Amgen, Inc., the largest independent biotech firm in the world, revealed that while there were high hopes for trebananib, a late-stage trial drug for treating ovarian cancer, it failed its third test in proving its ability to significantly improve patient survival.
According to a company spokesperson, trebananib, designed to be used in conjunction with the chemotherapy drug paclitaxel, was being evaluated in a Phase III study to determine both safety and efficacy. However, in this third test, the drug failed to meet the desired secondary endpoint goals pertaining to survival rate.
Findings of the study showed that patients who were administered trebananib along with paclitaxel had an overall survival rate of 19.3 months compared to 18.3 months for participants in the control group receiving a placebo.
Amgen also reported a number of side effects to include edema, alopecia, and nausea as part of the Phase III study, as well as a 20% dropout rate. Although this was the third time that trebananib failed to meet its goal, the company stressed that evaluations in combination with other cancer treatment drugs would continue.
Phase III Trinova-1 was a worldwide, multicenter, double-blind, and placebo-controlled study used to evaluate trebananib in more than 900 women suffering from fallopian tube or recurrent cancer. In addition to these two forms of cancer, trebananib is being studied as a treatment for breast, lung, kidney, and liver cancer.
Amgen admitted the results of the Phase III study were disappointing. Dr. Sean E. Harper, executive vice president of Amgen’s Research and Development said that although survival results fell short, this study is the first of three Phase III trials. For that reason, further exploration of trebananib’s anti-tumor mechanism of action will be done for other cancer settings.
According to medical experts, roughly 14,000 women in the United States alone die annually from ovarian cancer. There are also over 21,000 new cases of this form of cancer diagnosed every year. Of women with ovarian cancer, 70% will have an advanced case when diagnosed and of those, 80% experience a recurrence that eventually leads to death.