Pfizer’s Rituxan Biosimilar Equally Effective at Treating Follicular Lymphoma, Trial Shows

Pfizer’s Rituxan Biosimilar Equally Effective at Treating Follicular Lymphoma, Trial Shows

Pfizer‘s biosimilar therapy candidate PF-05280586 has shown equal effectiveness as Rituxan (rituximab) at treating indolent follicular lymphoma in a Phase 3 trial, the company announced.

Indolent, or slow-growing, follicular lymphoma is the most common form of non-Hodgkin’s lymphoma.

“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 at Pfizer Essential Health Research and Development, said in a press release.

A biosimilar is a nearly identical, but lower-priced, version of the treatment on which it is based. Companies manufacturing biosimilars can do so once patents to original therapies expire. Before a company can manufacture a biosimilar, however, it must conduct clinical trials showing that it is as effective and safe as the original.

Similar to Rituxan, PF-05280586 is an engineered antibody that helps the immune system fight cancer cells producing the CD20 factor. The original therapy is approved for patients with certain types of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis, and rheumatoid arthritis. Pfizer expects to have its product approved for the same indications.

The double-blind Phase 3 REFLECTIONS B328-06 trial (NCT02213263) was designed to determine if PF-05280586 is equivalent to Rituximab in terms of safety and effectiveness. The treatment is being tested as a first-line therapy in adults with CD20-positive, low tumor burden follicular lymphoma.

Pfizer anticipates enrolling 394 participants. Patient recruitment is currently ongoing. (More information is available here.)

A similar number of patients achieved a partial or complete eradication of their tumors with PF-05280586 and Rituxan, meeting the trial’s primary goal of objective response rate.

Additional goals include time to treatment failure, progression-free survival and overall survival, complete disease remission, and duration of response.

PF-05280586 is the fifth Pfizer biosimilar antibody to show positive results, Ray said. The company’s biosimilar pipeline is composed of seven different molecules in mid- to late-stage development, three of which are 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,” Ray added.

Pfizer will present the study’s final results at a future medical meeting or in a scientific journal.

José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has also studied Biochemistry at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario in London, Ontario, Canada. His work has ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
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José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has also studied Biochemistry at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario in London, Ontario, Canada. His work has ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
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