Results from the exploratory analyses of the Phase III study analyzing the efficacy of the bevacizumab biosimilar Aybintio® (previously known as SB8) developed by Samsung Bioepis, compared to reference bevacizumab (Avastin®; Genentech/Roche) 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 in an e-poster format on Thursday, September 17, 2020, at 9:00 a.m. (CEST).[1]

“The data observed in the Phase III 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 with the medical community which further highlights our commitment and dedication towards delivering life-changing scientific research to make high-quality biologic medicines,” Han concluded.

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%). [1][2]

Advertisement #3

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).[1][2]

The European Commission granted marketing authorization for Aybintio®  in August 2020.

ESMO sessions
The results of the Aybintio® Phase III 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.

Is not yet approved by the U.S. Food and Drug Administration.

Clinical trials
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects – NCT02453672
A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer – NCT02754882

Summary of Opinion (EMA)
Bevacizumab (Aybintio®; Samsung Bioepis) [Initial Authoirization]

Summary of Product Characteristics (Europe)
Bevacizumab (Avastin®; Roche) [SPC]

Highlights of Prescribing Information
Bevacizumab (Avastin®; Genentech) [Prescribing Information]

[1] Planchard D, Shin D, Choi J, Seo Y, Jeong JA, Park M, Reck M. 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.
[2] Reck M, et al. A phase III study comparing SB8, a proposed bevacizumab biosimilar, and reference bevacizumab in patients with metastatic or recurrent non-squamous NSCLC. Presented at: European Society for Medical Oncology Congress 2019; September 27 to October 1, 2019; Barcelona, Spain. Abstract 1565P.

Featured image: Before going virtual, the ESMO 2018. Photo courtesy: © 2020 ESMO 2010 – 2020. Used with permission.

Advertisement #5