Summary

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• Gazyva (obinutuzumab) is indicated in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia; in combination with bendamustine followed by Gazyva monotherapy for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen; and in combination with chemotherapy followed by Gazyva monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma.
• This summary is based on the review of eight systematic review(s)/meta-analysis(es). ^[1-8]
• Follicular Lymphoma (FL): Obinutuzumab significantly improved progression-free survival (PFS) with a hazard ratio (HR) of 0.43 (95% CI: 0.22-0.79) compared to observation and demonstrated superiority over Rituximab in PFS but not in overall survival (OS). The combination regimen of Obinutuzumab with Bendamustine (G-Benda-G) yielded the best PFS with an HR of 0.41, SUCRA of 0.97, and a 72% probability of being the best treatment.
• Chronic Lymphocytic Leukemia (CLL): Obinutuzumab combined with Acalabrutinib was highly effective in most sub-analyses, particularly improving PFS compared to other frontline treatments for fludarabine-ineligible patients. In the del17/P53mut subgroup, it was nearly as effective as the aCD20 mAbs/Ibrutinib combination, with SUCRA values of 93.5% and 91%, respectively.
• Immune-mediated Disorders: Obinutuzumab showed promising results in a case series for phospholipase A2 receptor-associated membranous nephropathy but had mixed outcomes in systemic lupus erythematosus.
• Obinutuzumab in follicular lymphoma (FL) was associated with higher incidences of grade 3-4 adverse events, including thrombocytopenia (RR 2.8), infusion-related reactions (RR 2.8), and cardiac events (RR 1.65) compared to Rituximab.
• In chronic lymphocytic leukemia (CLL), Obinutuzumab in combination with Acalabrutinib showed better safety outcomes compared to other regimens, though some studies noted an increased incidence of grade 3-4 adverse events, with specific safety concerns not detailed.
• Advanced follicular lymphoma (FL) patients, fludarabine-ineligible chronic lymphocytic leukemia (CLL) patients, and those with specific genetic mutations (del17/P53 and IGHV statuses) were identified as key subgroups, with Obinutuzumab + Acalabrutinib showing notable efficacy in CLL for most subgroups, while immune-mediated disorder patients (e.g., systemic lupus erythematosus) had an increased risk of serious infections.