) recently presented data on its late-stage oncology candidate,
trebananib. Results from the phase III global, multicenter,
randomized, double-blind, placebo-controlled TRINOVA-1 study
showed that trebananib met its primary endpoint of
progression-free survival (PFS).
The study is evaluating trebananib plus paclitaxel versus
placebo plus paclitaxel in patients with recurrent ovarian
cancer. Amgen said that results were statistically significant
with a 34% reduction in the risk of disease progression or death
being observed. Median PFS was better in the trebananib arm
compared to the control arm (7.2 months versus 5.4 months).
However, an early imbalance of deaths favoring the control arm
was observed. Moreover, the rate of discontinuation due to
adverse events was higher in the trebananib arm compared to the
control arm (20% versus 7%). Most frequently reported adverse
events in the trebananib arm included localized edema, nausea and
Apart from the TRINOVA-1 study, Amgen is evaluating trebananib
in two more phase III trials for ovarian cancer - TRINOVA-2 and
TRINOVA-3. While TRINOVA-2 is being conducted to evaluate whether
trebananib plus pegylated liposomal doxorubicin (PLD) is superior
to placebo plus PLD in recurrent epithelial ovarian, primary
peritoneal or fallopian tube cancer, TRINOVA-3 is evaluating
trebananib or placebo plus paclitaxel and carboplatin in the
first-line treatment of epithelial ovarian, primary peritoneal or
fallopian tube cancer.
The positive PFS data is encouraging. However, we believe that
trebananib's approval and market potential depends on the overall
survival (OS) data which will be out next year. Amgen said that
there was an overall favorable OS trend for trebananib in a
pre-planned interim analysis.
Amgen currently carries a Zacks Rank #3 (Hold). Companies that
currently look well-positioned include
). While Biogen and Anika are Zacks Rank #1 (Strong Buy) stocks,
Alexion is a Zacks Rank #2 (Buy) stock.
ALEXION PHARMA (ALXN): Free Stock Analysis
AMGEN INC (AMGN): Free Stock Analysis Report
ANIKA THERAPEUT (ANIK): Free Stock Analysis
BIOGEN IDEC INC (BIIB): Free Stock Analysis
To read this article on Zacks.com click here.