Obinutuzumab-Based Induction and Maintenance Prolongs Progression-Free Survival (PFS) in Patients with Previously Untreated Follicular Lymphoma: Primary Results of the Randomized Phase 3 GALLIUM Study

• Published in: Blood 2016-12, Vol.128 (22), p.6-6
• Main Authors: Marcus, Robert E, Davies, Andrew J, Ando, Kiyoshi, Klapper, Wolfram, Opat, Stephen, Owen, Carolyn J, Phillips, Elizabeth H, Sangha, Randeep, Schlag, Rudolf, Seymour, John F, Townsend, William, Trněný, Marek, Wenger, Michael K, Fingerle-Rowson, Günter, Rufibach, Kaspar, Moore, Tom, Herold, Michael, Hiddemann, Wolfgang
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V128.22.6.6

▪ Background: Immunochemotherapy induction followed by maintenance with rituximab (R) is the standard of care (SoC) for pts with advanced-stage symptomatic follicular lymphoma (FL), achieving a median PFS of 6-8 yrs and a median survival of 12-15 yrs. However, FL is incurable and most pts eventually relapse. Relapse occurs in 30% of pts within 3 yrs, and is associated with a poor prognosis. Obinutuzumab (GA101; GAZYVA/GAZYVARO; G) is a glycoengineered type II anti-CD20 monoclonal antibody with enhanced direct cell killing and antibody-dependent cellular cytotoxicity that has promising activity and manageable toxicity when combined with chemotherapy in relapsed indolent non-Hodgkin lymphoma (iNHL). We report the results of GALLIUM (NCT01332968), a global, open-label, randomized Phase 3 study comparing the efficacy and safety of R or G with chemotherapy followed by maintenance as first-line treatment in iNHL. Methods: Pts entered were aged ≥18 yrs with previously untreated FL (grades 1-3a) or chemotherapy-naïve marginal zone lymphoma (MZL), stage III/IV disease or stage II with tumor diameter ≥7cm, ECOG PS 0-2, and requiring treatment according to GELF criteria. CHOP, CVP, or bendamustine (B) were allocated according to center (FL) or pt (MZL). Pts were randomized 1:1 and stratified by chemotherapy, FLIPI or IPI group, and geographic region to R 375mg/m2 on Day (D) 1 of each cycle or G 1000mg on D1, 8 and 15 of Cycle 1 and D1 of subsequent cycles, for either 8 x 21-day cycles (CHOP and CVP) or 6 x 28-day cycles (B). Pts with a CR or PR at the end of induction (EOI) as per modified Cheson criteria received R or G every 2 mo for 2 yrs or until disease progression. The primary endpoint was investigator (INV)-assessed PFS in FL pts. At final analysis, based on 370 PFS events having occurred, the study would have 80% power to detect a HR of 0.741. The current data are from a planned interim efficacy analysis done when 67% of the 370 PFS events had occurred (cut-off date: January 31, 2016) after which the study was unblinded on IDMC recommendation. Efficacy was assessed in all randomized FL pts. Safety was assessed in all FL pts who received any study treatment. Results: Results are reported for 1202 FL pts (R-chemo, 601; G-chemo, 601) with a median age of 59 yrs (53.2% female); data for 195 MZL pts will be reported elsewhere. Treatment arms were well balanced by disease stage (Ann Arbor: I, 1.5%; II, 7.1%; III, 34.9%; IV, 56.5%) and prognostic factors (FLIPI: 0+1