In a head to head phase 3 study comparing Amgen/Onyx’s carfilzomib (Kyprolis) versus Millenium’s bortezomib (Velcade) in patients with relapsed multiple myeloma who were also given low dose dexamethasone, an interim analysis found that patients in the carfilzomib group had twice the progressive free survival (PFS) time compared to those in bortezomib group (median PFS 18.7 months versus 9.4 months, HR=0.53, 95% CI, 0.44 – 0.65).
The phase 3 study known as ENDEAVOR (RandomizE
Label, Phase 3 Study of Carfilzomib Plus DE
s Bortezomib Plus DexamethasO
ne in Patients With R
elapsed Multiple Myeloma) will be presented the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting being held in Chicago May 29 – June 2, 2015.
In addition to meeting the primary endpoint (PFS difference), the carfilzomib combination demonstrated superiority over the bortezomib combination for secondary objectives of higher overall response rate and lower neuropathy events. Overall survival data are not yet mature and continue to be monitored.
Pablo J. Cagnoni, MD, president, Onyx Pharmaceuticals, Inc. "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."
About ENDEAVOR trial
The ENDEAVOR trial randomized 929 patients with relapsed multiple myeloma after at least one, but not more than three prior therapeutic regimens. The primary endpoint of the trial was PFS, defined as the time from treatment initiation to disease progression or death. Patients received carfilzomib as a 30 minute infusion along with low-dose dexamethasone (20 mg). For Cycle 1 only, carfilzomib was administered at 20 mg/m2
on days 1 and 2, followed by escalation to 56 mg/m2
on days 8, 9, 15, and 16. Patients who tolerated 56 mg/m2
in Cycle 1 were kept at this dose for subsequent cycles on days 1, 2, 8, 9, 15, and 16 on a 28 day cycle. Patients who received bortezomib (1.3 mg/m2
) with low-dose dexamethasone (20 mg) were administered bortezomib subcutaneously or intravenously at the discretion of the investigator and in accordance with regulatory approval of bortezomib. This study was conducted at 235 sites worldwide.
About Multiple Myeloma
Multiple myeloma is a hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the US, approximately 83,000 people are living with multiple myeloma and more than 22,000 new cases were diagnosed and more than 10,000 people died in 2013. Multiple myeloma is an incurable disease with a high rate of relapse and patients often become refractory, despite currently available treatments.
Phase 3 Head-to-Head ENDEAVOR Study Demonstrates Superiority Of Kyprolis® (carfilzomib) Over Velcade® (bortezomib) In Patients With Relapsed Multiple Myeloma [press release]. San Francisco, CA; Amgen; March 1, 2015. http://www.amgen.com/media/media_pr_detail.jsp?releaseID=2021291
. Accessed March 1, 2015.