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Therapy Name Toripalimab-tpzi
Synonyms
Therapy Description

Loqtorz (toripalimab-tpzi) 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, PMID: 32321714). Loqtorz (toripalimab-tpzi) in combination with cisplatin and gemcitabine is FDA-approved for use in adult patients with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Toripalimab-tpzi Loqtorz Toripalimab|JS001|JS-001|TAB001 Immune Checkpoint Inhibitor 147 PD-L1/PD-1 antibody 117 Loqtorz (toripalimab-tpzi) 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, PMID: 32321714). Loqtorz (toripalimab-tpzi) in combination with cisplatin and gemcitabine is FDA-approved for use in adult patients with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
CD274 positive Advanced Solid Tumor predicted - sensitive Toripalimab-tpzi Phase I Actionable In a Phase I trial, patients with CD274 (PD-L1)-positive (membrane staining in 1% or more of tumor cells, n=16) advanced solid tumors demonstrated improved objective response rate (ORR) (43.8% vs 0%, p=0.0081) and progression-free survival (HR=0.36, p=0.034) compared to CD274 (PD-L1)-negative (n=12) patients in response to Loqtorz (toripalimab-tpzi) treatment, with an ORR of 57.1% in CD274 (PD-L1)-high (membrane staining in >50% of tumor cells, n=7) patients (PMID: 30642373; NCT02836795). 30642373
CD274 positive stomach cancer no benefit Toripalimab-tpzi Phase Ib/II Actionable In a Phase I/II trial, Loqtorz (toripalimab-tpzi) treatment resulted in an objective response rate (ORR) of 12.1% (7/58, 7 partial responses) and a disease control rate of 39.7% (23/58) in patients with advanced gastric cancer, the CD274 (PD-L1)-positive group demonstrated improved ORR (3/8, 37.5% vs 4/47, 8.5%, p=0.023) but not overall survival (12.1 vs 5.3 months, p=0.45) compared to the CD274 (PD-L1)-negative group (PMID: 31236579; NCT02915432). 31236579
BRAF V600E melanoma decreased response Toripalimab-tpzi Clinical Study Actionable In a retrospective analysis, real-world treatment with either Keytruda (pembrolizumab) or Loqtorz (toripalimab-tpzi) resulted in a median disease-free survival of 17 months in melanoma patients harboring BRAF V600E compared to 32 months in patients with wild-type BRAF, NRAS, and KIT (p=0.022) (PMID: 37403699). 37403699
NRAS act mut melanoma decreased response Toripalimab-tpzi Clinical Study Actionable In a retrospective analysis, real-world treatment with either Keytruda (pembrolizumab) or Loqtorz (toripalimab-tpzi) resulted in a median disease-free survival of 9 months in melanoma patients harboring activating NRAS mutations in either G12 (29%) or Q61 (67.1%) compared to 32 months in patients with wild-type BRAF, NRAS, and KIT (p<0.0001) (PMID: 37403699). 37403699
KIT exon11 melanoma not predictive Toripalimab-tpzi Clinical Study Actionable In a retrospective analysis, real-world treatment with either Keytruda (pembrolizumab) or Loqtorz (toripalimab-tpzi) resulted in a median disease-free survival of 33 months in melanoma patients harboring KIT mutations in either exon 11 (64.8%), exon 13 (17.6%), or exon 17 (17.6%) compared to 32 months in patients with wild-type BRAF, NRAS, and KIT (p=0.200) (PMID: 37403699). 37403699
KIT exon17 melanoma not predictive Toripalimab-tpzi Clinical Study Actionable In a retrospective analysis, real-world treatment with either Keytruda (pembrolizumab) or Loqtorz (toripalimab-tpzi) resulted in a median disease-free survival of 33 months in melanoma patients harboring KIT mutations in either exon 11 (64.8%), exon 13 (17.6%), or exon 17 (17.6%) compared to 32 months in patients with wild-type BRAF, NRAS, and KIT (p=0.200) (PMID: 37403699). 37403699
CD274 positive melanoma predicted - sensitive Toripalimab-tpzi Phase II Actionable In a Phase II trial (POLARIS-01), Loqtorz (toripalimab-tpzi) resulted in a more favorable objective response rate (38.5% vs 11.9%, p=0.0065), disease control rate (80.8% vs 48.8%, p=0.006), progression-free survival (7.7 vs 2.7 mo, HR=0.53, p=0.013), and overall survival (not reached vs 14.4 mo, HR=0.35, p=0.0005) in patients with CD274 (PD-L1)-positive advanced melanoma (n=26) compared to patients with CD274 (PD-L1)-negative (n=84) tumors (PMID: 32321714; NCT03013101). 32321714
KIT exon13 melanoma not predictive Toripalimab-tpzi Clinical Study Actionable In a retrospective analysis, real-world treatment with either Keytruda (pembrolizumab) or Loqtorz (toripalimab-tpzi) resulted in a median disease-free survival of 33 months in melanoma patients harboring KIT mutations in either exon 11 (64.8%), exon 13 (17.6%), or exon 17 (17.6%) compared to 32 months in patients with wild-type BRAF, NRAS, and KIT (p=0.200) (PMID: 37403699). 37403699
CD274 positive transitional cell carcinoma predicted - sensitive Toripalimab-tpzi Phase II Emerging In a Phase II trial (POLARIS-03), CD274 (PD-L1)-positive urothelial carcinoma patients (n=48) had an improved objective response rate (42% vs 17%, p=0.002) and median progression-free survival (3.7 months vs 1.8 months; p=0.001) compared to patients without CD274 (PD-L1) expression (n=96) following treatment with Loqtorz (toripalimab-tpzi) (PMID: 34740921; NCT03113266). 34740921

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03474640 Phase I Toripalimab-tpzi Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies Unknown status USA 0
NCT06095583 Phase III Icatolimab + Toripalimab-tpzi Toripalimab-tpzi Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC) Recruiting USA 3


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