Welcome to our dedicated page for Immutep news (Ticker: IMMP), a resource for investors and traders seeking the latest updates and insights on Immutep stock.
Immutep Limited (IMMP) news covers a late-stage biotechnology company focused on Lymphocyte Activation Gene-3 (LAG-3)–related immunotherapies for cancer and autoimmune disease. The company regularly reports clinical, regulatory and corporate developments across its diversified LAG-3 portfolio, led by the MHC Class II agonist eftilagimod alfa (efti) and the LAG-3 agonist antibody IMP761.
On this page, readers can follow updates on Immutep’s major oncology programs, including the global TACTI-004 (KEYNOTE-F91) Phase III trial in first-line non-small cell lung cancer, as well as Phase II and investigator-initiated studies in head and neck squamous cell carcinoma, soft tissue sarcoma and metastatic breast cancer. News items highlight trial milestones such as patient enrolment progress, primary endpoint readouts, translational biomarker data and presentations at international conferences like the European Society for Medical Oncology (ESMO), the World Conference on Lung Cancer and the San Antonio Breast Cancer Symposium.
For autoimmune disease, Immutep publishes updates on the Phase I program for IMP761, a first-in-class LAG-3 agonist antibody designed to silence dysregulated self-antigen-specific memory T cells. News coverage includes safety, pharmacodynamic findings and proof-of-concept data from the ongoing first-in-human study.
Investors can also track regulatory interactions, such as Fast Track designations, FDA feedback on late-stage development strategies and completion of Project Optimus requirements, alongside business developments like the strategic collaboration and exclusive licensing agreement with Dr. Reddy’s Laboratories for efti in selected global markets. Corporate news, including R&D tax incentives from French and Australian government programs and quarterly activity reports, provides additional context on funding and operational progress.
Bookmark this page to monitor Immutep’s latest announcements, clinical data disclosures and SEC Form 6-K filings that shape the outlook for IMMP and its LAG-3–focused pipeline.
Immutep (NASDAQ: IMMP) reported two posters at ESMO Congress 2025 highlighting clinical activity of eftilagimod alfa (efti) combined with KEYTRUDA and chemotherapy in first-line non-small cell lung cancer (1L NSCLC).
In the investigator-led INSIGHT-003 trial (cut-off 01 Sep 2025, 51 evaluable patients) the combo achieved a 61.7% ORR in patients with TPS <50% versus a 40.8% historical control, with overall ORR by PD-L1: No PD-L1 54.5%, Low 68.0%, High 75.0%; DCRs were 86.4%, 92.0% and 100% respectively. A Trial-in-Progress ePoster described the registrational TACTI-004 Phase III planned to enroll ~756 patients at >150 sites across >25 countries.
Immutep (NASDAQ: IMMP) announced the FDA has confirmed completion of Project Optimus requirements and agreed that 30mg is the optimal biological dose for eftilagimod alfa (efti).
The dosing agreement is described as a major de-risking step for efti’s oncology programs and a building block toward potential future BLA filings.
Immutep said the global TACTI-004 (KEYNOTE-F91) Phase III registrational trial in first-line advanced/metastatic NSCLC (efti + pembrolizumab + chemotherapy) is now in the process of opening clinical sites in the United States.
Immutep (NASDAQ: IMMP) announced that its registrational Phase III TACTI-004 (KEYNOTE-F91) trial in first-line advanced/metastatic non-small cell lung cancer has enrolled and randomised over 170 patients, exceeding the threshold required to trigger a futility analysis. The study now has more than 100 active sites across 24 countries. An independent data monitoring committee will assess futility using predefined criteria and a minimum 12-week follow-up, with the futility analysis on track for completion in Q1 CY2026. The announcement cites supportive prior data from TACTI-002 and INSIGHT-003 (combined >165 patients) reporting enhanced responses, PFS, and improved overall survival with efti plus pembrolizumab.
Immutep (NASDAQ: IMMP) has announced a new Phase II trial collaboration with the George Washington University Cancer Center to evaluate eftilagimod alfa (efti) in early-stage HR+/HER2-negative breast cancer patients. The trial will assess efti as both a monotherapy and in combination with standard chemotherapy before surgery.
The study will enroll up to 50 evaluable patients in a two-stage design, primarily funded by grants and GW Cancer Center. The trial will be led by Dr. Pavani Chalasani and aims to determine pathological complete response (pCR) in Stage I-III breast cancer patients.
Efti's unique mechanism targets antigen-presenting cells via MHC Class II, activating a broad anti-cancer immune response, including cytotoxic CD8+ T cells. The trial is registered under NCT07102940.
Immutep (NASDAQ: IMMP) announced that data from its EFTISARC-NEO Phase II trial has been accepted for oral presentation at the CTOS 2025 Annual Meeting. The groundbreaking study evaluates eftilagimod alpha (efti) in combination with radiotherapy and KEYTRUDA® for soft tissue sarcoma (STS) patients in a neoadjuvant setting.
The presentation will be delivered by Dr. Pawel Sobczuk on November 13, 2025, focusing on the primary endpoint and translational correlates from the trial. This research addresses a significant unmet medical need, as STS affects approximately 13,520 new patients in the US annually, with an estimated 5,420 deaths in 2025.
The study is being conducted at the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, with primary funding from the Polish government.
Immutep (NASDAQ: IMMP) has received positive FDA feedback regarding the clinical development of eftilagimod alfa (efti) for first-line treatment of head and neck cancer patients with PD-L1 expression below 1 (CPS <1). The feedback follows encouraging data from the TACTI-003 Phase IIb trial evaluating efti in combination with KEYTRUDA®.
The FDA has outlined two potential development paths: a randomized registrational trial against standard-of-care therapy or a smaller single-arm study (70-90 patients) followed by a confirmatory randomized study. This development aligns with FDA's Project FrontRunner initiative, targeting earlier clinical settings in cancer treatment.
The company notes that up to 20% of first-line HNSCC patients have CPS <1, representing a significant unmet medical need, as current treatment options for these patients all include chemotherapy.
Immutep (NASDAQ: IMMP) reported significant progress in Q4 FY25 across multiple clinical trials. The company's pivotal TACTI-004 Phase III trial in first-line non-small cell lung cancer is advancing with 78 sites across 23 countries. Notable achievements include a 60.8% response rate in the INSIGHT-003 trial combining efti with KEYTRUDA® and chemotherapy in 1L NSCLC.
Key highlights include a 17.6-month median Overall Survival in head and neck cancer patients, successful primary endpoint achievement in the EFTISARC-NEO Phase II trial for soft tissue sarcoma, and positive initial data from IMP761's Phase I autoimmune trial. The company maintains a strong financial position with A$129.69 million in cash, providing runway through end of 2026.
Immutep (NASDAQ: IMMP) announces an upcoming poster presentation of its pivotal TACTI-004 Phase III trial at the 2025 World Conference on Lung Cancer in Barcelona. The trial evaluates eftilagimod alfa (efti) in combination with KEYTRUDA® and chemotherapy as first-line therapy for advanced non-small cell lung cancer.
The global study will enroll approximately 750 patients across 150 clinical sites in over 25 countries, including patients with all PD-L1 expression levels. The presentation, scheduled for September 9, 2025, will showcase the trial design and overview, which aims to potentially change the treatment paradigm for NSCLC patients.
Immutep (NASDAQ: IMMP) announced the acceptance of three abstracts for presentation at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin. The presentations will showcase clinical trials of their first-in-class MHC Class II agonist, eftilagimod alfa (efti).
The presentations include a Proffered Paper oral presentation on the EFTISARC-NEO Phase II trial in soft tissue sarcoma, a poster presentation on the INSIGHT-003 Phase I trial in first-line non-small cell lung cancer (NSCLC), and a Trials in Progress ePoster on the pivotal TACTI-004 Phase III trial in first-line NSCLC. The abstracts will be available on October 13, 2025.