Skip to content
Bending the Curve Trial by Trial
?

GALLIUM

Obinutuzumab for the First-Line Treatment of Follicular Lymphoma

Phase 3N = 1,202NCT01332968

Population
Previously untreated advanced-stage follicular lymphoma; 601 randomised to each group.
Design
Randomised phase 3 trial in previously untreated advanced-stage follicular lymphoma: induction with obinutuzumab-based or rituximab-based chemotherapy, then maintenance for up to 2 years with the same antibody in patients with a response. Primary endpoint: investigator-assessed progression-free survival; the primary analysis was a planned interim analysis. 1202 patients were randomised.
Primary endpoint
PFS
Arms
  • Rituximab-based chemotherapy (control, n = 601): Rituximab-based chemotherapy induction, then rituximab maintenance for up to 2 years in responders
  • Obinutuzumab-based chemotherapy (experimental, n = 601): Obinutuzumab-based chemotherapy induction, then obinutuzumab maintenance for up to 2 years in responders
People
Marcus R
PFSHR 0.66 (95% CI 0.51–0.85)Δ 36-month PFS+6.7 pointsΔ ORR+1.6 points
Show the numbers
Results reported for GALLIUM
EndpointAnalysisObinutuzumab-based chemotherapyRituximab-based chemotherapyEffect
PFSRandomised patients (601 per group)Investigator-assessed progression-free survival.interimmedian follow-up 34.5 monthsMarcus 201780% at 3 y73.3% at 3 yHR 0.66 (95% CI 0.51–0.85)P=0.001Planned interim analysis; estimated 3-year rates. The hazard ratio is for progression, relapse or death. Median follow-up range 0 to 54.5 months. Similar results were reported with independently reviewed PFS.
ORRRandomised patients (601 per group)interimMarcus 201788.5%86.9%The abstract describes response rates as similar in the two groups.
Results reported for GALLIUM
EndpointAnalysisObinutuzumab-based chemotherapyRituximab-based chemotherapyEffect
PFSRandomised patients (601 per group)Investigator-assessed progression-free survival.interimmedian follow-up 34.5 monthsMarcus 201780% at 3 y73.3% at 3 yHR 0.66 (95% CI 0.51–0.85)P=0.001Planned interim analysis; estimated 3-year rates. The hazard ratio is for progression, relapse or death. Median follow-up range 0 to 54.5 months. Similar results were reported with independently reviewed PFS.
ORRRandomised patients (601 per group)interimMarcus 201788.5%86.9%The abstract describes response rates as similar in the two groups.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.660.51–0.85
Primary publication: Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, et al. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017;377(14):1331-1344. PubMedDOI

Appears in

Sources

  1. Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, et al. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017;377(14):1331-1344.

    PubMedDOI