Date: 2015-03-01
Type of information: Interim results
phase: 3
Announcement: interim results
Company: Amgen (USA - CA)
Product: Kyprolis® (carfilzomib)
Action
mechanism: proteasome inhibitor
Disease: multiple myeloma
Therapeutic area: Cancer - Oncology
Country: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Republic of Korea, New Zealand, Poland, Romania, Russian Federation, Singapore, Taiwan, Thailand, Ukraine, UK, USA
Trial
details: The randomized ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial of 929 patients 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 primary endpoint of the trial was PFS, defined as the time from treatment initiation to disease progression or death. Patients received Kyprolis as a 30 minute infusion along with low-dose dexamethasone (20 mg). For Cycle 1 only, Kyprolis 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 Velcade (1.3 mg/m2) with low-dose dexamethasone (20 mg) were administered Velcade subcutaneously or intravenously at the discretion of the investigator and in accordance with regulatory approval of Velcade. More than 75 percent of the patients in the control arm received Velcade subcutaneously. This study was conducted at 235 sites worldwide. (NCT01568866)
Latest
news: * On March 1, 2015, Amgen and its subsidiary Onyx Pharmaceuticals announced the results from a planned interim analysis showing that the Phase 3 head-to-head clinical trial ENDEAVOR evaluating Kyprolis® (carfilzomib) for Injection in combination with low-dose dexamethasone versus Velcade® (bortezomib) and low-dose dexamethasone met the primary endpoint of progression-free survival (PFS). Patients with relapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade (median PFS 18.7 months versus 9.4 months, HR=0.53, 95 percent CI, 0.44 – 0.65). The Kyprolis® combination demonstrated superiority over the Velcade 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. Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. The rates of cardiac failure and renal failure for Kyprolis were comparable to those observed in the Phase 3 ASPIRE study. In ENDEAVOR, the rates for cardiac and renal failure were higher in the Kyprolis® arm versus the Velcade® arm. There was an increase in the incidence of hypertension and dyspnea in the Kyprolis® arm compared to Velcade® and that observed in the ASPIRE study. Full data will be submitted for presentation at the American Society of Clinical Oncology 2015 Annual Meeting.
