FDA Approves Obinutuzumab for Frontline Treatment of Patients With Follicular Lymphoma

The U.S. Food and Drug Administration approved obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone, for the firstline treatment of patients with stage II bulky, stage III, or stage IV follicular lymphoma (FL).

The approval was based on results from the international, phase III GALLIUM study, which randomized 1,401 treatment-naïve patients with indolent non-Hodgkin lymphoma (1,202 of whom had FL) to receive obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone (n=601), or rituximab plus chemotherapy, followed by rituximab alone (n=601).

Obinutuzumab plus chemotherapy reduced the risk of disease progression or death by 28 percent, compared with rituximab plus chemotherapy (hazard ratio [HR] = 0.72; 95% CI 0.56-0.93; p=0.0118).

At a median follow-up of 41.1 months (range not provided), median progression-free survival (PFS; primary endpoint) was not reached in either cohort. The HR for PFS per investigator assessment was 0.68 (95% CI 0.54-0.87; p=0.0016) and 0.72 per independent review (95% CI 0.56-0.93; p=0.0018).

The ORR was 91 percent in the obinutuzumab cohort and 88 percent in the rituximab arm, with complete remission rates of 28 percent and 27 percent, respectively.

The most common grade 3-5 AEs that occurred more frequently in the obinutuzumab group included neutropenia (46.7% vs. 39.5%), infection (20.3% vs. 16.4%), IRR (12.4% vs. 6.7%), thrombocytopenia (6.1% vs. 2.7%), secondary malignancy (4.7% vs. 2.7%), and cardiac event (3.9% vs. 2.8%).

Obinutuzumab previously received approval for use in combination with bendamustine for patients with FL who have received prior therapy.

Source: Genentech press release, November 16, 2017.

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