Venetoclax meets pivotal Phase II endpoint in CLL

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said venetoclax (ABT-199, RG7601) met the primary endpoint in a pivotal Phase II trial to treat relapsed or refractory chronic lymphocytic leukemia (CLL) patients with the 17p deletion. In the 107-patient study, venetoclax monotherapy reduced the number of cancer cells in a pre-defined patient population, meeting the study's primary endpoint of objective response rate (ORR).

Genentech is co-developing the small molecule B cell lymphoma 2 (MCL-2; BCL2) inhibitor with AbbVie Inc. (NYSE:ABBV), which plans to submit marketing applications to FDA and EMA by YE15. The candidate has Breakthrough Therapy designation from FDA. ...