Celgene announced results from a Phase 2 study evaluating the combination of Revlimid (lenalidomide) plus Vidaza (azacitidine) in patients ≥60 years with untreated acute myeloid leukemia (AML). Lenalidomide is an immunomodulator and azacitidine is a cytidine analogue.

In the investigator-initiated study, patients received azacitidine 75 mg/m2/day on Days 1–7 followed by lenalidomide 50mg/day on Days 8–28 of 42 day cycles. Treatment was continued until disease progression, unacceptable adverse event or completion of 12 cycles. With 42 patients enrolled in the study, the overall response rate was 41%, with 28% of patients achieving a complete response (CR/CRi). The median time to CR and CRi was 12 and 6 weeks, respectively; the median duration of response (CR/CRi/PR) was 28 weeks (range 6 to >104 weeks). Median overall survival for all patients in the study was 20 weeks (range 1 to >121 weeks) and 69 weeks (range 10 to >121 weeks) for patients who responded to therapy. Additionally, median overall survival for responders was superior to non-responders (69 vs. 15 weeks P<0.01).

Revlimid is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Revlimid is also approved for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Vidaza is indicated for treatment of patients with the following French-American-British myelodysplastic syndromes subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.


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