The researchers concluded that the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of PF-05280586 and the reference were similar at the conclusion of the study at week 26.
In a study to be presented at the American Society of Hematology’s annual meeting held in San Diego, California from December 1-4, 2018, researchers evaluated PF-05280586, a proposed rituximab biosimilar, versus the EU-licensed reference product, MabThera, in patients with previously untreated CD20-positive, low tumor burden follicular lymphoma.
"If approved this may help provide a more cost-effective treatment option and expand access for patients and physicians," said Jeff Sharman, MD, medical director, US Oncology Hematology Research.
The 52-week comparative study investigated the efficacy, safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-05280586 compared with the reference. In total, 394 patients enrolled in the study and were randomized to receive either PF-05280586 (n = 196) or the reference (n = 198).
The primary end point of the study was overall response rate (ORR) at week 26, defined as the percentage of patients achieving complete response (CR) or partial response (PR) based on central review. Secondary end points included progression free survival, safety, immunogenicity, PK and PD.
Overall, the study found that ORR at week 26 was 75.5% in the PF-05280586 arm, compared with 70.7% in the reference arm, for a difference of 4.66%. The corresponding 95% CI, —4.16 to 13.47, was within the prespecified equivalence margin of ±16%.
At week 26, 11.5% of patients in the potential biosimilar arm had stable disease, compared with 19.6% in the reference. Additionally, 3.4% versus 4.3% had progressive disease in the PF-05280586 group versus the reference group, respectively.
The researchers found that the incidence of treatment-emergent adverse events (TEAEs) was similar, with 78.6% for PF-05280586 versus 72.1% for the reference. The most frequently reported TEAEs were infusion-related reactions (25.5% versus 29.9%), pruritus (6.6% versus 11.2%), and headache (8.2% versus 9.6%) in the PF-05280586 and the reference groups, respectively.
The most frequently reported grade 3 TEAEs were infusion-related reactions and hypertension, seen in 2.6% versus 0.5% and 1.0% versus 2.0% in the PF-05280586 group versus the reference group.
The researchers concluded that the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of PF-05280586 and the reference were similar at the conclusion of the study at week 26.
"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," said Joe McClellan, vice president of biosimilars development at Pfizer, in announcing the results.
Reference
Sharman J, Liberati A, Silva R, et al. A randomized, double-blind efficacy and safety study of PF-05280586 (a potential rituximab biosimilar) compared with rituximab reference product (MabThera®) in subjects with previously untreated CD20-positive, low tumor burden follicular lymphoma (LTB-FL). Presented at the American Society of Hematology Annual Meeting, December 1-4, 2018; San Diego, California. Abstract 394. ash.confex.com/ash/2018/webprogram/Paper111248.html.
Switching From Avastin to Bevacizumab-bvzr in CRC, NSCLC Can Reduce Medicare Costs
May 10th 2025Monthly savings from fully converting Medicare patients with metastatic colorectal cancer (CRC) and non-squamous metastatic non-small cell lung cancer (NSCLC) from reference bevacizumab to bevacizumab-bvzr could fund 13,887 and 8,959 additional patient-months of treatment, respectively, according to a cost-effectiveness study.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Oncology Biosimilars Cut Costs; Diabetes and Other Diseases Could Follow
May 6th 2025Shreehas P. Tambe, MD, highlighted the significant potential for biosimilars to expand into other disease areas like diabetes, offering crucial cost-saving solutions amid a rising global burden of noncommunicable diseases.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access
April 28th 2025Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA.