Posted on November 25th, 2013 by
The combination of Kyprolis® (carfilzomib), Revlimid® (lenalidomide), and low-dose dexamethasone was well tolerated and produced durable responses in patients with relapsed progressive multiple myeloma, according to the results of a study published in Blood.
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. 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® (bortezomib) have limited treatment options. There is no standard treatment for these patients and they typically have a poor prognosis, with a median overall survival of 9 months.
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. Kyprolis is administered by infusion.
Researchers reported on a phase II dose expansion study that included 52 patients with relapsed progressive multiple myeloma who were part of a maximum planned dose (MPD) cohort. The MPD consisted of Kyprolis 20 mg/m(2) days 1 and 2 of cycle 1 and 27 mg/m(2) days 8, 9, 15, 16, and thereafter; Revlimid 25 mg days 1 to 21; and dexamethasone 40 mg once weekly on 28-day cycles.
The median follow-up was 24.4 months. The overall response rate in the MPD cohort was 76.9 percent. Median time to response was .95 months and the duration of response was 22.1 months. Median progression-free survival was 15.4 months.
Among patients refractory to Velcade, the overall response rate was 69.2 percent and the median duration of response was 22.1 months. Among those who were refractory to Revlimid, the overall response rate was 69.6 percent and the median duration of response was 10.8 months.
A median of 9.5 Kyprolis cycles were started and 7.7 percent of patients required dose reductions and 19.2 percent discontinued the combination (referred to as CRd) due to adverse events. Grade 3-4 adverse events included lymphopenia, neutropenia, thrombocytopenia, and anemia.
The researchers concluded that Kyprolis, Revlimid, and low-dose dexamethasone (CRd) at the maximum planned dose was “well tolerated with robust, rapid, and durable responses.”
Wang M, Martin T, Bensinger W, et al. Phase 2 dose-expansion study (PX-171-006) of carfilzomib, lenalidomide, and low-dose dexamethasone in relapsed or progressive multiple myeloma. Blood. 2013; 122(18):3122-3128.
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