IMMUNOCHEMOTHERAPY WITH OBINUTUZUMAB OR RITUXIMAB IN PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA IN THE RANDOMISED PHASE III GALLIUM STUDY: ANALYSIS BY CHEMOTHERAPY REGIMEN

Introduction: The Phase III GALLIUM study (NCT01332968) showed that obinutuzumab (GA101; G) significantly prolonged PFS in previously untreated follicular lymphoma (FL) pts relative to rituximab (R) when combined with chemotherapy (chemo; CHOP, CVP or bendamustine [B]). Grade 3–5 AEs and SAEs were more common with G-chemo. Updated results for each immunochemotherapy regimen are reported here. Methods: Pts were aged ≥18 years with documented, previously untreated FL (grades 1–3a), advanced disease (stage III/IV or stage II with tumour diameter ≥ 7 cm), ECOG PS 0–2, and requiring treatment according to GELF criteria. Chemo regimen was allocated by centre. Pts were randomised 1:1 (stratified by chemo, FLIPI-1 group and geographical region) to R 375 mg/m2 on day (D) 1 of each cycle (C) or G 1000 mg on D1, 8 and 15 of C1 and D1 of C2–8, for 6 or 8 cycles depending on chemo. Pts with CR or PR at end of induction (per Cheson 2007) continued to receive R or G every 2 months for 2 years or until progression. The cut-off date for this analysis was 10 September 2016. All pts gave informed consent. Conclusions: In treatment-naive FL pts, PFS was superior with G-chemo relative to R-chemo with consistent effects across chemo regimens. Some differences were seen in safety profiles between chemo regimens, but comparisons may be confounded by the lack of randomisation. Keywords: follicular lymphoma (FL); obinutuzumab; rituximab.