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Clinical Trial
. 2016 Oct;143(1):27-34.
doi: 10.1016/j.ygyno.2016.07.112. Epub 2016 Aug 18.

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  1 , Andrés Poveda  2 , Ignace Vergote  3 , Francesco Raspagliesi  4 , Keiichi Fujiwara  5 , Duk-Soo Bae  6 , Ana Oaknin  7 , Isabelle Ray-Coquard  8 , Diane M Provencher  9 , Beth Y Karlan  10 , Catherine Lhommé  11 , Gary Richardson  12 , Dolores Gallardo Rincón  13 , Robert L Coleman  14 , Christian Marth  15 , Arija Brize  16 , Michel Fabbro  17 , Andrés Redondo  18 , Aristotelis Bamias  19 , Haijun Ma  20 , Florian D Vogl  21 , Bruce A Bach  21 , Amit M Oza  22
Affiliations
Clinical Trial

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 et al. Gynecol Oncol. 2016 Oct.

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<12months) were randomized to receive intravenous paclitaxel 80mg/m(2) (3weeks on/1week off) plus intravenous trebananib 15mg/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 18.3months; 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 12.3months; 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 10.9months; 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.

Keywords: Ascites; Overall survival; Recurrent epithelial ovarian cancer; TRINOVA-1; Time to second disease progression; Trebananib.

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