The study results will be presented for the first time today at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain.
“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 Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. “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 primary endpoint of the study was the overall response rate (ORR) by 24 weeks; risk ratio was analyzed in the full analysis set (FAS) with pre-defined equivalence margin of 0.737 to 1.357 and the risk difference was analyzed in the per-protocol set (PPS) with pre-defined equivalence margin of ±12.5%. The ORR in FAS was 47.6% for SB8 and 42.8% for reference bevacizumab; the risk ratio was 1.11 (90% CI: 0.975, 1.269). The ORR in PPS was 50.1% for SB8 and 44.8% for reference bevacizumab; the risk difference was 5.3% (95% CI: −2.2%, 12.9%). 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%) and the incidence of overall anti-drug antibodies (16.1% vs 11.0%) were also comparable between SB8 and reference bevacizumab.
Marketing Authorization Application (MAA) for SB8 was accepted for review by the European Medicines Agency (EMA) in July 2019.
The results of the SB8 Phase 3 study will be presented as a poster during ESMO as follows: [1565P] 12:00-13:00, September 28, Hall 4. Samsung Bioepis will also host a satellite symposium, titled ‘Quality Assurance to Optimize HER2+ Breast Cancer Treatment’, which will discuss the importance of quality maintenance in oncology biologics. The symposium will take place between 13:00-14:30 on September 30, 2019 in Toledo Auditorium, Hall 5, Fira Gran Via, Barcelona. Topics include:
- Building confidence in biosimilars
- Acknowledging importance of biologics quality in clinical practice
- Reassuring biosimilarity based on clinical evidence
- Interactive discussion: perspective on biosimilars in oncology
Source: Company Press Release