The European Commission approved obinutuzumab in combination with chemotherapy as firstline treatment for patients with previously untreated, advanced follicular lymphoma (FL), followed by obinutuzumab maintenance in patients who respond to initial treatment.
Approval was based on data from the phase III GALLIUM study, which included 1,401 patients with treatment-naïve, indolent non-Hodgkin lymphoma. In the study, 1,202 patients with FL were randomized to receive frontline obinutuzumab (1,000 mg on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles) plus chemotherapy (n=601) or rituximab (375 mg/m2 on day 1 of each cycle) plus chemotherapy (n=601). The chemotherapy regimen was either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), CVP (cyclophosphamide, vincristine, prednisone), or bendamustine, depending on physician’s choice.
After a median follow-up of 34.5 months, the rate of three-year progression-free survival was 80 percent in the obinutuzumab arm, compared with 73.3 percent in the rituximab arm, for a 34 percent reduction in the risk of disease progression or death (hazard ratio [HR] = 0.66; 95% CI 0.51-0.85; p=0.0012).
Median progression-free survival was not reached in either treatment arm, but investigator assessment showed that 80 percent of obinutuzumab patients were progression-free at a median follow-up of 41.1 months (range not provided), compared with 73 percent in the rituximab arm (p value not provided).
The most common grade 3-5 adverse events that occurred more often in the obinutuzumab cohort were neutropenia (46.7% vs. 39.5%), infection (20.3% vs. 16.4%), infusion-related reaction (12.4% vs. 6.7%), thrombocytopenia (6.1% vs. 2.7%), second malignancies (4.7% vs. 2.7%), and cardiac events (3.9% vs. 2.8%).
The European Commission also approved obinutuzumab for the treatment of giant cell arteritis. Obinutuzumab is approved in the U.S. for patients with previously treated FL, in combination with bendamustine.
Sources: Roche press release, September 22, 2017; Reuters, September 22, 2017.