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abstract:
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
Highlights
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- Trebananib did not improve overall survival in the intent-to-treat population.
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- Trebananib improved overall survival in patients with baseline ascites.
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- Trebananib prolonged time to second disease progression.
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.
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