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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 136 | 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 |
|---|---|---|---|---|---|---|---|
| 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... |
| 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 |
| MSH2 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... |
| 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 |
| 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 |
| PMS2 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... |
| MSH6 negative | appendix adenocarcinoma | sensitive | Toripalimab-tpzi | Guideline | Actionable | Loqtorz (toripalimab-tpzi) is included in guidelines (category 2A) for patients with advanced or metastatic appendiceal adenocarcinoma 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 |
| 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... |
| 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 |
| PMS2 negative | appendix adenocarcinoma | sensitive | Toripalimab-tpzi | Guideline | Actionable | Loqtorz (toripalimab-tpzi) is included in guidelines (category 2A) for patients with advanced or metastatic appendiceal adenocarcinoma 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... |
| MSH2 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... |
| MSH2 negative | small intestine adenocarcinoma | sensitive | Toripalimab-tpzi | Guideline | Actionable | Loqtorz (toripalimab-tpzi) is included in guidelines as systemic therapy (category 2A) for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| 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... |
| 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... |
| 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 |
| MLH1 negative | appendix adenocarcinoma | sensitive | Toripalimab-tpzi | Guideline | Actionable | Loqtorz (toripalimab-tpzi) is included in guidelines (category 2A) for patients with advanced or metastatic appendiceal adenocarcinoma 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 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 |
| MSH2 negative | appendix adenocarcinoma | sensitive | Toripalimab-tpzi | Guideline | Actionable | Loqtorz (toripalimab-tpzi) is included in guidelines (category 2A) for patients with advanced or metastatic appendiceal adenocarcinoma 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... |
| PMS2 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, MSH2, PMS2, or MSH6 expression by IHC) (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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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