Samsung Bioepis Annou

• In a Phase 3 study, SB8 demonstrated equivalent      efficacy in terms of risk ratio of overall response rate (ORR) to      reference bevacizumab AVASTIN^{® i} in patients with metastatic or      recurrent non-squamous non-small cell lung cancer (NSCLC)

• Safety, pharmacokinetics, and immunogenicity were      also comparable

• Marketing authorization application for SB8      accepted for review by the European Medicines Agency (EMA)

INCHEON, Korea -- (BUSINESS WIRE) --

Samsung Bioepis Co., Ltd. today announced results from the Phase 3 study evaluating the efficacy and safety of SB8, a bevacizumab biosimilar candidate, compared to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).ⁱⁱ 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

SB8 Phase 3 Study

The SB8 Phase 3 study is a randomized, double-blind, multicenter study evaluating 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 non-squamous non-small cell lung cancer (NSCLC). 763 patients were randomized (1:1) 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 1 year from the randomization of the last patient. The primary endpoint is the overall response rate (ORR) which is defined as the proportion of patients whose best overall response by 24 weeks is either complete response or partial response. Secondary endpoints were progression free survival (PFS), overall survival (OS), duration of response (DOR), safety, PK, and immunogenicity.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen.