Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 105 |
| INN | Margetuximab |
| Status | Approved |
| Drug code(s) | MGAH22 |
| Brand name | MARGENZA |
| mAb sequence source | mAb chimeric |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | HER2 |
| Indications of clinical studies | HER2 Positive Cancers (breast, gastric) |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 01, 2010 |
| Start of Phase 2 | March 15, 2013 |
| Start of Phase 3 | August 31, 2015 |
| Date BLA/NDA submitted to FDA | December 18, 2019 |
| Year of first approval (global) | 2020 |
| Date of first US approval | December 16, 2020 |
| INN, US product name | Margetuximab, margetuximab-cmkb |
| US or EU approved indications | Margetuximab in combination with chemotherapy, is approved for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. |
| Company | MacroGenics |
| Licensee/Partner | Zai Lab |
| Comments about company or candidate | Dec. 16, 2020 MacroGenics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved MARGENZA, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. June 2020: MacroGenics' investigational monoclonal antibody candidate margetuximab, a treatment for gastric and gastroesophageal junction cancer, was granted orphan drug designation by the FDA. May 28, 2020: The FDA also stated it continues to anticipate meeting the Prescription Drug User Fee Act (PDUFA) goal date for the application review, which is December 18, 2020. BLA submission announced Dec 19, 2019. NCT04082364 Combination Margetuximab, INCMGA00012, MGD013, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (MAHOGANY) started in Sep 2019. Feb 2019: MacroGenics Announces Positive Results from Pivotal Phase 3 SOPHIA Study of Margetuximab; BLA planned for H2 2019. Nov 2018: Zai Lab obtained regional development and commercialization rights for margetuximab in mainland China, Hong Kong, Macau and Taiwan. Jan 2018: MacroGenics announced that the U.S. FDA has granted Fast Track designation for the investigation of margetuximab for treatment of patients with metastatic or locally advanced HER2 positive breast cancer who have previously been treated with anti-HER2-targeted therapy. Aug 2017: Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. MacroGenics remains on track for completing enrollment of this study by late 2018. NCT02492711 Phase 3 study of margetuximab in HER2-positive metastatic breast cancer recruiting as of late July 2017. NCT01828021 Phase 2 study complete. June 2010, Green Cross entered into a collaboration agreement with MacroGenics for the exclusive development and commercialization of MGAH22 in Korea. Margetuximab has been developed under IND 107768 for treatment of HER2+ carcinomas since 2010. [https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761150Orig1s000MultidisciplineR.pdf] |
| Full address of company | 9704 Medical Center Drive, Rockville, MD 20850 North America United States of America https://macrogenics.com/contact-us/ |
Margetuximab (MGAH22) is derived from 4D5, the parent antibody of trastuzumab. Margetuximab and trastuzumab bind the same epitope of HER2 with similar high affinities. Fc region optimized to markedly increase binding to the low affinity allele of FcγR (F243L; R292P; Y300L; V305I; P396L). The intent is to reduce population differences related to FcγR genotype. Monospecifc, bivalent. Phase 1 study results published in Ann Oncol. 2017 Apr 1;28(4):855-861. doi: 10.1093/annonc/mdx002
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |