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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