Vidaza misses in Phase III AML trial

Celgene Corp. (NASDAQ:CELG) said once-daily subcutaneous Vidaza azacitidine for seven days of each 28-day cycle missed the primary endpoint of improving median overall survival (OS) vs. conventional care regimens in the Phase III AML-001 trial to treat acute myelogenous leukemia (AML) (10.4 vs. 6.5 months, p=0.0829). In the open-label, 488-patient study, Vidaza led to a one-year OS rate of 47% vs. 34% for conventional care regimens, which included intensive chemotherapy with cytarabine and an anthracycline plus best supportive care (BSC), low-dose cytarabine plus BSC or BSC alone. In a pre-specified analysis excluding patients who received subsequent AML therapy after the trial, Vidaza significantly improved median OS vs. conventional care regimens (12.1 vs. 6.9 months, p=0.019). Data were presented at the European Hematology Association meeting in Milan.

The company said it plans to meet with regulatory authorities to determine next steps for Vidaza in AML. The hypomethylating agent is also in the Phase III QUAZAR trial as maintenance therapy of AML. Celgene markets Vidaza to treat myelodysplastic syndrome (MDS). ...