Sept. 12 Clinical Quick Takes: Celgene meets in Phase III for AML maintenance therapy; plus Roche, Tocagen, Adverum, Daiichi Sankyo, Apple, Navitor
On Phase III AML meet, Celgene to submit regulatory applications 1H20
Celgene Corp. (NASDAQ:CELG) plans to submit regulatory applications for CC-486 next half after the cytosine nucleoside analog met the primary and secondary endpoints in the Phase III QUAZAR AML-001 trial as a maintenance therapy in newly diagnosed acute myelogenous leukemia patients. CC-486 extended overall survival, the primary endpoint, and improved relapse-free survival, a key secondary endpoint, vs. placebo.
Roche's mAb reduces relapse risk in rare CNS