Randomized phase II trial of farletuzumab plus chemotherapy versus placebo plus chemotherapy in low CA-125 platinum-sensitive ovarian cancer

Thomas J. Herzog, Sandro Pignata, Sharad A. Ghamande, Maria Jesús Rubio, Keiichi Fujiwara, Christof Vulsteke, Deborah K. Armstrong, Jalid Sehouli, Robert L. Coleman, Hani Gabra, Giovanni Scambia, Bradley J. Monk, José A. Arranz, Kimio Ushijima, Rabbie Hanna, Claudio Zamagni, Robert M. Wenham, Antionio González-Martín, Brian Slomovitz, Yan JiaLisa Ramsay, Krishnansu S. Tewari, Susan C. Weil, Ignace B. Vergote

Research output: Contribution to journalArticlepeer-review

2 Scopus citations


Objective: The primary purpose of this study was to determine if farletuzumab, an antifolate receptor-α monoclonal antibody, improved progression-free survival (PFS) versus placebo when added to standard chemotherapy regimens in patients with platinum-sensitive recurrent ovarian cancer (OC) in first relapse (platinum-free interval: 6–36 months) with low cancer antigen 125 (CA-125) levels. Methods: Eligibility included CA-125 ≤ 3 x upper limit of normal (ULN, 105 U/mL), high-grade serous, platinum-sensitive recurrent OC, previous treatment with debulking surgery, and first-line platinum-based chemotherapy with 1st recurrence between 6 and 36 months since frontline platinum-based treatment. Patients received investigator's choice of either carboplatin (CARBO)/paclitaxel (PTX) every 3 weeks or CARBO/pegylated liposomal doxorubicin (PLD) every 4 weeks x6 cycles in combination with either farletuzumab [5 mg/kg weekly] or placebo randomized in a 2:1 ratio. Maintenance treatment with farletuzumab (5 mg/kg weekly) or placebo was given until disease progression or intolerance. Results: 214 patients were randomly assigned to farletuzumab+chemotherapy (142 patients) versus placebo+chemotherapy (72 patients). The primary efficacy endpoint, PFS, was not significantly different between treatment groups (1-sided α = 0.10; p-value = 0.25; hazard ratio [HR] = 0.89, 80% confidence interval [CI]: 0.71, 1.11), a median of 11.7 months (95% CI: 10.2, 13.6) versus 10.8 months (95% CI: 9.5, 13.2) for farletuzumab+chemotherapy and placebo+chemotherapy, respectively. No new safety concerns were identified with the combination of farletuzumab+chemotherapy. Conclusions: Adding farletuzumab to standard chemotherapy does not improve PFS in patients with OC who were platinum-sensitive in first relapse with low CA-125 levels. Folate receptor-α expression was not measured in this study.

Original languageEnglish (US)
Pages (from-to)300-308
Number of pages9
JournalGynecologic Oncology
StatePublished - Mar 2023


  • Farletuzumab
  • Folate receptor-α
  • MORAb-003
  • Ovarian cancer
  • Progression-free survival

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology


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