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 in first relapse

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: 2271-8
https://www.ncbi.nlm.nih.gov/pubmed/27001568