Obinutuzumab plus chemotherapy provides long-term benefits over rituximab plus chemotherapy in patients with previously untreated follicular lymphoma (FL), according to final results from the phase 3 GALLIUM trial.
The data showed that obinutuzumab plus chemotherapy improved progression-free survival (PFS) and time to next lymphoma treatment, when compared with rituximab plus chemotherapy.
These results, from the phase 3 GALLIUM trial (ClinicalTrials.gov Identifier: NCT01332968), were presented at the EHA 2022 Hybrid Congress.
The trial enrolled patients with previously untreated, grade 1-3a FL. All patients received chemotherapy, which consisted of bendamustine alone, CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone), or CVP (cyclophosphamide, vincristine, and prednisolone).
In addition to receiving chemotherapy, patients were randomly assigned to receive obinutuzumab (n=601) or rituximab (n=601). Patients who achieved a complete or partial response with induction could continue with the same monoclonal antibody for 2 years of maintenance or until disease progression.
At baseline, the median patient ages were 60 years in the obinutuzumab arm and 58 years in the rituximab arm. Approximately 91% of patients in each arm had stage III/IV disease. About 57% of patients in each arm received bendamustine, roughly a third received CHOP, and about 10% received CVP.
The median follow-up was 7.9 years, and the primary endpoint was PFS. The 7-year PFS rate was higher in the obinutuzumab arm than in the rituximab arm — 63.4% and 55.7%, respectively (hazard ratio [HR], 0.77; 95% CI, 0.64-0.93; P =.006).
Similarly, the proportion of patients who were free from subsequent lymphoma treatment at 7 years was higher in the obinutuzumab arm than in the rituximab arm — 74.1% and 65.4%, respectively (HR, 0.71; 95% CI, 0.58-0.87; P =.001).
The 7-year overall survival rates were similar between arms — 88.5% in the obinutuzumab arm and 87.2% in the rituximab arm (HR, 0.86; 95% CI, 0.63-1.18; P =.36).
No new safety signals were observed. During induction, the rate of grade 3 or higher adverse events (AEs) was 61.8% in the obinutuzumab arm and 58.6% in the rituximab arm.
The rate of grade 3 or higher AEs in the maintenance phase was 40.0% in the obinutuzumab arm and 33.1% in the rituximab arm. During follow-up, the rate of grade 3 or higher AEs was 21.3% and 15.7%, respectively.
Since the primary analysis, there were 2 fatal AEs in the obinutuzumab arm and 7 in the rituximab arm. Overall, there were 28 fatal AEs in the obinutuzumab arm and 34 in the rituximab arm. Most fatal AEs occurred among patients receiving bendamustine — 20 in the obinutuzumab arm and 27 in the rituximab arm.
Disclosures: This research was supported by F. Hoffmann-La Roche Ltd. The presenter declared affiliations with F. Hoffmann-La Roche, Gilead Sciences, Bristol Myers Squibb, Incyte, and Takeda.
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. Presented at EHA 2022; June 9-12, 2022. Abstract S206.