Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 81 |
| INN | Retifanlimab |
| Status | Approved |
| Drug code(s) | INCMGA00012, MGA012 |
| Brand name | Zynyz |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Head & neck cancer, Urothelial Carcinoma, Squamous Cell Carcinoma of the Anal Canal, Triple negative breast cancer, Liposarcoma, Penile Cancer, Glioblastoma, Non-small cell lung cancer, Pancreatic Cancer, Merkel cell carcinoma, squamous cell carcinoma, Colorectal cancer, advanced solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2016 |
| Start of Phase 2 | August 30, 2018 |
| Start of Phase 3 | September 15, 2019 |
| Date BLA/NDA submitted to FDA | August 06, 2022 |
| Year of first approval (global) | 2023 |
| Date of first US approval | March 22, 2023 |
| INN, US product name | Retifanlimab, retifanlimab-dlwr |
| US or EU approved indications | Treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma |
| Company | Macrogenics |
| Licensee/Partner | Incyte |
| Comments about company or candidate | Merkel Cell Carcinoma is approved for EU on Apr 19, 2024 with Incyte Corp March 23, 2023: EMA's CHMP begins evaluation of MAA for retifanlimab. March 22, 2023 I Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz™ (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The Biologics License Application (BLA) for Zynyz for this indication has been approved under accelerated approval by the U.S. FDA based on tumor response rate and duration of response Oct 2021: EMA revealed that Incyte has withdrawn its marketing authorization application for Zynyz (retifanlimab) for the treatment of squamous carcinoma of the anal canal, after the agency raised major concerns about the application, which the company was unable to satisfactorily address. https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/zynyz July 23, 2021 I Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. Jan 21, 2021: Incyte announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. FDA granted Fast Track, Orphan Drug and Priority Review designations for retifanlimab. Oct 5. 2020: Zai Lab Limited, an innovative commercial stage biopharmaceutical company, announced dosing of the first patient in China in the global Phase 3 POD1UM-304 study evaluating retifanlimab, an investigational anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with first-line metastatic non-small-cell lung cancer (NSCLC). NCT04472429 Phase 3 in Squamous Cell Carcinoma of the Anal Canal started Sep 30 2020. NCT04205812 Phase 3 study in NSCLC started in June 2020. Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer. NCT04082364 Combination Margetuximab, INCMGA00012, MGD013, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (MAHOGANY) started in Sep 2019. Nov 2018: Results of Phase 1 NCT03059823 study reported at SITC https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6220479/. Oct 2018: start of Phase 2 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy. Aug 2018: Phase 2 studies (NCT03599713 in Metastatic Merkel Cell Carcinoma) started Aug 30, 2018. NCT03597295 in Squamous Cell Carcinoma of Anal Canal started Sep 10 2018. NCT03531632 Phase 1/2 study in colorectal cancer started in June 2018. In October 2017, Incyte and MacroGenics announced that the companies have entered into an exclusive global collaboration and license agreement for MacroGenics’ MGA012, an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1). Incyte has obtained exclusive worldwide rights for the development and commercialization of MGA012 in all indications, while MacroGenics retains the right to develop its pipeline assets in combination with MGA012. MacroGenics expects to initiate a combination study of MGD009 and MGA012 in the first quarter of 2018. NCT03059823 Phase 1 started in Nov 2016 |
| Full address of company | Rockville, Maryland, United States North America United States of America https://macrogenics.com/ |
Immune checkpoint inhibitor. MGA012, a humanized, hinge-stabilized IgG4κ mAb, was selected based on binding and biophysical properties as well as a functional characterization inclusive of enhanced T-cell activation following superantigen restimulation. (La Motte-Mohs et al 2017 SITC poster; http://ir.macrogenics.com/static-files/f4487126-6659-45e2-9b2a-0dac3d05256f). S228P hinge mutation.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |