PF-05280586 biosimilar versus MabThera/Rituxan meets endpoint in REFLECTIONS study. - Pfizer.
Pfizer Inc. announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera (rituximab-EU)/Rituxan, met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan (rituximab-US)/MabThera.
The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma.
About the REFLECTIONS B3281006 Study- REFLECTIONS B3281006 is a randomized, double-blind clinical trial evaluating the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280586 versus MabThera (rituximab-EU)for the first-line treatment of patients with cd20-positive, low tumor burden, follicular lymphoma. The primary endpoint measure, ORR, is defined according to the revised response criteria for malignant lymphoma [Time Frame: Week 26]. Results of the study will be presented in full at a future medical meeting or summarized in publication.
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