Interim analysis of the GALLIUM (NCT01332968) clinical trial shows that treatment with Gazyva plus chemotherapy improves progression-free survival in patients with advanced, CD20-positive, untreated follicular lymphoma.
The GALLIUM trial set out to compare the effectiveness and safety of Gazyva compared to Rituxan (rituximab) as both induction and maintenance therapy in patients with previously untreated, advanced CD20-positive non-Hodgkin’s lymphoma (follicular lymphoma or marginal-zone lymphoma). This clinical trial was sponsored by Roche, the company that produces the engineered CD20 monoclonal antibody.
The results of the interim analysis were published in the New England Journal of Medicine, in the study, “Obinutuzumab for the First-Line Treatment of Follicular Lymphoma.”
Like Rituxan, Gazyva is a monoclonal antibody that targets the CD20 antigen present in a subset of tumors. Preclinical studies of this immunotherapy suggest it is more specific for CD20 and induces greater immune-dependent killing of tumor cells. Rituxan is commonly used as maintenance therapy. However, the majority of patients eventually will relapse and better therapies are required.
In the GALLIUM trial, 1,201 patients with follicular lymphoma were randomized to receive intravenous infusions of Gazyva or Rituxan plus chemotherapy for 6-8 cycles. Chemotherapy regimens included: cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP); cyclophosphamide, vincristine, and prednisone (CVP); or bendamustine.
If a positive or partial response was obtained at the end of this induction therapy, patients continued receiving the same monoclonal antibody as a maintenance therapy. This was given for an additional two years or until disease progression, relapse, or death.
The median age of the patients in this study was 59 years. Approximately half of them were female (53.2 percent). The majority of the patients in both the Gazyva (557 of 601) and the Rituxan (551 of 601) groups successfully completed induction therapy.
After a median follow-up of 34.5 months, 361 patients in the Gazyva group and 341 in the Rituxan group completed maintenance therapy.
At this point, the planned interim analysis showed that patients treated with Gazyva plus chemotherapy had significantly lower risk of disease progression. The estimated three-year progression-free survival was 80 percent for patients treated with Gazyva, compared to 73.3 percent for patients treated with Rituxan plus chemotherapy.
These results show that the combination of Gazyva and chemotherapy prolonged time to disease progression, which translated to a 34 percent lower risk of progression, relapse, or death.
Patients in the Gazyva-treated group experienced more serious adverse events than patients treated with Rituxan. The most common adverse events reported were infusion-related reactions, nausea, and low blood counts.