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Phase III Study Shows Significant Benefit of Obinutuzumab in Refractory Indolent Non-Hodgkin Lymphoma

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Key Points

  • Interim analysis of the phase III GADOLIN trial found that obinutuzumab plus bendamustine followed by obinutuzumab alone significantly improved progression-free survival compared to bendamustine alone in patients with indolent, refractory non-Hodgkin lymphoma.
  • No unexpected adverse events were seen with obinutuzumab.

In a preplanned interim analysis of the phase III GADOLIN trial, obinutuzumab (Gazyva) plus bendamustine (Trenada) followed by obinutuzumab alone was found to significantly improve progression-free survival compared to bendamustine alone in patients with indolent, refractory non-Hodgkin lymphoma. The study was stopped prior to its protocol-specified final analysis due to the high level of benefit seen in the obinutuzumab arm compared to the bendamustine arm. There were no unexpected adverse events with obinutuzumab.

“GADOLIN is the first of our pivotal phase III studies of [obinutuzumab] to be completed in the non-Hodgkin lymphoma setting, building on the positive results we have seen in chronic lymphocytic leukemia,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Genentech, in a statement.

Obinutuzumab is a monoclonal antibody targeting the CD20 antigen expressed on the surface of B cells. The agent attacks targeted cells both directly and together with the body's immune system. Obinutuzumab is thought to have an increased ability to induce direct cell death and induces greater activity in how it recruits the body’s immune system to attack B cells (antibody dependent cellular cytotoxicity) when compared to rituximab (Rituxan).

GADOLIN Study

GADOLIN is a phase III, open-label, multicenter, randomized trial evaluating obinutuzumab plus bendamustine followed by obinutuzumab alone for up to 2 years compared to bendamustine alone in 413 patients with indolent non-Hodgkin lymphoma whose disease progressed during or following rituximab-based therapy. The primary endpoint of the study is progression-free survival, with secondary endpoints including response rate, best response, and overall survival.

Data from this study will be presented at an upcoming medical meeting and to the U.S. Food and Drug Administration for approval consideration.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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