The results from the pivotal phase III GALLIUM trial in people with previously untreated follicular lymphoma, the most common type of indolent ( slow-growing ) non-Hodgkin lymphoma ( iNHL ), were annoounced.
The study compared the efficacy and safety of Obinutuzumab ( Gazyva / Gazyvaro ) plus chemotherapy ( CHOP, CVP or Bendamustine ) followed by Obinutuzumab alone, head-to-head with Rituximab ( MabThera / Rituxan ) plus chemotherapy followed by Rituximab alone.
Results from a pre-planned interim analysis showed that Obinutuzumab-based treatment significantly reduced the risk of disease worsening or death ( progression-free survival; PFS, as assessed by investigator ) compared to Rituximab-based treatment.
Adverse events with either Obinutuzumab or Rituximab were consistent with what was seen in previous clinical trials when each was combined with various chemotherapies.
In the first head-to-head comparison of Obinutuzumab and Rituximab, the CLL11 study in people with previously untreated chronic lymphocytic leukaemia and comorbidities, Obinutuzumab plus Chlorambucil significantly extended progression-free survival compared to treatment with Rituximab plus Chlorambucil ( median PFS 26.7 months versus 14.9 months, respectively; hazard ratio, HR=0.42; 95% CI, 0.33-0.54; p less than 0.0001 ).
The most common side effects of Obinutuzumab plus Chlorambucil were infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhoea.
GALLIUM is a global phase III open-label, multi-centre, randomised two-arm study examining the efficacy and safety of Obinutuzumab plus chemotherapy, as compared to Rituximab plus chemotherapy, followed by Obinutuzumab or Rituximab alone for up to two years.
Chemotherapies used were CHOP, CVP or Bendamustine as selected by each participating study site.
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 progression-free survival in patients with follicular lymphoma, with secondary endpoints including progression-free survival assessed by independent review committee ( IRC ), progression-free survival in the overall study population ( iNHL ), response rate ( overall response, ORR; and complete response, CR ), overall survival ( OS ), disease-free survival ( DFS ) and safety.
Obinutuzumab is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Obinutuzumab destroys targeted B-cells both directly and together with the body's immune system.
Gazyva / Gazyvaro is currently approved in combination with Chlorambucil, for people with previously untreated chronic lymphocytic leukaemia. The approval was based on the CLL11 study, showing significant improvements with Obinutuzumab plus Chlorambucil across multiple clinical endpoints, including progression-free survival, overall response rate, complete response rate, and minimal residual disease ( MRD ) when compared head-to-head with Rituximab plus Chlorambucil.
Furthermore, Gazyva was recently approved by the FDA ( Food and Drug Administration ) in combination with Bendamustine followed by Gazyva alone for people with follicular lymphoma who did not respond to a Rituximab-containing regimen, or whose follicular lymphoma returned after such treatment. The approval was based on the GADOLIN study, showing a significant improvement in progression-free survival with Obinutuzumab-based therapy compared to Bendamustine alone.
Follicular lymphoma is the most common indolent form of non-Hodgkin lymphoma, accounting for about one in five cases of non-Hodgkin lymphoma. It is considered incurable and relapse is common.
It is estimated that more than 75,000 people are diagnosed with follicular lymphoma each year worldwide. ( Xagena )
Source: Roche, 2016