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 disorder
Roche (SIX:ROG; OTCQX:RHHBY) reported satralizumab as monotherapy reduced the risk of relapse by 55% vs. placebo in the Phase III SAkuraStar trial to treat neuromyelitis optica spectrum disorder (NMOSD) (HR=0.45, 95% CI: 0.23-0.89; p=0.0184). Soliris eculizumab from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) is approved in the U.S. to treat the rare disorder; a BLA for inebilizumab from Viela Bio Inc. (Gaithersburg, Md.) is under review with a decision expected next half. Roche said it will work with regulators over the coming months on regulatory submission for satralizumab, which is partnered with Chugai Pharmaceutical Co. Ltd. (Tokyo:4519). ...