Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 79 |
| INN | Mirvetuximab soravtansine |
| Status | Approved |
| Drug code(s) | IMGN853 |
| Brand name | ELAHERE |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Sulfo-SPDB, Cleavable linker |
| Ave. DAR | 3.3 to 4 drugs per mAb |
| Conjugated/fused moiety | Tubulin inhibitor, DM4 maytansine |
| Discovery method/technology | None |
| Target(s) | FR alpha |
| Indications of clinical studies | Epithelial malignancies e.g., ovarian cancer adenocarcinoma |
| 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) | March 15, 2012 |
| Start of Phase 2 | January 15, 2016 |
| Start of Phase 3 | January 15, 2017 |
| Date BLA/NDA submitted to FDA | March 28, 2022 |
| Year of first approval (global) | 2022 |
| Date of first US approval | November 14, 2022 |
| INN, US product name | Mirvetuximab soravtansine, mirvetuximab soravtansine-gynx |
| US or EU approved indications | EU: Treatment of adult patients with folate receptor-alpha-positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. US: Treatment of adult patients with folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. |
| Company | AbbVie |
| Licensee/Partner | None |
| Comments about company or candidate | Nov. 18, 2024: AbbVie announced the European Commission (EC) granted marketing authorization for ELAHERE® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. ELAHERE is the first and only folate receptor alpha (FRɑ)-directed antibody drug conjugate (ADC) medicine approved in the European Union (EU), as well as Iceland, Liechtenstein, Norway, and Northern Ireland. Feb. 12, 2024: AbbVie announced that it has completed its acquisition of ImmunoGen. Oct. 27, 2023-- ImmunoGen, Inc. announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (ELAHERE®) for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Mar. 29, 2022-- ImmunoGen, Inc. announced that it has submitted a Biologics License Application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. PDUFA date is November 28, 2022. NCT04296890 Phase 3 study in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (SORAYA) not yet recruiting as of March 5, 2020. Dec 2019: ImmunoGen announced that FDA has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine. Based on this guidance, the company will initiate SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab). ImmunoGen anticipates enrolling the first patient in SORAYA next quarter and expects top-line data from the study in mid-2021. May 15, 2019-- ImmunoGen, Inc., announced the United States Food and Drug Administration (FDA) has recommended that the Company conduct a new Phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer. Mar. 1, 2019: ImmunoGen, Inc. today announced that its Phase 3 FORWARD I trial evaluating the safety and efficacy of mirvetuximab soravtansine compared to chemotherapy in patients with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer did not meet its primary endpoint of progression-free survival (PFS) in either the entire study population or in the pre-specified subset of patients with high FRα expression. NCT03835819 Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer not yet recruiting as of Jul 6, 2019. June 2018: ImmunoGen granted Fast Track designation by the FDA for treatment of patients with, medium to high, FRα+ve platinum resistant ovarian cancer. Jan 2016 ImmunoGen press release: first patient has been dosed in FORWARD I, the Company’s Phase 3 clinical trial evaluating mirvetuximab soravtansine as a single-agent therapy for the treatment of platinum-resistant ovarian cancer. Mirvetuximab soravtansine is a first-in-class, folate receptor alpha (FRα)-targeting ADC. Mirvetuximab soravtansine is being assessed as a single-agent therapy in the NCT02631876 FORWARD I trial, which is being changed from a Phase 2 to a Phase 3 trial. Mirvetuximab soravtansine is also being assessed in combination regimens in the FORWARD II trial. NCT01609556 recruiting as of June 2015; orphan drug designation for ovarian cancer in US and EU. |
| Full address of company | Waltham, Massachusetts, United States North America United States of America https://www.immunogen.com/ |
M9346A-sulfo-SPDB-DM4 is denoted as IMGN853. M9346A-sulfo-SPDB-DM4 (denoted as IMGN853). DAR range is reported for multiple ADC, including IMGN853 in Ab et al (https://aacrjournals.org/mct/article/14/7/1605/132016/IMGN853-a-Folate-Receptor-FR-Targeting-Antibody)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |