Pfizer Positive 26-Week Data For Biosimilar To Rituximab At ASH

• 26-week data from the ongoing 52-week REFLECTIONS B328-06 study met its primary endpoint, demonstrating comparable safety and efficacy for patients with indolent follicular lymphoma
• The U.S. Food and Drug Administration (FDA) accepted for review, a Biologics License Application (BLA) for PF-05280586 in September 2018

Pfizer, Inc. (NYSE:PFE) announced today at the American Society of Hematology Annual Meeting 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 (ORR) at Week 26 of the 52-week study.¹

“It is encouraging to see new data supporting a potential rituximab Biosimilar. If approved this may help provide a more cost-effective treatment option and expand access for patients and physicians,” said Dr. Jeff Sharman, medical director, US Oncology Hematology Research. “The data presented today will help us understand the nuances of the medicine without the confounding influence of additional concurrent treatments.”

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).¹ The results also show that PF-05280586 had a similar safety profile to MabThera.¹

“With a patient centered approach and over a decade of experience globally,² Pfizer remains dedicated to developing and delivering high quality biosimilars with similar efficacy and safety profiles to originator medicines that help have a meaningful impact on people living with various conditions including cancer,” said Joe McClellan, vice president, Biosimilars Development at Pfizer. “We have also been a committed global partner to the oncology community for almost 20 years, and the continued growth of our oncology and supportive care presence, through both novel therapies and biosimilars, means we are able to provide patients, physicians and healthcare systems with a wider range of treatment options.”

PF-05280586 has been accepted for review by the FDA, the BsUFA goal date for a decision by the FDA is in second-quarter 2019. Pfizer is also working towards making PF-05280586 available for patients in Europe. Further results on the safety and efficacy from this ongoing 52-week study in LTB-FL are expected to be presented next year.

https://www.biospace.com/article/releases/pfizer-presents-positive-26-week-data-for-pf-05280586-a-potential-biosimilar-to-rituximab-at-the-american-society-of-hematology-annual-meeting/