Therapy Detail
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| Therapy Name | Retifanlimab |
| Synonyms | |
| Therapy Description |
Zynyz (retifanlimab) is a humanized IgG4 monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT085). Zynyz (retifanlimab) is FDA approved for use in adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma, and in combination with Paraplatin (carboplatin) and Taxol (paclitaxel) or as a single agent for patients with anal canal squamous cell carcinoma (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Retifanlimab | Zynyz | MGA 012|INCMGA00012|MGA012|retifanlimab-dlwr | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 132 | Zynyz (retifanlimab) is a humanized IgG4 monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT085). Zynyz (retifanlimab) is FDA approved for use in adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma, and in combination with Paraplatin (carboplatin) and Taxol (paclitaxel) or as a single agent for patients with anal canal squamous cell 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 | rectum cancer | sensitive | Retifanlimab | Guideline | Actionable | Zynyz (retifanlimab) 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 | rectum cancer | sensitive | Retifanlimab | Guideline | Actionable | Zynyz (retifanlimab) 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 | Retifanlimab | Guideline | Actionable | Zynyz (retifanlimab) 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... |
| MLH1 negative | colon cancer | sensitive | Retifanlimab | Guideline | Actionable | Zynyz (retifanlimab) 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04116073 | Phase II | Retifanlimab | INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic Cancer | Completed | USA | 0 |
| NCT03597295 | Phase II | Retifanlimab | A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy | Completed | USA | NOR | ITA | GBR | FRA | ESP | DNK | DEU | BEL | 0 |
| NCT03599713 | Phase II | Retifanlimab | A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma | Completed | USA | POL | ITA | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | AUS | 0 |
| NCT03059823 | Phase I | Retifanlimab | A Phase 1 Study of MGA012 in Patients With Advanced Solid Tumors | Completed | USA | POL | NZL | LVA | LTU | ITA | GBR | FRA | FIN | ESP | DEU | BGR | BEL | AUS | 2 |
| NCT05083754 | Phase I | Retifanlimab Temozolomide Retifanlimab + Temozolomide | Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma | Recruiting | USA | 0 |
| NCT03679767 | Phase II | Retifanlimab | A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203) | Completed | USA | ROU | POL | ITA | HUN | FRA | ESP | AUT | 0 |
| NCT04205812 | Phase III | Retifanlimab Pemetrexed Disodium Carboplatin + Nab-paclitaxel Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium + Retifanlimab Carboplatin + Nab-paclitaxel + Retifanlimab Cisplatin + Pemetrexed Disodium + Retifanlimab Pemetrexed Disodium + Retifanlimab Carboplatin + Pemetrexed Disodium Carboplatin + Paclitaxel + Retifanlimab Carboplatin + Paclitaxel | Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer (POD1UM-304) | Active, not recruiting | USA | TUR | ROU | POL | HUN | CZE | BRA | BGR | 9 |
| 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 |
| NCT05287113 | Phase II | INCAGN02385 + Retifanlimab Retifanlimab INCAGN02385 + INCAGN02390 + Retifanlimab | Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS >= 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck | Active, not recruiting | USA | POL | NLD | ITA | GRC | FRA | ESP | DEU | CAN | BEL | 4 |
| NCT04586244 | Phase II | Retifanlimab Epacadostat + Retifanlimab Epacadostat | An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma (Optimus) | Terminated | USA | ITA | FRA | 0 |
| NCT04463771 | Phase II | Pemigatinib + Retifanlimab Epacadostat + Retifanlimab Retifanlimab | Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. (POD1UM-204) | Active, not recruiting | USA | ITA | GRC | FRA | DEU | BEL | 1 |
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