Therapy Detail

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Therapy Name Spartalizumab
Synonyms
Therapy Description

Spartalizumab (PDR001) is a monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (NCI Drug Dictionary).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Spartalizumab PDR001|PDR-001 Immune Checkpoint Inhibitor 94 PD-L1/PD-1 antibody 62 Spartalizumab (PDR001) is a monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (PMID: 32364844, PMID: 32179633).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown pulmonary neuroendocrine tumor not applicable Spartalizumab Case Reports/Case Series Actionable In a Phase I trial, Spartalizumab (PDR001) treatment in a patient with an atypical carcinoid lung tumor with initial CD8-positive lymphocyte tumor infiltration of 5.6% resulted in a partial response lasting 8.5 months, with an increase in CD8-positive lymphocyte infiltration to 37.6% after two weeks and subsequent reduction of target lesion size (PMID: 32179633; NCT02404441). 32179633
Unknown unknown Advanced Solid Tumor not applicable Spartalizumab Phase I Actionable In a Phase I trial, Spartalizumab (PDR001) treatment in advanced solid tumor patients demonstrated tolerability and an overall response rate of 3.4% (2/58), with one atypical carcinoid lung tumor patient and one anal cancer patient achieving partial responses, and an additional 41.4% (24/58) of patients demonstrating stable disease (PMID: 32179633; NCT02404441). 32179633
Unknown unknown thyroid gland anaplastic carcinoma not applicable Spartalizumab Phase I Actionable In a Phase I trial, Spartalizumab (PDR001) demonstrated tolerability in patients with anaplastic thyroid carcinoma, and resulted in an overall response rate of 19% (8/42), including three complete responses and five partial responses, median progression-free survival of 1.7 months, and median overall survival of 5.9 months (PMID: 32364844; NCT02404441). 32364844

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03111992 Phase I LCL161 + Spartalizumab CJM112 + Spartalizumab Spartalizumab Study of Single Agent CJM112, and PDR001 in Combination With LCL161 or CJM112 in Patients With Multiple Myeloma Completed
NCT02955069 Phase II Spartalizumab Study of Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin Completed
NCT02605967 Phase II Spartalizumab Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma Active, not recruiting
NCT03365791 Phase II LAG525 Spartalizumab PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies Active, not recruiting
NCT04058756 Phase I Spartalizumab Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments Recruiting
NCT02608268 Phase Ib/II Spartalizumab Sabatolimab Safety and Efficacy of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies Recruiting
NCT02404441 Phase Ib/II Spartalizumab Phase I/II Study of PDR001 in Patients With Advanced Malignancies Active, not recruiting
NCT02795429 Phase Ib/II Spartalizumab Capmatinib + Spartalizumab Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC Active, not recruiting
NCT02460224 Phase Ib/II LAG525 Spartalizumab Safety and Efficay of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies Active, not recruiting


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