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SORAYA

Efficacy and Safety of Mirvetuximab Soravtansine in Patients With Platinum-Resistant Ovarian Cancer With High Folate Receptor Alpha Expression: Results From the SORAYA Study

Phase 2N = 106NCT04296890

Population
Platinum-resistant epithelial ovarian cancer with high folate receptor alpha expression, one to three prior therapies including bevacizumab (all patients); 51% had three prior lines and 48% a prior PARP inhibitor
Design
Single-arm phase 2 study of mirvetuximab soravtansine in patients with platinum-resistant epithelial ovarian cancer with high folate receptor alpha expression who had received one to three prior therapies, including required bevacizumab. Primary end point confirmed ORR by investigator; DOR was the key secondary end point.
Primary endpoint
ORR
Arms
  • Mirvetuximab soravtansine (experimental, n = 106): Mirvetuximab soravtansine (antibody-drug conjugate targeting folate receptor alpha)
People
Matulonis UA
Show the numbers
Results reported for SORAYA
EndpointAnalysisMirvetuximab soravtansineControlEffect
ORRFRα-high patients evaluable for efficacy (n=105 of 106 enrolled)primarymedian follow-up 13.4 monthsMatulonis 202332.4% (23.6–42.2%)—Investigator-assessed confirmed ORR (primary end point): five complete and 29 partial responses. Single-arm study; CT.gov labels the record phase 3, the paper calls it phase II.
DORFRα-high patients with a confirmed responseprimarymedian follow-up 13.4 monthsMatulonis 2023median 6.9 months (5.6–9.7)—Key secondary end point.
Results reported for SORAYA
EndpointAnalysisMirvetuximab soravtansineControlEffect
ORRFRα-high patients evaluable for efficacy (n=105 of 106 enrolled)primarymedian follow-up 13.4 monthsMatulonis 202332.4% (23.6–42.2%)—Investigator-assessed confirmed ORR (primary end point): five complete and 29 partial responses. Single-arm study; CT.gov labels the record phase 3, the paper calls it phase II.
DORFRα-high patients with a confirmed responseprimarymedian follow-up 13.4 monthsMatulonis 2023median 6.9 months (5.6–9.7)—Key secondary end point.
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%051015Months (modelled)
  • Mirvetuximab soravtansine (experimental)

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

Data table (modelled values)
MonthsMirvetuximab soravtansine
0100.0%
466.9%
940.5%
1327.1%
1718.1%
Primary publication: Matulonis UA, Lorusso D, Oaknin A, Pignata S, Dean A, Denys H, et al. Efficacy and Safety of Mirvetuximab Soravtansine in Patients With Platinum-Resistant Ovarian Cancer With High Folate Receptor Alpha Expression: Results From the SORAYA Study. J Clin Oncol. 2023;41(13):2436-2445. PubMedDOI

Appears in

Sources

  1. Matulonis UA, Lorusso D, Oaknin A, Pignata S, Dean A, Denys H, et al. Efficacy and Safety of Mirvetuximab Soravtansine in Patients With Platinum-Resistant Ovarian Cancer With High Folate Receptor Alpha Expression: Results From the SORAYA Study. J Clin Oncol. 2023;41(13):2436-2445.

    PubMedDOI