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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 150 PD-L1/PD-1 antibody 132 | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
| MSH6 negative | rectum cancer | sensitive | Toripalimab-tpzi | Guideline | Actionable | Loqtorz (toripalimab-tpzi) is included in guidelines (category 2A) for patients with advanced or metastatic rectal cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | colon cancer | sensitive | Toripalimab-tpzi | Guideline | Actionable | Loqtorz (toripalimab-tpzi) is included in guidelines (category 2A) for patients with advanced or metastatic colon cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, MSH2, PMS2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| 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 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 |
| MLH1 negative | rectum cancer | sensitive | Toripalimab-tpzi | Guideline | Actionable | Loqtorz (toripalimab-tpzi) is included in guidelines (category 2A) for patients with advanced or metastatic rectal cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| 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 |
| MLH1 negative | colon cancer | sensitive | Toripalimab-tpzi | Guideline | Actionable | Loqtorz (toripalimab-tpzi) is included in guidelines (category 2A) for patients with advanced or metastatic colon cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
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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 |
| NCT04387084 | Phase I | Durvalumab Pembrolizumab Retifanlimab Avelumab Cemiplimab Toripalimab-tpzi Atezolizumab Nivolumab Dostarlimab-gxly | Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy | Active, not recruiting | 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 |
| NCT07140679 | Phase II | Toripalimab-tpzi | Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer | Recruiting | USA | 0 |
| NCT06940180 | Phase II | Carboplatin + Docetaxel + Toripalimab-tpzi Toripalimab-tpzi Cisplatin | Toripalimab With Chemotherapy for Sinus Cancer | Recruiting | USA | 0 |
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