Maintenance farletuzumab following chemotherapy in combination with farletuzumab did not improve progression-free survival (PFS) for women with recurrent ovarian cancer, according to results from a study published in the Journal of Clinical Oncology.1

However, this global, multicenter, phase 3 study showed that risk for progression was reduced by 51% in a subset of patients with CA-125 not more than 3 times the upper limit of normal (ULN).

“These observations provide a dose-efficacy relationship for farletuzumab, and hence, proof of principle,” corresponding author Ignace Vergote, MD, chairman of the Leuven Cancer Institute, University Hospital Leuven, Belgium, told Cancer Therapy Advisor.

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For women with epithelial ovarian cancer that has relapsed following initial response to a platinum-based regimen, treatment options are limited to further chemotherapy-based regimens.

“Despite a high initial response rate to first-line platinum doublet chemotherapy following surgical resection of EOC [epithelial ovarian cancer], there is an ongoing unmet need for improved treatment outcome,” the study investigators wrote.

Farletuzumab is a humanized monoclonal antibody against the folate receptor-alpha, which is expressed in 80% to 100% of epithelial ovarian cancers and is significantly absent in normal tissue. The study was undertaken following demonstrated antitumor activity in preclinical models of ovarian cancer and response rates seen in phase 2 studies.

Dr Vergote explained that the earlier phase 2 study, which provided initial observations on its efficacy, was small and might have overestimated the effect of farletuzumab, but added that it might still be effective.

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MORab-003-004—the largest randomized trial in this population that attempted to expand treatment options for these women—was a double-blind, placebo-controlled study that involved 1100 women with epithelial ovarian tumors that relapsed after first-line treatment with platinum-based therapy. Patients were randomly assigned to placebo, farletuzumab 1.25 mg/kg, or farletuzumab 2.5 mg/kg administered once weekly in combination with the standard of care—6 cycles of carboplatin (area under the curve 5 to 6) and either paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 given intravenously every 3 weeks.

Following 6 weeks of combination therapy, patients continued to receive placebo, farletuzumab 1.25 mg/kg, or farletuzumab 2.5 mg/kg administered once weekly until disease progression as determined from modified Response Evaluation Criteria in Solid Tumors version 1.0.