Therapy Detail
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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 149 PD-L1/PD-1 antibody 122 | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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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 | Completed | 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 | TUR | ROU | POL | NLD | ITA | FRA | ESP | DEU | BEL | 4 |
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