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 ; Duhoux, Francois P. ; Armstrong, Anne ; Brignone, Chrystelle ; Marme, Frederik ; Kuemmel, Sherko ; Jager, Agnes ; Dirix, Luc ; Cuypere, Eveline ; Triebel, Frederic ; Wildiers, Hans ; Schröder, Carolina P. ; 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.

222

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）

2025-10-20

·GlobeNewswire-Health Care

Primary Endpoint Met in EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma and Data Presented at ESMO Congress 2025

Novel combination including eftilagimod alfa (efti) in neoadjuvant setting drives 51.5% tumour hyalinization/fibrosis in patients with soft tissue sarcoma (p<0.001) High level of tumour hyalinization/fibrosis, achieved across multiple STS subtypes, over 3-fold greater than historical results from standard-of-care radiotherapy alone Data from investigator-initiated Phase II selected for Proffered Paper oral presentation SYDNEY, AUSTRALIA, Oct. 20, 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 positive data from the EFTISARC-NEO Phase II trial were shared in a Proffered Paper oral presentation by Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the 2025 European Society of Medical Oncology (ESMO) Congress in Berlin, Germany. The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) met the primary endpoint and significantly exceeded the study’s prespecified 35% tumour hyalinization/fibrosis. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001). This impressive outcome, over three times greater than 15% from standard-of-care radiotherapy alone based on historical data, may hold significance in terms of future outcomes as tumour hyalinization/fibrosis serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients.1,2 These promising results were achieved across multiple STS subtypes and the study proved a very good safety profile for the therapy, with only one grade ≥3 toxicity related to immunotherapy. Dr. Katarzyna Kozak, said: “The novel combination with neoadjuvant efti has significantly exceeded the originally established target for the trial’s primary endpoint in resectable soft tissue sarcoma. These outcomes achieved in a diverse population of multiple STS subtypes further substantiate the hypothesis that efti’s unique stimulation of antigen-presenting cells, resulting in a robust adaptive and innate immune response, contributes to modifying the immunosuppressed tumour microenvironment and achieving notable anti-cancer efficacy in soft tissue sarcomas. We hope these findings can help pave a path to a new therapeutic option for the substantial unmet medical need in this challenging indication.” Marc Voigt, CEO of Immutep, noted: “We sincerely thank the principal investigators leading this study, as well as the patients and their families for taking part in this important trial. There is a significant unmet medical need for novel therapies in STS that have the potential to provide better outcomes for patients than the current standard of care radiotherapy.” 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.3 The EFTISARC-NEO study has been primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program. For more information on EFTISARC-NEO, visit clinicaltrials.gov (NCT06128863). The presentation slides can be found on the Posters & Publications page of Immutep’s website. About Eftilagimod Alfa (Efti)Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, 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. 1. Schaefer IM et al. Histologic Appearance After Preoperative Radiation Therapy for Soft Tissue Sarcoma: Assessment of the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group Response Score. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):375-383. doi: 10.1016/j.ijrobp.2017.02.087. Epub 2017 Feb 24. PMID: 28463157.2. Rao SR et al. Extent of tumor fibrosis/hyalinization and infarction following neoadjuvant radiation therapy is associated with improved survival in patients with soft-tissue sarcoma. Cancer Med. 2022 Jan;11(1):194-206. doi: 10.1002/cam4.4428. Epub 2021 Nov 27. PMID: 34837341; PMCID: PMC8704179.3. 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

临床结果临床2期免疫疗法快速通道临床3期

2025-10-20

·GlobeNewswire-Health Care

Two Posters at ESMO Congress 2025 Highlight Immutep’s Focus on Changing Treatment Landscape in First Line Non-Small Cell Lung Cancer

Novel combination of efti with KEYTRUDA® and chemotherapy generates strong response rates across all PD-L1 expression levels in first line non-small cell lung cancer (1L NSCLC) including 61.7% ORR in low & no PD-L1 (TPS <50%), well above 40.8% from historical controlsEfti’s ability to expand responders & enhance efficacy with PD-1 inhibitors, the best selling class of drugs in oncology, holds great promise to change 1L NSCLC treatment paradigm SYDNEY, AUSTRALIA, Oct. 20, 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 two poster presentations at the European Society for Medical Oncology (ESMO) Congress 2025 highlight the Company’s focus on changing the treatment paradigm in first line non-small cell lung cancer (1L NSCLC). Promising data from the investigator-initiated INSIGHT-003 trial with a cut-off date of 01 September 2025 were detailed in a poster presented by Dr. med. Akin Atmaca, Head of the Thoracic Oncology, Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany. In this multi-centre study, the novel combination of eftilagimod alfa (efti) with KEYTRUDA® (pembrolizumab) and chemotherapy (carboplatin/pemetrexed) has generated strong objective response rates (ORR) and disease control rates (DCR) in 51 evaluable patients with advanced or metastatic non-squamous 1L NSCLC across all PD-L1 expression levels (see table below). Notably, the ORR and DCR reported in INSIGHT-003 outperforms historical controls irrespective of PD-L1 levels. This is particularly important for patients with low and no PD-L1 (TPS <50%), who represent over two-thirds of the 1L NSCLC patient population and for whom PD-(L)1 inhibitors typically perform suboptimally. In patients with TPS <50% (N=47), the combination with efti has achieved a strong and improved 61.7% ORR (with an additional partial response since 06 May 2025 data cutoff) as compared to historical control of 40.8%.1,2 Efti+KEYTRUDA+Chemo Generates High ORR & DCR Across All PD-L1 Levels (RECIST 1.1) No PD-L1 (TPS <1%, N=22)Low PD-L1 (TPS 1-49%, N=25)High PD-L1 (TPS ≥50%, N=4)ORR, %54.568.075.0DCR, %86.492.0100 Dr. Atmaca, Head of Thoracic Oncology at Krankenhaus Nordwest, stated: “While the introduction of PD-(L)1 inhibitors, both alone and with chemotherapy, has revolutionised 1L NSCLC treatment, their limited effectiveness in cases with minimal or absent PD-L1 expression highlights the ongoing need for innovative strategies that better harness the immune system against cancer. The favourable safety results and strong clinical responses seen when adding efti, a novel immunotherapy bridging adaptive and innate immunity, to KEYTRUDA and chemotherapy are highly promising and could benefit NSCLC patients irrespective of their PD-L1 status.” Marc Voigt, CEO of Immutep, stated: “We are increasingly confident that efti can set a new standard of care as first line treatment for non-small cell lung cancer patients through our pivotal TACTI-004 Phase III trial, supported by strong data from multiple clinical trials evaluating efti in lung cancer including INSIGHT-003. Efti has safely and consistently delivered impressive improvements in response rates and progression free survival compared to KEYTRUDA alone or with chemotherapy, and encouragingly these have translated into compelling overall survival. Notably, the data is especially promising in patients with PD-L1 expression under 50%, who have a high unmet need and represent more than two-thirds of the 1L NSCLC patient population.” Further to the strong efficacy data from INSIGHT-003, the combination with efti continues to have a favourable safety profile. Additionally, a Trial in Progress ePoster for the TACTI-004 Phase III was presented at ESMO Congress 2025. This registrational trial is evaluating the same immunotherapy/chemotherapy combination used in INSIGHT-003. This global study will enrol approximately 756 patients with advanced/metastatic 1L NSCLC regardless of PD-L1 expression (Tumour Proportion Score or TPS of 0-100%) with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. The poster for INSIGHT-003 and the Trial in Progress ePoster for TACTI-004 can be found at the Posters & Publications section of Immutep’s website. About Eftilagimod Alfa (Efti)Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, 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. Shirish Gadgeel et al. Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non–Small-Cell Lung Cancer. JCO 38, 1505-1517(2020). DOI:10.1200/JCO.19.03136Immutep’s Efti with KEYTRUDA® (pembrolizumab) & Chemotherapy Achieves High Response Rates in First-Line Non-Small Cell Lung Cancer - May 2025 press release 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

临床3期免疫疗法快速通道临床结果

2025-10-20

·ioncology

腱鞘大学丨破局TGCT精准治疗-MANEUVER研究长期数据发布，靶向CSF1R肿瘤缓解疗效持续增强，症状功能结局持续改善

2025年10月17日，欧洲肿瘤内科学会（ESMO）年会于德国柏林盛大开幕。在此次ESMO大会上，骨与软组织肉瘤领域的研究成果备受瞩目，其中在肉瘤专场Mini Oral环节，由首都医科大学附属北京积水潭医院牛晓辉教授报告的MANEUVER研究最新数据（摘要号：2690MO）引起国内外学者的广泛关注。这项全球多中心Ⅲ期研究的最新数据，为腱鞘巨细胞瘤（TGCT）这一罕见疾病的治疗带来了新的希望。我们特邀牛晓辉教授就本次研究进展进行了专访，对其关键数据与临床意义做进一步分享。 01 首先恭喜您牵头的全球多中心Ⅲ期MANEUVER研究入选本次ESMO大会的Mini Oral，能否请您简要介绍一下这项研究开展的背景以及主要研究目的？牛晓辉教授首都医科大学附属北京积水潭医院腱鞘巨细胞瘤（TGCT）是一种罕见的、具有局部侵袭性的间叶源性肿瘤。虽然它极少发生远处转移，但其局部复发率很高，尤其对于弥漫型TGCT患者，反复手术可能导致严重的关节功能障碍，甚至截肢，严重影响患者的生活质量。而驱动TGCT发生的关键分子机制是CSF1/CSF1R信号通路的过度激活。因此，对于无法完整手术切除或手术会导致严重功能障碍的TGCT患者，靶向CSF1R的系统性治疗或可成为满足这部分患者临床需求的新希望。在2023年之前，已有CSF1R抑制剂获得美国食品药品监督管理局（FDA）的批准，用于治疗此类患者，展现出了较为可观的治疗效果。然而，其肝脏毒性等副作用也对该抑制剂在临床上的广泛应用形成了限制。因此，临床上迫切需要一种疗效良好、但安全性更高、患者耐受性更好的新治疗选择。 MANEUVER研究正是在这样的背景下开展的。它是一项全球多中心、随机、双盲的Ⅲ期临床试验，旨在评估一种新型、高选择性CSF1R抑制剂Pimicotinib在TGCT患者中的有效性和安全性。主要研究目的是验证这款新药相较于安慰剂，能否显著提高患者的客观缓解率（ORR），并评估其在肿瘤体积控制、患者症状改善以及长期安全性方面的数据，以期能为TGCT患者提供一个更优的治疗新选择。 02 MANEUVER研究已在今年ASCO大会上公布重要数据，请您为我们分享一下本次ESMO大会上公布的MANEUVER最新研究结果有何不同？以及对临床实践的意义？牛晓辉教授首都医科大学附属北京积水潭医院 MANEUVER研究分三部分进行，符合入组标准的患者以2:1的比例随机分配接受每日一次50mg Pimicotinib或安慰剂治疗，持续24周（第一部分）；在第25周时，患者继续接受或交叉换用Pimicotinib治疗24周（第二部分），随后进入扩展阶段（第三部分）。第一部分结果已在今年的ASCO年会上公布，Pimicotinib治疗组的ORR显著优于安慰剂组（54.0% vs 3.2%，P＜0.0001）。更重要的是，肿瘤体积的缩小显著改善了患者的临床症状和提高了生活质量，包括关节活动度、僵硬、疼痛控制以及整体身体机能。同时，研究也证实了Pimicotinib具有良好的耐受性。本次ESMO大会公布的数据显示，截至中位随访62周时，第一部分中随机分配至Pimicotinib组治疗的患者（n=63）ORR为76.2%（根据 RECIST v1.1 标准）和74.6%（根据肿瘤体积评分）。中位缓解持续时间尚未达到。在第二部分结束时，观察到所有临床结局评估（COAs）指标均持续改善（包括关节活动度、最严重僵硬评分、最剧烈疼痛评分、身体功能评分）。从安慰剂组交叉至Pimicotinib组（第二部分）的患者同样观察到ORR和COA获益。安全性方面，Pimicotinib组未出现新的安全性信号，无胆汁淤积性肝毒性或药物性肝损伤的证据，也未出现毛发/皮肤色素减退。该研究结果表明Pimicotinib有望成为TGCT患者一种高效且安全的治疗新选择。对于那些因肿瘤部位、血管神经侵犯或关节破坏而无法手术，或经历多次复发的患者，Pimicotinib能够有效控制肿瘤、缓解症状，并最终改善他们的生活质量，无疑为TGCT的临床治疗带来了新的希望。而且良好的安全性也意味着患者可以长期维持治疗，保障治疗的完成率，从而最大化临床获益。 03 随着精准医学的不断进步，TGCT的诊疗正逐步迈向分子驱动的精准治疗时代。您认为TGCT领域未来的诊疗发展方向将集中在哪些方面？牛晓辉教授首都医科大学附属北京积水潭医院 MANEUVER研究的成功，揭示了TGCT精准治疗的广阔前景。我认为未来的发展方向主要集中在以下几个方面： 1. 靶向药物的深度研发与优化：MANEUVER研究的成功验证了靶向CSF1R通路的有效性。未来，我们需要进一步探索驱动TGCT的其他潜在基因和信号通路，开发更多样化的靶向药物，以应对可能的耐药问题。 2. 探索联合治疗模式：探索靶向治疗与手术或其他创新疗法（如免疫治疗）的联合应用。例如，将靶向药物用作新辅助治疗，即在术前使用靶向药物缩小肿瘤体积，为手术创造更有利的条件，降低手术复杂性和并发症风险，从而为患者保留更多的关节功能。 3. 生物标志物的探索与应用：精准医学的核心是“为合适的患者，在合适的时间，使用合适的药物”。未来需要大力寻找能够预测疗效、评估预后和监测复发的生物标志物。通过基因组学、蛋白质组学等技术，更好地筛选出能从靶向治疗中最大获益的患者群体，实现真正的个体化治疗。总而言之，MANEUVER研究数据的持续更新，为TGCT治疗路径的精细化提供了新证据。随着随访时间的延长，这一高选择性CSF1R抑制剂显示出深度且持久的肿瘤缓解疗效，其未来表现如何让我们拭目以待。此外，本次ESMO大会上还公布了以下骨与软组织肿瘤领域的重要研究进展，在此进行简要分享：软组织肉瘤一线治疗新选择（摘要号：LBA97）公布了Legubicin（一种肿瘤微环境激活的抗体药物偶联物）对比阿霉素（DOX）治疗晚期软组织肉瘤的II/III期结果。Legubicin显示出更优的PFS和OS趋势，并将≥3级心脏毒性和血液学毒性发生率显著降低，为一线治疗提供了潜力新方案。免疫联合治疗探索 RAR-IMMUNE研究（摘要号：LBA98)：在罕见亚型晚期肉瘤中比较了纳武利尤单抗联合伊匹木单抗与帕唑帕尼的疗效。虽然未达到PFS主要终点，但免疫联合治疗组显示出更好的安全性和一定的ORR。 IMMUNOSARC II研究 (摘要号：2685O)：舒尼替尼联合纳武利尤单抗在肺泡状软组织肉瘤（ASPS）中显示出良好的活性，ORR达53%，为这一罕见类型提供了有效治疗选择。 COTESARC研究 (摘要号：2693MO)：评估了MEK抑制剂考比替尼联合阿特珠单抗在多种肉瘤亚型中的疗效，虽因有效性和心肌炎风险提前终止，但在部分特定患者中观察到长期获益。抗体药物偶联物（ADC）新突破 ARTEMIS-002研究(摘要号：2684O)更新了靶向B7-H3的ADC药物HS-20093在复发/难治性骨肉瘤和其他肉瘤中的数据，显示出有前景的疗效和可控的安全性。新辅助治疗新模式 EFTISARC-NEO研究(摘要号：2686O)探索了在可切除软组织肉瘤中，放疗联合Eftilagimod α（Efti）和帕博利珠单抗的新辅助模式，达到了主要病理终点，为改善患者预后提供了新思路。靶向治疗与生物标志物 BIOVAS试验 (摘要号：LBA99)：一项生物标志物驱动的II期研究，证实VEGFR抑制剂阿帕替尼在VEGFR2 SNP阳性或CSF1高表达的肉瘤患者中疗效显著。摘要号：2688MO：报道了β-catenin:TCF4直接抑制剂在纤维瘤中的I/II期数据，显示出初步疗效和可耐受的安全性。 *感谢默克公司对本项目的支持。支持公司未参与内容创作，本文观点不代表支持公司立场。牛晓辉教授北京积水潭医院主任医师，教授、博士生导师北京积水潭医院骨与软组织肿瘤诊疗研究中心主任中国临床肿瘤学会（CSCO）理事中国临床肿瘤学会（CSCO）肉瘤专家委员会前任主任委员中国临床肿瘤学会（CSCO）黑色素瘤专家委员会副主任委员中国抗癌协会（CACA）理事中国抗癌协会（CACA）肉瘤专业委员会名誉主任委员中国抗癌协会（CACA）骨软肿瘤整合康复专委会主任委员中国医师协会肿瘤多学科肿瘤诊疗专业委员会常务委员中国医师协会骨科分会骨肿瘤专业组副组长中华医学会骨科分会骨肿瘤专业组副组长北京医学会科分会骨肿瘤学组组长国际保肢协会（ISOLS）中国区唯一Board Member 亚太骨与软组织肿瘤学会（APMSTS）常务理事东亚骨与软组织肿瘤协作组（EAMOG）前主席、常务理事《中国骨与关节杂志》副总编辑担任34家SCI期刊审稿专家以第一作者或通讯作者发表论文262篇，其中SCI文章44篇（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议临床3期临床结果申请上市

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

适应症

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


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)	淵襯鹹願觸夢簾鏇蓋憲(鹹衊襯構夢選醖蓋窪鏇) = 網鬱夢製夢築繭鬱襯淵糧構膚蓋構願鹽製簾鬱 (憲齋鬱餘壓鹹製遞窪築 ) 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%)	憲選齋網簾鬱廠襯餘蓋(鏇簾鏇遞膚範選膚衊鹹) = 遞繭淵獵顧網餘網網壓鏇網鏇顧範築醖製範範 (網製構鏇選蓋夢壓範夢 ) 更多	积极	2025-05-15
				Eftilagimod alpha (Efti) + KEYTRUDA (Pembrolizumab) + Chemotherapy (PD-L1 TPS <1%)	憲選齋網簾鬱廠襯餘蓋(鏇簾鏇遞膚範選膚衊鹹) = 鬱選廠醖齋鑰積襯遞襯鏇網鏇顧範築醖製範範 (網製構鏇選蓋夢壓範夢 ) 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)	齋憲衊遞蓋範醖願鏇膚(繭壓艱選鹹製願鬱衊構) = 遞遞築鏇憲繭簾膚鹽齋壓願鬱醖鏇顧鑰糧製淵 (積選遞選淵鏇簾繭憲艱 )	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)	願繭製鹽糧積窪膚齋範 = 襯範衊醖糧糧餘醖餘鏇廠餘窪廠艱憲餘憲網構 (構製艱範鹹齋網顧餘繭, 襯夢齋膚蓋簾衊範簾糧 ~ 窪衊繭鹹蓋餘築願餘餘) 更多	-	2024-12-18
				eftilagimod alpha+pembrolizumab (KEYTRUDA®) (2nd Line NSCLC)	願繭製鹽糧積窪膚齋範 = 窪壓壓襯艱鬱鹽壓鏇衊廠餘窪廠艱憲餘憲網構 (構製艱範鹹齋網顧餘繭, 憲餘鹹繭夢構顧淵齋艱 ~ 鏇構夢選夢襯顧餘壓憲) 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)	衊鏇鏇顧蓋淵築願壓鬱(鏇窪觸壓糧築積醖顧觸) = 構廠簾壓蓋構選糧鹽窪壓夢醖壓網範網糧鬱餘 (遞鹹鑰築淵憲鑰醖鏇遞, 19.2 ~ 54.6) 更多	积极	2024-12-16
				eftilagimod alpha (iRECIST + Cohort B)	衊鏇鏇顧蓋淵築願壓鬱(鏇窪觸壓糧築積醖顧觸) = 淵範顧淵夢鏇糧觸積簾壓夢醖壓網範網糧鬱餘 (遞鹹鑰築淵憲鑰醖鏇遞, 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	鑰鬱鑰蓋鏇夢獵鑰鏇廠(窪築衊壓簾獵鏇淵糧築) = 齋廠積蓋鹽壓壓糧鏇鹹顧廠鹹構鑰鬱壓網衊獵 (遞繭憲齋積積積夢窪鑰 ) 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	築淵選憲窪鑰膚獵淵餘(願網網廠鏇範網餘壓餘) = 膚淵鏇築襯壓醖築蓋醖積獵築糧繭獵網鏇鹽積 (築選膚網齋蓋範憲鬱蓋 ) 更多	积极	2024-09-15
				Pembrolizumab	築淵選憲窪鑰膚獵淵餘(願網網廠鏇範網餘壓餘) = 膚網構積構積選鹽鑰餘積獵築糧繭獵網鏇鹽積 (築選膚網齋蓋範憲鬱蓋 ) 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))	繭糧鏇廠築艱憲壓願製(築鬱壓顧選築艱鑰構廠) = 蓋廠積醖鹽遞蓋齋壓廠築鬱簾鑰齋廠蓋繭構窪 (夢鏇餘製鏇齋繭膚廠廠 ) 更多	积极	2024-06-27
				Eftilagimod alfa (Efti) + KEYTRUDA (PD-L1 Expression (CPS 1-19))	繭糧鏇廠築艱憲壓願製(築鬱壓顧選築艱鑰構廠) = 壓齋鏇襯鹽艱壓獵窪築築鬱簾鑰齋廠蓋繭構窪 (夢鏇餘製鏇齋繭膚廠廠 )
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	廠鹽製鏇淵糧積艱繭遞(糧獵衊窪蓋製窪鹹範鹹) = none 範壓膚壓艱遞鑰觸糧遞 (願構壓醖鏇獵範願積願 ) 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.	網繭糧繭憲積壓齋鹽壓(簾鏇鏇構繭築壓積廠齋) = None 築繭繭衊築艱選淵廠壓 (積鹹鑰齋鑰艱壓簾範憲 ) 更多	积极	2024-05-15