Amgen's trebananib flunks key survival measure in ovarian cancer PhIII

Amgen R&D chief Dr. Sean Harper

Amgen's late-stage cancer drug trebananib is looking distinctly less valuable this morning. The Big Biotech ($AMGN) reported today that the drug missed the goal on a significant improvement for overall survival among patients suffering from platinum-resistant ovarian cancer. These new data follow a successful hit on the goal for progression-free survival.

Investigators reported that the median overall survival (OS) rate was 19.3 months in the trebananib (AMG 386) arm versus 18.3 months in the control arm, a painfully short 1-month improvement. Amgen had been hoping to report much better results for this secondary endpoint after seeing median progression-free survival of 7.2 months in the trebananib arm of the Phase III versus 5.4 months in the control arm, a 34% reduction in the risk of disease progression.

Analysts have been fretting over the OS data for some time now, well aware that the FDA has been reluctant to approve drugs for ovarian cancer without the survival data needed to support it. Also, one in 5 patients dropped out of the Phase III study, raising concerns about side effects.

Trebananib is a key part of Amgen's late-stage pipeline, which has been the subject of considerable discussion among analysts and the company's investors. Bernstein's Geoffrey Porges has been leading a charge calling for a breakup of the company, criticizing what it sees as a disjointed pipeline effort. Amgen, meanwhile, has launched a major reorganization that will cost the jobs of thousands of employees, including workers at an R&D campus in Seattle.

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."

- here's the release

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