The European Commission has approved Roche's Gazyvaro (obinutuzumab) in combination with chemotherapy, followed by Gazyvaro maintenance in people 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 (PFS) over MabThera (rituximab)-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 approval of Gazyvaro, 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. “By challenging our own MabThera medicine 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 Gazyvaro-based treatment reduced the risk of disease progression or death (progression-free survival; PFS), as evaluated by investigator assessment, by 34 per cent (HR=0.66; 95% CI 0.51-0.85, p=0.001). As supported by an independent review committee (IRC), the risk of disease progression or death was reduced by 29 per cent (HR=0.71; 95% CI 0.54-0.93, p=0.014) compared to MabThera-based treatment. Median PFS has not yet been reached in either treatment arm. Investigator assessment showed that at three years, 80 per cent of patients who received Gazyvaro-based treatment were progression-free compared to 73 per cent of patients who received MabThera-based treatment.

This is also supported by the IRC analysis, which found that 81.9 per cent of patients who received Gazyvaro-based treatment were progression-free compared to 77.9 per cent of patients who received MabThera-based treatment. Adverse events observed with either Gazyvaro or MabThera were consistent with those seen in previous clinical trials when each was combined with various chemotherapies.

This is the third approval for Gazyvaro in the EU. It was approved in 2014, in combination with chlorambucil, for people with previously untreated chronic lymphocytic leukaemia with comorbidities that make them unsuitable for full-dose fludarabine-based therapy. In June 2016 Gazyvaro was also approved in combination with bendamustine, followed by Gazyvaro maintenance, in people with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with MabThera or a MabThera-containing regimen.

GALLIUM (NCT01332968) is a global phase III open-label, multi-centre, randomised two-arm study examining the efficacy and safety of Gazyvaro plus chemotherapy followed by Gazyvaro alone for up to two years, as compared head-to-head against MabThera plus chemotherapy followed by MabThera alone for two years or until disease progression (whichever occurs first). Chemotherapies (CHOP, CVP or bendamustine) were selected by each participating study site prior to beginning enrolment. GALLIUM included 1401 patients with previously untreated indolent non-Hodgkin lymphoma (iNHL), of which 1202 patients had follicular lymphoma. The primary endpoint of the study was investigator-assessed PFS in patients with follicular lymphoma, with secondary endpoints including PFS assessed by IRC, PFS in the overall study population (iNHL), response rate (overall response, ORR; and complete response, CR), overall survival (OS), 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).