publication date: May. 2, 2016
Ovarian Cancer Phase III Farletuzumab Trial Fails to Meet Endpoints in Platinum-Sensitive Disease
A phase III trial of farletuzumab failed to meet its endpoints of significantly increasing progression-free survival or overall survival in ovarian cancer patients.
The MORAb-003-004 clinical trial, also known as FAR-131, was a randomized, double-blind, placebo-controlled, global study of the safety and efficacy of weekly farletuzumab in combination with a platinum standard chemotherapy regimen (carboplatin plus a taxane) in platinum-sensitive ovarian cancer patients in first relapse.
Farletuzumab is an investigational, humanized, monoclonal antibody that binds to folate receptor alpha. The study results were published in the Journal of Clinical Oncology.
Patients received carboplatin plus paclitaxel or docetaxel for six cycles, combined with randomized doses of (1:1:1) farletuzumab at 1.25 mg/kg, farletuzumab at 2.5 mg/kg, or placebo. Farletuzumab was continued weekly until disease progression.
Neither farletuzumab dose met the study’s primary progression-free survival endpoint when compared to placebo, with PFS of 9.0, 9.5 (HR = 0.99) and 9.7 months (HR = 0.86) for the placebo, farletuzumab 1.25 mg/kg, and farletuzumab 2.5 mg/kg arms, respectively. There was no difference in overall survival.
Continue reading CCL April – Phase III Farletuzumab Trial Fails to Meet Endpoints in Platinum-Sensitive Ovarian Cancer
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