Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), today reported final results from the phase II portion of a multi-center phase I/II study evaluating combination therapy with REVLIMID (lenalidomide) and VIDAZA (azacitidine) in patients with higher-risk myelodysplastic syndromes (MDS) not previously treated with either drug. These data were presented at the 53rd Annual Meeting of the American Society of Hematology in San Diego, CA.
At a median follow-up of 15 months and a median of five cycles of therapy, the overall response rate for 35 evaluable patients was 72%, with 15 patients (42%) achieving a complete response and 11 (28%) achieving hematologic improvement. Three patients had progressive disease while on therapy. The median duration of complete response at last study assessment was 16 months (range, 3-36) and median overall survival for patients achieving a complete response was 27 months (range, 7-55). Seven (50%) complete responders progressed to AML at a median of 20 months from achieving complete response.
Grade 3/4 non-hematologic adverse events (AEs) (related or unrelated) included cardiac (11%), febrile neutropenia (31%), other infection (8%), pulmonary (11%), vascular access-related thrombosis (6%), CNS hemorrhage (6%) or other (11%). Three (8%) patients died while on study. Median decreases from baseline in absolute neutrophil count (ANC) and platelets were 35% and 18%, respectively, within the first eight weeks.
VIDAZA and REVLIMID are not an approved combination for treatment of patients with higher-risk MDS.
Celgene International Sàrl