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Obinutuzumab Demonstrates Long-Term Benefit Over Rituximab in Patients with Previously Untreated Follicular Lymphoma

FL

Obinutuzumab plus chemotherapy demonstrated long-term benefit over rituximab plus chemotherapy in patients with previously untreated follicular lymphoma (FL), according to the final analysis of the phase III GALLIUM study.

Previous five-year results from the study demonstrated a significant improvement in PFS with obinutuzumab plus chemotherapy. The updated results presented followed patients for a median of eight years.

The study enrolled adult patients with previously untreated histologic grade 1-3a FL. Patients were randomized 1:1 to receive obinutuzumab 1,000 mg intravenously (IV) or rituximab 375 mg/m2 IV plus chemotherapy for six or eight cycles depending on the chemotherapy backbone selected (cyclophosphamide, doxorubicin, vincristine, and prednisolone [CHOP]; cyclophosphamide, vincristine, and prednisolone [CVP]; or bendamustine).

Seven-year progression-free survival (PFS) was improved with obinutuzumab (63.4%) versus rituximab (55.7%) plus chemotherapy (hazard ratio [HR], 0.77; 95% CI, 0.64-0.93; P=.006).

Time-to-next anti-lymphoma treatment was also improved with obinutuzumab versus rituximab plus chemotherapy (HR, 0.71; 95% CI, 0.58-0.87; P=.001). The percentage of patients who had not started their next treatment at seven years was 74.1% and 65.4%, respectively.

The incidence of serious adverse events was 48.9% with obinutuzumab plus chemotherapy and 43.4% with rituximab plus chemotherapy. Rates of fatal adverse events were similar in the obinutuzumab (4.4%) and rituximab (4.5%) cohorts, with pneumonia being the most common fatal adverse event (0.8% [n=5] and 0.2% [n=1], respectively) and serious adverse event (5.9% [n=35] and 6.2% [n=37], respectively).

The researchers concluded that “a meaningful improvement in PFS was maintained with [obinutuzumab plus chemotherapy versus rituximab plus chemotherapy] in patients with previously untreated FL, confirming the role of [obinutuzumab plus chemotherapy] as a standard of care for the first-line treatment of patient with FL.”

Reference

Townsend W, Hiddemann W, Buske C, et al. Obinutuzumab plus chemotherapy demonstrates long-term benefit over rituximab plus chemotherapy in patients with previously untreated follicular lymphoma: final analysis of the Gallium study. Abstract #S206. Presented at the 2022 European Hematology Association Congress, June 9-12, 2022.

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