Roche’s Gazyvaro approved in Europe for patients with the most common type of leukemia

• Gazyvaro, the first type II, glycoengineered anti-CD20 monoclonal antibody is now approved in Europe for patients with previously untreated chronic lymphocytic leukemia (CLL)
• Approval is based on the phase III CLL11 study which showed that Gazyvaro plus chlorambucil chemotherapy significantly extended the amount of time people lived without their disease worsening while increasing the depth of their remissions compared to standard treatments such as chlorambucil or MabThera plus chlorambucil

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy). Outside of the EU and Switzerland, Gazyvaro is marketed as Gazyva.

“We are proud to make Gazyvaro available for CLL patients in Europe,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. “Gazyvaro is a new option that helps patients achieve deep responses to treatment that translate to longer lasting remissions.”

The European approval was based on the outcomes of the CLL11 study which was conducted in close collaboration with the German CLL Study Group. The study showed that Gazyvaro plus chlorambucil met its primary endpoint by significantly reducing the risk of disease worsening or death by 61% compared to MabThera/Rituxan plus chlorambucil (progression free survival; PFS). For patients in the Gazyvaro arm, median PFS was 26.7 months compared with 15.2 months for those in the MabThera/Rituxan arm (HR 0.39, CI 0.31-0.49, p<0.001).

Additional Gazyvaro data from the CLL11 study showed higher complete response rates (21% compared with 7%) and a ten-fold increase in the percentage of people achieving minimal residual disease (MRD) negativity^* (37.7% compared with 3.3%) compared to the MabThera/Rituxan arm of the study.

Gazyvaro plus chlorambucil also increased the time people with previously untreated CLL lived (overall survival, OS) compared to those who received treatment with chlorambucil alone. The most common serious adverse events (AEs) for Gazyvaro were infusion-related reactions (IRRs), infections and low cell count of certain white blood cells (neutropenia). The incidence and severity of IRRs decreased dramatically after the first infusion and no serious IRRs have been reported beyond the first infusion. These data from the CLL11 study were published in the New England Journal of Medicine.¹

For CLL patients in Europe, Roche expects to begin launching Gazyvaro in a number of European countries in 2014. Roche is also studying Gazyvaro in other cancers of the blood where anti-CD20 antibodies have been shown to be effective, and where future combination therapies may reduce or eliminate the need for chemotherapy.

Reference

1. Goede V, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions NEJM 2014;370:1101-1110 DOI: 10.1056/NEJMoa1313984