Cheson BD, et al. - Patients with rituximab-refractory indolent non-Hodgkin lymphoma treated with obinutuzumab (GA101; G) and bendamustine (B) in the randomized phase III GADOLIN trial were assessed. The primary end point was progression-free survival (PFS). The PFS benefit for G-B demonstrated in the primary analysis was confirmed in this updated analysis. Intention-to-treat population and patients with follicular lymphoma were substantially benefitted in terms of overall survival. Both treatments offered similar toxicity.

• G 1,000 mg (days 1, 8, and 15, cycle 1; day 1, cycles 2 to 6) plus B 90 mg/m²/d (days 1 and 2, all cycles) or B 120 mg/m²/d monotherapy was given to patients with histologically documented, rituximab-refractory CD20⁺ indolent non-Hodgkin lymphoma.
• For up to 2 years, G maintenance (1,000 mg every 2 months) was given to patients who did not experience disease progression with G-B.
• The primary end point was progression-free survival (PFS).

• A total of 335 of 413 randomly assigned patients (intention-to-treat [ITT]: G-B, n = 204; B monotherapy, n = 209) had follicular lymphoma (FL; G-B, n = 164; B monotherapy, n = 171).
• A median follow-up of 31.8 months demonstrated a median PFS of 25.8 months (G-B) and 14.1 months (B monotherapy; hazard ratio [HR], 0.57; 95% CI, 0.44 to 0.73; P < .001) in ITT patients.
• Also, a prolonged overall survival (OS) (HR, 0.67; 95% CI, 0.47 to 0.96; P=.027) was reported.
• Patients with FL had similar PFS and OS benefits.
• Findings demonstrated that grade 3 to 5 adverse events (AEs) were reported by 148 (72.5%) and 133 (65.5%) patients in the G-B and B monotherapy arms, respectively, most commonly neutropenia (G-B, 34.8%; B monotherapy, 27.1%), thrombocytopenia (10.8% and 15.8%), anemia (7.4% and 10.8%), and infusion-related reactions (9.3% and 3.4%).
• In 89 G-B patients (43.6%) and 75 B monotherapy patients (36.9%), occurrence of serious AEs was reported; fatal AEs occurred in 16 (7.8%) and 13 (6.4%), respectively.