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Therapy Name | afamitresgene autoleucel + Pembrolizumab |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 | 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, 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). |
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 |