Obinutuzumab Versus Rituximab Immunochemotherapy in Previously Untreated iNHL: Final Results From the GALLIUM Study
- Study type
- Clinical trial
- Study name
- GALLIUM
- Phase
- Phase 3
- Design
- Randomised trial (1:1); final analysis with a median follow-up of 7.9 years
- Sample size
- 1202 patients with follicular lymphoma
- Source
- Hemasphere · 2023
- Trial registration
- NCT01332968
In plain words
Follicular lymphoma is a slow-growing type of lymphoma. The GALLIUM study compared two antibodies given with chemotherapy and then as maintenance treatment for up to two years: rituximab (the usual treatment) and obinutuzumab. After about eight years of follow-up, the disease came back later in the obinutuzumab group and patients needed their next treatment later, but survival was almost the same in the two groups (about 88% were alive in both groups). Serious side effects were slightly more common with obinutuzumab, so the choice between the two should be based on each patient's situation and made in consultation with the doctor.
Key results
Treatment arms and regimens
Obinutuzumab 1000 mg (flat dose) IV on days 1, 8 and 15 of cycle 1 and day 1 of subsequent cycles, with each centre's chosen chemotherapy (CHOP, CVP or bendamustine) for 6 to 8 cycles; patients with at least a partial response: obinutuzumab 1000 mg every 2 months until progression or for up to 2 years.
Rituximab with the same chemotherapy (CHOP, CVP or bendamustine) for 6 to 8 cycles; responders: rituximab every 2 months for up to 2 years. Rituximab dose in the full text.
Source of the regimen details: FDA label for GAZYVA (Clinical Studies section, GALLIUM trial); rituximab dose in the full text
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with untreated bulky stage II, stage III or stage IV follicular lymphoma requiring treatment (grade 3b and transformed lymphoma were excluded; neutrophils below 1500/µL, platelets below 75000, creatinine clearance below 40 mL/min and transaminases above 2.5 times the upper limit were excluded); 1202 patients.
Endpoints
Primary endpoint: investigator-assessed progression-free survival (PFS).
Other endpoints: time to next anti-lymphoma treatment, overall survival, association of complete metabolic response with outcomes, and safety.
Safety and side effects
Serious adverse events were reported in 48.9% of patients in the obinutuzumab group and 43.4% in the rituximab group. Rates of fatal adverse events did not differ (4.4% and 4.5%). No new safety signals were reported.
Clinical significance and place in guidelines
The final GALLIUM analysis confirms the durable benefit of obinutuzumab in progression-free survival and time to next treatment in advanced follicular lymphoma, with no difference in overall survival and slightly more serious adverse events. The authors consider it a standard first-line option to be chosen according to patient characteristics and safety considerations. Rituximab plus chemotherapy also remains a standard option.
Limitations
The progression-free survival benefit did not translate into improved overall survival. Serious adverse events were more frequent in the obinutuzumab group. The MZL subgroup analysis is exploratory, and the association of complete metabolic response with outcomes is an observational analysis. The accompanying chemotherapy regimen is not stated in the abstract.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.