AbbVie reports results from venetoclax Phase 2 clinical trial in AML at ASH 2014

AbbVieDec 8 2014

AbbVie (NYSE: ABBV) presented during an oral presentation at the American Society of Hematology's 56^th Annual Meeting new results from a Phase 2 study of investigational compound venetoclax (ABT-199/GDC-0199) in patients with acute myelogenous leukemia (AML). AML is an aggressive and deadly type of blood cancer, in which the body produces too many of a specific type of white blood cell (myeloblast), which can crowd out healthy blood cells. In the study, the venetoclax group showed an overall response rate (ORR) of 15.5 percent, with one patient achieving a complete response and four patients achieving a complete response with incomplete blood count recovery.

A complete response (CR) is sometimes called complete remission, and refers to the disappearance of all signs of cancer in response to cancer treatment. A complete response with incomplete blood count recovery (CRi) is when a patient fulfills most – but not all – criteria to be classified as a complete response. CRi indicates activity but is not the same as a complete response.

"Acute myelogenous leukemia is an aggressive cancer with low survival rates, and there is a high need among patients and healthcare providers for new, effective treatment options," said Marina Konopleva, M.D., Ph.D., associate professor of the Department of Leukemia, Division of Cancer Medicine, at the University of Texas MD Anderson Cancer Center. "The results of this trial of venetoclax are encouraging and warrant additional study in patients with AML."

"This is the first time we have reported results from the venetoclax Phase 2 clinical trial in AML. We believe venetoclax's potential in this indication warrants further investigation," said Gary Gordon, M.D., Ph.D., vice president, oncology clinical development, AbbVie. "The results from this study and AbbVie's other abstracts presented during ASH represent the continued progress of our strong blood cancer development program and demonstrate our commitment to discovering innovative treatment options."