retifanlimab   Click here for help

GtoPdb Ligand ID: 11583

Synonyms: hPD-1 mAb 7(1.2) [6] | INCMGA0012 | MGA012 | retifanlimab-dlwr | Zynyz®
Approved drug
retifanlimab is an approved drug (FDA (2023))
Compound class: Antibody
Comment: Retifanlimab (MGA012) is a humanized IgG4 anti-PD-1 monoclonal antibody. It was developed by MacroGenics for anti-cancer potential. Retifanlimab blocks the interaction between PD-1 and its ligands PD-L1/2, and it acts as an immune checkpoint modulator.
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Summary of Clinical Use Click here for help
Retifanlimab was evaluated in trials as a monotherapy [2], and in combination with platinum-based chemotherapy, for a range of advanced cancers. It was granted FDA orphan drug designations for the treatment of anal cancer (March 2020) and Merkel cell carcinoma (October 2020). The EMA also granted orphan drug designation for anal cancer (October 2020). FDA marketing approval was granted in March 2023 [3], for the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT04082364 Combination Margetuximab, INCMGA00012, MGD013, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (MAHOGANY) Phase 2/Phase 3 Interventional MacroGenics MAHOGANY trial. 1
NCT04472429 Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2). Phase 3 Interventional Incyte Corporation The POD1UM-303/InterAACT 2 study, was based on positive findings from the POD1UM-202 trial. 5
NCT03597295 A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202) Phase 2 Interventional Incyte Corporation The POD1UM-202 study was completed in November 2021. 4