Mirvetuximab soravtansine-gynx

(Elahere®)

Elahere®

Drug updated on 10/24/2024

Dosage FormInjection (intravenous; 100 mg/20 mL [5 mg/mL])
Drug ClassFolate receptor alpha (FRα)-directed antibodies and microtubule inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with FR positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens
  • Select patients for therapy based on an FDA-approved test.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • The Objective Response Rate (ORR) for mirvetuximab soravtansine in recurrent ovarian cancer with FRa-positive expression was 36% (95% Confidence Interval (CI): 27%-45%), and as a second-line and above treatment for advanced or recurrent ovarian cancer, it was 34.2% (95% CI: 25.0-43.5%).
  • The Progression-Free Survival (PFS) was 6.1 months (95% CI: 4.27-7.47) overall, with 6.26 months (95% CI: 4.67-7.85) specifically for platinum-resistant ovarian cancer, and 5.82 months (95% CI: 4.47-7.18) for another group of patients.
  • The Disease Control Rate (DCR) was reported at 88% (95% CI: 84-91%).
  • The most common adverse events (AEs) were blurred vision (45%, Grade III: 2%), nausea (42%, Grade III: 1%), and diarrhea (42%, Grade III: 2%). Another source reported an overall AE incidence of 87.4% (95% CI: 52.9-100.0) and grade ≥ 3 AEs incidence of 27.1% (95% CI: 18.9-36.1), with blurred vision (46.7%), nausea (41.8%), and diarrhea (41.3%) being the most frequent AEs.
  • There was a high incidence of blurred vision, nausea, and diarrhea, with grade ≥ 3 AEs occurring in 27.1% of patients.
  • There is no population types or subgroups information available in the reviewed documents.