The proposed biosimilar, TAB008, under development by TOT Biopharm, was compared with the reference bevacizumab in a randomized, double-blind, single-dose study conducted in 99 healthy adult males.
During the American Society of Clinical Oncology’s Annual Meeting, held June 1-5 in Chicago, Illinois, researchers presented results from a phase 1, randomized study that sought to evaluate the pharmacokinetic (PK) equivalence of a potential bevacizumab biosimilar with the originator product.
The proposed biosimilar, TAB008, under development by TOT Biopharm, was compared with the reference bevacizumab in a randomized, double-blind, single-dose study conducted in 99 healthy adult males.
Study participants were aged 18 to 45 years and were randomized to receive 1 mg/kg of TAB008 (n = 49) or reference bevacizumab (n = 50) over a 90-minute infusion. Participants were followed for 99 days post-infusion.
The study had 3 primary endpoints: area under the serum concentration—time curve from time 0 to time of last quantifiable concentration (AUC0-t), AUC from time 0 extrapolated to infinity (AUC0-∞), and the maximum observed serum concentration (Cmax). In addition, the study also evaluated the safety and immunogenicity of the potential biosimilar compared with the originator as secondary endpoints.
The treatment-group ratios of least squares geometric means for the 3 primary pharmacokinetic parameters were fully contained within the prespecified bioequivalence limits of 80% to 125% (90% CI, 103.66%-118.33% for Cmax; 94.32%-111.72% for AUC0-t; and 94.69%-112.23% for AUC0-∞).
Treatment-emergent adverse events (TEAEs) were reported in 25 participants (51%) in the TAB008 group and 22 (44%) subjects in the reference bevacizumab group. Drug-related TEAEs were reported in 19 (38%) of subjects in both groups.
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 3 TEAEs were demonstrated in 1 (2%) participant in the TAB008 arm, and 3 (6%) participants in the reference bevacizumab arm. However, no adverse events led to an individual’s discontinuation of participation in the study. In addition, the authors noted that no study participant developed binding or neutralizing anti-drug antibodies to the proposed biosimilar.
Researchers found that the proposed biosimilar demonstrated pharmacokinetic similarity to the reference product, and the safety and tolerability of the 2 products were also comparable.
Reference
Liu J, Wang X, Wang J, et al. A phase 1, randomized, single-dose study evaluating the pharmacokinetic equivalence of TAB008 and bevacizumab in healthy volunteers. J Clin Oncol. 2018;36(suppl; Abstract e14504).
AAD Posters Examine Clinical Effects of Switching to Ustekinumab, Adalimumab Biosimilars
March 20th 2024Two posters presented at the American Academy of Dermatology (AAD) annual meeting examined the effects of switching from reference ustekinumab and adalimumab to biosimilar versions in patients with different types of psoriasis.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Celltrion, Samsung Bioepis Unveil New Biosimilar Data in CD, UC at ECCO 2024
February 23rd 2024At the Congress of European Crohn’s and Colitis Organisation (ECCO), Celltrion and Samsung Bioepis presented new finding from their respective biosimilar analyses, demonstrating positive safety and efficacy measures for the biosimilars as treatments for Crohn disease (CD) and ulcerative colitis (UC).
SABCS Posters Review Use of Biosimilars in New Contexts as Breast Cancer Therapy
January 17th 2024As one study presented at the 2023 San Antonio Breast Cancer Symposium (SABCS) evaluated the use of circulating tumor DNA for response prediction after combination therapy with a trastuzumab biosimilar, another examined the efficacy of a pertuzumab biosimilar candidate.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Posters Show Efficacy for Combination Therapies With Trastuzumab Biosimilars in Breast Cancer
January 4th 2024Posters from San Antonio Breast Cancer Symposium 2023 found that combination therapies featuring trastuzumab biosimilars and other common cancer medicines were safe and effective in patients with breast cancer.