Therapy Detail
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| Therapy Name | Acasunlimab + Pembrolizumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Acasunlimab | GEN1046|GEN-1046|GEN 1046|DuoBody-PD-L1x4-1BB|BNT 311|BNT-311|BNT311 | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 132 TNFRSF9 Antibody 36 | Acasunlimab (GEN1046) is a bispecific antibody that binds to and simultaneously targets PD-L1 and TNFRSF9 (4-1BB), potentially resulting in T-cell activation leading to increased anti-tumor immune response and decreased tumor growth (PMID: 35176764). | |
| Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 132 | Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, HNSCC, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, in combination with chemoradiation for cervical cancer, and in combination with carboplatin and paclitaxel for endometrial carcinoma (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06635824 | Phase III | Docetaxel Acasunlimab + Pembrolizumab | Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06) | Recruiting | USA | TUR | POL | NLD | ITA | IRL | HUN | HRV | GRC | GBR | FRA | EST | ESP | DEU | CAN | BRA | BGR | BEL | AUT | AUS | ARG | 6 |
| NCT05117242 | Phase II | Acasunlimab + Pembrolizumab Acasunlimab | Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer | Active, not recruiting | USA | POL | NLD | ITA | GBR | FRA | ESP | DEU | 1 |
| NCT06046274 | Phase II | Acasunlimab + Pembrolizumab | GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer | Withdrawn | USA | ITA | ESP | DNK | BEL | 1 |
| NCT06984328 | Phase II | Acasunlimab Acasunlimab + Pembrolizumab | 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) | Active, not recruiting | USA | 1 |
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