Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2

Bradley J. Monk, Andrés Poveda, Ignace Vergote, Francesco Raspagliesi, Keiichi Fujiwara, Duk Soo Bae, Ana Oaknin, Isabelle Ray-Coquard, Diane M. Provencher, Beth Y. Karlan, Catherine Lhommé, Gary Richardson, Dolores Gallardo Rincón, Robert L. Coleman, Christian Marth, Arija Brize, Michel Fabbro, Andrés Redondo, Aristotelis Bamias, Haijun MaFlorian D. Vogl, Bruce A. Bach, Amit M. Oza

Research output: Contribution to journalArticle

Abstract

Purpose Trebananib, a peptibody that blocks binding of angiopoietin-1 and -2 to Tie2, significantly prolonged progression-free survival (PFS) in patients with recurrent epithelial ovarian cancer in the phase 3 TRINOVA-1 study. We report overall survival (OS) in the intent-to-treat population and clinically relevant subgroups and time to second disease progression (PFS-2). Patients and methods Women with recurrent disease (platinum-free interval < 12 months) were randomized to receive intravenous paclitaxel 80 mg/m2 (3 weeks on/1 week off) plus intravenous trebananib 15 mg/kg or placebo, weekly. OS in the intent-to-treat population was a key secondary endpoint. Exploratory analysis of PFS-2 was conducted according to guidance by the European Medicines Agency. Results Median OS was not significantly improved with trebananib compared with placebo (19.3 versus 18.3 months; HR, 0.95; 95% CI, 0.81–1.11; P = 0.52) in the intent-to-treat population (n = 919). In subgroup analysis, trebananib improved median OS compared with placebo (14.5 versus 12.3 months; HR, 0.72; 95% CI, 0.55–0.93; P = 0.011) in patients with ascites at baseline (n = 295). In the intent-to-treat population, trebananib significantly improved median PFS-2 compared with placebo (12.5 versus 10.9 months; HR, 0.85; 95% CI, 0.74–0.98; P = 0.024). The incidence and type of adverse events in this updated analysis was consistent with that described in the primary analysis; no new safety signals were detected. Conclusions OS was not significantly longer in the intent-to-treat population, although there was an improvement in OS in patients with ascites receiving trebananib. PFS-2 confirmed that the PFS benefit associated with trebananib was maintained through the second disease progression independent of the choice of subsequent therapy.

Original languageEnglish
Pages (from-to)27-34
Number of pages8
JournalGynecologic Oncology
Volume143
Issue number1
DOIs
Publication statusPublished - Oct 1 2016

Keywords

  • Ascites
  • Overall survival
  • Recurrent epithelial ovarian cancer
  • Time to second disease progression
  • Trebananib
  • TRINOVA-1

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynaecology

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    Monk, B. J., Poveda, A., Vergote, I., Raspagliesi, F., Fujiwara, K., Bae, D. S., Oaknin, A., Ray-Coquard, I., Provencher, D. M., Karlan, B. Y., Lhommé, C., Richardson, G., Rincón, D. G., Coleman, R. L., Marth, C., Brize, A., Fabbro, M., Redondo, A., Bamias, A., ... Oza, A. M. (2016). Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2. Gynecologic Oncology, 143(1), 27-34. https://doi.org/10.1016/j.ygyno.2016.07.112