The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment. This is a prospective single arm interventional trial in patients with early-stage HR+/HER2 -ve breast cancer (Stage I-III) who are eligible for neoadjuvant chemotherapy (NAC). Enrolled patients will be treated with single agent efti for 3 weeks and then start NAC in combination with efti. There are 2 standard NAC usually used and will be determined by treating physician prior to starting on this trial.

开始日期2025-09-01

申办/合作机构

Immutep SAS

CTIS2024-513621-23-00

/ Recruiting临床3期

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. - TACTI-004

开始日期2025-04-29

申办/合作机构

Immutep Ltd.

CTRI/2025/03/082306

/ Not yet recruiting临床3期

开始日期2025-03-31

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 ; Krebs, M.G. ; Barba, Andres ; 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 ; Marme, Frederik ; Kuemmel, Sherko ; 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.

216

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）

2025-09-26

·Biotech前瞻

恒瑞终究也入局了，PD-1激动剂，不卷肿瘤，剑指自免蓝海大市场

点击蓝字关注我们本期看点以PD-1、CTLA-4抑制剂为代表的免疫抑制剂的问世，深刻改变了肿瘤治疗格局，进入到免疫治疗新时代。而肿瘤与自身免疫之间的界限，并不是完全隔绝的。恒瑞医药近期在PD-1激动剂抗体领域有了新的研发动向。目前，全球范围内针对PD-1激动剂的研发竞争激烈，恒瑞的加入值得关注。本期内容 01 PD-1激动剂 02 CTLA-4激动剂 03 LAG3激动剂 04 总结与展望【01 PD-1激动剂】近日，恒瑞医药在PD-1激动剂抗体研发方面取得了显著进展。根据公开信息，公司已于2025年3月18日提交了PD-1激动剂抗体的专利申请，并于2025年9月25日公开了这项专利（CN202510000000.X）。临床前研究数据显示，恒瑞的PD-1激动剂在多个方面展现出优于国际同类产品的潜力：体外活性优异：在CMV recall试验体系中，其对抗原特异性CD8 T细胞的抑制活性显著优于礼来已终止开发的Peresolimab。体内模型效果突出：在移植物抗宿主病（GvHD）模型和胶原诱导的关节炎（CIA）模型中，均表现出比Peresolimab更强的激动活性，在CIA模型中的缓解比例达到了100%。恒瑞的研发进展是在全球PD-1激动剂竞争加剧的背景下取得的。 AnaptysBio 的 PD-1 药物在 II 期试验中减少类风湿性关节炎症状 AnaptysBio 去年可能经历了一段低谷，但 2025 年迎来了积极的消息：其 PD-1 激动剂 rosnilimab 在 II 期类风湿性关节炎（RA）试验中达到了研究目标。受此利好消息的影响，AnaptysBio（ANAB）股价2月12日大涨30%。也让外界对于PD-1激动剂在自免类型疾病的治疗前景充满期待。在 II 期b 级 RENOIR 研究中，研究人员评估了三种剂量的皮下注射 rosnilimab（每四周 100 mg、每四周 400 mg 或每两周 600 mg）与安慰剂在 424 名中重度 RA 患者中的疗效。这些患者同时接受了甲氨蝶呤（Methotrexate）等标准抗风湿药物治疗。根据公司 2 月 12 日的公告，所有三种剂量均达到了主要终点，即在 12 周后疾病活动度较基线的统计学显著变化： 100 mg 和 600 mg 组的 DAS28-CRP 评分平均降低 2.06； 400 mg 组的 DAS28-CRP 评分降低 2.12。行业背景与竞品对比在 2025 年初展望报告中，TD Owen分析师曾指出，该试验的结果备受讨论，尤其是在礼来（Eli Lilly）去年终止其自身的 PD-1 RA 项目之后。礼来丨PD-1激动剂丨Peresolimab 在PD-1激动剂赛道上，先行者是礼来，但也经历了初期效果惊艳，近日又被礼来从最新的研发管线中移除的结局，免疫检查点激动剂的研发，注定是坎坷的。 2023年5月18日，N Engl J Med 期刊上刊发了礼来PD-1激动剂Peresolimab治疗类风湿性关节炎的II期结果，在这项2a期双盲、随机、安慰剂对照试验中，研究者按照2:1:1的比例将患有中重度类风湿性关节炎的成年患者（这些患者对常规合成的抗风湿性疾病药物（DMARD）或生物或靶向合成的DMARD不应答、耐药或副作用不可耐受）分配给700 mg Peresolimab组，300mg Peresolimab组或安慰剂组，每4周静脉注射一次。Peresolimab在类风湿性关节炎患者的2a期试验中显示出疗效。这些结果证明对PD-1受体的刺激具有治疗类风湿性关节炎的潜在疗效。但遗憾的是，在礼来2024年三季度报中，礼来已经宣布将PD-1激动剂抗体Peresolimab移出研发管线，可见PD-1激动剂研发足够坎坷。近年来，肿瘤赛道内卷之下，不少企业也开始布局减肥、自免领域，自免领域市场潜力还是蛮大的，而且CTLA-4激动剂早已经获批上市。国内布局企业：国内方面，金赛药业的PD-1激动剂抗体GenSci120已率先推进到临床阶段，获批开展用于类风湿关节炎、系统性红斑狼疮、原发性干燥综合征及炎症性肠病等多个自身免疫病适应症的临床研究。 02 CTLA-4激动剂 Abatacept(阿巴西普) 2005年，百时美施贵宝（BMS）生产的全球第一款CTLA-4融合蛋白Orencia®（Abatacept，阿巴西普）获FDA审批上市，用于治疗成人类风湿性关节炎。国内由先声药业引进，商品名为恩瑞舒®。具体作用机制总结如下：活化T细胞数量的增加与类风湿性关节炎的发病机制相关 T细胞激活需要来自抗原呈递细胞 (APCs)的两个信号通路同时激活：第一个信号是抗原特异性的，TCR识别APCs表面MHCⅡ提呈的同源抗原（CD28信号传导促进细胞因子IL-2 mRNA的产生和进入细胞周期、T细胞存活、T辅助细胞分化和免疫球蛋白同型转换）。第二个信号来自于APCs配体 (CD80/CD86)和T细胞表面的共刺激受体 (CD28)的结合，共刺激受体CD28与CD80/CD86的相互作用在T细胞活化共刺激信号中起重要作用。 CTLA-4的免疫刹车作用 CTLA-4与T细胞共刺激受体CD28同源，当与APCs表面的CD80/CD86结合时，起到“关闭”开关的作用，可以作为一种免疫检查点来下调免疫反应。 Abatacept作用机制 Abatacept（CTLA-4Ig） Abatacept（CTLA-4Ig）是一种可溶性重组人源化融合蛋白（CTLA-4Ig），由CTLA-4的胞外区和IgG1的Fc部分组成。Abatacept与APC上的共刺激分子CD80和CD86结合，从而阻断与T细胞上的CD28的相互作用。在人类机体中，Abatacept治疗对包括类风湿性关节炎在内的各种自身炎症性疾病患者有效。【03 LAG3激动剂】作为LAG-3（淋巴细胞激活基因-3）治疗领域的先锋，Immutep公司一直就LAG3靶点进行药物的研发和布局，目前，主要有2款产品，IMP761和IMP321。 IMP761 IMP761是一种首创的免疫抑制性LAG-3激动剂抗体，具有治疗多种自身免疫疾病的潜力。它通过特异性沉默积累在疾病部位的自身免疫记忆T细胞，恢复免疫系统的平衡。IMP761在临床前研究中显示出了积极的安全性和免疫抑制效果，包括在体外和体内抑制抗原特异性T细胞介导的免疫反应。此外，IMP761在1期人体临床试验中显示出良好的安全性，没有治疗相关的不良事件。IMP761的临床试验由荷兰莱顿的人类药物研究中心（CHDR）进行，旨在评估其安全性和免疫抑制效果。 IMP321（eftilagimod alpha） IMP321，也称为eftilagimod alpha或“efti”，是一种可溶性LAG-3融合蛋白（LAG-3Ig），属于首创的抗原呈递细胞（APC）激活剂。efti能够结合MHC II类分子，激活并促进CD8+细胞毒性T细胞、CD4+辅助T细胞、树突细胞、NK细胞和单核细胞的增殖。此外，efti还能上调关键生物分子的表达，如IFN-γ和CXCL10，进一步增强免疫系统对抗癌症的能力。 cited by：immutep官网 2024年12月10日，Immutep 在ClinicalTrials网站登记一项双盲、随机、III期研究（TACTI-004），研究Eftilagimod Alfa（Efti，LAG-3融合蛋白）联合标准治疗（帕博利珠单抗+铂类双药化疗）对比安慰剂联合标准治疗针对晚期一线非小细胞肺癌（NSCLC）患者的疗效。研究计划招募756名患者，预计2027年6月初步完成。研究的主要终点为OS和PFS。美国时间2024年7月12日，eftilagimod alfa（efti）联合帕博利珠单抗一线治疗PD-L1表达阴性的头颈鳞状细胞癌（HNSCC）患者取得突破性进展：在TACTI-003（KEYNOTE-PNC-34）IIb期临床试验的Cohort B中，eftilagimod alfa联合帕博利珠单抗，在31名可评估患者中达到了35.5%的ORR（根据RECIST 1.1标准评估）；这一数据在不含化疗的治疗手段中属于最高记录之一。特别值得一提的是，该联合疗法的完全反应率（CR）高达9.7%，意味着三名患者在接受治疗后肿瘤完全消失。基于既往展示出的良好安全性和疗效数据，efti已获得FDA授予的一线治疗HNSCC（无论PD-L1表达如何）的快速通道指定。2022年10月5日，FDA已授予eftilagimod alpha（efti，又名IMP321）快速通道资格，与帕博利珠单抗联用，一线治疗非小细胞肺癌（NSCLC）。 04 总结与展望 PD-1激动剂抗体通过激活PD-1通路，理论上可用于治疗自身免疫性疾病，通过抑制过度活跃的免疫反应来发挥作用，有望为PD-1靶点开辟一个全新的治疗赛道。 AnaptysBio的Rosnilimab在类风湿关节炎领域取得的优异疗效，证明了这一方向的潜力。国内如恒瑞医药、金赛药业等企业的陆续布局，预示着未来该领域的研发竞争将更加激烈。当然，PD-1激动剂的研发也充满挑战，其科学机制复杂，如何精确调控免疫平衡是关键。恒瑞的PD-1激动剂目前仍处于早期专利阶段，后续仍需密切关注其临床研究进展和数据披露。 ★

临床2期免疫疗法临床结果

2025-09-22

·GlobeNewswire-Health Care

Immutep Announces Research Collaboration with the George Washington University Cancer Center to Evaluate Neoadjuvant Efti

GW Cancer Center to initiate Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in HR+/HER2-neg breast cancer patientsSecond investigator-initiated trial to evaluate efti in earlier stage disease where its unique activation of a broad anti-cancer immune response may drive optimal benefit and high pathologic response rates SYDNEY, AUSTRALIA, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces the initiation of an investigator-initiated Phase II trial evaluating neoadjuvant eftilagimod alfa (efti) administered subcutaneously as monotherapy and then in combination with standard-of-care chemotherapy prior to surgery in patients with early-stage HR+/HER2-negative breast cancer. The study will treat up to 50 evaluable patients in a two-stage design and will be primarily funded by grants and The George Washington (GW) University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding that falls within its existing budget. The trial will be led by Principal Investigator, Pavani Chalasani, MD, MPH, Division Director of Hematology and Medical Oncology at the GW Cancer Center and a leader of the GW Cancer Center Breast Cancer clinical research team. Dr. Chalasani stated, “Given my clinical experience with efti in the AIPAC-003 study coupled with promising data from additional trials evaluating efti in metastatic breast cancer settings, we look forward to evaluating this unique immunotherapy at earlier stage disease in patients with HR+/HER2 -ve breast cancer. As a novel neoadjuvant immunotherapy option, efti’s powerful and safe activation of a broad anti-cancer immune response in combination with chemotherapy may lead to high rates of pathologic complete responses, the primary endpoint of this study. Additionally, we are hopeful that efti’s immune activation in these patients with early stage cancer who have stronger immune systems may lead to improved disease free survival.” Efti’s targeting and unique activation of powerful antigen-presenting cells via MHC Class II leads to a broad anti-cancer immune response. This includes the activation and proliferation of cytotoxic CD8+ T cells that can be armed in vivo with chemotherapy-induced tumour antigens, as well as numerous other immune cells and cytokines enhancing the immune system’s ability to fight cancer. This novel immunotherapy has yielded encouraging clinical results in metastatic disease and earlier stage disease in its initial trial as a neoadjuvant treatment in soft tissue sarcoma. Immutep CEO, Marc Voigt added, “We are thankful for the interest and investment by academia in the United States and elsewhere to evaluate the promise of efti at earlier-stage disease. This trial helps us cost-efficiently expand our clinical pipeline for neoadjuvant efti in areas of high unmet need. Our belief is this novel immune system activator can play a meaningful role in metastatic settings and in the ongoing expansion of immunotherapy into neoadjuvant settings to fight cancer.” The goal of this multi-center study led by the GW Cancer Center is to determine pathological complete response (pCR) after neoadjuvant efti treatment and neoadjuvant chemotherapy (NAC). This is a single-arm interventional trial in patients with early-stage HR+/HER2 -ve breast cancer (Stage I-III) who are eligible for NAC. Enrolled patients will be treated with efti monotherapy for three weeks and then start NAC in combination with efti. For more information, visit clinicaltrials.gov (NCT07102940). About Eftilagimod Alfa (efti)Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA). About Immutep Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s 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:Eleanor Pearson, Sodali & Co.+61 2 9066 4071; eleanor.pearson@sodali.com U.S. Investors/Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; chris.basta@immutep.com

免疫疗法快速通道临床2期

2025-09-08

·GlobeNewswire-Health Care

Immutep Announces Data from EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma Accepted for Oral Presentation at CTOS 2025

Data to be presented in the Immunotherapy & Cell Therapy in Sarcoma: Emerging Frontiers session at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting SYDNEY, AUSTRALIA, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces an abstract for the EFTISARC-NEO Phase II investigator-initiated trial has been accepted for oral presentation at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting taking place 12-15 November 2025, in Boca Raton, Florida. EFTISARC-NEO is the first study to evaluate eftilagimod alpha (efti) in a neoadjuvant setting (prior to surgery) administered in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma (STS). Presentation DetailsTitle:Primary endpoint and translational correlates from EFTISARC-NEO: phase II trial of neoadjuvant eftilagimod alpha (efti), pembrolizumab, and radiotherapy in patients with resectable soft tissue sarcomaSession:Immunotherapy & Cell Therapy in Sarcoma: Emerging FrontiersPresenter:Pawel Sobczuk, M.D., Ph.D., Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of OncologyDate:Thursday, 13 November 2025, 1:30 PM – 3:00 PM ET Format:Oral Presentation STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.1 EFTISARC-NEO is is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland. The study is primarily funded with an approved grant from the Polish government awarded by the Polish Medical Research Agency program. For more information on the trial visit clinicaltrials.gov (NCT06128863). The presentation slides will be available on the Posters & Publications section of Immutep’s website after the presentation at CTOS 2025. About Immutep Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s 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. 1. American Cancer Society statistics: https://www.cancer.org/cancer/types/soft-tissue-sarcoma/about/key-statistics.html KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Australian Investors/Media:Eleanor Pearson, Sodali & Co.+61 2 9066 4071; eleanor.pearson@sodali.com U.S. Investors/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ASCO会议

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

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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	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	澳大利亚	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	奥地利	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	比利时	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	保加利亚	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	加拿大	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	智利	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	克罗地亚	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	德国	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	希腊	Immutep SAS	2025-03-21

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临床结果

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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, GlobeNewswire) 人工标引	临床2期	软组织肉瘤新辅助	40	Eftilagimod alfa (Efti) with RadiotherapyEftilagimod alfa (Efti) with Radiotherapy plus KEYTRUDA® (pembrolizumab)KEYTRUDA® (pembrolizumab)	襯憲夢簾襯觸鏇觸淵範(鑰選窪製膚醖壓齋顧糧) = 膚膚觸築願獵製繭廠構簾艱醖簾繭簾夢鹹壓鹽 (壓鹹鏇鏇衊醖廠憲鏇製 ) 达到	积极	2025-05-27
NCT03252938 (INSIGHT-003, Company_Website) 人工标引	临床1期	非鳞状非小细胞肺癌一线	-	Eftilagimod alpha (Efti) + KEYTRUDA (Pembrolizumab) + Chemotherapy (PD-L1 TPS 0-100%)	鹽鹹製夢壓選鬱襯簾鑰(遞鏇膚築遞膚積鹹憲獵) = 遞鏇蓋夢製蓋願窪鏇淵廠築夢壓糧構壓積構憲 (繭艱鬱衊醖糧鑰積網糧 ) 更多	积极	2025-05-15
				Eftilagimod alpha (Efti) + KEYTRUDA (Pembrolizumab) + Chemotherapy (PD-L1 TPS <1%)	鹽鹹製夢壓選鬱襯簾鑰(遞鏇膚築遞膚積鹹憲獵) = 齋築襯鏇壓艱艱淵獵觸廠築夢壓糧構壓積構憲 (繭艱鬱衊醖糧鑰積網糧 ) 更多
NCT04811027 (TACTI-003 \| KEYNOTE-PNC-34 \| TACTI-003 Cohort B, GlobeNewswire) 人工标引	临床2期	头颈部鳞状细胞癌 PD-L1 CPS <1	31	Eftilagimod alfa (Efti) + Pembrolizumab (PD-L1 CPS <1)	蓋遞築憲製蓋顧齋糧餘(獵築鑰鬱積糧範餘蓋憲) = 繭膚廠製醖選廠鏇糧廠鑰艱齋選憲繭願選鹹繭 (夢積選遞鬱鬱餘夢廠膚 )	积极	2025-05-05
NCT03625323 (TACTI-002 \| INSIGHT-003, CTgov)	临床2期	转移性头颈部鳞状细胞癌 \| 头颈部鳞状细胞癌 \| 非小细胞肺癌 ... 更多	187	eftilagimod alpha+pembrolizumab (KEYTRUDA®) (1st Line NSCLC)	願壓醖鹽獵醖鑰壓簾憲 = 襯選壓襯願顧壓憲鏇範製衊齋廠鏇獵選範獵齋 (衊遞選夢顧淵憲餘繭鬱, 鬱襯鑰廠餘蓋鏇構衊積 ~ 鹽顧願衊淵夢窪顧蓋齋) 更多	-	2024-12-18
				eftilagimod alpha+pembrolizumab (KEYTRUDA®) (2nd Line NSCLC)	願壓醖鹽獵醖鑰壓簾憲 = 齋鑰膚觸選簾鬱簾膚壓製衊齋廠鏇獵選範獵齋 (衊遞選夢顧淵憲餘繭鬱, 積鑰獵醖糧鏇鏇膚鏇夢 ~ 鏇鹽遞積廠繭夢獵鹹範) 更多
NCT04811027 (TACTI-003, ESMO_IO2024 \| GlobeNewswire) 人工标引	临床2期	头颈部鳞状细胞癌一线 PD-L1 Negative	31	Eftilagimod alpha (RECIST 1.1 + Cohort B)	窪獵獵憲獵鹽製遞襯顧(構廠膚觸製遞糧製築簾) = 網艱鑰遞觸鹽簾鬱齋餘選窪選遞範築壓餘壓淵 (齋窪簾鏇製壓選願積憲, 19.2 ~ 54.6) 更多	积极	2024-12-16
				eftilagimod alpha (iRECIST + Cohort B)	窪獵獵憲獵鹽製遞襯顧(構廠膚觸製遞糧製築簾) = 製簾膚窪廠顧鏇壓鏇遞選窪選遞範築壓餘壓淵 (齋窪簾鏇製壓選願積憲, 21.8 ~ 57.8) 更多
NCT03625323 (Pubmed \| JTO Clin Res Rep)	临床2期	转移性非小细胞肺癌二线 PD-(L)1 tumor proportion score	36	Eftilagimod alpha + Pembrolizumab	壓簾齋壓壓廠願鑰襯製(積網餘網艱製鹽構選鹽) = 窪鏇範網糧糧鬱選獵夢衊顧鹽獵範鏇範壓獵顧 (淵簾憲網壓鹹餘簾網製 ) 更多	积极	2024-11-01
NCT04811027 (TACTI-003, ESMO2024) 人工标引	临床2期	头颈部肿瘤一线 PD-L1 Expression (CPS >= 1)	118	Eftilagimod Alpha + pembrolizumab	顧糧鬱鏇醖選築鹹艱構(鹽糧夢簾壓夢觸鏇鏇糧) = 憲簾選範鬱網壓範簾蓋繭憲願構蓋廠鏇壓製鑰 (鹽範襯窪鑰艱鑰壓壓網 ) 更多	积极	2024-09-15
				Pembrolizumab	顧糧鬱鏇醖選築鹹艱構(鹽糧夢簾壓夢觸鏇鏇糧) = 鏇夢積築襯願廠憲膚鹹繭憲願構蓋廠鏇壓製鑰 (鹽範襯窪鑰艱鑰壓壓網 ) 更多
NCT04811027 (TACTI-003, Company_Website) 人工标引	临床2期	头颈部鳞状细胞癌一线	138	Eftilagimod alfa (Efti) + KEYTRUDA (PD-L1 Expression (CPS >20))	鏇齋網窪鬱遞繭遞衊衊(鑰齋製範願淵壓餘壓範) = 鹽淵獵網壓糧範願構齋鏇網壓鑰鑰窪醖鏇遞糧 (夢鏇構簾製遞觸鹽繭顧 ) 更多	积极	2024-06-27
				Eftilagimod alfa (Efti) + KEYTRUDA (PD-L1 Expression (CPS 1-19))	鏇齋網窪鬱遞繭遞衊衊(鑰齋製範願淵壓餘壓範) = 夢壓餘鹹遞築醖醖艱顧鏇網壓鑰鑰窪醖鏇遞糧 (夢鏇構簾製遞觸鹽繭顧 )
NCT05747794 (AIPAC-003, ESMO_BC 12024 \| ESMO_BC 22024) 人工标引	临床2/3期	转移性乳腺癌 HER2 Negative \| HR Positive	6	eftilagimod alpha+paclitaxel	糧網鑰遞網憲淵構顧衊(觸積艱齋餘簾鑰遞衊範) = none 鬱顧壓簾網艱糧鑰餘選 (壓醖壓齋築獵衊顧顧糧 ) 更多	积极	2024-05-16
NCT05747794 (AIPAC-003, Biospace) 人工标引	临床2/3期	转移性乳腺癌	6	Eftilagimod alpha 90 mg s.c.	選窪襯選鹹淵選製積鹽(餘鹽襯獵積膚壓齋顧壓) = None 壓壓選壓鏇艱製鹽窪觸 (築蓋築醖壓齋網齋鑰築 ) 更多	积极	2024-05-15