Roche reports positive results from Phase III trial of Gazyva to treat iNHL

4th February 2015 (Last Updated February 4th, 2015 18:30)

Roche has reported positive results from the Phase III GADOLIN trial of a monoclonal antibody Gazyva (obinutuzumab) in people with indolent non-Hodgkin’s lymphoma (iNHL) who are refractory to MabThera/Rituxan (rituximab) treatment.

Mantle cell lymphoma intermed mag

Roche has reported positive results from the Phase III GADOLIN trial of a monoclonal antibody Gazyva (obinutuzumab) in people with indolent non-Hodgkin's lymphoma (iNHL) who are refractory to MabThera/Rituxan (rituximab) treatment.

An independent data monitoring committee determined that the trial met its primary endpoint early.

The trial showed that people lived significantly longer without disease worsening or death (progression-free survival, PFS) when treated with Gazyva plus bendamustine followed by Gazyva alone, compared to bendamustine alone.

"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."

As the Gazyva arm showed high level of benefit compared to the bendamustine arm, the trial was stopped prior to its protocol-specified final analysis.

Roche chief medical officer and head of Global Product Development Dr Sandra Horning 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.

"We are delighted that this study could be evaluated early due to the strength of its data, which we believe supports Gazyva's potential in combination with bendamustine for people whose MabThera/Rituxan-based therapy failed to adequately control their disease."

Data from this trial will be submitted to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other health authorities worldwide for approval consideration.

A total of 413 patients with indolent non-Hodgkin's lymphoma were evaluated in the open-label, multi-centre, randomised two-arm trial with Gazyva plus bendamustine followed by Gazyva alone for up to two years compared to bendamustine alone.

The trial's primary endpoint is PFS, while secondary endpoints included response rate (RR), best response and overall survival (OS).

In the EU and Switzerland, Gazyva is marketed as Gazyvaro and is designed to attach to CD20, a protein found only on the surface of B-cells.


Image: Micrograph of mantle cell lymphoma, a type of non-Hodgkin lymphoma. Photo: courtesy of Nephron.