Roche reports positive results from lymphoma drug trial

Roche has announced positive results from a phase III clinical trial assessing its monoclonal antibody therapy Gazyvaro in the treatment of indolent non-Hodgkin's lymphoma.

Data from the Gadolin study showed that people lived significantly longer without disease worsening or death when treated with Gazyvaro plus bendamustine followed by Gazyvaro alone, compared to bendamustine alone.

At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint early, leading to the trial being halted ahead of schedule in light of the high level of benefit seen in the Gazyvaro cohort.

The drug – known as Gazyva in the US – can be used to treat patients who are refractory to MabThera/Rituxan treatment. Data from this trial will be submitted to regulators in the US, EU and elsewhere in order to help secure marketing approval.

Dr Sandra Horning, Roche's chief medical officer and head of global product development, said: "Gadolin is the first of our pivotal phase III studies of Gazyva to be completed in the non-Hodgkin's lymphoma setting, building on the positive results we have seen in chronic lymphocytic leukaemia."

The drug was approved for the treatment of chronic lymphocytic leukaemia in Europe last year.