Farletuzumab (a monoclonal antibody against folate receptor alpha) in relapsed platinum-sensitive ovarian cancer

Deborah Kay Armstrong, Allen J. White, Susan C. Weil, Martin Phillips, Robert L. Coleman

Research output: Contribution to journalArticle

Abstract

Objective Farletuzumab is a humanized monoclonal antibody to folate receptor-α, which is over-expressed in most epithelial ovarian cancers but largely absent on normal tissue. We evaluated clinical activity of farletuzumab, alone and combined with chemotherapy, in women with first-relapse, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancers. Methods Fifty-four eligible subjects received open-label farletuzumab weekly, single agent or combined with carboplatin (AUC5-6) and taxane (paclitaxel 175 mg/m2 or docetaxel 75 mg/m2), every 21 days for 6 cycles, followed by farletuzumab maintenance until progression. Twenty-eight subjects with asymptomatic CA125 relapse received single-agent farletuzumab and could receive platinum/taxane chemotherapy plus farletuzumab after single-agent progression. Twenty-six subjects with symptomatic relapse entered the combination arm directly; 21 subjects entered after single agent. Primary endpoints included normalized CA125 and Overall Response Rate (ORR). Duration of each subject's second progression-free interval (PFI2) was compared with her own first response interval (PFI1). Results Farletuzumab was well-tolerated as single agent, without additive toxicity when administered with chemotherapy. Of 47 subjects who received farletuzumab with chemotherapy, 38 (80.9%) normalized CA125. In 9/42 (21%) evaluable subjects, PFI2 was ≥ PFI1, better than the historical rate (3%). There was a high response rate among subjects with PFI1 <12 months (75%), comparable to that in subjects with PFI1 ≥ 12 months (84%). Complete or partial ORR was 75% with combination therapy. Conclusion Based on this study, farletuzumab with carboplatin and taxane may enhance the response rate and duration of response in platinum-sensitive ovarian cancer patients with first relapse after remission of 6-18 months.

Original languageEnglish (US)
Pages (from-to)452-458
Number of pages7
JournalGynecologic Oncology
Volume129
Issue number3
DOIs
StatePublished - Jun 2013

Fingerprint

Folate Receptor 1
Platinum
Ovarian Neoplasms
Monoclonal Antibodies
Recurrence
Drug Therapy
Carboplatin
docetaxel
Antibodies, Monoclonal, Humanized
farletuzumab
Fallopian Tubes
Paclitaxel
Folic Acid

Keywords

  • Carboplatin
  • Farletuzumab
  • Ovarian cancer
  • Platinum-sensitive
  • Taxane

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Farletuzumab (a monoclonal antibody against folate receptor alpha) in relapsed platinum-sensitive ovarian cancer. / Armstrong, Deborah Kay; White, Allen J.; Weil, Susan C.; Phillips, Martin; Coleman, Robert L.

In: Gynecologic Oncology, Vol. 129, No. 3, 06.2013, p. 452-458.

Research output: Contribution to journalArticle

Armstrong, Deborah Kay ; White, Allen J. ; Weil, Susan C. ; Phillips, Martin ; Coleman, Robert L. / Farletuzumab (a monoclonal antibody against folate receptor alpha) in relapsed platinum-sensitive ovarian cancer. In: Gynecologic Oncology. 2013 ; Vol. 129, No. 3. pp. 452-458.
@article{93413bb55e864ed1b1b39477607a9c23,
title = "Farletuzumab (a monoclonal antibody against folate receptor alpha) in relapsed platinum-sensitive ovarian cancer",
abstract = "Objective Farletuzumab is a humanized monoclonal antibody to folate receptor-α, which is over-expressed in most epithelial ovarian cancers but largely absent on normal tissue. We evaluated clinical activity of farletuzumab, alone and combined with chemotherapy, in women with first-relapse, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancers. Methods Fifty-four eligible subjects received open-label farletuzumab weekly, single agent or combined with carboplatin (AUC5-6) and taxane (paclitaxel 175 mg/m2 or docetaxel 75 mg/m2), every 21 days for 6 cycles, followed by farletuzumab maintenance until progression. Twenty-eight subjects with asymptomatic CA125 relapse received single-agent farletuzumab and could receive platinum/taxane chemotherapy plus farletuzumab after single-agent progression. Twenty-six subjects with symptomatic relapse entered the combination arm directly; 21 subjects entered after single agent. Primary endpoints included normalized CA125 and Overall Response Rate (ORR). Duration of each subject's second progression-free interval (PFI2) was compared with her own first response interval (PFI1). Results Farletuzumab was well-tolerated as single agent, without additive toxicity when administered with chemotherapy. Of 47 subjects who received farletuzumab with chemotherapy, 38 (80.9{\%}) normalized CA125. In 9/42 (21{\%}) evaluable subjects, PFI2 was ≥ PFI1, better than the historical rate (3{\%}). There was a high response rate among subjects with PFI1 <12 months (75{\%}), comparable to that in subjects with PFI1 ≥ 12 months (84{\%}). Complete or partial ORR was 75{\%} with combination therapy. Conclusion Based on this study, farletuzumab with carboplatin and taxane may enhance the response rate and duration of response in platinum-sensitive ovarian cancer patients with first relapse after remission of 6-18 months.",
keywords = "Carboplatin, Farletuzumab, Ovarian cancer, Platinum-sensitive, Taxane",
author = "Armstrong, {Deborah Kay} and White, {Allen J.} and Weil, {Susan C.} and Martin Phillips and Coleman, {Robert L.}",
year = "2013",
month = "6",
doi = "10.1016/j.ygyno.2013.03.002",
language = "English (US)",
volume = "129",
pages = "452--458",
journal = "Gynecologic Oncology",
issn = "0090-8258",
publisher = "Academic Press Inc.",
number = "3",

}

TY - JOUR

T1 - Farletuzumab (a monoclonal antibody against folate receptor alpha) in relapsed platinum-sensitive ovarian cancer

AU - Armstrong, Deborah Kay

AU - White, Allen J.

AU - Weil, Susan C.

AU - Phillips, Martin

AU - Coleman, Robert L.

PY - 2013/6

Y1 - 2013/6

N2 - Objective Farletuzumab is a humanized monoclonal antibody to folate receptor-α, which is over-expressed in most epithelial ovarian cancers but largely absent on normal tissue. We evaluated clinical activity of farletuzumab, alone and combined with chemotherapy, in women with first-relapse, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancers. Methods Fifty-four eligible subjects received open-label farletuzumab weekly, single agent or combined with carboplatin (AUC5-6) and taxane (paclitaxel 175 mg/m2 or docetaxel 75 mg/m2), every 21 days for 6 cycles, followed by farletuzumab maintenance until progression. Twenty-eight subjects with asymptomatic CA125 relapse received single-agent farletuzumab and could receive platinum/taxane chemotherapy plus farletuzumab after single-agent progression. Twenty-six subjects with symptomatic relapse entered the combination arm directly; 21 subjects entered after single agent. Primary endpoints included normalized CA125 and Overall Response Rate (ORR). Duration of each subject's second progression-free interval (PFI2) was compared with her own first response interval (PFI1). Results Farletuzumab was well-tolerated as single agent, without additive toxicity when administered with chemotherapy. Of 47 subjects who received farletuzumab with chemotherapy, 38 (80.9%) normalized CA125. In 9/42 (21%) evaluable subjects, PFI2 was ≥ PFI1, better than the historical rate (3%). There was a high response rate among subjects with PFI1 <12 months (75%), comparable to that in subjects with PFI1 ≥ 12 months (84%). Complete or partial ORR was 75% with combination therapy. Conclusion Based on this study, farletuzumab with carboplatin and taxane may enhance the response rate and duration of response in platinum-sensitive ovarian cancer patients with first relapse after remission of 6-18 months.

AB - Objective Farletuzumab is a humanized monoclonal antibody to folate receptor-α, which is over-expressed in most epithelial ovarian cancers but largely absent on normal tissue. We evaluated clinical activity of farletuzumab, alone and combined with chemotherapy, in women with first-relapse, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancers. Methods Fifty-four eligible subjects received open-label farletuzumab weekly, single agent or combined with carboplatin (AUC5-6) and taxane (paclitaxel 175 mg/m2 or docetaxel 75 mg/m2), every 21 days for 6 cycles, followed by farletuzumab maintenance until progression. Twenty-eight subjects with asymptomatic CA125 relapse received single-agent farletuzumab and could receive platinum/taxane chemotherapy plus farletuzumab after single-agent progression. Twenty-six subjects with symptomatic relapse entered the combination arm directly; 21 subjects entered after single agent. Primary endpoints included normalized CA125 and Overall Response Rate (ORR). Duration of each subject's second progression-free interval (PFI2) was compared with her own first response interval (PFI1). Results Farletuzumab was well-tolerated as single agent, without additive toxicity when administered with chemotherapy. Of 47 subjects who received farletuzumab with chemotherapy, 38 (80.9%) normalized CA125. In 9/42 (21%) evaluable subjects, PFI2 was ≥ PFI1, better than the historical rate (3%). There was a high response rate among subjects with PFI1 <12 months (75%), comparable to that in subjects with PFI1 ≥ 12 months (84%). Complete or partial ORR was 75% with combination therapy. Conclusion Based on this study, farletuzumab with carboplatin and taxane may enhance the response rate and duration of response in platinum-sensitive ovarian cancer patients with first relapse after remission of 6-18 months.

KW - Carboplatin

KW - Farletuzumab

KW - Ovarian cancer

KW - Platinum-sensitive

KW - Taxane

UR - http://www.scopus.com/inward/record.url?scp=84877579319&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84877579319&partnerID=8YFLogxK

U2 - 10.1016/j.ygyno.2013.03.002

DO - 10.1016/j.ygyno.2013.03.002

M3 - Article

C2 - 23474348

AN - SCOPUS:84877579319

VL - 129

SP - 452

EP - 458

JO - Gynecologic Oncology

JF - Gynecologic Oncology

SN - 0090-8258

IS - 3

ER -