Phase 1b safety study of farletuzumab, carboplatin and pegylated liposomal doxorubicin in patients with platinum-sensitive epithelial ovarian cancer

Kenneth H. Kim, Danijela Jelovac, Deborah K. Armstrong, Benjamin Schwartz, Susan C. Weil, Charles Schweizer, Ronald D. Alvarez

Research output: Contribution to journalArticle

Abstract

Objective Farletuzumab is a humanized monoclonal antibody that binds to folate receptor alpha, over-expressed in epithelial ovarian cancer (EOC) but largely absent in normal tissue. Previously, carboplatin plus pegylated liposomal doxorubicin showed superior progression-free survival and an improved therapeutic index compared with carboplatin/paclitaxel in relapsed platinum-sensitive EOC. This study assessed safety of farletuzumab/carboplatin/pegylated liposomal doxorubicin in women with platinum-sensitive recurrent EOC. Methods This multicenter, single-arm study enrolled patients with platinum-sensitive EOC in first or second relapse for treatment with weekly farletuzumab 2.5 mg/kg plus carboplatin AUC5-6 and pegylated liposomal doxorubicin 30 mg/m2 every 4 weeks for 6 cycles. Subsequently, maintenance with single-agent farletuzumab 2.5 mg/kg once weekly or farletuzumab 7.5 mg/kg once every three weeks continued until progression. The primary objective was to assess the safety of farletuzumab/carboplatin/pegylated liposomal doxorubicin. Results Fifteen patients received a median of 12.0 cycles (range, 3-26) of farletuzumab as combination therapy or maintenance, for a median of 45.0 weeks (range 9-95). Farletuzumab/carboplatin/pegylated liposomal doxorubicin was generally well tolerated, with no farletuzumab-related grades 3-4 adverse events. The most commonly reported adverse events were associated with combination chemotherapy: fatigue (73.3%), nausea (46.7%), and neutropenia (40%). Ten patients had grade ≥ 3 adverse events, most frequently neutropenia and fatigue. No cardiac toxicity was seen. Best overall responses (RECIST) were a complete response for one patient, partial responses for 10 patients, and stable disease for four patients. Conclusions Farletuzumab plus carboplatin/pegylated liposomal doxorubicin in women with platinum-sensitive EOC demonstrated a safety profile consistent with that of carboplatin plus pegylated liposomal doxorubicin.

Original languageEnglish (US)
Pages (from-to)210-214
Number of pages5
JournalGynecologic oncology
Volume140
Issue number2
DOIs
StatePublished - 2016

Keywords

  • Farletuzumab
  • Monoclonal antibody therapy
  • Ovarian cancer
  • Pegylated liposomal doxorubicin
  • Platinum-sensitive relapse

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

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