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    DRUG CLASS:

    MHC II agonist

    Related drugs:
    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
    |
    docetaxel • doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide • ImmuFact (eftilagimod alpha)
    8ms
    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)
    9ms
    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)
    |
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    12ms
    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)
    |
    ER positive • HR positive • PGR positive
    |
    paclitaxel • ImmuFact (eftilagimod alpha)
    12ms
    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
    |
    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
    |
    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)
    over1year
    Eftilagimod alpha (soluble LAG-3 protein) combined with pembrolizumab as second-line therapy for patients with metastatic head and neck squamous cell carcinoma. (PubMed, Clin Cancer Res)
    Efti plus pembrolizumab was safe and showed encouraging antitumor activity and pharmacodynamic effects in 2nd line HNSCC patients, thus supporting further evaluation of this combination in earlier treatment lines.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • CXCL10 (Chemokine (C-X-C motif) ligand 10)
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • ImmuFact (eftilagimod alpha)
    over2years
    AIPAC-002: A Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients to Test a New Schedule of Efti (IMP321, Eftilagimod Alpha) as Adjunctive to a Weekly Treatment Regimen of Paclitaxel (clinicaltrials.gov)
    P1, N=0, Withdrawn, Immutep S.A.S. | N=24 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor) • IFNG (Interferon, gamma)
    |
    ER positive • PGR positive
    |
    paclitaxel • ImmuFact (eftilagimod alpha)