HLA class II antigen modulators, LAG3 inhibitors(Lymphocyte activation gene 3 protein inhibitors), Antigen-presenting cells stimulants(Antigen-presenting cells stimulants)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesRespiratory Diseases+ [1]

Active Indication

metastatic non-small cell lung cancerMetastatic breast cancerMetastatic HER2-Negative Breast Carcinoma+ [12]

Inactive Indication

COVID-19Hepatitis BHormone Receptor Positive Breast Adenocarcinoma+ [3]

Originator Organization

Immutep Ltd.

Active Organization

Merck Sharp & Dohme LLCImmutep SAS

Immutep Ltd.

+ [2]

Inactive Organization

CYTLIMIC, Inc.Startup

Wuxi Biologics (Cayman), Inc.Immutep Australia Pty Ltd.

Drug Highest PhasePhase 3

First Approval Date-

RegulationFast Track (US)

Gene Sequence

Sequence Code 17007211

Source: *****

Clinical Trials associated with Eftilagimod alpha

NCT06726265 / Not yet recruitingPhase 3

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.

Start Date01 Mar 2025

Sponsor / Collaborator

Immutep SAS

[+1]

NCT06128863 / RecruitingPhase 2IIT

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.

Start Date17 Jul 2023

Sponsor / Collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

[+1]

NCT04252768 / WithdrawnPhase 1

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.

Start Date01 Jun 2023

Sponsor / Collaborator

Immutep SAS

100 Clinical Results associated with Eftilagimod alpha

100 Translational Medicine associated with Eftilagimod alpha

100 Patents (Medical) associated with Eftilagimod alpha

Literatures (Medical) associated with Eftilagimod alpha

01 Nov 2024·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

Author: Roxburgh, Patricia ; Krebs, Matthew G. ; Majem, Margarita ; Clay, Tim ; Mueller, Christian ; Andres, B. ; Doger, Bernard ; Triebel, F. ; Krebs, Matthew G ; 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.

03 Sep 2024·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

Author: 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.

01 Feb 2024·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

Author: 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.

145

News (Medical) associated with Eftilagimod alpha

16 Dec 2024

·www.globenewswire.com

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

ImmunotherapyAACR

12 Dec 2024

·www.globenewswire.com

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.libproxy1.nus.edu.sg/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

ImmunotherapyPhase 2Clinical Result

10 Dec 2024

·www.globenewswire.com

Immutep Announces Initiation of TACTI-004 Phase III Trial in First Line Non-Small Cell Lung Cancer

Media Release SYDNEY, AUSTRALIA, Dec. 10, 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 the initiation of the pivotal TACTI-004 Phase III clinical trial for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC). “The receipt of regulatory approval from the Australian Therapeutic Goods Administration to commence the TACTI-004 trial is a significant milestone for Immutep and marks its transformation into a Phase III company. This also represents a key step towards potentially establishing a new standard of care for patients with metastatic NSCLC. We are confident based on the strength of eftilagimod alfa’s data that it can make a meaningful difference in cancer patients’ lives, and we eagerly anticipate enrolling the first patient into this important study during the first quarter of 2025,” said Marc Voigt, CEO of Immutep. Immutep has successfully completed regulatory submissions to the vast majority of the more than 25 countries that will be part of the global TACTI-004 trial. Australia represents the first approval by all regulatory authorities including ethics committees and Institutional Review Boards (IRB). The Company also anticipates full approval in the United Kingdom shortly as it has received clearances from the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics Committee (REC). Additional approvals from multiple countries are expected in the weeks and months ahead. The registrational TACTI-004 Phase III trial will evaluate eftilagimod alfa, a soluble LAG-3 protein that activates dendritic cells, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and chemotherapy compared to KEYTRUDA in combination with chemotherapy and placebo in ~750 metastatic 1L NSCLC patients, regardless of PD-L1 expression. The 1:1 randomized, double-blind, multinational, controlled study, with dual primary endpoints of progression-free survival and overall survival, will include over 150 clinical sites in over 25 countries across the globe. The Company expects to enrol the first patient in Q1 of CY2025. 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. 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

ImmunotherapyPhase 3

100 Deals associated with Eftilagimod alpha

External Link

KEGG	Wiki	ATC	Drug Bank
-	Eftilagimod alpha	-	DB16150

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
metastatic non-small cell lung cancer	Phase 3	-	Immutep SAS	01 Mar 2025
Metastatic breast cancer	Phase 3	US	Immutep SAS	22 May 2023
Metastatic breast cancer	Phase 3	BE	Immutep SAS	22 May 2023
Metastatic breast cancer	Phase 3	GE	Immutep SAS	22 May 2023
Metastatic breast cancer	Phase 3	MD	Immutep SAS	22 May 2023
Metastatic breast cancer	Phase 3	ES	Immutep SAS	22 May 2023
Metastatic HER2-Negative Breast Carcinoma	Phase 3	US	Immutep SAS	22 May 2023
Metastatic HER2-Negative Breast Carcinoma	Phase 3	BE	Immutep SAS	22 May 2023
Metastatic HER2-Negative Breast Carcinoma	Phase 3	GE	Immutep SAS	22 May 2023
Metastatic HER2-Negative Breast Carcinoma	Phase 3	MD	Immutep SAS	22 May 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03625323 (TACTI-002 \| INSIGHT-003, CTgov)	Phase 2	Squamous cell carcinoma of head and neck metastatic \| Squamous Cell Carcinoma of Head and Neck \| Non-Small Cell Lung Cancer ... View more	187	eftilagimod alpha+pembrolizumab (KEYTRUDA®) (1st Line NSCLC)	ogmxutzefq(ubbhcrulrp) = wcoobseupe ylpgsfdzdu (ebdkepxuzu, cqtpqepqgi - iodbgmiavj) View more	-	18 Dec 2024
				eftilagimod alpha+pembrolizumab (KEYTRUDA®) (2nd Line NSCLC)	ogmxutzefq(ubbhcrulrp) = fjnwzshdwa ylpgsfdzdu (ebdkepxuzu, hjzdsarrct - ruewgjlnkh) View more
NCT04811027 (TACTI-003, ESMO_IO2024 \| GlobeNewswire) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line PD-L1 Negative	31	Eftilagimod alpha (RECIST 1.1 + Cohort B)	tbrjykjztz(awfihfryxu) = tgnozpkcsd psufdetzpv (qweeqdhfkx, 19.2 - 54.6) View more	Positive	16 Dec 2024
				eftilagimod alpha (iRECIST + Cohort B)	tbrjykjztz(awfihfryxu) = ahsbqaynqt psufdetzpv (qweeqdhfkx, 21.8 - 57.8) View more
NCT04811027 (TACTI-003 Cohort B, ESMO_IO2024)	Phase 2	First line PD-L1 negative	33	Eftilagimod alpha (E) 30 mg	wwptkqwuvt(fzbibwslks) = ojzeagxclu dbilbblhwh (cweffygyey ) View more	Positive	12 Dec 2024
				Pembrolizumab (P) 400 mg	wwptkqwuvt(fzbibwslks) = btlsyyittx dbilbblhwh (cweffygyey ) View more
NCT03625323 (Pubmed \| JTO Clin Res Rep) Manual	Phase 2	metastatic non-small cell lung cancer Second line	36	Eftilagimod alpha + Pembrolizumab	wnpxpubqqk(gvtpmmfqdn) = fzdfhjalmj lksmpofknx (rwflshlyef ) View more	Positive	01 Nov 2024
NCT04811027 (TACTI-003, ESMO2024) Manual	Phase 2	Head and Neck Neoplasms First line PD-L1 Expression (CPS >= 1)	118	Eftilagimod Alpha + pembrolizumab	njoalikaao(teidcddjje) = qvlqkhwjha eivgtrmphr (azpagkibpy ) View more	Positive	15 Sep 2024
				Pembrolizumab	njoalikaao(teidcddjje) = hxjbhtpdzp eivgtrmphr (azpagkibpy ) View more
NCT04811027 (TACTI-003, Company_Website) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line	138	Eftilagimod alfa (Efti) + KEYTRUDA (PD-L1 Expression (CPS >20))	vxfgkwwxim(zyiateakyp) = mfpugxtnba wonjewsgvu (apzjkjsgku ) View more	Positive	27 Jun 2024
				Eftilagimod alfa (Efti) + KEYTRUDA (PD-L1 Expression (CPS 1-19))	vxfgkwwxim(zyiateakyp) = zrhtbxporv wonjewsgvu (apzjkjsgku )
NCT05747794 (AIPAC-003, ESMO_BC 12024 \| ESMO_BC 22024) Manual	Phase 2/3	Metastatic breast cancer HER2 Negative \| Hormone Receptor Positive	6	eftilagimod alpha+paclitaxel	kdvmxmrtsh(yfxswnuxps) = none jcbcvoowaq (jafpolwpgd ) View more	Positive	16 May 2024
NCT06128863 (EFTISARC-NEO, Corporate Publications) Manual	Phase 2	Soft Tissue Sarcoma Neoadjuvant	6	eftilagimod alpha+pembrolizumab+radiotherapy	oibwmgdjws(rcgbapugur) = xpuinggnzp mwzpitdger (slgylvdiqu )	Positive	02 May 2024
NCT04811027 (TACTI-003 \| KEYNOTE-PNC-34, Biospace) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line PD-L1 Negative	26	Eftilagimod alpha + KEYTRUDA	impbrqcuuf(ysfvfiofzs) = kdeeeqimsf jwagzcaxua (eacougubfd ) View more	Positive	24 Apr 2024
NCT03252938 (INSIGHT 003, ESMO 12023 \| ESMO 22023) Manual	Phase 1	Non-Small Cell Lung Cancer First line	21	Eftilagimod alpha + carboplatin + pemetrexed + pembrolizumab	tqcrnkacxo(xslhhaeata) = vmufxkubju tzbpkhnthv (vskvbzembr ) View more	Positive	23 Oct 2023

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