Abbvie and Roche report success in Phase II leukaemia trial
pharmafile | August 13, 2015 | News story | Research and Development | AbbVie, Breakthrough Therapy Designation, CLL, EMA, FDA, Roche, chronic lymphocytic leukaemia, leukaemia, venetoclax
AbbVie plans to submit regulatory applications for its leukaemia drug venetoclax to the FDA and the EMA before the end of 2015, after scoring positive mid-stage trial results.
AbbVie’s investigational leukaemia medicine venetoclax achieved its primary endpoint of achieving overall response rates in a Phase II trial. The study evaluated the efficacy and safety of venetoclax in chronic lymphocytic leukaemia (CLL) patients with the 17p gene deletion who had either relapsed, were refractory to existing therapies, or were previously not treated for their condition. The study has enrolled 157 patients, 107 in the main study cohort evaluating efficacy, and 50 patients in the safety expansion cohort.
CLL is a slow-progressing cancer of the bone marrow and blood in which the bone marrow makes too many lymphocytes, a type of white blood cell. It is the most common leukaemia diagnosed in adults in western countries and accounts for some 14,620 new cases of leukaemia in the US each year, out of about 200,000.
AbbVie is developing venetoclax, an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor, in partnership with Switzerland’s Roche and its subsidiary Genentech. The BCL-2 protein prevents apoptosis of some cells, including lymphocytes, and can be expressed in some cancer types. Venetoclax is designed to selectively inhibit the function of the BCL-2 protein. People with this type of CLL typically have a median life expectancy of less than three years.
Data from the Phase II study will be presented at an upcoming medical conference, and the companies say it will serve as the pivotal registration data for applications to the FDA, EMA and other health authorities. The safety profile was similar to previous studies and no unexpected safety signals were reported for venetoclax.
Venetoclax was recently granted Breakthrough Therapy Designation by the FDA for the treatment of previously treated CLL with the 17p deletion.
Michael Severino, executive vice president of research and development and chief scientific officer at AbbVie, says: “Based on these results, we intend to advance regulatory submissions for venetoclax and remain committed to the further development of this investigational medicine, and others in our pipeline, with the goal of delivering new treatment options for people affected by cancer.”
“Approximately 30 to 50% of people with relapsed or refractory chronic lymphocytic leukaemia have the 17p deletion that makes their disease difficult to treat,” says Sandra Horning, chief medical officer and head of global product development at Genentech. “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.”
Joel Levy
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