ImmuFact (eftilagimod alpha) / Immutep, EOC Pharma - LARVOL DELTA

Immutep’s Efti in Combination with KEYTRUDA (pembrolizumab) Drives Strong Overall Survival in Head and Neck Cancer with CPS <1 (Immutep Limited Press Release) - P2b | N=171 | TACTI-003 (NCT04811027) | Sponsor: Immutep S.A.S | "Immutep Limited...announces an excellent median Overall Survival (OS) of 17.6 months has been achieved in Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. The mature 17.6-months median OS in evaluable patients (N=31) with a data cut-off of 31 March 2025 compares favourably to historical results from the two current standard-of-care approaches for 1L HNSCC patients with CPS <1 including 10.7-months from cetuximab + chemotherapy and 11.3-months from anti-PD-1 therapy + chemotherapy, as well as 7.9-months from anti-PD-1 monotherapy....Efti has Fast Track designation in 1L HNSCC and Immutep has requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss next steps including potential paths to approval for 1L HNSCC with PD-L1 CPS <1. Patient follow up, data collection, cleaning and analysis continue for TACTI-003, and the Company plans to provide a further update later this year."

FDA event • P2 data • Squamous Cell Carcinoma of Head and Neck

TACTI-004: A double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (P) and chemotherapy (C) versus placebo + P + C. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT06726265 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TACTI-003 (KEYNOTE-C34) – Phase IIb Trial in 1L HNSCC (GlobeNewswire) - "Immutep continued to follow patients in the TACTI-003 (KEYNOTE-C34) Phase IIb trial, which is evaluating efti in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC), during Q3 FY25....Immutep will continue to follow the maturing data from TACTI-003 and plans to engage with regulatory authorities regarding potential paths forward by mid of this year."

P2b data • Squamous Cell Carcinoma of Head and Neck

Immutep Quarterly Activities Report Q3 FY25 (GlobeNewswire) - "Immutep continues to execute the AIPAC-003 trial, which enrolled 71 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors.... Patient follow up, data cleaning and analysis is ongoing and an update is anticipated in CY2025....Data updates from INSIGHT-003 are expected in CY2025....Data updates from EFTISARC-NEO are expected in CY2025."

P1 data • P2 data • P2/3 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Non-Squamous Non-Small Cell Cancer • Soft Tissue Sarcoma • Triple Negative Breast Cancer

KEYNOTE-F91: 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 | Recruiting | Sponsor: Immutep S.A.S. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TACTI-004: A double-blinded, randomized phase III trial in patients with advanced/metastatic non-small cell lung cancer receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (P) and chemotherapy (C) versus placebo + P + C (ELCC 2025) - P1, P2, P3 | "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...Pts may not have tumours with EGFR mutations nor ALK or ROS1 translocations. Stable brain metastasis is acceptable."

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

First Patient Dosed in Immutep’s TACTI-004 Phase III Trial in First Line Non-Small Cell Lung Cancer (Immutep Limited Press Release) - "Immutep Limited...announces the first patient has been successfully dosed in the Company’s pivotal TACTI-004 Phase III trial. TACTI-004 will evaluate Immutep’s eftilagimod alfa, a first-in-class MHC Class II agonist, in combination with MSD’s...anti-PD-1 therapy KEYTRUDA (pembrolizumab) and chemotherapy as first line treatment for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC)....First patient safely dosed at Calvary Mater Newcastle Hospital in Australia, marking a significant milestone for Immutep. Global Phase III with efti will enrol approximately 756 patients at more than 150 clinical sites."

Trial status • Non Small Cell Lung Cancer

Immutep to Present Pivotal TACTI-004 Trial in Progress Poster at the European Lung Cancer Congress 2025 (Immutep Limited Press Release) - "Immutep Limited...announces an upcoming poster presentation for the pivotal TACTI-004 Phase III trial. The poster will be presented at the European Lung Cancer Congress (ELCC) 2025....The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company’s MHC Class II agonist, eftilagimod alfa (efti) in combination with...KEYTRUDA (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries."

Clinical protocol • Non Small Cell Lung Cancer

KEYNOTE-C34: Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC (clinicaltrials.gov) - P2 | N=171 | Active, not recruiting | Sponsor: Immutep S.A.S. | Trial completion date: Mar 2025 ➔ Oct 2025

IO biomarker • Trial completion date • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CTLA4

Pembrolizumab in Combination with Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients with Soft Tissue Sarcoma - EFTISARC-NEO Trial (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Immutep Quarterly Activities Report Q2 FY25 (GlobeNewswire) - "During the quarter, Immutep continued to advance its clinical trial programs for efti and for IMP761. The Company is well funded with a strong cash, cash equivalent and term deposit balance as at 31 December 2024 of approximately A$159.26 million in total, which gives Immutep an expected cash reach to the end of CY2026. The A$159.26 million total balance consists of: a cash and cash equivalent balance of A$73.89 million and; bank term deposits totalling A$85.37 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months."

Commercial • HER2 Negative Breast Cancer • Lung Non-Squamous Non-Small Cell Cancer • Soft Tissue Sarcoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Patient Enrolment Completed for EFTISARC-NEO Phase II Trial (Immutep Limited Press Release) - "Immutep Limited...announces that patient enrolment has been completed in the investigator-initiated EFTISARC-NEO trial. EFTISARC-NEO is evaluating eftilagimod alpha (efti) in combination with radiotherapy plus KEYTRUDA (pembrolizumab) in the neoadjuvant setting for patients with resectable soft tissue sarcoma (STS). The Phase II trial conducted by the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, has reached its enrolment target of 40 patients....Data updates from EFTISARC-NEO are expected in 2025."

Enrollment closed • P2 data • Soft Tissue Sarcoma

Patient Enrolment Completed for INSIGHT-003 (GlobeNewswire) - "Immutep Limited...today announces that patient enrolment has been completed in the investigator-initiated INSIGHT-003 trial. INSIGHT-003 is evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy, KEYTRUDA (pembrolizumab) and doublet chemotherapy as first line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC)....Additional data updates from INSIGHT-003 are expected in 2025 and beyond."

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

TACTI-003 Cohort B: Eftilagimod alpha (Soluble LAG-3) and pembrolizumab in first-line recurrent or metastatic head & neck squamous cell carcinoma with PD-L1 negative (ESMO-IO 2024) - P2 | "Table: 152P RECIST 1.1 N=31 iRECIST N=31 Complete response (%) 9.7 9.7 Partial response (%) 25.8 29.0 Stable disease (%) 22.6 25.8 Progressive disease (%) 41.9 35.5 Overall Response Rate (ORR)* (%), [95% CI] 35.5, [19.2-54.6] 38.7, [21.8-57.8] Disease Control Rate (DCR) (%), [95% CI] 58.1, [39.1-75.5] 64.5, [45.4-80.8] *10/11 responses confirmed by RECIST 1.1 and 11/12 by iRECIST.Conclusions E + P leads to high ORR and DCR in a CPS negative pt population, which is typically unresponsive to P alone. Further late-stage clinical investigation is warranted for E+P in this disease setting."

Clinical • IO biomarker • Metastases • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD4 • CD8 • LAG3 • PD-L1

TACTI 002: Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC (clinicaltrials.gov) - P2 | N=187 | Completed | Sponsor: Immutep S.A.S. | Active, not recruiting ➔ Completed

Metastases • Trial completion • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

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 | Not yet recruiting | Sponsor: Immutep S.A.S.

Combination therapy • Metastases • New P3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

AIPAC-003: Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination with Paclitaxel Chemotherapy (clinicaltrials.gov) - P2/3 | N=849 | Active, not recruiting | Sponsor: Immutep S.A.S. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PD-L1 • PGR

Immutep Announces Initiation of TACTI-004 Phase III Trial in First Line Non-Small Cell Lung Cancer (GlobeNewswire) - "Immutep Limited...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....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....The Company expects to enrol the first patient in Q1 of CY2025."

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Immutep Reports Promising New Data in Head and Neck Cancer at ESMO Immuno-Oncology 2024 (Immutep Limited Press Release) - P2b | N=171 | TACTI-003 (NCT04811027) | Sponsor: Immutep S.A.S. | "Immutep Limited...announces positive clinical results from Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial....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 months; Strong durability with interim median duration of response (DOR) of 9.3 months; High 35.5% objective response rate (ORR) and 58.1% disease control rate (DCR), as reported on 12 July; Complete response rate increases to 12.9% and 16.1%, according to RECIST 1.1 and iRECIST, respectively."

P2b data • Squamous Cell Carcinoma of Head and Neck

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

Positive Data from Phase II Trial in Soft Tissue Sarcoma Presented at CTOS 2024 Annual Meeting (Immutep Limited Press Release) - P2 | N=40 | EFTISARC-NEO (NCT06128863) | "Immutep Limited...today announces the presentation of new data from EFTISARC-NEO...Based on preliminary analysis among 21 patients available for primary endpoint assessment, the triple combination therapy demonstrates significant efficacy in the neoadjuvant setting for resectable STS....The EFTISARC-NEO trial, with a data cut-off of 20 October 2024, also showed 71.4% of patients achieved a pathologic response defined as ≥35% of hyalinization/fibrosis and 9.5% of patients achieved a complete pathologic response. The triple combination therapy is safe with no grade ≥3 toxicities related to efti and pembrolizumab."

P2 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Immutep’s Efti Shows Excellent Survival Data from INSIGHT-003 Trial in Non-Small Cell Lung Cancer (Immutep Limited Press Release) - P1 | N=110 | INSIGHT-003 (NCT03252938) | "Mature data in patients with a minimum follow-up of 22 months (N=21) shows excellent results, well above historical controls and exceeding expectations: Median Overall Survival is 32.9 months, with median Progression Free Survival reaching 12.7 months, and a 24-month Overall Survival rate of 81.0%; Data from all evaluable patients to date (N=40) demonstrates significant improvement of Overall Response Rate compared to historical controls...Safety continues to be favourable for efti in combination with pembrolizumab and chemotherapy, with no new safety signals...Additional data updates from this trial are expected in 2025 and beyond....The study is evaluating a triple combination therapy in front line non-small cell lung cancer patients consisting of efti administered subcutaneously in conjunction with an existing approved standard-of-care combination of anti-PD-1 therapy (pembrolizumab) and doublet chemotherapy..."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Immutep Quarterly Activities Report Q1 FY25 (GlobeNewswire) - "During the quarter, Immutep continued to advance its clinical trial programs for efti and preclinical program for IMP761 to create value for shareholders. The Company is well funded with a strong cash and cash equivalent balance as at 30 September 2024 of approximately A$120.3 million. In addition to this cash balance, Immutep has an A$52.0 million bank term deposit, which has been recognised as a short-term investment due to the maturity date of 5-12 months. This aggregate position of A$172.3 million as at 30 September 2024 gives Immutep an expected cash reach to the end of CY2026."

Commercial • Immunology • Non Small Cell Lung Cancer • Soft Tissue Sarcoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

INTELLECTUAL PROPERTY (GlobeNewswire) - "During the quarter, Immutep was granted seven new patents for efti, IMP761 and LAG525 (ieramilimab) in various territories...Two patents were granted for efti in combination with a PD-1 pathway inhibitor in South Korea and Brazil and one patent was granted in Mexico for a binding assay for determining MHC Class II binding activity...New patents were also granted for IMP761 in India and Israel. For LAG525, which is exclusively licensed to Novartis by Immutep, two new patents were granted in Australia and Taiwan."

Patent • Breast Cancer • Colorectal Cancer • Inflammatory Bowel Disease • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Ovarian Cancer • Prostate Cancer • Rheumatoid Arthritis

Immutep to Present New Phase IIb Data in PD-L1 Negative (CPS <1) Head and Neck Cancer at ESMO Immuno-Oncology 2024 (GlobeNewswire) - "Immutep Limited...announces it will present new data from Cohort B of the TACTI-003 Phase IIb trial in first line recurrent/metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression (CPS <1) at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2024 taking place 11-13 December in Geneva, Switzerland."

P2b data • Squamous Cell Carcinoma of Head and Neck