GALLIUM
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.
Overview
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.
- 80 vs 73.3 out of 100 alive without the cancer growing at 3 years with Obinutuzumab + chemotherapy, then obinutuzumab maintenance compared with Rituximab + chemotherapy, then rituximab maintenance; 6.7 more per 100.
- Roughly one extra person helped for every 15 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 34 percent lower chance of the event at any given time (hazard ratio 0.66, likely range 0.51 to 0.85).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 16.8 vs 24 out of 100 alive without the cancer growing with Obinutuzumab + chemotherapy compared with Rituximab + chemotherapy; 7.2 fewer per 100.
- On this measure the first group did worse, not better.
- Put another way, the treated group had about 34 percent lower chance of the event at any given time (hazard ratio 0.66, likely range 0.51 to 0.85).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 88.5 vs 86.9 out of 100 had their tumour shrink with Obinutuzumab + chemotherapy compared with Rituximab + chemotherapy; 1.6 more per 100.
- Roughly one extra person helped for every 63 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- 74.6 vs 67.8 out of 100 reached this endpoint with Obinutuzumab + chemotherapy compared with Rituximab + chemotherapy; 6.8 more per 100.
- On this measure the first group did worse, not better.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- 59.3 vs 48.9 out of 100 reached this endpoint with Obinutuzumab + chemotherapy compared with Rituximab + chemotherapy; 10.4 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Previously untreated advanced indolent non-Hodgkin lymphoma, mainly follicular lymphoma: obinutuzumab or rituximab with the investigator's chemotherapy (bendamustine, CHOP or CVP), followed by two years of maintenance with the same antibody. People in a different situation may not see the same effect.
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% |
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