Comparison of efficacy and safety with obinutuzumab plus chemotherapy versus rituximab plus chemotherapy in patients with previously untreated follicular lymphoma: Updated results from the phase III Gallium Study.

Abstract

8023 Background: Immunochemotherapy is standard of care for patients (pts) with previously untreated advanced stage follicular lymphoma (FL). Four-year data from the Phase III GALLIUM study (NCT01332968) have previously demonstrated an improvement in the primary endpoint of investigator-assessed progression-free survival (PFS) for obinutuzumab (GA101, G) plus chemotherapy (G-chemo) versus rituximab plus chemotherapy (R-chemo) (Townsend et al. ASH 2018). Here, we report efficacy and safety results from an updated analysis. Methods: Eligibility criteria: ≥18 years; advanced stage, previously untreated grade 1–3a FL; requiring treatment according to Groupe d’Etude des Lymphomes Folliculaires criteria. Pts were randomized 1:1 to receive G 1000mg IV (day [D] 1, 8 and 15 of Cycle 1; D1 of each subsequent cycle) or R 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. Results: 1202 pts (median age 59 years) were enrolled (n = 601 per treatment arm). Median duration of follow-up was 76.5 months. Pts receiving G- vs R-chemo demonstrated improved PFS (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- vs 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). Conclusions: These data further demonstrate the clinically meaningful and durable benefit of treatment with G-chemo relative to R-chemo in previously untreated FL pts. Acknowledgement: GALLIUM was sponsored by F. Hoffmann-La Roche Ltd. Third-party medical writing assistance, under the direction of William Townsend, was provided by Louise Profit and Stephanie Lacey of Gardiner-Caldwell Communications, and was funded by F. Hoffmann-La Roche Ltd. Clinical trial information: NCT01332968 .