Key clinical point : The combination of obinutuzumab and bendamustine is a potent treatment option with a manageable safety profile for patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
Major finding: At a median follow-up of 33.4 months, the median progression-free survival was 26.0 (95% CI 20.3-31.7) months and the median overall survival was not reached. The overall response rate was 78.6%, with 28.6% of patients achieving complete response. The grade ≥3 adverse event (AE) rate was 76.4%, with neutropenia (58.3%), thrombocytopenia (26.4%), and febrile neutropenia (11.1%) being the most common grade ≥3 AE.
Study details: Findings are from the multicenter, phase 2 GABRIELL study that included 72 adult patients with relapsed or refractory CLL who received ≤6 cycles of obinutuzumab plus bendamustine.
Disclosures: This study was funded by Roche Farma SA. Some authors declared serving as advisory board or speaker bureau members with or without honoraria and receiving research support or attendance fees and travel expenses from Roche or others.
Source: Bravo J et al on behalf of the GABRIELL Study Group/Investigators. Obinutuzumab plus bendamustine for relapsed/refractory chronic lymphocytic leukemia and predictive and prognostic impact of genetic alterations: The phase II GABRIELL study. Leuk Lymphoma. 2023;64(5):913-926 (May 31). doi: 10.1080/10428194.2023.2216327