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Sustained clinical benefit of Obinutuzumab plus chemotherapy versus Rituximab plus chemotherapy in patients with previously untreated follicular lymphoma: updated results from the GALLIUM study


Immunochemotherapy is standard of care for patients with previously untreated advanced stage follicular lymphoma ( FL ).
Four-year data from the phase III GALLIUM study have previously demonstrated an improvement in investigator-assessed progression-free survival ( PFS ) for Obinutuzumab ( Gazyvaro, G ) plus chemotherapy ( G-chemo ) versus Rituximab ( MabThera ) plus chemotherapy ( R-chemo ) ( Townsend et al. ASH 2018 ).

The aim of study was to assess whether the clinical superiority of G-chemo versus R-chemo is sustained.

Eligibility criteria: 18 years or more; advanced stage, previously untreated grade 1–3a follicular lymphoma; requiring treatment according to Groupe d’Etude des Lymphomes Folliculaires ( GELF ) criteria.

Patients were randomized 1:1 to receive induction therapy of Obinutuzumab 1000mg IV ( day [ D ] 1, 8 and 15 of Cycle 1; D1 of each subsequent cycle ) or Rituximab 375mg/m2 IV ( D1 of each cycle ) with CHOP, CVP, or Bendamustine for 6 or 8 cycles.
Patients achieving complete or partial response at end of induction received maintenance therapy with the same monoclonal antibody every 2 months for 2 years or until disease progression or withdrawal from the study.

Primary endpoint was investigator-assessed progression-free survival ( PFS ). Secondary endpoints included time-to-next-treatment ( TTNT ), overall survival ( OS ) and incidence of adverse events.

1202 patients ( median age 59 years ) were enrolled ( n=601 per treatment arm ). Median duration of follow-up was 76.5 months.

Patients receiving G-chemo versus R-chemo demonstrated improved progression-free survival ( hazard ratio [ HR ] 0.76; 95% CI: 0.62–0.92; p=0.0043; 5-year PFS: 70.5% [ 95% CI: 66.4–74.1 ] vs 63.2% [ 95% CI: 59.0–67.1 ] ).

TTNT was greater in the G-chemo versus R-chemo arm ( HR=0.72; 95% CI: 0.57–0.90; p=0.0039; 5-year TTNT rate: 79.7% [ 95% CI: 76.1–82.7 ] vs 72.9% [ 95% CI: 69.1–76.4 ] ).

There was no notable difference in 5-year overall surival, with few events in either arm ( HR=0.87; 95% CI: 0.62–1.22; p=0.41; G-chemo: 90.2% [ 95% CI: 87.5–92.4 ]; R-chemo: 89.4% [ 95% CI: 86.6–91.6 ] ).

Incidence of grade 3–5 adverse effects was 79.3% in the G-chemo arm and 71.2% in the R-chemo arm, with no difference in the incidence of fatal adverse effects ( 4.2% for both treatment arms ) consistent with the primary analysis ( Marcus et al. N Engl J Med 2017 ).

In conclusion, these data further have demonstrated the clinically meaningful and durable benefit of treatment with Obinutuzumab plus chemotherapy relative to Rituxumab plus chemotherapy in previously untreated patients with follicular lymphoma. ( Xagena )

Source: EHA25 - European Hematology Association Virtual Meeting, 2020

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