Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 5 mg/mL) |
Drug Class | Receptor alpha (FRα)-directed antibodies and microtubule inhibitor conjugates |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
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Summary
- Elahere (mirvetuximab soravtansine-gynx) is indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
- This summary is based on the review of two systematic reviews/meta-analyses. [1-2]
- Objective Response Rate (ORR): Reported ORR was 36% (95% CI: 27%-45%) in one study and 34.2% (95% CI: 25.0%-43.5%) in another study for patients with recurrent or advanced FRα-positive ovarian cancer.
- Progression-Free Survival (PFS): Median PFS was 6.1 months (95% CI: 4.27-7.47) in one study and 5.82 months (95% CI: 4.47-7.18) in another study, with a reported PFS of 6.26 months (95% CI: 4.67-7.85) in patients with platinum-resistant ovarian cancer.
- Disease Control Rate (DCR): DCR was reported as 88% (95% CI: 84%-91%) in a study for the general population of patients with advanced or recurrent ovarian cancer expressing FRα.
- Incidence of Adverse Events (AEs): The overall incidence of adverse events was 87.4% (95% CI: 52.9-100%), with 27.1% (95% CI: 18.9-36.1%) of these being grade ≥3 AEs. The most common AEs included blurred vision (46.7%), nausea (41.8%), and diarrhea (41.3%), with a low incidence of grade III severity for these events.
- Subgroup Findings: Mirvetuximab soravtansine demonstrated an objective response rate (ORR) of 29% and a progression-free survival (PFS) of 6.26 months in patients with platinum-resistant ovarian cancer, with no specific subgroup-related safety concerns noted. The studies primarily focused on patients with advanced or recurrent folate receptor alpha (FRα)-positive ovarian cancer, including those with platinum-resistant disease, without detailing other subgroups.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Elahere (mirvetuximab soravtansine-gynx) Prescribing Information. | 2022 | ImmunoGen, Inc. Waltham, MA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of mirvetuximab soravtansine in recurrent ovarian cancer with FRa positive expression: A systematic review and meta-analysis. | 2024 | Critical Reviews In Oncology/Hematology |
The efficacy and toxicity of mirvetuximab soravtansine, a novel antibody-drug conjugate, in the treatment of advanced or recurrent ovarian cancer: A meta-analysis. | 2023 | Expert Review Of Clinical Pharmacology |