A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

Trial ID #	NCT00849667
Phase	III
Drug Class	Immunotherapy: Antibodies/FRalpha
Drug Name	Farletuzumab
Alternate Drug Names	anti-GP-3 monoclonal antibody, MORAb-003
Drugs in Trial	Carboplatin, Farletuzumab, Paclitaxel
Eligible Participant	Platinum sensitive ovarian cancer at first recurrence
Patients Enrolled	1,100
Therapy Setting	Maintenance, Recurrence
Study Design	Double Blind, Randomized
Endpoints	PFS, OS, evaluated per RECIST
Biomarkers	Exploratory: CA125 protein
Efficacy	CarboPt+Pac+Far vs CarboPt+Pac+Placebo: PFS: 9.7 vs 9.0 months, HR: 0.86 (0.70-1.06) Exploratory analysis baseline CA125 levels ≤3xULN: PFS: 13.6 vs 8.8 months, HR: 0.49 (0.3-0.79, p=0.0028) OS: NR vs 29.1 months, HR: 0.44 (0.23-0.84, p=0.0108)
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: neutropenia (41%), thrombocytopenia (12%), leukopenia (11%), anemia (10%), similar in all treatment groups
Conclusion	PFS and OS benefit with addition of farletuzumab in patients with baseline CA125 levels ≤3xULN
Reference	Vergote I et al. A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess Efficacy and Safety of Weekly Farletuzumab in Combination With Carboplatin and Taxane in Patients With Ovarian Cancer in First Platinum-Sensitive Relapse. J Clin Oncol (2016) 34(19): 2271-8 https://www.ncbi.nlm.nih.gov/pubmed/27001568