In a late-stage trial of an ovarian cancer drug known as trebananib, it failed to result in significantly improved patient survival, the drug's maker Amgen, Inc., has reported.
The anti-tumor treatment drug, intended to be used alongside the chemotherapy drug paclitaxel, was in a Phase 3 study to evaluate it efficacy and safety but did not meet desired secondary endpoint goals for overall patient survival, Amgen said.
In patients being administered the drug in the trial along with chemotherapy, there was an overall survival of 19.3 months, as against 18.3 months for the placebo control group.
Participants in the trial, called the Phase 3 TRINOVA-1 trial, also reported several adverse side effects including edema, alopecia (hair loss) and nausea, and the trial's dropout rate was 20 percent.
The company announced it would continue its evaluations of trebananib, in combination with other drugs, as a treatment for cancer.
"While the overall survival results of the TRINOVA-1 study are disappointing, this study is the first of three Phase 3 trials designed to evaluate the safety and efficacy of trebananib in patients with ovarian cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
The data resulting from the trial would be submitted at a future medical conference and would be published in a journal article, the company said.
"We continue to explore the potential of trebananib's novel anti-tumor mechanism of action in other cancer settings," Harper said.
The drug is also under study as a possible treatment for breast, kidney, lung and liver cancer.
The Phase 3 trial was a global, randomized, multicenter, placebo-controlled, double-blind study evaluating trebananib in over 900 women with recurrent ovarian or fallopian tube cancer, said Amgen, the world largest independent biotechnology company.
About 14,000 women in the United States die each year from ovarian cancer, and more than 21,000 new cases are diagnosed each year, experts say.
Seventy percent of women with ovarian cancer show an advanced case at the time of diagnosis, and 80 percent of them will experience a recurrence of the disease and will eventually succumb to it.
Analysts at the global investment firm Jefferies said the failure of the drug to meet overall survival goals means Amgen is unlikely to get federal approval for the drug, noting the agency has demonstrated a reluctance to approve ovarian cancer treatments without the survival data needed to support such approval.
