Genentech, a member of the Roche Group, announced positive results from the Phase II M13-982 study of venetoclax, an investigational medicine being developed in partnership with AbbVie. According to a press release, the study met its primary endpoint, showing that venetoclax monotherapy resulted in a clinically meaningful reduction in the number of cancer cells (overall response rate, ORR) in a pre-defined proportion of people with previously treated (relapsed or refractory) chronic lymphocytic leukemia (CLL) harboring the 17p deletion. No unexpected safety signals were reported for venetoclax.
“Approximately 30 to 50 percent of people with relapsed or refractory chronic lymphocytic leukemia have the 17p deletion that makes their disease difficult to treat,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Venetoclax may help restore the natural process that allows these leukemic cells to self destruct, representing a potential new way of helping people with this form of CLL who typically have a poor prognosis and limited treatment options.”
Venetoclax was recently granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of previously treated CLL with the 17p deletion.