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PURPOSE: To evaluate the pharmacology, efficacy, safety, and dosing and administration considerations (including adjusted ideal body weight [AIBW] dosing) for mirvetuximab soravtansine-gynx, a first-in-class folate receptor �� (FR��)-directed antibody-drug conjugate for platinum-resistant ovarian cancer (PROC).
SUMMARY: A literature search was conducted in PubMed using the terms "ovarian cancer" and "mirvetuximab soravtansine" of articles published from inception to April 16, 2024. Relevant publications, abstracts, and clinical trials were reviewed. Mirvetuximab soravtansine-gynx is dosed at 6 mg/kg AIBW every 3 weeks and comprises an FR-binding antibody, a hydrophilic disulfide linker, and a maytansinoid DM4 payload. Mirvetuximab soravtansine-gynx binds to FR��, which induces receptor-mediated internalization, lysosomal degradation, and release of DM4-containing cytotoxic metabolites. Meaningful anticancer activity in PROC was demonstrated in the single-arm phase 2 SORAYA trial (objective response rate, 32.4%; 95% confidence interval, 23.6% to 42.2%) and the confirmatory, randomized phase 3 MIRASOL trial (median progression-free survival with mirvetuximab soravtansine-gynx vs chemotherapy, 5.62 vs 3.98 months; hazard ratio, 0.65; 95% confidence interval, 0.52-0.81; P < 0.0001]). Ocular disorders (eg, keratopathy and blurred vision), nausea, diarrhea, and fatigue were among the most common adverse events (AEs) that occurred during clinical trials.
CONCLUSION: This review of trial data and pharmacology information for AIBW dosing of mirvetuximab soravtansine-gynx will help support its integration into the PROC treatment landscape. The review also discusses recommendations for prophylaxis, monitoring, and management of common AEs, including eye drop regimens to mitigate ocular events. Mirvetuximab soravtansine-gynx is an effective, novel agent for PROC that targets a newly established biomarker. Established interventions can help mitigate AEs and support the safe use of mirvetuximab soravtansine-gynx.
