Gazyvaro stalls growth and spread of indolent non-Hodgkin’s lymphoma

Results from a Phase III study show that Roche’s Gazyvaro® (obinutuzumab), in combination with bendamustine chemotherapy, followed by Gazyvaro alone provided significant benefit for people with indolent non-Hodgkin’s lymphoma (NHL) that is refractory to MabThera®/Rituxan® (rituximab)-based treatment.

The results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Gazyvaro is a targeted therapy that works by launching a two-pronged attack on cancer cells: it recognises and seeks out the ‘enemy’ cells and causes them to self-destruct on contact with the drug,while at the same time signalling to the body’s own immune system to attack and remove the cell.This targeted mode of action means the drug, currently only available to treat a type of leukaemia, can lead to deeper and longer-lasting remissions compared with other treatments, while also having a manageable tolerability profile.

Exact benefit of Gazyvaro cannot be calculated until a median PFS has been reached

In the study, Gazyvaro plus bendamustine followed by Gazyvaro alone reduced the risk of disease worsening or death (progression-free survival, PFS) by 45%, compared to bendamustine alone. The GADOLIN study was stopped early due to the strength of the data for Gazyvaro as determined by an independent data monitoring committee. The median PFS (the point in time when 50% of patients have had their disease progress or have passed away) for patients receiving bendamustine alone was 14.9 months at the time of the analysis, but the median was not reached for patients receiving Gazyvaro. The data presented at ASCO are based on 51% of patients either experiencing disease progression or death in the bendamustine arm, but only 37% of patients experienced the same in the Gazyvaro arm. This indicates that patients in the Gazyvaro arm are living for significantly longer without their disease progressing, but its exact benefit cannot be calculated until a median PFS has been reached.

There were no unexpected safety signals identified with Gazyvaro.

“Unfortunately, some people with indolent non-Hodgkin’s lymphoma have disease that is refractory to MabThera/Rituxan-based therapy, a standard of care treatment. We’re excited by these data showing that Gazyvaro could help these people who have few treatment options remaining,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development.

Data from this pivotal study will be submitted to the US Food and Drug Administration, European Medicines Agency and other health authorities around the world for approval consideration.