Roche announced that it has ended its late-stage study evaluating its leukemia drug Gazyva earlier than expected following positive results.
The company announced positive results from the Phase III GADOLIN study, which evaluated treatment options for patients with indolent non-Hodgkin’s lymphoma (NHL) who are refractory to MabThera/Rituxan (rituximab) treatment. After an interim analysis, an independent data monitoring committee determined that the study met its primary endpoint early, with patients receiving Gazyva (obinutuzumab) plus bendamustine, followed by Gazyva alone, demonstrating a significant improvement in progression-free survival (PFS) compared to patients receiving bendamustine alone. Additionally, no unexpected adverse events were associated with the drug.
Due to the high level of benefit seen in the Gazyva group, the study was stopped prior to its final analysis. Full results from the trial will be submitted for presentation at an upcoming medical meeting.
The positive results of the study helps Roche position its Gazyva medicine as a successor to Rituxan, which generated roughly $7.46 billion in sales last year, and is set to lose patent protection in the US in 2018. Rituxan has already lost patent protection in Europe.
“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 leukemia,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
Gazyva, marketed as Gazyvaro in the European Union (EU) and Switzerland, is a monoclonal antibody designed to attach to CD20, a protein found on the surface of B-cells. The drug attacks and destroys targeted cells both directly and together with the body’s immune system.
Gazyva’s clinical program includes the head-to-head Phase III GOYA study comparing Gazyva plus chemotherapy to Rituxan plus chemotherapy in newly-diagnosed diffuse large B-cell lymphoma and the head-to-head Phase III GALLIUM study comparing Gazyva plus chemotherapy to Rituxan plus chemotherapy in previously untreated indolent non-Hodgkin’s lymphoma.