Roche has reported positive results from the Phase II M13-982 study, which is designed to assess the efficacy and safety of venetoclax in people with relapsed or refractory chronic lymphocytic leukaemia (CLL) harbouring the 17p deletion.
Venetoclax is an investigational medicine being developed in collaboration with AbbVie. It is designed to selectively bind and inhibit the BCL-2 protein that plays a crucial role in a process known as apoptosis (programmed cell death).
According to Roche, the trial reached its primary endpoint demonstrating that venetoclax monotherapy resulted in a clinically meaningful reduction in the number of cancer cells in a pre-defined proportion of people with previously treated CLL harbouring the 17p deletion.
Roche chief medical officer and global product development head Dr Sandra Horning said: "Approximately 30% to 50% of people with relapsed or refractory chronic lymphocytic leukaemia have the 17p deletion that makes their disease difficult to treat.
"Venetoclax may help restore the natural process that allows these leukaemia 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."
The M13-982 (NCT01889186) is a Phase II, open label, single arm and multi-centre trial that included 107 patients and around 50 patients will be enrolled in the safety expansion cohort.
The trial’s primary endpoint is overall response rate (ORR) as determined by an independent review committee, and secondary endpoints include complete response (CR), partial response (PR) and progression free survival (PFS).
AbbVie intends to use the M13-982 study data for approval with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other health authorities across the globe.
Recently, venetoclax obtained breakthrough therapy status from the FDA to treat previously treated CLL with the 17p deletion.
Image: High-power magnification of a Wright’s stained peripheral blood smear showing chronic lymphocytic leukaemia. Photo: courtesy of Mary Ann Thompson.
