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Pfizer Presents Positive Data For PF-05280586, Potential Biosimilar To Rituximab

Pfizer Inc. (PFE) announced that the REFLECTIONS B328-06 study, a comparative safety and efficacy study of PF-05280586 versus Rituxan/MabThera (rituximab-EU)i, met its primary endpoint of overall response rate or ORR at Week 26 of the 52-week study.

26-week data from the ongoing 52-week REFLECTIONS B328-06 study (n=394) demonstrated no clinically meaningful differences in efficacy, in terms of ORR at Week 26, between PF-05280586 and MabThera, for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma (LTB-FL).1 ORR at Week 26 was 75.5% (PF-05280586) vs 70.7% (rituximab-EU), and was within the pre-specified equivalence margin.

ORR is defined as the percentage of patients achieving complete response (CR) or partial response (PR), based on central review. Additionally, estimated rates of one-year progression-free survival were similar across groups (76.4% vs. 81.2% in the PF-05280586 and MabThera groups, respectively). The results also show that PF-05280586 had a similar safety profile to MabThera.

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