Bristol-Myers Says CC-486 As Maintenance Therapy Provided Improvement in Overall Survival
December 10 2019 - 8:42AM
Dow Jones News
By Michael Dabaie
Bristol-Myers Squibb Co. (BMY) presented survival and safety
data from its study evaluating CC-486 as maintenance therapy in a
broad population of patients with front-line, newly diagnosed acute
myeloid leukemia.
In the QUAZAR AML-001 study, treatment with CC-486 in the
maintenance setting provided patients a statistically significant
and clinically meaningful improvement in overall survival and
relapse-free survival, as compared to those patients treated with
placebo, Bristol-Myers said.
At a median follow-up of 41.2 months, the primary endpoint of
overall survival was significantly improved for patients receiving
CC-486 compared to placebo, the company said. Median OS from time
of randomization was 24.7 months in the CC-486 arm compared to 14.8
months for placebo. Median relapse-free survival, the key secondary
endpoint, was 10.2 months for those receiving CC-486 compared to
4.8 months for those receiving placebo.
Based on the results of QUAZAR AML-001, Bristol-Myers Squibb
said it is planning regulatory submissions in the first half of
2020.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
December 10, 2019 08:27 ET (13:27 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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