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Bending the Curve Trial by Trial
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MIRASOL

Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer

Phase 3N = 453NCT04209855

Population
Platinum-resistant, high-grade serous epithelial ovarian cancer with high FRα expression (at least 75% of cells with 2+ staining), one to three prior lines of therapy
Design
Global, confirmatory, open-label, randomised phase 3 trial. Participants with platinum-resistant high-grade serous ovarian cancer who had received one to three lines of therapy and had high FRα tumour expression (at least 75% of cells with 2+ or greater staining intensity) were randomised 1:1 to mirvetuximab soravtansine 6 mg/kg of adjusted ideal body weight every 3 weeks or investigator's-choice chemotherapy (paclitaxel, pegylated liposomal doxorubicin or topotecan). Primary end point investigator-assessed PFS.
Primary endpoint
PFS
Arms
  • Mirvetuximab soravtansine (experimental, n = 227): Mirvetuximab soravtansine 6 mg/kg adjusted ideal body weight every 3 weeks
  • Investigator's-choice chemotherapy (control, n = 226): Paclitaxel, pegylated liposomal doxorubicin or topotecan
People
Moore KN
Δ median PFS+1.64 monthsΔ ORR+26.4 pointsOSHR 0.67 (95% CI 0.50–0.89)Δ median OS+3.71 months
Show the numbers
Results reported for MIRASOL
EndpointAnalysisMirvetuximab soravtansineInvestigator's-choice chemotherapyEffect
PFSRandomised patients (N=453); analysis population not stated in the abstractprimaryMoore 2023median 5.62 months (4.34–5.95)median 3.98 months (2.86–4.47)P<0.001Investigator-assessed. The abstract gives no hazard ratio for PFS.
ORRRandomised patients (N=453); analysis population not stated in the abstractprimaryMoore 202342.3%15.9%P<0.001Key secondary end point. Odds ratio 3.81 (95% CI 2.44-5.94).
OSRandomised patients (N=453); analysis population not stated in the abstractprimaryMoore 2023median 16.46 monthsmedian 12.75 monthsHR 0.67 (95% CI 0.50–0.89)P=0.005Key secondary end point.
Results reported for MIRASOL
EndpointAnalysisMirvetuximab soravtansineInvestigator's-choice chemotherapyEffect
PFSRandomised patients (N=453); analysis population not stated in the abstractprimaryMoore 2023median 5.62 months (4.34–5.95)median 3.98 months (2.86–4.47)P<0.001Investigator-assessed. The abstract gives no hazard ratio for PFS.
ORRRandomised patients (N=453); analysis population not stated in the abstractprimaryMoore 202342.3%15.9%P<0.001Key secondary end point. Odds ratio 3.81 (95% CI 2.44-5.94).
OSRandomised patients (N=453); analysis population not stated in the abstractprimaryMoore 2023median 16.46 monthsmedian 12.75 monthsHR 0.67 (95% CI 0.50–0.89)P=0.005Key secondary end point.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.670.5–0.89
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%02468101214Months (modelled)
  • Mirvetuximab soravtansine (experimental)
  • Investigator's-choice chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsMirvetuximab soravtansineInvestigator's-choice chemotherapy
0100.0%100.0%
461.1%49.8%
742.2%29.5%
1125.8%14.7%
1417.8%8.7%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Mirvetuximab soravtansine (experimental)
  • Investigator's-choice chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsMirvetuximab soravtansineInvestigator's-choice chemotherapy
0100.0%100.0%
1065.6%58.1%
2141.3%31.9%
3127.1%18.5%
4117.8%10.8%
Primary publication: Moore KN, Angelergues A, Konecny GE, García Y, Banerjee S, Lorusso D, et al. Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer. N Engl J Med. 2023;389(23):2162-2174. PubMedDOI

Appears in

Sources

  1. Moore KN, Angelergues A, Konecny GE, García Y, Banerjee S, Lorusso D, et al. Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer. N Engl J Med. 2023;389(23):2162-2174.

    PubMedDOI