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.