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 (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 146 PD-L1/PD-1 antibody 107 | 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 (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 7 |
| 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) | Recruiting | USA | ITA | FRA | 0 |
| 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 |
| NCT03599713 | Phase II | Retifanlimab | A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 4 |
| NCT04116073 | Phase II | Retifanlimab | INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic Cancer | Recruiting | USA | 0 |
| NCT03059823 | Phase I | Retifanlimab | A Phase 1 Study of MGA012 in Patients With Advanced Solid Tumors | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | BEL | AUS | 8 |
| 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 | 16 |
| NCT03679767 | Phase II | Retifanlimab | A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203) | Completed | USA | ITA | FRA | ESP | AUT | 3 |
| 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) | Recruiting | USA | ITA | FRA | DEU | BEL | 3 |
| NCT03597295 | Phase II | Retifanlimab | A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy | Completed | USA | ITA | GBR | FRA | ESP | DEU | BEL | 2 |
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