Biotechnology company Amgen, Inc. (AMGN) on Wednesday announced top-line results of late stage Trebananib (AMG 386) TRINOVA-1 trial in recurrent ovarian cancer. The study met its primary endpoint of progression-free survival or PFS.
"The TRINOVA-1 study is the first of three Phase 3 trials designed to evaluate the safety and efficacy of trebananib in patients with ovarian cancer. Angiopoietin inhibition has been a focus of research at Amgen and these results suggest that the novel biology of trebananib may offer a promising approach for patients with ovarian cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
The Phase 3 study evaluated trebananib plus paclitaxel versus placebo plus paclitaxel in recurrent ovarian cancer. The study revealed PFS with a 34 percent reduction in the risk of disease progression or death. The median PFS was 7.2 months in the trebananib arm versus 5.4 months in the control arm.
The company noted that key secondary endpoint, which is the primary analysis of overall survival (OS), is expected to mature in 2014 in line with previous guidance. Although an early imbalance of deaths favoring the control arm was observed, there was an overall favorable OS trend for trebananib in a pre-planned interim analysis.
Trebananib is an investigational peptibody designed to inhibit the angiopoietin axis. The angiopoietin axis is involved in angiogenesis, a process used by the body to grow new blood vessels, which is also involved in the pathogenesis of several diseases.
Ovarian cancer is the ninth most common cancer among women, excluding non-melanoma skin cancers. It ranks fifth in cancer deaths among women. In the U.S., about 22,240 new cases of ovarian cancer will be diagnosed in 2013, and about 14,230 of the women will die from ovarian cancer, according to key statistics from the American Cancer Society.
The global, multicenter, randomized, double-blind, placebo-controlled Phase 3 TRINOVA-1 trial evaluated trebananib in over 900 women with recurrent partially platinum-sensitive or -resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.
The patients were randomized 1:1 to receive either 15 mg/kg of intravenous trebananib weekly plus 80 mg/m2 of intravenous paclitaxel weekly (three weeks on, one week off) or weekly intravenous placebo plus 80 mg/m2 of intravenous paclitaxel weekly (three weeks on, one week off).
Two other late stage studies of trebananib are ongoing, the TRINOVA-2 and TRINOVA-3.
The TRINOVA-2 trial is evaluating whether trebananib plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by PFS in recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer.
Meanwhile, the TRINOVA-3 trial 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.
In Wednesday's regular trading session, AMGN is currently trading at $97.64, down $0.29 or 0.30% on a volume of 0.51 million shares.
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