Obinutuzumab demonstrated a higher overall response rate with significant differences in safety compared with rituximab for patients with relapsed CD20+ indolent B-cell non-Hodgkin lymphoma, a new study published online ahead of print in the Journal of Clinical Oncology has shown.
For the phase 2 study, a team of researchers led by Laurie H. Sehn, MD, Medical Oncologist at the BC Cancer Agency in British Columbia, Canada, prospectively evaluated the safety and efficacy of obinutuzumab compared with rituximab in relapsed indolent non-Hodgkin lymphoma.
Researchers enrolled 175 patients who had previously achieved a response to a rituximab-containing regimen and randomly assigned them 1:1 to receive induction obinutuzumab 1,000 mg IV weekly for 4 weeks or rituximab 375 mg/m2 weekly for 4 weeks.
Patients who showed no evidence of disease progression then received obinutuzumab or rituximab maintenance therapy every 2 months for a maximum of 2 years.
Results showed that the overall response rate was 44.6% with obinutuzumab and 33.3% with rituximab among patients with follicular lymphoma (P=0.08); however, researchers found no improvement in progression-free survival with obinutuzumab.
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In regard to safety, infusion-related reactions and cough were more frequently observed in the obinutuzumab arm compared with the rituximab arm.
The findings suggest that obinutuzumab should be evaluated in phase 3 trials to better determine its clinical benefit in this setting.
Preliminary findings were presented at the American Society of Hematology 53rd Annual Meeting in San Diego, CA, in 2011.
- Sehn LH, Goy A, Offner FC, Martinelli G, et al. Randomized phase II trial comparing obinutuzumab (GA101) with rituximab in patients with relapsed CD20+ indolent B-cell non-Hodgkin lymphoma: final analysis of the GAUSS study. J Clin Oncol. 2015. [epub ahead of print]. doi: 10.1200/JCO.2014.59.2139.