Amgen (AMGN) 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 alopecia.
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.
Our Take
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 Biogen Idec (BIIB), Anika Therapeutics (ANIK) and Alexion Pharmaceuticals (ALXN). While Biogen and Anika are Zacks Rank #1 (Strong Buy) stocks, Alexion is a Zacks Rank #2 (Buy) stock.
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