Roche’s leukaemia drug Gazyva has shown significant benefit in a late-stage trial for refractory indolent non-Hodgkin’s lymphoma, meeting its primary endpoint early.
The Phase III 413-patient GADOLIN study, for people with iNHL who are refractory to Roche’s own MabThera/Rituxan (rituximab) treatment, has been stopped after an interim analysis. This showed that people lived significantly longer without disease worsening or death (progression-free survival) when treated with Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone, compared to bendamustine alone.
Roche chief medical officer Sandra Horning said “we are delighted that this study could be evaluated early due to the strength of its data”. She added that the figures are “building on the positive results we have seen in chronic lymphocytic leukaemia”, for which Gazyva (marketed as Gazyvaro in Europe) is already approved; it is partnered with Biogen Idec in the USA.
The Phase III GOYA and GALLIUM studies, which compare Gazyva regimens head-to-head with Rituxan combos in previously-untreated aggressive and iNHL, respectively, are ongoing.
Data from the study will be submitted for presentation at an upcoming medical meeting and to the US Food and Drug Administration, European Medicines Agency and other regulators for approval in iNHL. Gazyva had sales of 49 million Swiss francs last year and is widely expected to become a blockbuster.