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| Therapy Name | Cemiplimab + REGN5678 |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Cemiplimab | Libtayo | REGN2810|SAR439684 | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 132 | Libtayo (cemiplimab) is a human antibody that targets PD-1 (PDCD1) and prevents interaction with PD-L1 (CD274) and PD-L2 (PDCD1LG2), potentially resulting in increased anti-tumor immune response and decreased tumor growth (PMID: 28265006). Libtayo (cemiplimab) is FDA approved for use in patients with cutaneous squamous cell carcinoma, who are not not eligible for curative surgery or radiation, in patients with locally advanced or metastatic basal cell carcinoma who have received or are not eligible for a hedgehog pathway inhibitor, as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (TPS>=50%) and no EGFR, ALK, or ROS1 aberrations, and in combination with platinum-based chemotherapy as first-line treatment for patients with NSCLC without EGFR, ALK, or ROS1 alterations (FDA.gov). |
| REGN5678 | REGN 5678|REGN-5678|nezastomig | CD28 Antibody 12 PSMA Antibody 22 | REGN5678 is a bispecific antibody that targets prostate-specific membrane antigen (PSMA) and CD28, which may couple T-cells to PSMA-expressing tumor cells, potentially leading to enhanced T-lymphocyte activation and antitumor activity (J Clin Oncol 2021 39:6_suppl, TPS174). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06826768 | Phase I | Cemiplimab + REGN5678 | A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC | Recruiting | USA | 0 |
| NCT03972657 | Phase Ib/II | REGN5678 Cemiplimab + REGN5678 | A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors | Recruiting | USA | 0 |