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    DRUG:

    acasunlimab (GEN1046)

    i
    Other names: GEN1046, BNT311, DuoBody-PD-L1x4-1BB, GEN1046-DS, BNT 311, BNT-311, GEN 1046, GEN-1046
    Associations

    News

    Trials
    Company:
    Genmab
    Drug class:
    PD-L1 inhibitor, CD137 agonist
    Related drugs:
    Associations

    News

    Trials
    4d
    Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06) (clinicaltrials.gov)
    P3, N=190, Active, not recruiting, Genmab | N=702 --> 190 | Trial completion date: Oct 2029 --> Sep 2028 | Trial primary completion date: Jun 2028 --> Jul 2027
    Enrollment change • Trial completion date • Trial primary completion date • Head-to-Head
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
    25d
    Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment With an Approved Checkpoint Inhibitor Therapy (ABBIL1TY MELANOMA-07) (clinicaltrials.gov)
    P2, N=1, Active, not recruiting, Genmab | N=90 --> 1
    Enrollment change • Checkpoint inhibition
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    25d
    Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06) (clinicaltrials.gov)
    P3, N=702, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
    Enrollment closed • Head-to-Head
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
    2ms
    Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06) (clinicaltrials.gov)
    P3, N=702, Recruiting, Genmab | Trial primary completion date: Jan 2027 --> Jun 2028
    Trial primary completion date • Head-to-Head
    |
    Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
    3ms
    Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment With an Approved Checkpoint Inhibitor Therapy (ABBIL1TY MELANOMA-07) (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
    Enrollment closed • Checkpoint inhibition
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    7ms
    Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment With an Approved Checkpoint Inhibitor Therapy (ABBIL1TY MELANOMA-07) (clinicaltrials.gov)
    P2, N=90, Recruiting, Genmab | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    9ms
    Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment With an Approved Checkpoint Inhibitor Therapy (ABBIL1TY MELANOMA-07) (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Genmab
    New P2 trial • Checkpoint inhibition
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    10ms
    Acasunlimab, an Fc-inert PD-L1×4-1BB bispecific antibody, combined with PD-1 blockade potentiates antitumor immunity via complementary immune modulatory effects. (PubMed, J Immunother Cancer)
    These preclinical results demonstrate that conditional 4-1BB stimulation combined with complete PD-1 blockade enhances antitumor immunity through complementary mechanisms. The acasunlimab and pembrolizumab combination is being evaluated in Phase 2 (NCT05117242) and pivotal Phase 3 (NCT06635824) trials in patients with metastatic non-small cell lung cancer after checkpoint inhibitor therapy failure.
    Journal
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • PD-L2 (Programmed Cell Death 1 Ligand 2) • IL2 (Interleukin 2) • GZMB (Granzyme B)
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    10ms
    GEN1046 Safety Trial in Patients With Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=429, Active, not recruiting, Genmab | Trial primary completion date: Feb 2026 --> Apr 2025
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
    1year
    GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies (clinicaltrials.gov)
    P1, N=18, Completed, Genmab | Active, not recruiting --> Completed | Trial completion date: Aug 2025 --> Oct 2024 | Trial primary completion date: Aug 2025 --> Oct 2024
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    over1year
    GEN1046 Safety Trial in Patients With Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=429, Active, not recruiting, Genmab | Trial completion date: Oct 2025 --> Feb 2026 | Trial primary completion date: Jan 2025 --> Feb 2026
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
    over1year
    Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06) (clinicaltrials.gov)
    P3, N=702, Recruiting, Genmab
    New P3 trial
    |
    Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)