Amgen’s Kyprolis Phase III Focus trial fails to meet primary endpoint

14th August 2014 (Last Updated August 14th, 2014 18:30)

Amgen and its subsidiary Onyx Pharmaceuticals have reported top-line results from Phase III Focus trial of Kyprolis in patients with relapsed and advanced refractory multiple myeloma.

Amgen and its subsidiary Onyx Pharmaceuticals have reported top-line results from Phase III Focus trial of Kyprolis in patients with relapsed and advanced refractory multiple myeloma.

The 315-patient, open-label Focus (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study) trial did not meet its primary endpoint of improving overall survival (OS).

The secondary endpoints included progression-free survival, overall response rate, clinical benefit rate, duration of response and safety.

The randomised trial evaluated single-agent Kyprolis (carfilzomib) for Injection compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in these patients following treatment with at least three prior therapies.

"We believe the results from the recent positive ASPIRE Phase III clinical trial will be sufficient to support regulatory submissions worldwide."

Onyx Pharmaceuticals president Pablo Cagnoni said: "While it is unfortunate that the FOCUS study did not meet its primary endpoint of overall survival, we believe the results from the recent positive ASPIRE Phase III clinical trial will be sufficient to support regulatory submissions around the world."

The company said that almost all patients in the control arm received cyclophosphamide.

Patients were heavily pre-treated and had received a median of five therapeutic regimens prior to trial entry.

In July 2012, the US Food and Drug Administration (FDA) granted accelerated the approval of Kyprolis (carfilzomib) for Injection to treat patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD), and have showed disease progression on or within 60 days of completion of the last therapy.

In the US, Kyprolis is marketed by Onyx Pharmaceuticals.