Bristol-Myers Squibb (NYSE:BMY) announces positive results from a Phase 3 clinical trial, QUAZAR AML-001, evaluating CC-486 as maintenance therapy in newly diagnosed patients with acute myeloid leukemia (AML) who have achieved remission with intensive induction chemo. The data were presented as ASH in Orlando.
The primary endpoint was overall survival (OS) at month 60. At a median follow-up of 41.2 months, median OS was 24.7 months compared to 14.8 months for placebo (p=0.0009).
Median relapse-free survival, a secondary endpoint, was 10.2 months versus 4.8 months for control (p=0.0001).
Median duration of treatment was 12 cycles.
On the safety front, the most common adverse events (AEs) were nausea (65%), vomiting (60%) and diarrhea (50%). The most common serious/life-threatening AEs were neutropenia (41%), thrombocytopenia (23%) and anemia (14%). Serious AEs occurred in 34% of treated patients. The discontinuation rate was 13% versus 4% for placebo.
The company plans to submit regulatory filings in H1 2020.
CC-486 is an orally administered cytidine nucleoside analogue that incorporates into DNA and RNA and is believed to kill rapidly dividing cancer cells via DNA hypomethylation (loss of a methyl group in the cytosine base).
#ASH19
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