UPDATE : Friday, July 10, 2020
Samsung Bioepis releases P3 results of Bevacizumab biosimilar in EU
  • By Lee Han-soo
  • Published 2019.09.27 11:37
  • Updated 2019.09.27 11:37
  • comments 0

Samsung Bioepis has presented the results of phase 3 study clinical evaluating the efficacy and safety of SB8, a bevacizumab biosimilar, at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain.

Samsung Bioepis headquarters in Songdo, Incheon.

The research compared SB8 to the original in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).

The primary endpoint of the study was the overall response rate (ORR) by 24 weeks.

The company analyzed the risk ratio through 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 percent.

The ORR in FAS was 47.6 percent for SB8 and 42.8 percent for reference bevacizumab, with a risk ratio of 1.11. The ORR in PPS was 50.1 percent for SB8 and 44.8 percent for reference bevacizumab, with a risk difference of 5.3 percent.

The median progression-free survival (8.5 months vs. 7.9 months) and overall survival (14.9 months vs. 15.8 months) were comparable between SB8 and reference bevacizumab.

The overall incidence of treatment-emergent adverse events (92.1 vs. 91.1 percent) and the incidence of overall anti-drug antibodies (16.1 vs. 11.0 percent) was also comparable between SB8 and reference bevacizumab.

The company added that the European Medicines Agency accepted the marketing authorization application for SB8 in July.

“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,” said Kim Chul, Samsung Bioepis’ senior vice president of the clinical sciences division. “We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of the oncology’s most pressing challenges.”


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