Efficacy of Mirvetuximab soravtansine-gynx

Mirvetuximab soravtansine-gynx (Mirvetuximab soravtansine-gynx) is the first and only treatment option proven to be effective for FR-α-positive, platinum-resistant ovarian cancer. It is recommended for ovarian cancer by the National Comprehensive Cancer Network (NCCN) Oncology Clinical Practice Guidelines as the 2A preferred option for the recurrent treatment of patients with folate receptor α-positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

In the clinical study (0417), patients received mivituximab 6 mg/kg (based on adjusted ideal body weight) as an intravenous infusion every three weeks until disease progression or unacceptable toxicity. Tumor response assessments were performed every 6 weeks for the first 36 weeks and every 12 weeks thereafter. The primary efficacy outcome measures were investigator-assessed overall response rate (ORR) and duration of response (DOR) assessed according to the RECIST version. In the efficacy-evaluable population, patients with platinum-resistant, measurable disease who received at least one dose of therapy (104 patients), the confirmed ORR was 31.7% (95% confidence interval [CI], 22.9-41.6) and the median DOR was 6.9 months (95% confidence interval [CI], 5.6-9.7). In clinical studies, approximately one-third of patients had a complete or partial response to mivituximab treatment.

The most common adverse reactions (including laboratory abnormalities) include visual impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, lymphopenia, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, leukopenia, neutropenia, and hemoglobinopenia.

Since milvituximab has been on the market for a short time, there may be less information on its price and other related information.