Biotechnology company Amgen has reported that its Phase III TRINOVA-1 trial of trebananib plus paclitaxel has met the primary endpoint of progression-free survival (PFS) in the treatment of patients suffering from recurrent ovarian cancer.
In the study, more than 900 women suffering from recurrent partially platinum-sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer were randomised to receive trebananib plus paclitaxel or placebo plus paclitaxel.
Results from the global, multicenter, double-blind study showed the median PFS for patients in the trebananib arm to be 7.2 months, a 34% reduction in the risk of disease progression or death, against 5.4 months in the control arm.
The study’s secondary endpoint of overall survival (OS) is currently under primary analysis and is expected to mature in 2014.
Adverse events like localised edema, nausea and alopecia in the trebananib arm led to about 20% of the patients discontinuing the treatment with the investigational product as compared to 7% in control arm.
Amgen Research and Development executive vice president Dr Sean Harper said that the TRINOVA-1 study was the first of three Phase III 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," Harper said.
The other Phase III studies of trebananib, TRINOVA-2 and TRINOVA-3, are currently underway.
TRINOVA-2 seeks to evaluate superiority of trebananib plus pegylated liposomal doxorubicin (PLD) to placebo plus PLD, while TRINOVA-3 will study trebananib or placebo in combination with paclitaxel and carboplatin in the first-line treatment of epithelial ovarian, primary peritoneal or fallopian tube cancer.
Image: Micrograph of a low malignant potential (LMP) mucinous ovarian tumour, H&E stain. Photo: Courtesy of Nephron.