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acasunlimab (GEN1046)
i
Other names: GEN1046, BNT311, DuoBody-PD-L1x4-1BB, GEN1046-DS, BNT 311, BNT-311, GEN 1046, GEN-1046
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Company:
Genmab
Drug class:
PD-L1 inhibitor, CD137 agonist
Related drugs:
7d
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, Terminated, Genmab | Trial completion date: Jul 2029 --> May 2026 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2027 --> May 2026; Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision was not related to safety concerns.
Trial completion date • Trial termination • Trial primary completion date • Checkpoint inhibition
|
BRAF (B-raf proto-oncogene)
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BRAF mutation • BRAF V600
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Keytruda (pembrolizumab) • acasunlimab (GEN1046)
2ms
GCT1046-04: Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer (clinicaltrials.gov)
P2, N=125, Active, not recruiting, Genmab | Trial completion date: May 2027 --> Aug 2026
Trial completion date • Checkpoint inhibition
|
PD-L1 expression
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Keytruda (pembrolizumab) • acasunlimab (GEN1046)
2ms
GEN1046 Safety Trial in Patients With Malignant Solid Tumors (clinicaltrials.gov)
P1/2, N=429, Active, not recruiting, Genmab | Trial completion date: Feb 2026 --> Aug 2026
Trial completion date • First-in-human
|
Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
4ms
GCT1046-07: Study of the Effectiveness and Safety of Acasunlimab Alone or With Pembrolizumab in treating Advanced Melanoma of the Skin That Has Returned After or did not respond to Cancer Immunotherapy (ABBIL1TY MELANOMA-07) (2025-520468-16-00)
P1/2, N=129, Completed, Genmab A/S
New P1/2 trial • Checkpoint inhibition
|
BRAF (B-raf proto-oncogene)
|
BRAF mutation • BRAF V600
|
Keytruda (pembrolizumab) • acasunlimab (GEN1046)
5ms
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)
5ms
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)
5ms
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)
6ms
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)
8ms
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)
12ms
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)
1year
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)
1year
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
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • PD-L2 (Programmed Cell Death 1 Ligand 2) • IL2 (Interleukin 2) • GZMB (Granzyme B)
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Keytruda (pembrolizumab) • acasunlimab (GEN1046)
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