Global, multicenter, randomized, phase ii trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer

B. M. Wolpin, E. M. O'Reilly, Y. J. Ko, L. S. Blaszkowsky, M. Rarick, C. M. Rocha-Lima, P. Ritch, E. Chan, J. Spratlin, T. Macarulla, E. McWhirter, D. Pezet, M. Lichinitser, L. Roman, A. Hartford, K. Morrison, L. Jackson, M. Vincent, L. Reyno, M. Hidalgo

Research output: Contribution to journalArticle

24 Scopus citations

Abstract

Background: We evaluated AGS-1C4D4, a fully human monoclonal antibody to prostate stem cell antigen (PSCA), with gemcitabine in a randomized, phase II study of metastatic pancreatic cancer. Patients and methods: Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0/1 and previously untreated, metastatic pancreatic adenocarcinoma were randomly assigned 1:2 to gemcitabine (1000 mg/m2 weekly seven times, 1 week rest, weekly three times q4weeks) or gemcitabine plus AGS-1C4D4 (48 mg/kg loading dose, then 24 mg/kg q3weeks IV). The primary end point was 6-month survival rate (SR). Archived tumor samples were collected for pre-planned analyses by PSCA expression. Results: Between April 2009 and May 2010, 196 patients were randomly assigned to gemcitabine (n = 63) or gemcitabine plus AGS-1C4D4 (n = 133). The 6-month SR was 44.4% (95% CI, 31.9-57.5) in the gemcitabine arm and 60.9% (95% CI, 52.1-69.2) in the gemcitabine plus AGS-1C4D4 arm (P = 0.03), while the median survival was 5.5 versus 7.6 months and the response rate was 13.1% versus 21.6% in the two arms, respectively. The 6-month SR was 57.1% in the gemcitabine arm versus 79.5% in the gemcitabine plus AGS-1C4D4 arm among the PSCA-positive subgroup and 31.6% versus 46.2% among the PSCA-negative subgroup. Conclusions: This randomized, phase II study achieved its primary end point, demonstrating an improved 6-month SR with addition of AGS-1C4D4 to gemcitabine among patients with previously untreated, metastatic pancreatic adenocarcinoma.

Original languageEnglish (US)
Article numbermdt066
Pages (from-to)1792-1801
Number of pages10
JournalAnnals of Oncology
Volume24
Issue number7
DOIs
StatePublished - Jul 2013

Keywords

  • Chemotherapy
  • Clinical trial
  • Gemcitabine
  • Metastatic disease
  • Pancreatic cancer
  • Prostate stem cell antigen

ASJC Scopus subject areas

  • Oncology
  • Hematology

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