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    DRUG CLASS:

    MHC II agonist

    Related drugs:
    1d
    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)
    9d
    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)
    2ms
    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)
    2ms
    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)
    5ms
    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)
    5ms
    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)
    over1year
    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)
    2years
    Feasibility of eftilagimod alpha combined with avelumab in advanced solid tumors: advanced safety and efficacy data from Stratum D of the phase I INSIGHT platform trial (DKK 2022)
    30 mg efti appears to be feasible and safe.
    Clinical • P1 data
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    Bavencio (avelumab) • ImmuFact (eftilagimod alpha)
    2years
    Soluble LAG3 Primes T Cells to Attack NSCLC. (PubMed, Cancer Discov)
    When combined with a PD-1 checkpoint inhibitor, the soluble LAG3 drug eftilagimod alpha activates antigen-presenting cells, offering deep and durable responses against non-small cell lung cancer. Even patients whose tumors express low levels of PD-L1 experienced an anticancer benefit.
    Journal
    |
    PD-L1 (Programmed death ligand 1) • LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression
    |
    ImmuFact (eftilagimod alpha)
    2years
    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."
    Late-breaking abstract • P2 data • Clinical
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CD4 (CD4 Molecule)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    2years
    TACTI-003: A randomized Phase IIb study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab as first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (SITC 2022)
    Secondary EPs include overall survival, ORR according to iRECIST, time to and duration of response, disease control rate, progression-free survival, the occurrence of anti-efti -specific antibodies, safety, and quality of life. Exploratory endpoints comprise biomarkers.
    Clinical • P2b data • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    Keytruda (pembrolizumab) • 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=24, Not yet recruiting, Immutep S.A.S. | Trial completion date: Feb 2024 --> Feb 2026 | Trial primary completion date: Jun 2023 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor) • IFNG (Interferon, gamma)
    |
    ER positive • PGR positive
    |
    paclitaxel • ImmuFact (eftilagimod alpha)
    over2years
    TACTI-002: A Phase II Study of Eftilagimod Alpha (Soluble LAG-3) & Pembrolizumab in 2nd line PD-1/PD-L1 Refractory Metastatic NSCLC (IASLC-WCLC 2022)
    Efti in combination with pembrolizumab is safe and shows encouraging signs of antitumor activity in truly PD-1/PD-L1 refractory 2nd line NSCLC pts.
    P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression • PD-L1 negative
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    over2years
    KEYNOTE-PN798: 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=189, Active, not recruiting, Immutep S.A.S. | Trial completion date: May 2023 --> Nov 2023
    Trial completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    over2years
    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)
    E + P is safe and shows encouraging antitumor activity in first-line metastatic NSCLC patients unselected for PD-L1, warranting further investigation.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    over2years
    TACTI-003: A randomized phase IIb study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab as first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma. (ASCO 2022)
    Exploratory endpoints comprise biomarkers. The study has been approved by relevant competent authorities, ethic committees and IRBs.
    Clinical • P2b data • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    over2years
    HR Positive, HER2 Negative Advanced Breast Cancer With Progression After Endocrine Therapy (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Taizhou EOC Pharma Co., Ltd.
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • IFNG (Interferon, gamma) • CXCL10 (Chemokine (C-X-C motif) ligand 10)
    |
    HR positive • HER-2 negative
    |
    albumin-bound paclitaxel • ImmuFact (eftilagimod alpha)
    over2years
    Phase I Study of EOC202 Plus Paclitaxel in Chinese Patients With Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=12, Completed, Taizhou EOC Pharma Co., Ltd. | Recruiting --> Completed | N=18 --> 12 | Trial completion date: Sep 2020 --> Dec 2021 | Trial primary completion date: Aug 2019 --> Dec 2021
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative
    |
    paclitaxel • ImmuFact (eftilagimod alpha)
    almost3years
    Immune Checkpoint LAG3 and Its Ligand FGL1 in Cancer. (PubMed, Front Immunol)
    IMP321 and relatlimab are promising monoclonal antibodies targeting LAG3 in melanoma. Finally, high FGL1 and LAG3 expression induces EGFR-TKI and gefitinib resistance, and anti-PD-1 therapy resistance, respectively. We present a comprehensive overview of the role of LAG3/FGL1 in cancer, suggesting novel anti-tumor therapy strategies.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • LAG3 (Lymphocyte Activating 3) • FGL1 (Fibrinogen Like 1)
    |
    EGFR expression • LAG3 expression • LAG3 elevation
    |
    gefitinib • ImmuFact (eftilagimod alpha) • relatlimab (BMS-986016)
    almost3years
    Results of a phase II study investigating eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in second-line PD-1/PD-L1 refractory metastatic non-small cell lung carcinoma pts (ELCC 2022)
    Both responses were reported in pts pre-treated with chemo + PD-1 and under therapy since 7+ and 12+ months at data cut-off. Conclusions Efti in combination with pembrolizumab is safe and shows encouraging signs of antitumor activity in PD-1 refractory 2 nd line NSCLC pts.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression • PD-L1 negative
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    almost3years
    KEYNOTE-PN798: 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=189, Active, not recruiting, Immutep S.A.S. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    3years
    Keynote- PNC-34: Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting | Trial primary completion date: Apr 2023 --> Jul 2023
    Combination therapy • Trial primary completion date • Enrollment open • Clinical
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    3years
    Results from a Phase II study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with PD-L1 unselected metastatic 2nd line head and neck squamous cell carcinoma (HNSCC) (SITC 2021)
    For further investigation of this combination, a 1st line HNSCC trial (NCT04811027) has been initiated. Trial Registration NCT03625323
    P2 data • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)
    over3years
    [VIRTUAL] Results from a phase II study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with PD-L1 unselected metastatic second-line squamous head and neck carcinoma. (ASCO 2021)
    Efti in combination with pembrolizumab is safe and shows encouraging antitumor activity in platinum pre-treated 2nd line HNSCC patients.
    P2 data • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • ImmuFact (eftilagimod alpha)