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 115 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
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, resulting in an objective response rate of 30.4% (7/23) and a disease control rate of 65.2% (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 2571-2571; NCT03679767). 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 urothelial cancer, resulting in an objective response rate of 37.9% (11/29) and a disease control rate of 55.2% (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 2571-2571; NCT03679767). detail...
CD274 positive anal canal squamous cell carcinoma predicted - sensitive Retifanlimab Phase II Actionable In a Phase II trial (POD1UM-202), Zynyz (retifanlimab) treatment resulted in an objective response rate of 13.8% (13/94, 1 complete response, 12 partial responses), a disease control rate of 48.9%, and a median progression-free survival of 7.4 mo (patients with disease control) in patients with advanced or metastatic anal canal squamous carcinoma, with a significant correlation between tumor PD-L1 (CD274) expression and overall survival (p=0.0088) (PMID: 35816951; NCT03597295). 35816951

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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
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
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
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
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
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
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
NCT03679767 Phase II Retifanlimab A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203) Completed USA | ITA | FRA | ESP | AUT 3
NCT04116073 Phase II Retifanlimab INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic Cancer Recruiting USA 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


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