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|Therapy Name||ALX148 + Pembrolizumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|ALX148||ALX-148|ALX 148||CD47 Antibody 14 Immune Checkpoint Inhibitor 98||ALX148 is a chimeric protein consisting of the Fc region of immunoglobulin fused to the CD47 SIRPa-binding domain, that blocks the ability of CD47 to bind SIRPa on macrophages thereby promoting phagocytosis of tumor cells (PMID: 28286286), and may also stimulate cytotoxic T-cells (PMID: 29873856).|
|Pembrolizumab||Keytruda||MK-3475||Immune Checkpoint Inhibitor 98 PD-L1/PD-1 antibody 69||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, primary mediastinal large B-cell lymphoma, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous squamous cell carcinoma, MSI-H or dMMR or TMB high advanced solid tumors, PD-L1 expressing NSCLC, gastric and GEJ adenocarcinoma, squamous esophageal carcinoma, cervical cancer, and triple-negative breast cancer, in combination with pemetrexed and platinum in non-squamous NSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in squamous NSCLC, with axitinib in RCC, with Lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemotherapy for patients with esophageal or gastroesophageal carcinoma, and in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||head and neck squamous cell carcinoma||not applicable||ALX148 + Pembrolizumab||Phase I||Actionable||In a Phase I trial, ALX148 and Keytruda (pembrolizumab) combination treatment resulted in a partial response in 18% (3/17) and stable disease in 24% (4/17) of patients with head and neck squamous cell carcinoma that progressed on platinum therapy (J Clin Oncol 37, no. 15_suppl (May 20, 2019) 2514-2514; NCT03013218).||detail...|
|Unknown unknown||lung non-small cell carcinoma||not applicable||ALX148 + Pembrolizumab||Phase I||Actionable||In a Phase I trial, ALX148 and Keytruda (pembrolizumab) combination treatment resulted in a partial response in 4% (1/23) and stable disease in 35% (8/23) of patients with non-small cell lung cancer resistant or refractory to immune checkpoint inhibitors (J Clin Oncol 37, no. 15_suppl (May 20, 2019) 2514-2514; NCT03013218).||detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT04675294||Phase II||ALX148 + Pembrolizumab Pembrolizumab||ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03).||Recruiting||USA||0|