Non-Hodgkin's Lymphoma Treatment Shows Significant Benefit in Clinical Trial

Progression-free survival improved from treatment during phase 3 trial.

A combination therapy showed a significant benefit for patients with indolent non-Hodgkin’s lymphoma (iNHL) during a recent clinical trial.

The researchers examined treatment options for iNHL patients who are refractory to treatment with rituximab (Rituxan) treatment. The phase 3 GADOLIN trial found that patients experienced significantly longer progression-free survival from treatment with Genentech’s obinutuzumab (Gazyva) plus bendamustine followed by obinutuzumab alone, compared with bendamustine alone.

The study halted before the protocol-specified final analysis due to a high level of benefit found in the obinutuzumab arm compared with the bendamustine arm. Additionally, patients did not suffer from any unexpected adverse events with obinutuzumab.

"GADOLIN is the first of our pivotal Phase 3 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," Sandra Horning, MD, Genentech chief medical officer and head of Global Product Development said in a press release. "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 Rituxan-based therapy failed to adequately control their disease."

Obinutuzumab is an engineered monoclonal antibody that attaches to the CD20 protein found only on B-cells. The treatment attacks targeted cells directly and in tandem with the immune system.

In comparison with rituximab, obinutuzumab is believed to carry an enhanced ability to induce direct cell death and greater activity in recruiting the immune system to attack B-cells.

Obinutuzumab is currently under investigation in a large clinical program, which includes a head-to-head Phase 3 study comparing obinutuzumab plus chemotherapy with rituximab plus chemotherapy in first-line diffuse large B-cell lymphoma. It is also in a head-to-head Phase 3 trial that compares obinutuzumab plus chemotherapy with rituximab plus chemotherapy in first-line iNHL.

Future combination studies are planned to evaluate obinutuzumab across a range of blood cancers.

The most common side effects from treatment with obinutuzumab are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea.