New data from the Phase III GADOLIN study demonstrated that Gazyvaro, in combination with bendamustine chemotherapy, followed by Gazyvaro alone, reduced the risk of disease worsening or death by 45% in patients with a difficult-to-treat type of blood cancer, compared with bendamustine alone (progression-free survival or PFS; HR=0.55, 95% CI 0.40-0.74, p=0.0001). This means that the risk of disease progression or death in patients receiving Gazyvaro was cut by nearly half compared to those receiving bendamustine alone. These results were unveiled today at the American Society of Clinical Oncology (ASCO), the world's largest cancer congress.
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.
Gazyvaro has been shown to have a manageable tolerability profile when used in combination with chemotherapy. In the GADOLIN study, the incidence of side-effects was higher in patients receiving Gazyvaro in combination with bendamustine compared to bendamustine alone but no new safety concerns were raised.
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 (HR=0.55, 95% CI 0.40-0.74, p=0.0001). 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.
Roche will submit data from the GADOLIN study to regulatory authorities in Europe for approval consideration.
About the GADOLIN study
GADOLIN is a Phase III open-label, multicentre, randomised study evaluating the safety and efficacy of Gazyvaro plus bendamustine, followed by Gazyvaro alone compared with bendamustine alone in 413 patients with indolent non-Hodgkin lymphoma whose disease progressed during or within 6 months treatment with MabThera (rituximab)-based treatment. The primary endpoint of the study is progression free survival (PFS), with secondary endpoints including response rates and overall survival (OS).