Celgene Corporation CELG today announced results from an
international phase III study of REVLIMID® (lenalidomide) compared with
placebo in patients with red-blood cell (RBC) transfusion dependent low-risk
myelodysplastic syndromes (MDS) who were unresponsive or refractory to
erythropoietin stimulating agents (ESA) and did not have a deletion 5q
cytogenic abnormality. The results were presented during the 56th American
Society of Hematology (ASH) annual meeting.
The study, presented by Valeria Santini, M.D., found that significantly more
patients treated with lenalidomide achieved RBC-transfusion independence of at
least 56 days compared with placebo (26.9%, [43/160 patients] vs. 2.5%,[2/79
patients]; p<0.001), the primary endpoint of the study. The majority of
patients (90%) with transfusion independence responded within 16 weeks of
treatment. For patients who became transfusion independent, the median
duration of transfusion independence was 8.2 months (range 5.2-17.8).
Additionally, transfusion independence of at least 168 days was reached in
17.5% (28/160) of patients receiving lenalidomide compared with no patients
receiving placebo. The incidence of AML progression (per 100 person-years) was
1.91 (95% CI 0.80-4.59) and 2.46 (95% CI 0.79-7.64) for lenalidomide and
placebo patients, respectively. The follow-up period was not long enough to
permit an overall survival comparison.
Myelosuppression was the main adverse event (AE). Grade 3–4 neutropenia
occurred in 61.9% versus 12.7% in the lenalidomide and placebo groups,
respectively, and grade 3–4 thrombocytopenia occurred in 35.6% versus 3.8% in
the lenalidomide and placebo groups, respectively.
“This confirmation of the Phase II data is extremely encouraging. Based on
this study, REVLIMID may offer this refractory patient population an
additional option beyond their current limited choices,” said Guillermo
Garcia-Manero, M.D. of the M.D. Anderson Cancer Center at the University of
Texas.
REVLIMID is not indicated for the treatment of non-del5q MDS in any country.
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