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 136 | 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 |
|---|---|---|---|---|---|---|---|
| PMS2 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 | endometrial carcinoma | sensitive | Retifanlimab | Guideline | Actionable | Zynyz (retifanlimab) is included in guidelines as a second-line or subsequent-line therapy (category 2B) 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... |
| PMS2 negative | appendix adenocarcinoma | sensitive | Retifanlimab | Guideline | Actionable | Zynyz (retifanlimab) 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 | 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... |
| 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 | 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 | endometrial carcinoma | sensitive | Retifanlimab | Guideline | Actionable | Zynyz (retifanlimab) is included in guidelines as a second-line or subsequent-line therapy (category 2B) 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... |
| MSH2 negative | appendix adenocarcinoma | sensitive | Retifanlimab | Guideline | Actionable | Zynyz (retifanlimab) 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 | endometrial carcinoma | sensitive | Retifanlimab | Guideline | Actionable | Zynyz (retifanlimab) is included in guidelines as a second-line or subsequent-line therapy (category 2B) 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... |
| MSH2 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 | appendix adenocarcinoma | sensitive | Retifanlimab | Guideline | Actionable | Zynyz (retifanlimab) 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... |
| CD274 positive | transitional cell carcinoma | predicted - sensitive | Retifanlimab | Phase II | Actionable | In a Phase II trial (POD1UM-203), Zynyz (retifanlimab) treatment was well tolerated and demonstrated antitumor activity in patients with CD274 (PD-L1)-positive (CPS >/= 10%) urothelial carcinoma, resulting in an overall response rate of 37.9% (11/29, 1 complete and 10 partial responses), disease control rate of 55.2%, median progression-free survival of 5.7 months, median duration or response of 11.5 months, and median overall survival of 15.2 months (PMID: 38401247; NCT03679767). | 38401247 |
| PMS2 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... |
| MLH1 negative | appendix adenocarcinoma | sensitive | Retifanlimab | Guideline | Actionable | Zynyz (retifanlimab) 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 | endometrial carcinoma | sensitive | Retifanlimab | Guideline | Actionable | Zynyz (retifanlimab) is included in guidelines as a second-line or subsequent-line therapy (category 2B) 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... |
| 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... |
| CD274 over exp | lung non-small cell carcinoma | predicted - sensitive | Retifanlimab | Phase II | Actionable | In a Phase II trial (POD1UM-203), Zynyz (retifanlimab) treatment was well tolerated and demonstrated antitumor activity in non-small cell lung cancer patients with high CD274 (PD-L1) expression (TPS >/= 50%), resulting in an overall response rate of 34.8% (8/23, 8 partial responses), disease control rate of 65.2%, median progression-free survival of 4.4 months, and median duration of response and median overall survival were not reached (PMID: 38401247; NCT03679767). | 38401247 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT04116073 | Phase II | Retifanlimab | INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic Cancer | Completed | 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 |
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