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 the primary endpoint of investigator-assessed progression-free survival ( PFS ) for Obinutuzumab ( G; Gazyvaro ) plus chemotherapy ( G-chemo ) versus Rituximab ( MabThera ) plus chemotherapy ( R-chemo ) ( Townsend et al. ASH 2018 ).
Researchers have reported efficacy and safety results from an updated analysis.
Eligibility criteria were: 18 years or more; advanced stage, previously untreated grade 1–3a; requiring treatment according to Groupe d’Etude des Lymphomes Folliculaires criteria.
Patients were randomized 1:1 to receive 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.
Responders received maintenance therapy with the same monoclonal antibody every 2 months for 2 years.
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 have demonstrated improved progression-free survival ( 5-year PFS: hazard ratio [ HR ] 0.76; 95% CI: 0.62–0.92; p = 0.0043; 70.5% [ 95% CI: 66.4–74.1 ] vs 63.2% [ 95% CI: 59.0–67.1 ] ).
There was no notable difference in 5-year overall survival ( OS ), 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 ] ).
Time-to-next-treatment ( TTNT ) was greater in the G-chemo versus R-chemo arm ( 5-year TTNT rate: HR 0.72; 95% CI: 0.57–0.90; p = 0.0039; 79.7% [ 95% CI: 76.1–82.7 ] vs 72.9% [ 95% CI: 69.1–76.4 ] ).
Incidence of grade 3–5 adverse events was 79.3% in the G-chemo arm and 71.2% in the R-chemo arm, and consistent with those reported in the primary analysis ( Marcus et al. N Engl J Med 2017 ).
In conclusion, these data have further demonstrated the clinically meaningful and durable benefit of treatment with Obinutuzumab + chemotherapy relative to Rituximab + chemotherapy in previously untreated patients with follicular lymphoma. ( Xagena )
Source: American Society of Clinical Oncology ( ASCO ) Virtual Meeting, 2020