pharmafileDecember 07, 2018
Joining the chorus of data presentations at the American Society of Hematology (ASH) Annual Meeting 2018, Pfizer has announced new data for its biosimilar version of Genentech’s Rituxan/MabThera (rituximab), revealing that the drug met its primary endpoint.
The 26-week data show that PF-05280586, as the biosimilar is known, proved itself to be clinically non-inferior in terms of overall response rate compared to rituximab in the first-line treatment of CD20-positive, low tumour burden, follicular lymphoma (LTB-FL); the drug recorded an ORR of 75.7% versus 70.7% for rituximab.
One-year progression-free survival rates were also found to be similar, with 76.4% for Pfizer’s drug and 81.2% for rituximab. The ongoing study will continue on until 52 weeks of treatment have passed.
"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."
"With a patient centered approach and over a decade of experience globally, 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," commented 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."
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