The results from a planned interim analysis of the Phase 3 head-to-head clinical trial ENDEAVOR evaluating Kyprolis® (carfilzomib in combination with low-dose dexamethasone versus Velcade® (bortezomib) and low-dose dexamethasone have demonstrated that the Kyprolis® treated patients lived twice as long without their disease worsening.
Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. In the U.S., approximately 70,000 people are living with multiple myeloma and approximately 24,000 new individuals are diagnosed annually. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine. Patients with multiple myeloma who have become refractory—or resistant—to the drugs Revlimid and Velcade® have limited treatment options. There is no standard treatment for these patients and they typically have a poor prognosis.
Kyprolis belongs to a class of drugs known as proteasome inhibitors. They work by preventing the breakdown of protein in cancer cells, triggering their death.
The ENDEAVOR study is the first of two head-to-head studies for Kyprolis versus Velcade, an established proteasome inhibitor, currently approved to treat multiple myeloma. 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. This study was conducted at 235 sites worldwide.
The results of the study reveled that patients with relapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening compared to Velcade. Kyprolis treated patients survived on average 18.7 months compared to only 9.4 months for those receiving Velcade.
The Kyprolis combination was also reported to have higher overall response rates and less neuropathy. Overall survival data are not yet mature and continue to be monitored. More mature data will be available at the American Society of Clinical Oncology 2015 Annual Meeting in late May.
Reference: Amgen. 2015. Phase 3 Head-to-Head ENDEAVOR Study Demonstrates Superiority Of Kyprolis® (carfilzomib) Over Velcade® (bortezomib) In Patients With Relapsed Multiple Myeloma. Mar. 1.
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