• Exploratory analyses of Phase 3 study further demonstrate equivalence between AYBINTIO^® and reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
• Risk difference in best ORR and maximum percentage change from baseline in tumor burden were analyzed by 11,17 and 24 weeks
• Marketing authorization for AYBINTIO^® was granted by the European Commission (EC) in August 2020

INCHEON, Korea – September 14, 2020 – Samsung Bioepis Co., Ltd. today announced results from the exploratory analyses of the Phase 3 study analyzing efficacy of AYBINTIO® (bevacizumab), compared to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). The study results will be presented for the first time at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
 

“The data observed in the Phase 3 exploratory analyses reinforce equivalent clinical efficacy between AYBINTIO and reference bevacizumab,” said Seongwon Han, Vice President and Team Lead of Medical & Lifecycle Safety Team at Samsung Bioepis. “We look forward to sharing our data to the medical community which further highlights our commitment and dedication towards delivering life-changing scientific research to make high quality biologic medicines.”
 

The study enrolled 665 patients with metastatic or recurrent non-squamous NSCLC. Of the 665 patients, 337 patients received AYBINTIO^® while 328 patients received reference bevacizumab with paclitaxel and Q3W carboplatin up to six cycles followed by AYBINTIO^® or reference bevacizumab maintenance monotherapy. The primary endpoint of the analyses was the overall response rate (ORR) by 24 weeks of the induction treatment period; risk difference was analyzed in the per-protocol set (PPS) within in the pre-defined equivalence margin of ±12.5%. In the previous analysis, the ORR in PPS was 50.1% for AYBINTIO^® and 44.8% for reference bevacizumab; the risk difference by 24 weeks was 5.3% (95% CI: -2.2%, 12.9%). 
 

Expanding on the key findings from the previous analyses, this abstract showed the risk difference in best ORR by 11 and 17 weeks was 2.2% (95% CI: -4.6%, 9.1%) and 2.4% (95% CI: -5.1%, 10.0%), respectively. Additionally, the mean of maximum percentage change from baseline in tumor burden by 24 weeks was -27.8% for AYBINTIO^® and -27.3% for reference bevacizumab with a difference of 0.59% (p-value: 0.7452).
 

Marketing authorization for AYBINTIO^® was granted by the European Commission (EC) in August 2020.
 

The results of the AYBINTIO^® Phase 3 exploratory analyses will be presented in an e-poster format during ESMO’s Science Weekend on Thursday, September 17, 2020 at 9:00 a.m. (CEST). 
 

Samsung Bioepis will also host an industry satellite symposium titled "Navigating the Optimized Oncology Treatment Options in Colorectal Cancer, Lung Cancer and Breast Cancer through Multidisciplinary Discussions" which will be available on demand from September 22 - 29, 2020. 
 

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AYBINTIO^® (bevacizumab) Exploratory Analyses of Phase 3 study
The AYBINTIO^® exploratory analyses of the Phase 3 study evaluate equivalent efficacy compared to reference bevacizumab in combination with paclitaxel and carboplatin in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). 665 patients were included in the per-protocol set to receive AYBINTIO^® or reference bevacizumab with paclitaxel and carboplatin Q3W up to six cycles followed by AYBINTIO^® or reference bevacizumab maintenance monotherapy. The primary endpoint is the best overall response rate which is defined as the proportion of patients whose best overall response was either CR (complete response) or PR (partial response) according to RECIST v1.1 by 24 weeks of the induction treatment period. Subgroup analyses by age group, gender, cancer type, Eastern Cooperative Oncology Group (ECOG) performance status, smoking status, and status of distant metastasis were conducted. Sensitivity analysis adjusted for the status of distant metastasis were also performed for the primary endpoint.
 

MEDIA CONTACT
Yoon Kim: +82-31-8061-1783, yoon1.kim@samsung.com
Jane Chung: +82-31-8061-1067, ejane.chung@samsung.com

ⁱ AYBINTIO^®, Samsung Bioepis’ fifth product approved for use in Europe, is recommended for the treatment of certain types of cancer, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology; in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC with Epidermal Growth Factor Receptor (EGFR) activating mutations; in combination with interferon alfa-2a for advanced and/or metastatic renal cell cancer; in combination with carboplatin and paclitaxel for advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer; in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel for platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer; in combination with topotecan, or pegylated liposomal doxorubicin for platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix. AYBINTIO^® is not recommended for use in combination with paclitaxel for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

ⁱⁱ D. Planchard, D. Shin, J. Choi, Y. Seo, J. A. Jeong, M. Park, M. Reck. Exploratory Analyses of Efficacy from a Phase III Study Comparing SB8, a Proposed Bevacizumab Biosimilar, and Reference Bevacizumab in Patients with Metastatic or Recurrent Non-squamous NSCLC. ESMO 2020. Abstract 1337P.