ImmuFact (eftilagimod alpha) / Immutep, EOC Pharma, Dr. Reddy’s - LARVOL DELTA

Health-related quality of life (HRQoL) during neoadjuvant treatment with eftilagimod alfa, pembrolizumab and radiotherapy in patients with soft tissue sarcoma (STS) – results from EFTISARC-NEO trial (ESMO 2026) - No abstract available

Clinical • HEOR • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Combining the antigen-presenting cell activator eftilagimod alpha (soluble LAG-3) and pembrolizumab: efficacy results from the 1st line non-small cell lung cancer cohort of TACTI-002 (Phase II) (SITC 2022) - P2 | "Early & sustained increases of circulating CXCL-10 & IFN-gamma levels were observed. Conclusions E + P is safe & shows encouraging antitumor activity in 1st line metastatic NSCLC patients unselected for PD-L1, warranting late-stage clinical investigation."

Clinical • Late-breaking abstract • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • CXCL10 • IFNG • LAG3

TACTI-004, a Phase 3 Trial of Eftilagimod Alfa Plus Pembrolizumab (P) + Chemotherapy (C) vs Placebo + P + C in 1St Line NSCLC (IASLC-WCLC 2025) - P1, P2 | "Chemotherapy choice will be histology-dependent: non-squamous NSCLC pts will receive IV cisplatin (75 mg/m2) or carboplatin (AUC 5 or 6) + pemetrexed (500 mg/m2) q3w for 3 mo, then maintenance pemetrexed q3w. Squamous NSCLC pts will receive carboplatin (AUC 5 or 6) + paclitaxel (175 or 200 mg/m2) q3w for 3 mo.Imaging will be performed q6w until week 18, q9w until week 54 & q12w thereafter...Pts may not have tumours with EGFR mutations nor ALK or ROS1 translocations. Stable brain metastasis is acceptable."

Clinical • IO biomarker • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • CD4 • CD8 • EGFR • PD-L1 • ROS1

PRELIMINARY RESULTS FROM A PHASE 2 EFTISARC-NEO TRIAL OF NEOADJUVANT SOUBLE LAG-3 PROTEIN EFTILAGIMOD ALPHA, PEMBROLIZUMAB, AND CONCURRENT RADIOTHERAPY IN PATIENTS WITH RESECTABLE SOFT TISSUE SARCOMA (CTOS 2024) - P2 | "Based on the preliminary analysis, combining efti and pembro with radiotherapy demonstrates significant efficacy in the neoadjuvant settings in patients with resectable STS. The combination is safe and leads to higher tumor hyalinization than radiotherapy alone compared to historical data. The EFTISARC-NEO trial is currently ongoing to reach the planned enrolment of 40 patients Q1 2025."

Clinical • P2 data • Angiosarcoma • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • LAG3

Final data from a phase II study (TACTI-002) of eftilagimod alpha (soluble LAG-3) & pembrolizumab in 2nd line metastatic NSCLC pts resistant to PD-1/PD-L1 inhibitors (ELCC 2023) - P2 | "Most common (>15%) adverse events were decreased appetite (33%), dyspnea (31%), cough (28%), asthenia (22%), fatigue (19%), arthralgia (17%) and weight decreased (17%). Conclusions Efti + pembrolizumab is safe and shows encouraging signs of antitumor activity in NSCLC pts resistant to PD-1/PD-L1 inhibitors, warranting further investigation."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • LAG3

A phase II study (TACTI-002) in first-line metastatic non–small cell lung carcinoma investigating eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab: Updated results from a PD-L1 unselected population. (ASCO 2022) - P2 | "E + P is safe and shows encouraging antitumor activity in first-line metastatic NSCLC patients unselected for PD-L1, warranting further investigation."

Clinical • IO biomarker • P2 data • Anemia • Constipation • Cough • Dermatology • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pruritus • Pulmonary Disease • Respiratory Diseases • Solid Tumor • CD8 • LAG3 • PD-L1

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. (PubMed, JTO Clin Res Rep) - P2 | "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."

IO biomarker • Journal • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • LAG3

Immutep Outlines Focused Development Strategy for Eftilagimod Alfa ("efti”) (The Manila Times) - Root cause analysis following the discontinuation of TACTI-004 has identified subtle analytical differences between efti manufactured at 200 L scale and efti manufactured at 2,000 L scale. A new manufacturing run of efti at 200 L scale has been contracted...The Company will provide a further update on completion of the root cause analysis....Immutep currently intends to focus the registration-directed clinical development of efti on: HNSCC in patients with CPS; the neoadjuvant setting of STS....Preparations for the next clinical trials have commenced. Subject to final decisions on strategy and trial design, regulatory interactions, manufacturing timelines, partnering and resources, Immutep is targeting study start during 2H CY2027."

Commercial • New trial • Trial status • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Soft Tissue Sarcoma • Squamous Cell Carcinoma of Head and Neck

EFTISARC-NEO: A phase II study of neoadjuvant eftilagimod alpha, pembrolizumab and radiotherapy in patients with resectable soft tissue sarcoma (ESMO 2025) - P2 | "The most common TRAEs of any grade were wound infection (38%), pain in efti injection site (35%), radiation dermatitis (35%) and hypothyroidism (18%). Conclusions The trial has met its primary endpoint, indicating that this novel combination of efti and pembrolizumab could be further tested in late-stage trials in the neoadjuvant setting in patients with resectable STS treated with radiotherapy."

Clinical • P2 data • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • LAG3

Combining the antigen-presenting cell activator eftilagimod alpha (soluble LAG-3) and pembrolizumab: Overall survival data from the first line non-small cell lung carcinoma (NSCLC) cohort of TACTI-002 (phase II) (ESMO 2023) - "Conclusions E + P shows encouraging OS results in line with excellent ORR, PFS and DOR in 1st line NSCLC overall and in all PD-L1 subgroups. This combination warrants further late-stage clinical investigation."

Clinical • IO biomarker • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • LAG3

AIPAC-003: Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy (clinicaltrials.gov) - P2/3 | N=72 | Terminated | Sponsor: Immutep S.A.S. | N=849 ➔ 72 | Trial completion date: Jul 2027 ➔ Jun 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Oct 2026 ➔ Apr 2026; Sponsor Decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PD-L1 • PGR

Immutep Limited…announced that an abstract for the investigator-initiated EFTISARC-NEO Phase II trial evaluating its first-in-class MHC Class II agonist, eftilagimod alfa ('efti'), has been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2026 (GlobeNewswire) - "The abstract reports health-related quality of life (HRQoL) data from EFTISARC-NEO."

P2 data • Patient reported outcomes • Soft Tissue Sarcoma

Key Results from INSIGHT-003 – Data Cutoff – 27 March 2026 (GlobeNewswire) - "With a minimum of 30 months of follow-up, median Overall Survival (mOS) was 30.9 months in the overall population regardless of PD-L1 expression (N=51), with the same mOS observed in patients with TPS =50% (N=4)...These mature results continue to compare favourably to the 22.0 month mOS from a registrational trial of anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC regardless of PD-L1 expression. Notably, patients with TPS <50%, for whom PD-L1 inhibitor-based therapies typically perform suboptimally, were over-represented in INSIGHT-003 compared with historical benchmarks (~92% versus ~68%). No new safety signal was identified since the previous data cut-off."

P1 data • Lung Non-Squamous Non-Small Cell Cancer

Immutep Limited…announced the grant of a new patent (number 12,673,088) entitled 'Combined Preparations for the Treatment of Cancer or Infection' by the United States Patent and Trademark Office (USPTO) (GlobeNewswire) - "This patent is the fourth in the series and follows the grant of the United States parent patent, first divisional patent, and second divisional patent announced in December 2020, March 2021 and June 2023, respectively. The claims of the new patent build on the protection provided by the three previously granted patents and are directed to methods for the treatment of cancer by administering eftilagimod alfa in combination with an anti-PD-1 antibody or an anti-PD-L1 antibody, or fragments thereof. The expiry date of the patent is 20 January 2036."

Patent • Oncology

Update on TACTI-004 Root Cause Analysis (GlobeNewswire) - "In March 2026, following a planned interim futility analysis, Immutep announced that it would discontinue the TACTI-004 Phase III trial in 1st line NSCLC based on a recommendation from the Independent Data Monitoring Committee (IDMC). In the TACTI-004 futility analysis (N=173), the objective response rate (ORR) in the overall patient population receiving standard of care plus efti ('efti arm') was 42.9% compared with 55.1% in patients receiving standard of care plus placebo ('control arm')...The TACTI-004 analysis, which includes all recruited and evaluable patients who received a minimum of 12 weeks of treatment, remains ongoing, with additional results expected in Q3 CY2026. The Company will continue to analyse this data as part of its ongoing root cause analysis of a range of potential factors, including manufacturing, and will share the outcome of that analysis as soon as it becomes available."

P3 data • Trial status • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer

Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: George Washington University | Initiation date: May 2026 ➔ Sep 2026

Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Impact of eftilagimod alfa, an APC activator via MHC class II, on lymphocyte activation and survival outcomes in metastatic cancer patients. (ASCO 2026) - P3 | "30 mg E in combination with either P (pembrolizumab IV at 200 mg q3w or 400 mg q6w or 2 mg/kg q3w) or C (paclitaxel 80 mg/m2 day 1, 8, 15, q4w) was administered SC biweekly for 6 months (mo), then every 2-4 weeks for 6-18 mo in pts with late-stage metastatic NSCLC, HNSCC, melanoma, or breast cancer. E leads to immediate and sustained ALC increase and TH1 type reaction, which is associated with clinical efficacy in combination with P or C."

Clinical • IO biomarker • Metastases • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD4 • CD8 • CXCL10 • IFNG

Immutep Announces Abstract Accepted for Presentation at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting (GlobeNewswire) - "The accepted abstract, titled 'Impact of eftilagimod alfa, an APC activator via MHC class II, on lymphocyte activation and survival outcomes in metastatic cancer patients', will be presented within the Developmental Therapeutics-Immunotherapy sessions....The poster will present cumulative clinical and translational data demonstrating that eftilagimod alfa (efti), an antigen-presenting cell (APC) activator targeting MHC Class II, induces rapid and sustained lymphocyte activation."

Clinical data • Solid Tumor

Immutep Receives FDA Orphan Drug Designation for Eftilagimod Alfa in Soft Tissue Sarcoma (Immutep Limited Press Release) - "This designation recognises the potential therapeutic relevance of efti in STS, supported by encouraging clinical data from the investigator-initiated Phase II EFTISARC-NEO trial which has been evaluating efti in combination with radiotherapy and KEYTRUDA (pembrolizumab) in the neoadjuvant setting in patients with resectable soft tissue sarcoma."

Orphan drug • Soft Tissue Sarcoma

Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004) (clinicaltrials.gov) - P3 | N=756 | Active, not recruiting | Sponsor: Immutep S.A.S. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Preliminary immunophenotype analysis of the systemic immune response to neoadjuvant immuno-radiotherapy in soft tissue sarcoma (ITOC 2026) - P2 | "The EFTISARC-NEO clinical trial (NCT06128863) explores the neoadjuvant combination of eftilagimod alfa (sLAG-3Ig, a potential APC activator), pembrolizumab (antiPD-1 antibody, affecting the PD-1/PD-L1/2 axis) and radiotherapy. Conclusions There are significant indications of activated systemic immune response; however, there are also signs of induced immunosuppressive mechanisms associated with the development of immune tolerance. Further research is planned to more precisely analyse the systemic immune response and its correlation with local response and therapy outcome."

Clinical • IO biomarker • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CCR7 • CD8 • FOXP3 • GATA3 • IL2RA • LAG3

TACTI-004 Phase III Study in First Line NSCLC to be discontinued following Futility Analysis (Immutep Limited Press Release) - "Based on its review of the available safety and efficacy data, the IDMC recommended that the trial be discontinued for futility. In response to the IDMC’s recommendation, enrolment in the study will be halted and the Company will implement an orderly wind down of the study, including appropriate patient follow up and site close out in accordance with regulatory and ethical obligations."

Trial termination • Non Small Cell Lung Cancer

INSIGHT: Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Peritoneal Cancer • Solid Tumor • Urothelial Cancer

INSIGHT: Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest | N=38 ➔ 50 | Trial completion date: Feb 2020 ➔ Sep 2020 | Trial primary completion date: Aug 2019 ➔ Nov 2019

Enrollment change • Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Peritoneal Cancer • Solid Tumor • Urothelial Cancer

INSIGHT: Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Active, not recruiting ➔ Completed

Trial completion • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Peritoneal Cancer • Solid Tumor • Urothelial Cancer