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Ovarian Cancer Drug Trebananib Fails to Improve Overall Survival

Previous study showed reduced risk of disease progression or death

Secondary-endpoint results of overall survival (OS) have been reported from the phase III TRINOVA-1 trial in women with recurrent platinum-resistant ovarian cancer.

The study, which compared trebananib (Amgen) plus paclitaxel (Abraxane, Celgene) with placebo plus paclitaxel did not demonstrate a statistically significant improvement in OS. Median OS was 19.3 months in the trebananib arm compared with 18.3 months in the control arm.

In a previously reported primary-endpoint analysis, the data demonstrated a statistically significant difference in progression-free survival (PFS) for trebananib. In that analysis, patients treated with trebananib showed a 34% reduction in the risk of disease progression or death (hazard ratio, 0.66; P < 0.001). Median PFS was 7.2 months in the trebananib arm compared with 5.4 months in the control arm.

In the trebananib group, the most frequently reported adverse events were localized edema, nausea, and alopecia. The rates of discontinuation due to adverse events were 20% in the trebananib arm and 7% in the control arm.

TRINOVA-1 (A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer) was a global, randomized, double-blind, placebo-controlled trial evaluating trebananib in more than 900 women with recurrent partially platinum-sensitive or -resistant (platinum-free interval of 12 months or less) epithelial ovarian, primary peritoneal, or fallopian-tube cancer. The patients were randomly assigned to receive either intravenous (IV) trebananib 15 mg/kg weekly plus intravenous paclitaxel 80 mg/m2 weekly (3 weeks on and 1 week off) or weekly IV placebo plus IV paclitaxel 80 mg/m2 weekly (3 weeks on and 1 week off).

Other ongoing phase III studies of trebananib include TRINOVA-2 and TRINOVA-3. TRINOVA-2 is evaluating whether trebananib plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD, as measured by PFS, in patients with recurrent epithelial ovarian, primary peritoneal, or fallopian-tube cancer. TRINOVA-3 is evaluating trebananib or placebo in combination with paclitaxel and carboplatin in the first-line treatment of epithelial ovarian, primary peritoneal, or fallopian-tube cancer.

Trebananib is an investigational peptibody designed to inhibit the angiopoietin axis, which is involved in angiogenesis. Trebananib binds to both angiopoietin-1 and -2 (Ang1 and Ang2) and inhibits their interaction with the Tie2 receptor. Ang1 and Ang2 mediate separate actions after binding with Tie2. Ang1 affects vessel quality, whereas Ang2 influences vessel quantity. The angiopoietins are also involved in lymphangiogenesis, which plays a key role in tumor metastasis.

Approximately 21,980 women will be diagnosed with ovarian cancer in the U.S. in 2014, and about 14,270 will die from the disease. More than 70% of women with ovarian cancer will present with advanced disease at diagnosis. Of these patients, up to 80% will experience disease recurrence and will eventually die from their disease.

Source: Amgen; November 4, 2014.

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