Drug updated on 4/18/2024
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.
Summary
- Mirvetuximab soravtansine-gynx (Elahere) 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.
- Two studies were reviewed, focusing on the efficacy and safety of Elahere in treating these conditions.
- The first study reported an Objective Response Rate (ORR) of 36% and a Progression-Free Survival (PFS) rate of 6.1 months, while the second study showed slightly lower rates at ORR: 34.2% and PFS: 5.82 months.
- Adverse events such as blurred vision, nausea, diarrhea were commonly reported across both studies, with incidence rates varying between approximately 41%-46%. Severe adverse events occurred in about a quarter of patients according to data from the second study.
- No specific subgroups beyond those having FRα positive and platinum-resistant ovarian cancer were detailed in either study, making it difficult to understand if there are differential responses based on patient characteristics like age or genetic variances within this segment.
- While no direct comparisons with other treatments are provided by these studies alone, the efficacy metrics, along with a manageable side effects profile, suggest that Elahere could be considered as a promising option for treating challenging cases where options may be limited due to resistance against traditional therapies like platinum-based drugs.
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 |