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Biosimilar PF-05280586 equivalent to rituximab for follicular lymphoma
PF-05280586, a potential biosimilar to rituximab, met its primary endpoint of overall response rate in a clinical trial of patients with CD20-positive follicular lymphoma and low tumor burden, according to a manufacturer-issued press release.
PF-05280586 (Pfizer) — a monoclonal antibody — is being developed as a potential biosimilar to rituximab (Rituxan; Genentech, Biogen), which is indicated for certain types of CD20-positive non-Hodgkin lymphoma, CD20-positive chronic lymphocytic leukemia and other indications.
Researchers assessed the safety, efficacy, pharmacokinetics and immunogenicity of PF-05280586 in the randomized, double-blind REFLECTIONS B3281006 trial, which assessed the biosimilar compared with rituximab as the first-line treatment of patients with CD20-positive follicular lymphoma and low tumor burden.
PF-05280586 showed equivalence in the primary endpoint of ORR.
Study results will be presented at a future meeting or publication.
“We are pleased to report on our fifth proposed biosimilar monoclonal antibody with positive study results. These results reinforce the potential of our proposed rituximab biosimilar in providing a safe and effective treatment option for patients,” Amrit Ray, MD, global president of Pfizer Essential Health Research and Development, said in a press release. “As a global leader in novel biologics, and with one of the broadest global portfolios in oncology, we are delivering on our commitment to advancing high-quality medicines for the millions of patients with cancer around the world today and in the future.”