Non-Hodgkin's Lymphoma Treatment Shows Significant Survival Benefit

High level of benefit found in Gazyva compared with bendamustine.

Patients with non-Hodgkin’s lymphoma with few options left for treatment may soon have new hope.

In the recent phase 3 GADOLIN study, obinutuzumab (Gazyva) plus bendamustine followed by obinutuzumab alone showed a significant benefit in indolent non-Hodgkin’s lymphoma (NHL) that is refractory to rituximab (Rituxan)-based treatment.

The study found obinutuzumab plus bendamustine followed by obinutuzumab alone decreased the risk of worsening disease or progression free survival by 45% compared with bendamustine alone.

The trial was halted before the protocol-specified final analysis as a result of the high level of benefit seen in the obinutuzumab treatment group compared with the bendamustine alone group. Additionally, no unexpected safety signals were identified with obinutuzumab.

The GADOLIN study enrolled 413 indolent NHL patients who experienced disease progression during or within 6 months of prior Rituxan-based therapy.

The median progression free survival was 29.2 months in the obinutuzumab cohort compared with 14.9 months in the bendamustine alone group.

Grade 3-4 adverse events occurred in at least 2% of patients in the obinutuzumab group or bendamustine alone group, including low white blood cell count (33% vs. 26.3%), low blood platelet count (10.8% vs. 16.2%), infusion-related reactions (10.8% vs. 5.6%), low red blood cell count (7.7% vs. 10.1%), low white blood cell count with fever (4.6% vs. 3.5%), nausea (1% vs. 3%), fatigue (1.5% vs. 2.5%), diarrhea (1% vs. 2.5%), vomiting (2.1% vs. 1%), respectively.

“Unfortunately, some people with indolent non-Hodgkin's lymphoma have disease that is refractory to Rituxan-based therapy, a standard of care treatment,” said Sandra Horning, MD, Genentech chief medical officer in a press release. “We're excited by these data showing that Gazyva could help these people who have few treatment options remaining.”