Roche says new data for Gazyvaro shows progression free survival for up to 3 years in leukemia patients

Swiss drug company Roche (ROG: SIX) said data from two different studies showed the efficacy and safety of its Gazyvaro (obinutuzumab) to treat chronic lymphocytic leukemia (CLL) who are unsuitable for fludarabine-based therapy.

Peter Hillmen, Professor of Experimental Hematology and Honorary Consultant Haematologist at Leeds Teaching Hospitals NHS Trust, UK, said: “The primary aim of treatment in patients with CLL who are considered unfit for fludarabine-based therapy is to achieve durable remissions whilst maintaining quality of life. These updated CLL11 results highlight that after only 6 months of treatment with Gazyvaro plus chlorambucil, patients are treatment-free for a median of nearly four years which is an impressive outcome in this patient population. Encouragingly, we now have emerging data that Gazyvaro can be safely combined with bendamustine and the emerging results from the Green study show that 28% of patients were minimal residual disease (MRD) negative in the bone marrow with this combination. We know from historical data, that patients who achieve MRD negativity have a much better outcome, with durable remissions and prolonged overall survival.”

The company said treatment with Gazyvaro in combination with chlorambucil significantly prolonged progression free survival (PFS) compared with both chlorambucil monotherapy and MabThera (rituximab) plus chlorambucil.