below 1 (Combined Positive Score [CPS] <1) and who typically do not respond well to anti-PD-1 therapy alone shows: Positively, median overall survival (OS) has not yet been reached and the 12-month OS rate is 67%Promising progression-free survival (PFS) of 5.8 monthsStrong durability with interim median duration of response (DOR) of 9.3 monthsHigh 35.5% objective response rate (ORR) and 58.1% disease control rate (DCR), as reported on 12 JulyComplete response rate increases to 12.9% and 16.1%, according to RECIST 1.1 and iRECIST, respectively1Efti in combination with pembrolizumab continues to be well-tolerated with no new safety signals This data compares favourably to historical results from anti-PD-1 therapy alone in 1L HNSCC patients with PD-L1 CPS <1 including a 7.9-month median OS, 12-month OS rate of 39%, 2.1-month median PFS, 2.6-month median DOR, 5.4% ORR and 32.4% DCR with no complete responses2-3. Marc Voigt, CEO of Immutep, noted, “Despite the significant progress of cancer immunotherapy over the past decade and the positive change in the therapeutic landscape it has brought to bear, head and neck cancer patients with PD-L1 expression of less than one continue to have limited treatment options that all include chemotherapy. We believe this data is an encouraging step in the right direction towards potentially bringing a new approach to this underserved population, representing up to 20% of patients with this difficult disease.” Next StepsPatients with PD-L1 CPS <1 is an underserved patient population with limited treatment options. Immutep will continue to follow the maturing data from TACTI-003 and engage with regulatory authorities regarding potential paths forward. The ESMO IO poster is available on the Posters & Publications section of Immutep’s website. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About ImmutepImmutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com. Complete response rate was 9.6%, according to RECIST 1.1 and iRECIST, respectively, at earlier cut-off date as previously reported on 12 July 2024Burtness, B. et al. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. Journal of Clinical Oncology 2022 40:21, 2321-2332. Note, the 5.4% ORR and 32.4% DCR are calculated from the 37 evaluable patients with CPS <1.Burtness B. et al. Abstract LB-258: Efficacy of first-line (1L) pembrolizumab by PD-L1 combined positive score <1, 1-19, and ≥20 in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): KEYNOTE-048 subgroup analysis. Cancer Res 15 August 2020; 80 (16_Supplement): LB–258. https://doi.org/10.1158/1538-7445.AM2020-LB-258 Australian Investors/Media:Catherine Strong, Sodali & Co+61 (0)406 759 268; catherine.strong@sodali.com U.S. Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; chris.basta@immutep.com

免疫疗法临床2期临床结果

2024-12-11

·UmabsDB

中位OS提高10.9个月：Immutep启动LAG-3+PD-1一线非小细胞肺癌头对头三期临床试验

Umabs DB作为目前全球最全面的抗体药物专业数据库，收录全球近10000个从临床前到商业化阶段抗体药物，涉及靶点1600+，涉及疾病种类2400+，研发机构2900+，覆盖药物蛋白序列、专利和临床等多种专业信息。Umabs DB药物数据库已正式开放上线，可访问www.umabs.com注册享受7天免费试用。近期，根据UmabsDB数据库的记录，专注于LAG-3疗法开发的Immutep在clinical trials网站上，登记了一项LAG-3融合蛋白eftilagimod alpha（efti），联合PD-1抗体Pembrolizumab和化疗，在一线非细胞细胞肺癌患者中启动一项3期头对头临床试验TACTI-004（NCT06726265），该临床将于2025年3月启动，计划入组人数为756例。 TACTI-004的临床试验与默沙东联合进行开发，756例患者的入组不区分于PD-L1的表达，PFS和OS将作为双临床终点。此前完成的早期临床INSIGHT-003的结果显示，相较于Pembrolizumab的历史数据KEYNOTE-189，联合疗法的响应率均高于K药，同时响应率随着PD-L1提高而显著提升，全人群的PFS达到12.7个月，OS达到32.9个月，比K药分别提高了3.7个月和10.9个月，三期临床值得期待。 Immutep专注于LAG-3疗法开发，此前在一线头颈癌方面，eftilagimod alpha+K药组的ORR高于30%，这是目前报道的最好的低PD-L1（<1%）治疗数据，特别是达到10%左右的CR，并且这些响应独立于HPV的状态，DCR达到60%左右（Immutep涨15%，LAG-3低PD-L1头颈癌数据被认可）。同时Efti还在近10个癌种疗法中正在进行开发，一线头颈鳞状细胞癌也会基于目前顶线数据和监管机构沟通，进行进一步开发。根据UmabsDB数据库的记录，目前全球仅只有一款LAG-3抗体疗法获批。BMS的PD-1抗体Nivolumab+LAG-3抗体Relatlimab固定剂量组合此前已经获批黑色素的治疗，将12个月的无进展生存期提高了一倍以上，同时目前也在多个实体瘤中进行三期研究。 2024年8月，根据UmabsDB数据库的记录，BMS在clinical trials网站上，登记其一项PD-1抗体Nivolumab+LAG-3抗体Relatlimab，在PD-L1表达量为1-49%的非鳞状晚期非小细胞肺癌的一线治疗中，启动一项与默沙东PD-1抗体Pembrolizumab联合化疗的，头对头比对三期临床试验NCT06561386。该临床预计将于2024年9月启动，计划入组人数为800例，直接挑战K+化疗在非小细胞肺癌的一线治疗中的统治地位（挑战王炸：BMS启动PD-1+LAG-3在一线非小细胞肺癌中与K药+化疗的头对头三期临床）。此外，康方还启动了PD-1/LAG-3双抗药物AK129，联合CD47抗体，在PD-1/L1疗法耐药后的经典霍奇金淋巴瘤患者中，启动1/2期临床试验NCT06642792，该临床于2024年10月启动，计划入组人数为280例（280例：康方启动PD-1/LAG-3双抗+CD47联合疗法在霍奇金淋巴瘤临床）。显然随着肿瘤免疫的疗法的不断深入，联用或双抗等多种疗法在不断威胁K药在肿瘤领域的基石地位，因此默沙东也在不断加强其护城河，一方面快速跟进引进PD-1/VEGF双抗（MSD：收购PD-1/VEGF双抗后的回应），另一方面也和Immutep等合作开展多种形式的联合疗法临床试验。期待TACTI-004临床早日传来临床捷报，更多有关LAG3抗体的研发格局、具体信息、专利及临床等动态进展，敬请访问Umabs DB全球数据库（www.umabs.com）查阅。拓展阅读： Macrogenics启动下一代ADAM9 ADC临床 100% CR：默沙东更新ROR1 ADC二期淋巴瘤临床数据，即将启动三期临床 MSD：收购PD-1/VEGF双抗后的回应 HIV：中裕新药将ADC拓展至抗病毒领域全球首个：默沙东ROR1 ADC启动三期临床试验 HER3终成药：HER2/HER3双抗Zenocutuzumab获FDA批准上市百利天恒两款ADC在美启动临床 3000万美元首付：GSK引进映恩一款临床前ADC药物 “四字编码”时代下的信达全梳理 BioNtech启动PD-L1/VEGF双抗肺癌两项头对头三期临床大涨68%：Janux的PSMA/CD3双抗再次取得突破疗效 316例：诺华启动BAFF-R抗体在狼疮性肾炎的三期临床 250例：默克CEACAM5 ADC开展泛癌种临床试验 AK112 vs PM8002：PD-1/VEGF第三次交锋康方生物两款PD-1双抗均进入2024年医保目录 234例：安领科启动EGFR/c-Met双抗ADC临床科伦博泰：本土首款Trop2 ADC获批上市罗氏TIGIT抗体一线肺癌再次失败 876例：恒瑞启动c-met ADC单药及多种药物联用临床科伦博泰首个双抗ADC启动临床阿斯利康：ADC药物的临床剂量转化策略最惨18A：北海康成市值仅为7520万港元，累计跌幅达到98.55% 2~3分钟完成给药：K药皮下制剂三期临床取得成功 ORR仅为5%：Immatics公布PRAME/CD3 TCR双抗临床数据石药启动EGFR ADC+ATM抑制剂联合治疗临床康方启动CD73/LAG3双抗临床试验宫颈癌：迈威Nectin-4 ADC启动第3项三期临床大涨53%：中国资产再次拯救美股biotech 翰森HS-20124为ROR-1 ADC药物？翰森公开SEZ6 ADC专利翰森公开CDH17 ADC专利复宏汉霖公布两款ADC药物专利 BioNtech: 2024研发日默沙东终于信了：5.88亿美元首付款引进礼新PD-1/VEGF双抗映恩公开PD-L1/B7H3双抗ADC临床前数据 Hexagon：新型ADC毒素提高渗透性：antikor开发高DAR值片段抗体ADC Genmab终止两款CD3双抗开发，重聚焦后期管线第一三共开发皮下HER2 ADC 三抗来袭：Aditum Bio以3500万美元首付款引进维立志博CD3/CD19/BCMA 强生公布膜依赖性MSLN/CD3双抗金赛公开自主开发TOPOi ADC平台礼来公布PTK7 ADC药物临床前数据双payload ADC逐步工业化，多款药物即将进入临床恒瑞SHR-A2009：国内首个HER3 ADC进入三期 ADC：抗原高表达的必要性？关于Umabs DB Umabs DB是目前全球最全面的抗体药物专业数据库，收录全球近10000个从临床前到商业化阶段抗体药物，涉及靶点1600+，涉及疾病种类2400+，研发机构2900+，覆盖药物蛋白序列、专利和临床等多种专业信息。Umabs DB药物数据库已正式开放上线，可访问www.umabs.com注册享受7天免费试用，更多信息可联系info@umabs.com

临床3期临床2期临床失败临床结果

100 项与重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep)	-	DB16150

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	-	Immutep SAS	2025-03-01
转移性乳腺癌	临床3期	美国	Immutep SAS	2023-05-22
转移性乳腺癌	临床3期	比利时	Immutep SAS	2023-05-22
转移性乳腺癌	临床3期	格鲁吉亚	Immutep SAS	2023-05-22
转移性乳腺癌	临床3期	摩尔多瓦	Immutep SAS	2023-05-22
转移性乳腺癌	临床3期	西班牙	Immutep SAS	2023-05-22
转移性HER2阴性乳腺癌	临床3期	美国	Immutep SAS	2023-05-22
转移性HER2阴性乳腺癌	临床3期	比利时	Immutep SAS	2023-05-22
转移性HER2阴性乳腺癌	临床3期	格鲁吉亚	Immutep SAS	2023-05-22
转移性HER2阴性乳腺癌	临床3期	摩尔多瓦	Immutep SAS	2023-05-22

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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


NCT06128863 (EFTISARC-NEO, Corporate Publications) 人工标引	临床2期	软组织肉瘤新辅助	6	eftilagimod alpha+pembrolizumab+radiotherapy	窪醖鬱壓選鹽鏇遞憲顧(壓獵鏇鬱簾鹽壓願窪鹹) = 餘糧淵築製窪製襯衊糧簾築簾獵壓製獵襯壓獵 (鹹顧範廠鬱範夢膚遞構 )	积极	2024-05-02
EADV2023	N/A	局部晚期黑色素瘤	3,758	LAG-3 and PD-1 inhibitors	觸築繭鏇夢廠範齋襯糧(鑰憲鏇繭築構製醖觸遞) = 804 due to intolerable side effects with a p-value <0.00001 (95% CI; 2.57 to 6.68; I²=70%) 獵夢顧鏇淵製範醖鬱鏇 (襯齋觸選鏇廠鹹糧艱繭 )	不佳	2023-05-18
NCT02614833 (IMP321-P011, SITC2021)	临床2期	HR阳性/HER2阴性乳腺癌 HR+ \| HER2-	227	Eftilagimod alpha (efti)	糧夢積鏇繭膚餘膚窪遞(願獵選網觸繭壓鹹鬱鏇) = TEAEs leading to discontinuation were similar at 5.3%(efti) & 6.3%(placebo) 觸膚壓簾窪鹽網窪襯繭 (艱製積壓淵築餘憲淵積 ) 更多	积极	2021-11-10
				Placebo
NCT02614833 (AACR2021) 人工标引	临床2期	HR阳性乳腺腺癌二线 HR Positive	226	paclitaxel+eftilagimod alpha	鬱願獵壓構選繭簾築簾(顧鏇窪蓋鬱壓範鏇築襯) = 鏇獵醖窪選淵網憲齋願築艱襯觸獵衊鏇鑰鑰觸 (觸選遞壓鑰網蓋艱積醖, 6.64 ~ 7.46) 更多	不佳	2021-02-15
				paclitaxel+placebo	鬱願獵壓構選繭簾築簾(顧鏇窪蓋鬱壓範鏇築襯) = 膚艱製窪窪鬱積網窪網築艱襯觸獵衊鏇鑰鑰觸 (觸選遞壓鑰網蓋艱積醖, 5.52 ~ 7.46) 更多
NCT02676869 (TACTI-mel, GlobeNewswire) 人工标引	临床1期	黑色素瘤	24	Pembrolizumab+Eftilagimod alpha (Part A)	鹹鹽範構醖築積構襯蓋(壓鬱選蓋憲齋鏇範構襯) = 鏇築範遞網繭壓襯鏇壓憲願鹹網壓膚積構繭遞 (窪觸膚鹽艱獵願壓醖衊 ) 更多	积极	2019-03-06
				Pembrolizumab+Eftilagimod alpha (Part B)	襯鹽衊鬱製積醖窪夢艱(壓網鏇壓膚鹹範積構艱) = 窪鹽遞衊衊築餘壓糧蓋願壓壓壓蓋製夢觸積積 (製蓋淵簾網糧網構醖築 ) 更多
NCT02614833 (ASCO2018) 人工标引	临床2期	转移性乳腺癌一线	15	paclitaxel+eftilagimod alpha	餘積築網餘廠網構範淵(觸窪衊糧網憲憲膚淵鏇) = Thirty mg efti SC 衊範憲衊繭遞願鹽鹹餘 (構鏇淵簾淵糧鬱憲壓遞 ) 更多	积极	2018-06-02
NCT02676869 (ASCO2018)	临床1期	不可切除的黑色素瘤	18	Pembrolizumab + 1 mg Eftilagimod alpha	壓鹹顧窪壓襯鑰顧獵餘(簾鑰觸夢繭鬱製窪糧獵) = 構廠簾蓋觸觸憲壓鹹廠糧廠範願膚鏇網簾餘鏇 (壓願廠淵築範鏇願窪網 ) 更多	积极	2018-06-01
				Pembrolizumab + 6 mg Eftilagimod alpha	壓鹹顧窪壓襯鑰顧獵餘(簾鑰觸夢繭鬱製窪糧獵) = 壓夢鹹鏇繭選顧衊窪觸糧廠範願膚鏇網簾餘鏇 (壓願廠淵築範鏇願窪網 ) 更多