The European Commission has approved Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Roche has revealed that the approval is based on results from the primary analysis of the pivotal phase III CLL14 study, which evaluated the combination of 12-month, fixed-duration Venclyxto plus Gazyvaro, compared to Gazyvaro plus chlorambucil in adults with the disease.
In the trial, the combination led to a 65% reduction in the risk of disease worsening or death and also showed higher response rates (ORR), doubled the complete response rates (CR/CRi) and demonstrated higher rates of minimal residual disease (MRD)-negativity, meaning that no cancer can be detected using a specific and highly sensitive test.
Further, in peripheral blood, MRD-negativity rates were 76% for Venclyxto plus Gazyvaro versus 35% for Gazyvaro plus chlorambucil, and in bone marrow MRD-negativity rates were 57% versus 17%, respectively.
The combo is the “first fixed-duration, chemotherapy-free treatment option that has been shown to help patients with untreated chronic lymphocytic leukaemia live longer without their disease progressing,” said Levi Garraway, Roche’s chief medical officer and head of Global Product Development.
“This is an important step forward for adults with this disease in the EU, who will now have an effective treatment option that enables them to end treatment after one year.”
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in the Western world, mainly affecting men with a median age at diagnosis of about 70 years.