Nplate(R) Data From MDS Studies Presen... (d patients compared to placebo. Adverse ...)

Nplate(R) Data From MDS Studies Presented at ASH

Date:12/6/2009

d patients compared to placebo. Adverse events were mild to moderate with similar treatment-related adverse events between patients taking Nplate and placebo (33 percent vs. 21 percent, respectively). Similar findings have been reported for use of Nplate in combination with azacytidine (vidaza).

The other study (Abstract #1770) examined patients with low and intermediate risk MDS receiving lenalidomide in combination with Nplate. The objective of the study was to evaluate the effect of Nplate on the incidence of clinically significant thrombocytopenic events and the overall safety and efficacy of Nplate in combination with lenalidomide. The data showed that treatment was generally well-tolerated with a comparable incidence of adverse events between all treatment groups with most frequent adverse events (appearing in greater than or equal to 10 percent of patients) in patients taking Nplate vs. placebo being diarrhea (38.5 percent vs. 45.5 percent, respectively), thrombocytopenia (16.3 percent vs. 36.4 percent), rash (34.7 percent vs. 27.3 percent), edema peripheral (30.8 percent vs. 27.3 percent) and dizziness (11.6 percent vs. 27.3 percent). Data also showed increased platelet counts (31.5 percent vs. 17 percent) and reduced the need for platelet transfusions (19 percent vs. 25 percent) compared to placebo. Adverse events were mild to moderate with similar rates of adverse events between patients taking Nplate and placebo (100 percent vs. 91 percent).

Study Design

Both studies were multi-center, randomized, double-blind, placebo controlled studies that involved low and intermediate risk MDS patients receiving Nplate and decitabine (n=28) or lenalidomide (n=39). Patients received four 28-day cycles of decitabine or lenalidomide in addition to Nplate or placebo. At the end of treatment, there was an optional open-label extension period for patients taking the study drug and Nplate. MDS treatment response (complete response, par
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SOURCE Amgen Inc.
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