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Therapy Name Toripalimab
Synonyms
Therapy Description

Toripalimab (JS001) 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 and decreased tumor growth (PMID: 28317872; J Clin Oncol 35, 2017 (suppl; abstr e14581)).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Toripalimab JS001|JS-001|TAB001 Immune Checkpoint Inhibitor 94 PD-L1/PD-1 antibody 63 Toripalimab (JS001) 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 and decreased tumor growth (PMID: 28317872; PMID: 32277740, PMID: 32406293).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown transitional cell carcinoma not applicable Toripalimab Phase I Actionable In a Phase I trial, Toripalimab (JS001) demonstrated safety and preliminary efficacy, resulted in an objective response rate of 25.0% (2/8) and a disease control rate of 67.5% (5/8, 2 partial response, 3 stable disease) in patients with advanced urothelial carcinoma (PMID: 30642373; NCT02836795). 30642373
Unknown unknown neuroendocrine tumor not applicable Toripalimab Phase Ib/II Actionable In a Phase Ib trial, treatment with Toripalimab (JS001) resulted in an objective response rate of 20% (8/40), a disease control rate of 35% (14/40), a median duration of response of 15.2 months, a median progression-free survival of 2.5 months, and a median overall survival of 7.8 months in patients with neuroendocrine tumors (PMID: 32086343; NCT03167853). 32086343
Unknown unknown Advanced Solid Tumor not applicable Toripalimab Phase I Actionable In a Phase I trial, Toripalimab (JS001) demonstrated tolerability and preliminary efficacy in patients with advanced malignancies, resulting in an objective response rate of 45.5% (15/33), including complete response in 7/33, partial response in 8/33, and stable disease in 13/33 patients, and median progression-free survival of 7.1 months, with solid tumor patients demonstrating an objective response rate of 22.7% (5/22) and median progression-free survival of 5.7 months (PMID: 32224416; NCT02836834). 32224416
Unknown unknown lymphoma not applicable Toripalimab Phase I Actionable In a Phase I trial, Toripalimab (JS001) treatment in patients with advanced lymphomas resulted in an objective response rate of 90.9% (10/11) and median progression-free survival of 8.3 months, with all nine Hodgkin's lymphoma patients demonstrating objective responses including six complete responses and four partial responses, while one diffuse large B-cell lymphoma patient achieved a partial response and the other resulted in disease progression (PMID: 32224416; NCT02836834). 32224416
Unknown unknown renal cell carcinoma not applicable Toripalimab Phase I Actionable In a Phase I trial, Toripalimab (JS001) demonstrated safety and preliminary efficacy, resulted in an objective response rate of 33.3% (2/6) and a disease control rate of 50.0% (3/6, 2 partial response, 1 stable disease) in patients with advanced renal cell carcinoma (PMID: 30642373; NCT02836795). 30642373
Unknown unknown melanoma not applicable Toripalimab Phase I Actionable In a Phase I trial, JS001 demonstrated safety and preliminary activity in patients with melanoma, renal cell carcinoma, or urothelial carcinoma, with an overall response rate (ORR) of 22% (7/32; 1 complete response (melanoma), 6 partial responses), and an ORR of 20% and 25% and DCR of 53% and 50% in patients with acral or mucosal melanoma, respectively (J Clin Oncol 35, 2017 (suppl; abstr 3067)). detail...
Unknown unknown melanoma not applicable Toripalimab Phase I Actionable In a Phase I trial, Toripalimab (JS001) demonstrated safety and preliminary efficacy, resulted in an objective response rate of 18.2% (4/22) and a disease control rate of 45.5% (10/22, 1 complete response, 4 partial response, 6 stable disease) in patients with advanced melanoma (PMID: 30642373; NCT02836795). 30642373
Unknown unknown melanoma not applicable Toripalimab Phase II Actionable In a Phase II trial (POLARIS-01), Toripalimab (JS001) resulted in an objective response rate of 17.3% (22/127, 1 CR, 21 PR) and a disease control rate of 57.5% in melanoma patients, with a median progression-free survival (mPFS) of 3.6 mo and a median overall survival (mOS) of 22.2 mo, better ORR (31.0%, 14.0%, 0%), mPFS (5.5, 3.2, 1.9 mo), and mOS (not reached, 16.9, 10.3 mo) were observed in non-acral cutaneous melanoma (n=29) than in acral (n=50) and mucosal (n=22) subtypes (PMID: 32321714; NCT03013101). 32321714
Unknown unknown mucosal melanoma not applicable Toripalimab Phase II Actionable In a Phase II trial (POLARIS-01), Toripalimab (JS001) resulted in an objective response rate of 17.3% (22/127, 1 CR, 21 PR) and a disease control rate of 57.5% in melanoma patients, with a median progression-free survival (mPFS) of 3.6 mo and a median overall survival (mOS) of 22.2 mo, better ORR (31.0%, 14.0%, 0%), mPFS (5.5, 3.2, 1.9 mo), and mOS (not reached, 16.9, 10.3 mo) were observed in non-acral cutaneous melanoma (n=29) than in acral (n=50) and mucosal (n=22) subtypes (PMID: 32321714; NCT03013101). 32321714
Unknown unknown mucosal melanoma not applicable Toripalimab Case Reports/Case Series Actionable In a Phase I trial, Toripalimab (JS001) demonstrated safety and preliminary efficacy, resulted in partial response in 1 and stable disease in 1 of 4 patients with mucosal melanoma (PMID: 30642373; NCT02836795). 30642373
Unknown unknown skin melanoma not applicable Toripalimab Phase II Actionable In a Phase II trial (POLARIS-01), Toripalimab (JS001) resulted in an objective response rate of 17.3% (22/127, 1 CR, 21 PR) and a disease control rate of 57.5% in melanoma patients, with a median progression-free survival (mPFS) of 3.6 mo and a median overall survival (mOS) of 22.2 mo, better ORR (31.0%, 14.0%, 0%), mPFS (5.5, 3.2, 1.9 mo), and mOS (not reached, 16.9, 10.3 mo) were observed in non-acral cutaneous melanoma (n=29) than in acral (n=50) and mucosal (n=22) subtypes (PMID: 32321714; NCT03013101). 32321714
Unknown unknown acral lentiginous melanoma not applicable Toripalimab Phase II Actionable In a Phase II trial (POLARIS-01), Toripalimab (JS001) resulted in an objective response rate of 17.3% (22/127, 1 CR, 21 PR) and a disease control rate of 57.5% in melanoma patients, with a median progression-free survival (mPFS) of 3.6 mo and a median overall survival (mOS) of 22.2 mo, better ORR (31.0%, 14.0%, 0%), mPFS (5.5, 3.2, 1.9 mo), and mOS (not reached, 16.9, 10.3 mo) were observed in non-acral cutaneous melanoma (n=29) than in acral (n=50) and mucosal (n=22) subtypes (PMID: 32321714; NCT03013101). 32321714
Unknown unknown acral lentiginous melanoma not applicable Toripalimab Phase I Actionable In a Phase I trial, Toripalimab (JS001) demonstrated safety and preliminary efficacy, resulted in an objective response rate of 23.1% (3/13) and a disease control rate of 46.2% (6/13, 1 complete response, 2 partial response, 3 stable disease) in patients with acral melanoma (PMID: 30642373; NCT02836795). 30642373

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03474640 Phase I Toripalimab Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies Recruiting


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