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2026-05-01

申办/合作机构

Immutep SAS

NCT06726265

/ Active, not 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.

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2025-03-21

申办/合作机构

Immutep SAS

[+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 Eftilagimod alpha 相关的临床结果

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100 项与 Eftilagimod alpha 相关的转化医学

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100 项与 Eftilagimod alpha 相关的专利（医药）

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项与 Eftilagimod alpha 相关的文献（医药）

2025-12-20·Future Oncology

A phase III placebo-controlled study of eftilagimod alfa plus pembrolizumab and chemotherapy in metastatic non-small cell lung cancer

Article

作者: Lo Russo, Giuseppe ; Hegmane, Alinta ; Volovat, Constantin ; Atmaca, Akin ; Esteban, Emilio ; Majem, Margarita ; Ziogas, Dimitrios ; Sebastian, Martin ; Lee, Cheen Leng ; O’Byrne, Kenneth

BACKGROUND:

Although immune checkpoint inhibitors (ICIs) form the cornerstone of first-line treatment for non-small cell lung cancer (NSCLC), the challenge remains to improve patients' long-term outcomes. Eftilagimod alfa (efti) activates antigen-presenting cells, triggering T cell activation and a sustained immune response. Prior studies combining efti with an ICI, pembrolizumab, have shown encouraging efficacy, especially in PD-L1 low (tumor proportion score [TPS] 1-49%) and negative (<1%) tumors. TACTI-004 is a global double-blinded, randomized, placebo-controlled phase III study investigating efti plus standard-of-care (SoC: pembrolizumab plus chemotherapy) in first-line NSCLC, regardless of PD-L1 expression (TPS 0-100%).

PATIENTS AND METHODS:

About 756 participants with squamous or non-squamous first-line NSCLC, not amenable to EGFR/ROS1/ALK-targeted therapy, will be randomized to receive either efti plus SoC or placebo plus SoC. The dual primary endpoint is progression-free survival and overall survival. Key secondary endpoints include objective response rate, duration of response and safety. Participants will receive 30 mg efti subcutaneously every 2 weeks (q2w) for 24 weeks, then q3w and pembrolizumab 200 mg intravenously q3w, both for up to 2 years. Chemotherapy choice will be histology-dependent.

CONCLUSIONS:

TACTI-004 will evaluate whether efti can mitigate resistance to ICIs when added to SoC in NSCLC, irrespective of PD-L1 tumor status.

CLINICAL TRIAL REGISTRATION:

www.clinicaltrials.gov identifier is NCT06726265.

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 ; Doger, Bernard ; Krebs, Matthew ; 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.

281

项与 Eftilagimod alpha 相关的新闻（医药）

2026-05-18

·EndPoints

Regeneron's Phase 3 skin cancer miss adds to mounting failures in LAG-3

Regeneron Pharmaceuticals’ LAG-3 inhibitor called fianlimab has flunked a late-stage skin cancer trial, marking yet another blow for the drug class. The announcement follows a spate of recent clinical setbacks for candidates targeting the LAG-3 immune checkpoint. In March, Immutep’s eftilagimod alfa failed a Phase 3 lung cancer study. In February 2025, Bristol Myers Squibb’s fixed-dose combination of LAG-3 and PD-1 targeting drugs, known as Opdualag, failed in its bid to expand into the adjuvant setting in melanoma. Regeneron’s Phase 3 study is in first-line unresectable locally advanced or metastatic disease, and enrolled over 1,500 patients. Fianlimab, combined with the PD-1 inhibitor Libtayo, missed the trial’s progression-free survival primary endpoint. Jefferies analysts had only earmarked around $321 million in first-line melanoma peak sales for fianlimab. Even so, Regeneron’s $REGN stock was down about 10% premarket on Monday. If it had been successful, the fianlimab-Libtayo combo could have posed competition for Opdualag, which is the only LAG-3 drug approved for first-line melanoma. The high-dose fianlimab combination regimen produced an average 11.5-month PFS, while the low-dose regimen led to a 9.6-month PFS, according to Regeneron’s Friday release . While both of these figures were numerically higher than the average 6.4-month PFS achieved by Keytruda monotherapy in the study, neither was statistically significant. Regeneron plans to present full results from the trial at a future medical meeting. The drugmaker is still running two other Phase 3 melanoma studies of its fianlimab-Libtayo combo: one testing the regimen head-to-head against Opdualag in first-line disease and another against Keytruda in the adjuvant setting where patients have had their cancer surgically removed. That second study is closely watched as Opdualag failed in the same setting early last year. It is expected to have primary endpoint data in 2028, according to ClinicalTrials.gov. Opdualag has faced its share of clinical disappointments. Besides the miss in adjuvant melanoma, its positive mid-stage data in lung cancer drew skepticism in 2024 for relying on an analysis described as “cherry-picked.” Meanwhile, other drugmakers are exiting the LAG-3 space entirely. In 2024, Merck and Incyte shuttered their respective programs.

临床3期上市批准临床结果免疫疗法

2026-05-14

·中金财富证券

泽璟制药：ZG006成功出海新产品商业化放量可期

泽璟制药（688266）公司是专注于肿瘤、出血及血液疾病、肝胆疾病等多个治疗领域的创新驱动型化学及生物新药研发企业。公司专注于与国际新药研发接轨、安全优效、市场潜力大、国内空白的一系列新药的研发和产业化,产品潜在市场达几十亿。泽璟制药先后承担了5项国家“重大新药创制”、1项国家科技型中小企业技术创新基金、多项江苏省级科技项目。事件：泽璟制药公布2025年业绩及2026年一季度业绩。2025年公司实现营业收入8.10亿元，同比+52.07%；归母净利润-1.63亿元；扣非归母净利润-1.98亿元。 2026年一季度公司实现营业收入9.05亿元，同比+440.07%；归母净利润6.33亿元；扣非归母净利润6.32亿元。2026年一季度收入利润大幅增加系确认ZG006授权许可收入。营业收入快速增长，优质管线商业化放量可期。公司2025年营业收入8.10亿元，同比+52.07%，有赖于已上市优质管线商业化。公司已上市四款产品：1）泽普平（盐酸吉卡昔替尼）：2025年5月获批上市，并于同年进入国家医保目录，纳入三项重要指南；2）泽普生（甲苯磺酸多纳非尼片）：续约2025年医保目录，纳入国内权威指南/共识32个，进入1300余家医院，覆盖2350余家医院，覆盖1000余家药房。3）泽普凝（重组人凝血酶）：已纳入国家医保目录，纳入两项指南/共识，和远大生命科学下属子公司签订市场推广协议，加速产品商业化，目前已累计准入750余家医院，销量增长明显；4）泽速宁（注射用人促甲状腺素β）：2026年1月获批上市，和默克集团达成合作协议，同意授权ATSA作为rhTSH在中国大陆地区的独家市场推广服务商，双方将整合默克深耕中国甲状腺癌的商业网络和公司研发实力，加速填补国内甲状腺癌术后精准管理药物空白。在研管线稳步推进，核心单品ZG006成功出海。1）ZG006（CD3/DLL3/DLL3三抗）：开展三线及以上晚期小细胞肺癌的关键性临床试验、二线晚期小细胞肺癌的III期临床试验，多项针对一/二线小细胞肺癌及神经内分泌癌临床推进中。ZG006与艾伯维达成海外战略合作，与德国默克达成独家商业化合作。2）ZG005（PD-1/TIGIT双抗）：多项联合用药一线治疗实体瘤（肝癌、宫颈癌等），在ASCO及ESMO发布治疗宫颈癌及神经内分泌癌的多项I/II期临床研究成果。3）ZGGS15（LAG-3/TIGIT双抗）：全球首款进入临床研究的LAG-3/TIGIT双特异性靶点药物，在2025 ASCO发布临床数据显示出良好的药效及安全性。盈利预测与评级：华源证券预计公司2026-2028年归母净利润分别为5.38/4.70/8.66亿元。鉴于公司产品商业化放量可期，全球布局进展顺利，维持“买入”评级。风险提示：竞争格局恶化风险、销售不及预期风险、行业政策风险等。今日投资《在线分析师》显示：公司2026-2028年综合每股盈利预测值分别为1.88、1.45和2.13元，对应动态市盈率为53.39、69.44和47.22倍。当前共有10位分析师跟踪，其中建议强力买入、买入、观望、适度减持和观望的分别为7、3、0、0和0人，综合评级系数1.30。

2026-04-30

·immutep.com

Immutep Quarterly Activities Report Q3 FY26

Company Overview Company Overview Leadership Team Corporate Governance Partnering Career Our Science Our Science Posters & Publications Clinical Pipeline Clinical Pipeline Clinical Trials Investors & Media Investors & Media Press Releases Presentations Events Analyst Reports In the News & Media ASX Announcements SEC Filings Financial Reports FAQ Sign Up for Updates Contact Contact Patient Contact Follow Us LinkedIn X Facebook Youtube Sign Up for Updates Company Overview Leadership Team Corporate Governance Partnering Career Our Science Posters & Publications Clinical Pipeline Clinical Trials Investors & Media Press Releases Presentations Events Analyst Reports In the News & Media ASX Announcements SEC Filings Financial Reports FAQ Sign Up for Updates Contact Patient Contact LinkedIn X Facebook Youtube Sign Up for Updates April 30, 2026 Following IDMC recommendation after interim futility analysis the decision was made to discontinue the TACTI-004 Phase III trial Root cause analysis is ongoing and implications for the broader eftilagimod alfa development program are under review Phase I IMP761 data demonstrates favourable safety profile; trial progressing to multiple ascending dose phase; data expected at EULAR conference in June CY2026 Cash, cash equivalent and term deposit position of A$110.6 million, providing an expected cash reach into H1 CY2028 based on current assumptions. SYDNEY, AUSTRALIA, April 30, 2026 — Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, provides an update on its activities for the quarter ended 31 March 2026 (Q3 FY26). LUNG CANCER TACTI-004 (KEYNOTE-F91) – Phase III Trial in 1L NSCLC In March 2026, Immutep announced that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study evaluating eftilagimod alfa (“efti”) in patients in first-line non-small cell lung cancer (1L NSCLC) had recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol. The futility analysis was based on data from approximately 170 patients and included a review of baseline disease characteristics, safety, and overall response rate (“ORR”). After carefully considering the recommendation of the IDMC, as well as conducting its own internal review of the data, Immutep has followed the IDMC’s recommendation and decided to discontinue TACTI-004. Notably, Immutep’s review included additional data such as early interim progression-free survival data. More specifically, the Company decided that it was necessary to discontinue TACTI-004 because patients receiving a combination of efti, KEYTRUDA and chemotherapy (the “efti arm”) were underperforming relative to patients receiving a combination of placebo, KEYTRUDA and chemotherapy (the “control arm”). This outcome was unexpected, given that efti combined with standard of care has typically produced higher response rates when compared to historical studies or controls. In particular, this outcome was notably inferior to results observed in INSIGHT-003 which was testing the same combinations in non-squamous 1L NSCLC patients. In response to the IDMC’s recommendation, enrolment in TACTI-004 has been halted and Immutep is implementing an orderly wind-down of the study, including appropriate patient follow-up and site close-out in accordance with regulatory and ethical obligations. While this is a disappointing outcome, it is important to note that this decision relates specifically to TACTI-004 and does not necessarily mean that efti as a broader development program will be discontinued. Immutep is conducting a thorough review of available data to understand factors behind the futility outcome, examining clinical, operational, analytical, and manufacturing aspects. The process includes collecting and analysing patient samples from TACTI-004 across up to 150 sites and relevant data cleaning. This root cause analysis may extend into Q3 CY2026, depending on data availability and logistics, covering database lock, statistical analysis, and laboratory data review. Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”), a key licensing partner for Immutep’s efti, continues to demonstrate support and provide technical expertise to assist with the completion of the root cause analysis. “We continue to work collaboratively with Immutep on the ongoing evaluation of eftilagimod alfa, with a shared focus on determining the appropriate path forward” stated M.V. Ramana, CEO – Global Generics, Dr. Reddy’s. INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC Patients in the investigator-initiated INSIGHT-003 trial, in which dosing had been completed, continue to be followed up. In this study, the combination of efti with KEYTRUDA and chemotherapy 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.1 SOFT TISSUE SARCOMA EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma The investigator-initiated EFTISARC-NEO Phase II trial was evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS). The study met its primary objective and patients show a strong immune system activation in line with efti’s mode of action, with statistically significant increases in the expression of key cytokines and chemokines in peripheral blood — specifically CXCL9, CXCL10, IL-23, and IFN-γ.2,3 Dosing is completed, and patients are being followed up for disease free survival. In April 2026, Immutep announced that it had received an orphan drug designation for efti in this setting from the FDA. BREAST CANCER AIPAC-003 – Phase II Trial in Metastatic Breast Cancer Immutep continues to follow up patients in the AIPAC-003 Phase II trial which is evaluating efti in combination with chemotherapy in hormone receptor positive (HR+), HER2-negative/low metastatic breast cancer resistant to endocrine-based therapy or metastatic triple-negative breast cancer not eligible for PD-(L)1-based therapy. Patients were randomised 1:1 (N=66) to receive either 30 mg or 90 mg efti in combination with chemotherapy to determine the optimal biological dose (OBD) of efti consistent with the FDA’s Project Optimus initiative. Dosing is complete, and patients are being followed up for overall survival. Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer A proposed investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer patients is on hold and subject to the root cause analysis related to TACTI-004. IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE IMP761 – Phase I Trial In March 2026, Immutep announced an update from the placebo-controlled, double-blind first-in-human Phase I study in healthy participants evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases. The single ascending portion of the Phase I trial has now been completed, with dosing up to 14 mg/kg and no safety concerns observed. The study is now continuing in the multiple ascending dose (MAD) phase, which is evaluating pharmacokinetics and safety at two dose levels, with completion expected in 3Q CY2026. The Company will present details on IMP761 at the upcoming EULAR 2026 Congress, which will be held in London, from 3–6 June 2026 and plans to release additional data in 2H CY2026. INTELLECTUAL PROPERTY During the quarter, Immutep was granted a new patent in Mexico directed to an assay for use in measuring the potency of IMP761 as part of a quality control step in production of the agonist LAG-3 antibody. A new Japanese patent was also granted during the quarter directed to LAG525. The patent is co-owned by Immutep S.A.S. and Novartis AG and exclusively licensed to Novartis AG. FINANCIAL SUMMARY During the quarter, Immutep continued to exercise prudent cash management, particularly in light of the TACTI-004 Phase III discontinuation. The Company is well funded with a cash and cash equivalent, and term deposit balance as at 31 March 2026 of approximately A$110.6 million, which is better than the FY2026 budget. However, this cash balance will be reduced by the wind down costs of TACTI-004 and associated activities. The total balance consists of 1) a cash and cash equivalent balance of A$84.3 million and 2) bank term deposits totaling A$26.3 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months. In Q3 FY26, cash receipts from customers were A$28.85 million, which is mainly due to the US$20 million (A$28.84 million4) upfront payment from Dr. Reddy’s. The net cash used in G&A activities in the quarter was A$0.9 million compared to A$1.3 million in Q2 FY26. In respect of the upfront licence fee of US$20 million received from Dr. Reddy’s in January 2026, US$2.7million (A$4.1 million5) was recognised as revenue and US$17.3 million (A$25.8 million6) was recognised as unearned revenue in the Company’s Half Year Financial Report for the period ended 31 December 2025. Following the discontinuation of TACTI‑004, a payment obligation has arisen under the Company’s licence agreement with Dr. Reddy’s. Under the licence agreement terms, the Company must pay US$10 million to Dr. Reddy’s by June 2026 in these circumstances. No payment has been made to Dr. Reddy’s at the date of this announcement. The expected payment will result in a cash outflow of US$10 million in the June 2026 quarter and corresponding reduction in unearned revenue. The remaining balance of US$7.3 million in unearned revenue is expected to be recognised as revenue for the half-year ending 30 June 2026. As previously disclosed, under the terms of the licensing agreement, Dr. Reddy’s has the exclusive rights to develop and commercialise efti in the licensed territories; Immutep has an entitlement to potential regulatory, development and commercial milestone payments of up to US$349.5 million; royalties on commercial sales in the licensed territories; and Immutep retains global manufacturing rights and will supply the product to Dr. Reddy’s in the licensed markets. The cash used in R&D activities during the quarter was A$11.8 million, compared to A$9.9 million in Q2 FY26. Payment for staff costs was A$2.6 million in the quarter, remaining the same level as in Q2 FY26. Total net cash inflows from operating activities in the quarter were A$13.5 million compared to net cash outflow of A$9.4 million in Q2 FY26. Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$515k. Total net cash inflow received in investing activities for the quarter was A$20k, which is mainly the refund of an office security deposit. After the TACTI-004 Phase III futility outcome, the Company has started to initiate cost reduction measures to preserve capital and extend its cash runway. These measures include a targeted reduction in headcount and other operating expense reductions. The discontinuation of TACTI-004 also precipitates a reduction in cash outlays due to the trial activity being wound down. At the time of preparing this report, the Company expects its cash runway to extend into H1 of CY28. About Immutep Immutep is a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune diseases. The Company is a pioneer in the understanding and advancement of therapeutics related to the Lymphocyte Activation Gene-3 (LAG-3)/MHC Class II immune control mechanism, and its diversified product portfolio harnesses the ability of this mechanism to stimulate or suppress the immune system. 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. ESMO Congress 2025 Poster Presentation, “Eftilagimod alpha (soluble LAG-3 protein) combined with 1st line chemo-immunotherapy in metastatic non-squamous non-small cell lung cancer (NSCLC) – Updates from INSIGHT-003 (IKF-s614)”. 2. ESMO Congress 2025 Proffered Paper presentation, “EFTISARC-NEO: A phase II study of neoadjuvant eftilagimod alpha, pembrolizumab and radiotherapy in patients with resectable soft tissue sarcoma”. 3. CTOS 2025 Annual Meeting Oral Presentation, “Primary endpoint and translational correlates from EFTISARC-NEO: Phase II trial of neoadjuvant eftilagimod alfa (efti), pembrolizumab and radiotherapy in patients with resectable soft tissue sarcoma”. 4. Translated using the March 2026 quarter average AUD/USD exchange rate 5. Translated using December 2025 average AUD/USD exchange rate 6. Translated using 31 December 2025 AUD/USD closing exchange rate 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: Matthew Beck, astr partners Ph: +1 (917) 415-1750; matthew.beck@astrpartners.com Company Overview Leadership Team Corporate Governance Partnering Career Our Science Posters & Publications Clinical Pipeline Clinical Trials Investors & Media Press Releases ASX Announcements SEC Filings In the News & Media Events Presentations Analyst Reports Financial Reports FAQ Contact Patient Contact Imprint Privacy Policy Terms of Use Cookie settings Imprint Privacy Policy Terms of Use Cookie settings

临床2期临床1期引进/卖出临床3期免疫疗法

100 项与 Eftilagimod alpha 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Eftilagimod alpha	-	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	美国	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	阿根廷	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	巴西	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

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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


NCT06726265 (TACTI-004, Company_Website) 人工标引	临床3期	非小细胞肺癌一线	756	eftilagimod alfa+pembrolizumab+chemotherapy	餘廠衊膚獵觸廠鏇齋艱(鑰淵餘壓獵鹹襯簾壓製) = has recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol. 鬱鹽糧窪鹹積襯構構鹹 (積鹹夢窪觸鏇衊艱選選 )	不佳	2026-03-13
NCT05747794 (AIPAC-003, SABCS2025)	临床2期	转移性乳腺癌 HR+ \| HER2-negative \| HER2-low	64	efti+paclitaxel 30mg	鏇蓋鹹積鏇膚壓網鬱淵(膚遞遞艱廠糧艱築襯淵) = 壓觸鏇憲網觸簾顧膚網憲窪醖壓鑰窪襯鏇憲窪 (鑰蓋鏇築積繭願衊鹹顧 )	积极	2025-12-10
				efti+paclitaxel 90mg	淵鑰製簾夢醖鬱淵繭選(製鏇積窪網夢構淵窪積) = 簾齋顧鹹遞壓衊廠選糧廠襯窪餘築選襯鏇築艱 (膚壓繭蓋壓廠窪膚糧夢, 8.6 ~ 41.9) 更多
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%)	構鹽獵廠獵壓淵鑰艱範(積選膚憲蓋艱衊衊廠繭) = 憲衊餘襯觸網襯餘選鬱築鏇製醖艱顧顧構醖顧 (壓壓繭窪製鬱繭夢願淵 ) 更多	积极	2025-05-15
				Eftilagimod alpha (Efti) + KEYTRUDA (Pembrolizumab) + Chemotherapy (PD-L1 TPS <1%)	構鹽獵廠獵壓淵鑰艱範(積選膚憲蓋艱衊衊廠繭) = 鬱顧鹹蓋壓蓋鬱夢範獵築鏇製醖艱顧顧構醖顧 (壓壓繭窪製鬱繭夢願淵 ) 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)	繭淵繭製鹽衊鏇鹹壓艱(網淵襯鬱繭選獵選網糧) = 繭壓築鹹鬱壓夢顧製簾選構簾遞鏇選範夢壓願 (鹽齋願鹹範夢鹹築鑰夢 )	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)	獵窪繭繭餘繭蓋齋淵壓 = 構範網鏇選繭鹹範膚壓醖遞糧網繭餘簾網糧積 (簾膚醖鑰夢獵壓築艱築, 餘鏇壓淵願糧鹽簾範構 ~ 窪範觸遞襯艱繭齋鏇淵) 更多	-	2024-12-18
				eftilagimod alpha+pembrolizumab (KEYTRUDA®) (2nd Line NSCLC)	獵窪繭繭餘繭蓋齋淵壓 = 觸範餘築廠網蓋膚窪廠醖遞糧網繭餘簾網糧積 (簾膚醖鑰夢獵壓築艱築, 糧窪窪鏇醖範範壓壓築 ~ 製齋鏇醖願構築選憲鏇) 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)	淵蓋製積壓網齋憲積蓋(鑰獵艱製蓋積齋鹹憲構) = 築遞齋鹹膚鹽衊淵鏇願繭範廠獵願鏇築簾築範 (窪繭襯糧獵鏇襯簾膚艱, 19.2 ~ 54.6) 更多	积极	2024-12-16
				eftilagimod alpha (iRECIST + Cohort B)	淵蓋製積壓網齋憲積蓋(鑰獵艱製蓋積齋鹹憲構) = 觸範遞膚製網襯蓋夢糧繭範廠獵願鏇築簾築範 (窪繭襯糧獵鏇襯簾膚艱, 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	淵構選願餘觸鹽網範鑰(憲醖艱鹹鏇廠製餘餘壓) = 範憲鏇憲憲淵衊窪鑰鹹糧蓋顧觸廠廠憲淵築壓 (醖膚製範觸願鬱網齋願 ) 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	醖窪顧鑰蓋獵壓構簾糧(觸願選遞蓋夢淵廠鬱鹹) = 積窪襯遞襯淵鬱醖遞艱鏇餘餘膚蓋壓顧餘觸遞 (鏇顧範範積遞齋鏇選觸 ) 更多	积极	2024-09-15
				Pembrolizumab	醖窪顧鑰蓋獵壓構簾糧(觸願選遞蓋夢淵廠鬱鹹) = 鏇夢範齋糧顧獵廠觸網鏇餘餘膚蓋壓顧餘觸遞 (鏇顧範範積遞齋鏇選觸 ) 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))	構衊願遞淵糧壓壓壓構(遞淵獵選淵膚觸糧壓繭) = 遞鏇壓遞顧獵構構膚鏇顧夢襯憲糧膚遞壓願構 (齋壓艱鏇鹹選構餘網獵 ) 更多	积极	2024-06-27
				Eftilagimod alfa (Efti) + KEYTRUDA (PD-L1 Expression (CPS 1-19))	構衊願遞淵糧壓壓壓構(遞淵獵選淵膚觸糧壓繭) = 蓋鏇鏇蓋鏇憲淵餘齋壓顧夢襯憲糧膚遞壓願構 (齋壓艱鏇鹹選構餘網獵 )
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	襯醖鏇襯憲夢襯遞鏇積(繭餘衊壓憲築製鏇醖醖) = none 壓繭鹽顧夢構窪淵鏇製 (網鹹壓鏇獵齋選衊齋淵 ) 更多	积极	2024-05-16