Phase III results with Revlimid (lenalidomide) in non-del-5q Myelodysplastic Syndromes- Celgene

Results from a pre-specified secondary endpoint analysis of MDS-005, a multicenter, randomized, placebo controlled phase III study of Revlimid (lenalidomide), from Celgene Corp, compared with placebo in patients with non-del-5q myelodysplastic syndromes (MDS) found significantly more patients treated with lenalidomide achieved red-blood-cell-transfusion independence (RBC-TI) of at least 56 days compared with placebo (26.9%, [43/160 patients] vs. 2.5%, [2/79 patients]), the primary endpoint of the study. In a post hoc analysis, RBC-TI of at least 8 weeks was associated with significant improvement across all preselected domains, with improvements also exceeding the pre-specified threshold for clinically meaningful change.

In the study, the most common adverse event associated with lenalidomide was related to myelosuppression including neutropenia (64.4% vs 11.4%) and thrombocytopenia (39.4% and 7.6%). 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. Based on the results of MDS-005, Celgene plans to submit a regulatory filing with the FDA in the second half of 2015. The analysis was presented during the 13th International Symposium on Myelodysplastic Syndromes.