MIRASOL
In FRα-high platinum-resistant ovarian cancer after prior systemic therapy, does mirvetuximab soravtansine improve outcomes versus investigator-choice chemotherapy?
Evidence snapshot updated 23 October 2026. Source links are provided below; this is an evidence summary, not a substitute for current local guidelines or individual clinical judgement.
Population and treatment
453 patients with FRα-positive platinum-resistant ovarian, fallopian tube or primary peritoneal cancer.
Intervention and comparator: Mirvetuximab soravtansine 6 mg/kg adjusted ideal body weight IV every 3 weeks versus investigator-choice paclitaxel, pegylated liposomal doxorubicin or topotecan.
ClinicalTrials.gov: NCT04209855 ↗
Key results
ORR was 42.3% vs 15.9% (P<.001). Median PFS 5.62 vs 3.98 months; HR 0.65. Median OS 16.46 vs 12.75 months; HR 0.67 (95% CI 0.50–0.89). Grade ≥3 AEs were 41.7% vs 54.1%; discontinuations due to AEs 9.2% vs 15.9%.
Objective response rate · Best overall response
Absolute-effect interpretation: Absolute ORR difference 26.4 percentage points; approximate reciprocal is 4 patients treated for one additional objective response. This response-based figure is not an NNT for survival.
Toxicity and treatment burden
Important risks include ocular toxicity/keratopathy, pneumonitis, peripheral neuropathy and infusion-related reactions. Follow required eye-care/monitoring and dose-modification guidance.
Interpretation and limitations
Benefit depends on confirming the trial-defined high FRα expression using an appropriate validated assay and eligibility criteria. This is not interchangeable with unselected platinum-resistant ovarian cancer treatment.
Use endpoint definitions, follow-up, analysis population and comparator exactly as reported. Do not infer NNT from a hazard ratio or median survival. Subgroup findings should not be treated as predictive unless the trial design and interaction testing support that interpretation.
Primary source and further reading
Primary publication / authoritative source ↗
Trial registry (NCT04209855) ↗
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