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Therapy Name | afamitresgene autoleucel + Nivolumab |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Nivolumab | Opdivo | MDX-1106|BMS-936558 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 | Opdivo (nivolumab) is an antibody that targets PD-1 (PDCD1), which results in increased T-cell activation and enhanced anti-tumor immune response (PMID: 28891423). Opdivo (nivolumab) is FDA approved for use as a monotherapy in patients with non-small cell lung cancer (NSCLC) progressed on prior therapies, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma (UC) , esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) for melanoma, renal cell carcinoma (RCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (including patients 12 years or older), and hepatocellular carcinoma, in combination with Yervoy (ipilimumab) as first-line therapy for PD-L1-positive (>=1%) metastatic NSCLC without EGFR or ALK alterations, with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy for metastatic or recurrent NSCLC without EGFR or ALK alterations, with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, with Cabometyx (cabozantinib) for advanced RCC, with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma, and with cisplatin and gemcitabine as first-line treatment for unresectable or metastatic UC (FDA.gov). |
afamitresgene autoleucel | Tecelra | MAGE-A4 SPEAR T cells|MAGE-A4C1032T|ADP-A2M4 cells|afami-cel | Tecelra (afamitresgene autoleucel) are autologous T-cells that are modified to express a T-cell receptor that recognizes the human melanoma antigen 4 (MAGE-A4) peptide region from 230-239, which potentially inhibits growth of MAGE-A4-expressing tumor cells (PMID: 32002290). Tecelra (afamitresgene autoleucel) is FDA-approved for use in patients with MAGE-A4-positive unresectable or metastatic synovial sarcoma who have received prior chemotherapy, and are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive (FDA.gov). |
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 |
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NCT04044859 | Phase I | afamitresgene autoleucel afamitresgene autoleucel + Pembrolizumab afamitresgene autoleucel + Nivolumab | ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS) | Recruiting | USA | ESP | CAN | BEL | 0 |