On September 22, Roche announced that the European Commission has approved obinutuzumab (Gazyvaro in Europe; available in the United States as Gazyva) in combination with chemotherapy, followed by obinutuzumab maintenance in patients achieving a response, as a new treatment for previously untreated advanced follicular lymphoma.
The approval is based on results from the GALLIUM study, the first phase III study in previously untreated follicular lymphoma to show superior progression-free survival over rituximab (Rituxan)-based treatment, the current standard of care.
“Every year an estimated 19,000 people in Europe are diagnosed with follicular lymphoma, which is considered to be incurable. We are pleased that with today’s approval of obinutuzumab, these patients now have an improved initial treatment option available to them,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Roche. “By challenging [rituximab]…head-to-head, we have been able to set a new standard of care for people with follicular lymphoma.”
Results from the phase III GALLIUM study showed that obinutuzumab-based treatment reduced the risk of disease progression or death (progression-free survival), as evaluated by investigator assessment, by 34% (hazard ratio [HR] = 0.66; 95% confidence interval [CI] = 0.51–0.85, P = .001). As supported by an independent review committee (IRC), the risk of disease progression or death was reduced by 29% (HR = 0.71; 95% CI = 0.54-0.93, P = .014) compared to rituximab-based treatment. Median progression-free survival has not yet been reached in either treatment arm.
Investigator assessment showed that at 3 years, 80% of patients who received obinutuzumab-based treatment were progression-free, compared to 73% of patients who received rituximab-based treatment.
This is also supported by the IRC analysis, which found that 81.9% of patients who received obinutuzumab-based treatment were progression-free, compared to 77.9% of patients who received rituximab-based treatment. Adverse events observed with either obinutuzumab or rituximab were consistent with those seen in previous clinical trials when each was combined with various chemotherapies.
About the GALLIUM Study
GALLIUM is a global phase III open-label, multicenter, randomized two-arm study examining the efficacy and safety of obinutuzumab plus chemotherapy followed by obinutuzumab alone for up to 2 years, as compared head-to-head against rituximab plus chemotherapy followed by rituximab alone for 2 years or until disease progression (whichever occurs first). Chemotherapies (CHOP, CVP, or bendamustine) were selected by each participating study site prior to beginning enrollment. GALLIUM included 1,401 patients with previously untreated indolent non-Hodgkin lymphoma (NHL), of which 1,202 patients had follicular lymphoma.
The primary endpoint of the study was investigator-assessed progression-free survival in patients with follicular lymphoma, with secondary endpoints including progression-free survival assessed by IRC, progression-free survival in the overall study population (indolent NHL), response rate (overall response and complete response), overall survival, and safety. The GALLIUM study is being conducted in cooperation with the NCRI (United Kingdom), GLSG (Germany), the East German Study Group Hematology, and Oncology (OSHO; Germany).