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Therapy Name | hu14.18-IL2 + 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 121 | 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). |
hu14.18-IL2 | Lorukafusp alfa|EMD-273063|EMD 273063|APN301|APN-301|APN 301 | Hu14.18-IL2 (Lorukafusp alfa) is a fusion protein comprised of a monoclonal antibody targeting the GD2 disialoganglioside linked to interleukin-2, which may inhibit growth of and induce an immune response against GD2-expressing tumors (PMID: 22844125, PMID: 20921469, PMID: 30073390). |
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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NCT03958383 | Phase Ib/II | hu14.18-IL2 hu14.18-IL2 + Nivolumab hu14.18-IL2 + Ipilimumab + Nivolumab | IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma | Suspended | USA | 0 |