Amgen and Onyx’s multiple myeloma drug Kyprolis meets primary endpoint in Phase III trial

1st March 2015 (Last Updated March 1st, 2015 18:30)

Amgen and its subsidiary Onyx Pharmaceuticals have reported positive results from a Phase III head-to-head ENDEAVOR trial of Kyprolis (carfilzomib) for Injection in combination with low-dose dexamethasone versus Velcade (bortezomib) and low-dose dexamethasone in patients with relapsed multiple myeloma.

Kyprolis

Amgen and its subsidiary Onyx Pharmaceuticals have reported positive results from a Phase III head-to-head ENDEAVOR trial of Kyprolis (carfilzomib) for Injection in combination with low-dose dexamethasone versus Velcade (bortezomib) and low-dose dexamethasone in patients with relapsed multiple myeloma.

The planned interim analysis shows that the Phase III trial met the primary endpoint of progression-free survival (PFS).

"Demonstrating superiority over Velcade in this head-to-head trial supports our goal of ensuring continued improvement of patient outcomes and potentially establishing Kyprolis as the backbone of therapy for patients with multiple myeloma."

The trial showed that multiple myeloma patients treated with Kyprolis lived twice as long without their disease worsening as well as showed statistically and clinically significant superiority over Velcade.

Onyx Pharmaceuticals president Pablo Cagnoni said: "As new treatment options become available to patients with relapsed multiple myeloma, comparative trials, like ENDEAVOR, are becoming increasingly important to help physicians make informed decisions about the optimal care for patients.

"Demonstrating superiority over Velcade in this head-to-head trial supports our goal of ensuring continued improvement of patient outcomes and potentially establishing Kyprolis as the backbone of therapy for patients with multiple myeloma."

During the trial, Kyprolis combination showed superiority over the Velcade combination for secondary objectives of higher overall response rate and lower neuropathy events.

The company said that treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms, while the rates of cardiac failure and renal failure for Kyprolis were comparable to those observed in the Phase III ASPIRE trial.

In the ENDEAVOR trial, the rates for cardiac and renal failure were higher in the Kyprolis arm versus the Velcade arm, while there was an increase in the incidence of hypertension and dyspnea in the Kyprolis arm compared to Velcade and that observed in the ASPIRE trial.

The trial is the first of two head-to-head studies for Kyprolis versus Velcade, an established proteasome inhibitor, currently approved to treat multiple myeloma.

A total of 929 patients were included in the randomised ENDEAVOR trial, which evaluated Kyprolis in combination with low-dose dexamethasone, versus Velcade with low-dose dexamethasone in patients whose multiple myeloma has relapsed after at least one, but not more than three prior therapeutic regimens.

The trial's primary endpoint was PFS, defined as the time from treatment initiation to disease progression or death.

In the US, Kyprolis is marketed by Onyx Pharmaceuticals, which also holds development and commercialisation rights to the product globally, excluding Japan.


Image: Kyprolis (carfilzomib) for Injection. Photo: Courtesy of Amgen Inc.