A Phase 3 study comparing Samsung Bioepis’ SB8 with Avastin in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) demonstrated equivalent efficacy in terms of risk ratio of overall response rate (ORR).
The study results were presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain.
The randomised, double-blind, multicentre study is assessing the efficacy, safety, pharmacokinetics (PK), and immunogenicity of SB8 compared to reference bevacizumab in combination with paclitaxel and carboplatin in patients with metastatic or recurrent NSCLC.
A total of 763 patients were randomised to receive SB8 or reference bevacizumab with paclitaxel and carboplatin Q3W followed by SB8 or reference bevacizumab maintenance therapy until disease progression, unacceptable toxicity, death, or one year from the last patient’s randomisation.
The primary endpoint of the study was the ORR by 24 weeks. The company analysed the risk ratio via a full analysis set (FAS) with pre-defined equivalence margin of 0.737 to 1.357 and the risk difference in the per-protocol set (PPS) with pre-defined equivalence margin of ±12.5%.
Samsung Bioepis said the ORR in FAS was 47.6% for SB8 and 42.8% for reference bevacizumab, with a risk ratio of 1.11. The ORR in PPS was 50.1% for SB8 and 44.8% for reference bevacizumab, with a risk difference of 5.3%.
The company said it will present the results of the SB8 Phase 3 study as a poster during ESMO 2019.
Samsung Bioepis senior vice-president and head of clinical sciences division Chul Kim said: “Data from this study showed that there were no clinically meaningful differences between SB8 and reference bevacizumab in terms of efficacy, safety, pharmacokinetics and immunogenicity.
“We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of oncology’s most pressing challenges.”
The European Medicines Agency accepted SB8’s marketing authorisation application for review in July.
A joint venture between Samsung BioLogics and Biogen, Samsung Bioepis seeks to advance a pipeline of biosimilar candidates that cover several therapeutic areas, including immunology, oncology, ophthalmology and hematology.