Trebananib, the experimental last stage platinum-resistant ovarian cancer drug by Amgen, fails to improve overall survival (OS) rate very significantly, it was revealed earlier today. Patient on whom this new drug was tried out, along with a chemotherapy agent paclitaxel, were found to live only a month longer than those who were administered only a placebo. The survival period for people put on this drug was a very slightly higher 19.3 months, as against a period of 18.3 months for those who were not put on it.
These new data follow a successful hit on the goal for progression-free survival. Amgen was expecting much better results from this experimental drug. The drug has been hotly discussed among analysts ad the investors of the company.
Sensing that FDA was reluctant to approve of drugs for ovarian cancer without OS data to support the manufacturer’s claims, analysts had been fretting over this data for quite some time.
Earlier in 2013, the company had reported results of the main goal of the trial. At that time, they had claimed their patients had lived much longer than those not put on a placebo only. Jefferies analysts in a note published on Oct. 20 said oncologists expect the drug to have little or no benefits in terms of overall survival. “Thus, FDA approval is unlikely in our view,” they wrote.
For now, Amgen says it still has a long way to go before it determines the exact value of trebananib, a peptibody designed to inhibit the angiopoietin axis, which is involved in angiogenesis.
“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 R&D chief Dr. Sean Harper. “We continue to explore the potential of trebananib’s novel antitumor mechanism of action in other cancer settings.” The value of the company’s shares fell slightly after the reports were released.