Celgene International Sàrl (NASDAQ: CELG) today announced that results from a study evaluating the combination of REVLIMID (lenalidomide) plus VIDAZA (azacitidine) in patients 60 years or older with untreated acute myeloid leukemia (AML) were presented at the American Society of Hematology annual meeting in Atlanta, GA.
In the phase II investigator-initiated study, patients received azacitidine 75 mg/m2/day, days 1-7 followed by lenalidomide 50 mg/day, 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).
Most common adverse events were grade 1-2 and gastrointestinal in nature. There was one case each of grade 3 fever, sepsis, hyponatremia, pneumonitis and SIRS syndrome.
A three-arm phase II study in elderly AML patients is currently underway evaluating azacitidine monotherapy, azacitidine followed by lenalidomide (50 mg), and lenalidomide monotherapy.
These data are from an investigational study. REVLIMID® plus VIDAZA® is not approved for the treatment of acute myeloid leukemia.
Celgene International Sàrl