Therapy Detail
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| Therapy Name | Dostarlimab-gxly |
| Synonyms | |
| Therapy Description |
Jemperli (dostarlimab-gxly) 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 (PMID: 34313545). Jemperli (dostarlimab-gxly) is FDA approved for use in patients with recurrent or advanced endometrial cancer or solid tumors harboring mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have progressed on prior treatments (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Dostarlimab-gxly | Jemperli | TSR-042 | Immune Checkpoint Inhibitor 155 PD-L1/PD-1 antibody 105 | Jemperli (dostarlimab-gxly) 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 (PMID: 34313545). Jemperli (dostarlimab-gxly) is FDA approved for use in patients with recurrent or advanced endometrial cancer or solid tumors harboring mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have progressed on prior treatments (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| MSH6 negative | endometrial carcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as first-line or second-line therapy for patients with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent endometrial carcinoma (NCCN.org). | detail... |
| MLH1 negative | gastroesophageal junction adenocarcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic gastroesophageal junction 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... |
| MLH1 negative | small intestine adenocarcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as a subsequent therapy 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... |
| MLH1 negative | pancreatic adenocarcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for patients with recurrent or locally advanced, metastatic pancreatic 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... |
| MSH6 negative | breast cancer | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines for patients with metastatic or unresectable breast 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) who have progressed on or following prior treatment (NCCN.org). | detail... |
| MLH1 negative | breast cancer | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines for patients with metastatic or unresectable breast 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) who have progressed on or following prior treatment (NCCN.org). | detail... |
| MLH1 negative | gallbladder cancer | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy (category 2B) for patients with biliary tract cancer with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC), including gallbladder cancer (NCCN.org). | detail... |
| MLH1 negative | ovary epithelial cancer | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as systemic therapy for patients with recurrent or advanced epithelial ovarian, fallopian tube, or primary peritoneal 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 | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy 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... |
| MLH1 negative | endometrial carcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as first-line or second-line therapy for patients with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent endometrial carcinoma (NCCN.org). | detail... |
| MLH1 negative | esophagus adenocarcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic esophageal 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... |
| MSH6 negative | small intestine adenocarcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as a subsequent therapy 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... |
| MSH6 negative | ovary epithelial cancer | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as systemic therapy for patients with recurrent or advanced epithelial ovarian, fallopian tube, or primary peritoneal 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 | gastroesophageal junction adenocarcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic gastroesophageal junction 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... |
| MSH6 negative | ampulla of Vater adenocarcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for metastatic ampullary adenocarcinoma patients with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | gallbladder cancer | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy (category 2B) for patients with biliary tract cancer with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC), including gallbladder cancer (NCCN.org). | detail... |
| MSH6 negative | extrahepatic bile duct carcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy (category 2B) for patients with biliary tract cancer with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC), including extrahepatic cholangiocarcinoma (NCCN.org). | detail... |
| MLH1 negative | intrahepatic cholangiocarcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy (category 2B) for patients with biliary tract cancer with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC), including intrahepatic cholangiocarcinoma (NCCN.org). | detail... |
| MSH6 negative | esophagus adenocarcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic esophageal 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... |
| MSH6 negative | intrahepatic cholangiocarcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy (category 2B) for patients with biliary tract cancer with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC), including intrahepatic cholangiocarcinoma (NCCN.org). | detail... |
| MSH6 negative | endometrial cancer | sensitive | Dostarlimab-gxly | FDA approved - On Companion Diagnostic | Actionable | In a Phase I trial (GARNET) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 42.3% (30/71, 9 complete responses, 21 partial responses), with a median duration of response not reached in patients with recurrent or advanced endometrial cancer harboring mismatch repair deficiency (dMMR) as confirmed by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (PMID: 33001143; NCT02715284). | detail... 33001143 detail... |
| MSH6 negative | endometrial cancer | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) endometrial cancer who have failed platinum-based therapy (PMID: 35690222; ESMO.org). | 35690222 detail... |
| MLH1 negative | Adenocarcinoma of Unknown Primary | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines for patients with adenocarcinoma of unknown primary 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 | esophagus squamous cell carcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma 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 | pancreatic adenocarcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for patients with recurrent or locally advanced, metastatic pancreatic 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... |
| MLH1 negative | extrahepatic bile duct carcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy (category 2B) for patients with biliary tract cancer with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC), including extrahepatic cholangiocarcinoma (NCCN.org). | detail... |
| MLH1 negative | Advanced Solid Tumor | sensitive | Dostarlimab-gxly | FDA approved - On Companion Diagnostic | Actionable | In a Phase I trial (GARNET) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 41.6% (87/209), with a median duration of response not reached in patients with advanced mismatch repair deficient (dMMR) solid tumors, as indicated by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 2564-2564; NCT02715284). | detail... detail... detail... |
| MLH1 negative | rectum cancer | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy 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 | rectum cancer | sensitive | Dostarlimab-gxly | Phase II | Actionable | In a Phase II trial, neoadjuvant Jemperli (dostarlimab-gxly) treatment resulted in an objective response of 100% (12/12, all complete responses) in patients with stage II or III rectal cancer with deficient mismatch repair (dMMR) as defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC (PMID: 35660797; NCT04165772). | 35660797 |
| MSH6 negative | esophagus squamous cell carcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma 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 | endometrial cancer | sensitive | Dostarlimab-gxly | FDA approved - On Companion Diagnostic | Actionable | In a Phase I trial (GARNET) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 42.3% (30/71, 9 complete responses, 21 partial responses), with a median duration of response not reached in patients with recurrent or advanced endometrial cancer harboring mismatch repair deficiency (dMMR) as confirmed by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (PMID: 33001143; NCT02715284). | detail... 33001143 detail... |
| MLH1 negative | endometrial cancer | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) endometrial cancer who have failed platinum-based therapy (PMID: 35690222; ESMO.org). | 35690222 detail... |
| MSH6 negative | Advanced Solid Tumor | sensitive | Dostarlimab-gxly | FDA approved - On Companion Diagnostic | Actionable | In a Phase I trial (GARNET) that supported FDA aproval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 41.6% (87/209), with a median duration of response not reached in patients with advanced mismatch repair deficient (dMMR) solid tumors, as indicated by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 2564-2564; NCT02715284). | detail... detail... detail... |
| MLH1 negative | stomach cancer | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced or metastatic gastric cancer with 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 | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy 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... |
| MSH6 negative | Adenocarcinoma of Unknown Primary | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines for patients with adenocarcinoma of unknown primary 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 | ampulla of Vater adenocarcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for metastatic ampullary adenocarcinoma patients with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MLH1 negative | hepatocellular carcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for patients with mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) hepatocellular carcinoma (NCCN.org). | detail... |
| MSH6 negative | rectum cancer | sensitive | Dostarlimab-gxly | Phase II | Actionable | In a Phase II trial, neoadjuvant Jemperli (dostarlimab-gxly) treatment resulted in an objective response of 100% (12/12, all complete responses) in patients with stage II or III rectal cancer with deficient mismatch repair (dMMR) as defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC (PMID: 35660797; NCT04165772). | 35660797 |
| MSH6 negative | rectum cancer | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy 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 | stomach cancer | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced or metastatic gastric cancer with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | hepatocellular carcinoma | sensitive | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for patients with mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) hepatocellular carcinoma (NCCN.org). | detail... |
Filtering
- Case insensitive filtering will display rows if any text in any cell matches the filter term
- Use simple literal full or partial string matches
- Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
- Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
- Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")
Sorting
- Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
- Click on any column header arrows to sort by that column
- Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03955978 | Phase I | Dostarlimab-gxly | TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer | Recruiting | USA | 0 |
| NCT05405192 | Phase II | Dostarlimab-gxly | Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia | Withdrawn | USA | 0 |
| NCT04165772 | Phase II | Dostarlimab-gxly + Fluorouracil Dostarlimab-gxly Capecitabine + Dostarlimab-gxly | Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors | Recruiting | USA | 0 |
| NCT05565378 | Phase II | Dostarlimab-gxly Dostarlimab-gxly + EOS-448 Pembrolizumab | Phase 2 Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non Small Cell Lung Cancer | Recruiting | ITA | ESP | 5 |
| NCT03833479 | Phase II | Dostarlimab-gxly | TSR-042 as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiation (ATOMICC) (ATOMICC) | Recruiting | ESP | 1 |
| NCT04274023 | Phase II | Dostarlimab-gxly | Study on TSR-042 in Advanced Clear Cell Sarcoma (ACCeSs) | Recruiting | ITA | FRA | ESP | 0 |
| NCT02715284 | Phase I | Dostarlimab-gxly | A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors (GARNET) | Recruiting | USA | ITA | FRA | ESP | CAN | 4 |
| NCT04774419 | Phase II | Dostarlimab-gxly | Radiation and Dostarlimab in People With Endometrial Cancer After They Receive Surgery | Recruiting | USA | 0 |
| NCT04139902 | Phase II | Cobolimab + Dostarlimab-gxly Dostarlimab-gxly | PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor TSR-022 and PD-1 Inhibitor Dostarlimab (TSR-042) | Recruiting | USA | 0 |
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