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GALLIUM showed that the newer anti-CD20 antibody obinutuzumab kept follicular lymphoma at bay for longer than rituximab when given with chemotherapy and as maintenance, at the cost of more serious side effects, and it became a first-line option.
GALLIUM was an open-label phase 3 trial in 1,401 patients with previously untreated advanced indolent non-Hodgkin lymphoma, 1,202 of them with follicular lymphoma, randomised to obinutuzumab or rituximab with bendamustine, CHOP or CVP chosen by the centre, followed by antibody maintenance for two years in responders. The primary endpoint was investigator-assessed progression-free survival in the follicular lymphoma population.
At a planned interim analysis with a median follow-up of 34.5 months, obinutuzumab reduced the risk of progression, relapse or death by a third (three-year progression-free survival 80.0 against 73.3 percent). Response rates were similar, but grade 3 to 5 adverse events (74.6 against 67.8 percent) and serious adverse events were more frequent with obinutuzumab. The result led to approval of obinutuzumab for untreated follicular lymphoma in 2017, and the corpus's follicular lymphoma page lists bendamustine-obinutuzumab alongside bendamustine-rituximab on this trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,401 enrolled.
Median follow-up 34.5 months
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival at 3 years, follicular lymphoma (investigator-assessed)primary | Obinutuzumab + chemotherapy, then obinutuzumab maintenance | 601 | 80% | 0.66 (0.51 to 0.85) | 0.001 | link |
| Rituximab + chemotherapy, then rituximab maintenance | 601 | 73.3% | ||||
| Patients with a progression-free survival event, follicular lymphoma (registry results) | Obinutuzumab + chemotherapy | - | 16.8% | 0.66 (0.51 to 0.85) | 0.0012 | link |
| Rituximab + chemotherapy | - | 24% | ||||
| Overall response rate | Obinutuzumab + chemotherapy | 601 | 88.5% | - | - | link |
| Rituximab + chemotherapy | 601 | 86.9% | ||||
| Grade 3 to 5 adverse events | Obinutuzumab + chemotherapy | - | 74.6% | - | - | link |
| Rituximab + chemotherapy | - | 67.8% | ||||
| Infusion-related events attributed to the antibody | Obinutuzumab + chemotherapy | 595 | 59.3% | - | - | link |
| Rituximab + chemotherapy | 597 | 48.9% |
Obinutuzumab-based immunochemotherapy is a first-line option for follicular lymphoma; the choice against rituximab weighs longer progression-free survival against toxicity and cost.
Rituximab remains the CD20 antibody used in first-line diffuse large B-cell lymphoma. The result is a warning against assuming an antibody improvement carries from one B-cell malignancy to another: the same substitution improved progression-free survival in chronic lymphocytic leukaemia and in follicular lymphoma.
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