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    DRUG CLASS:

    MHC II agonist

    Related drugs:
    6d
    A phase III placebo-controlled study of eftilagimod alfa plus pembrolizumab and chemotherapy in metastatic non-small cell lung cancer. (PubMed, Future Oncol)
    TACTI-004 will evaluate whether efti can mitigate resistance to ICIs when added to SoC in NSCLC, irrespective of PD-L1 tumor status. www.clinicaltrials.gov identifier is NCT06726265.
    P3 data • Journal • PD(L)-1 Biomarker • IO biomarker
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    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    PD-L1 expression • PD-L1 underexpression
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    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    6d
    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, Completed, Immutep S.A.S. | Active, not recruiting --> Completed
    Trial completion
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    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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    PD-L1 IHC 22C3 pharmDx
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    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    4ms
    Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, George Washington University
    New P2 trial
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    docetaxel • doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide • ImmuFact (eftilagimod alpha)
    9ms
    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, Immutep S.A.S. | Not yet recruiting --> Recruiting
    Enrollment open
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    Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • pemetrexed • ImmuFact (eftilagimod alpha)
    10ms
    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, Immutep S.A.S. | Trial completion date: Mar 2025 --> Oct 2025
    Trial completion date • IO biomarker
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    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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    PD-L1 expression
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    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    10ms
    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, Maria Sklodowska-Curie National Research Institute of Oncology | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    12ms
    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, Immutep S.A.S. | Active, not recruiting --> Completed
    Trial completion • Metastases
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    PD-L1 (Programmed death ligand 1)
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    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    1year
    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, Immutep S.A.S. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    ER positive • HR positive • PGR positive
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    paclitaxel • ImmuFact (eftilagimod alpha)
    1year
    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, Immutep S.A.S.
    New P3 trial • Combination therapy • Metastases
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    Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • pemetrexed • ImmuFact (eftilagimod alpha)
    1year
    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)
    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 • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3) • CD4 (CD4 Molecule)
    |
    PD-L1 negative
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    1year
    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)
    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.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3) • CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    over1year
    Primary results from TACTI-003: A randomized phase IIb trial comparing eftilagimod alpha (soluble LAG-3) plus pembrolizumab versus pembrolizumab alone in first-line recurrent or metastatic head and neck squamous cell carcinoma with CPS ≥1 (ESMO 2024)
    E+P is well tolerated with positive efficacy data and should be investigated further in HNSCC.
    Late-breaking abstract • P2b data • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
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    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3) • CD4 (CD4 Molecule)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)