Samsung Bioepis Reports Positive Phase 3 Results for Aybintio

Samsung Bioepis reported positive phase 3 exploratory study results for its bevacizumab biosimilar, Aybintio, which received European Commission approval for marketing in August 2020.

The findings are set for presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which begins this week.

The Incheon, Republic of Korea–based company said the study results supported preexisting evidence in support of equivalence between Aybintio and reference bevacizumab in patients with metastatic or recurrent nonsquamous non–small cell lung cancer.

Reinforcement of Prior Findings

“The data observed in the phase 3 exploratory analyses reinforce equivalent clinical efficacy between Aybintio and reference bevacizumab,” said Seongwon Han, vice president and leader of the Medical & Lifecycle Safety Team at Samsung Bioepis.

The exploratory study enrolled 665 patients, of whom 337 received Aybintio and 328 were treated with reference bevacizumab with paclitaxel and carboplatin every 3 weeks for up to 6 cycles, followed by Aybintio or reference bevacizumab maintenance monotherapy. The risk difference was analyzed in the per-protocol set (PPS) within a predefined equivalence margin of ±12.5%.

The primary end point was overall response rate (ORR) after 24 weeks of induction therapy. In a previous analysis, the ORR in the PPS was 50.1% for Aybintio and 44.8% for reference bevacizumab, and the risk difference by week 24 was 5.3% (95% CI, –2.2% to 12.9%). The risk difference is a comparative measure of the likely harms and benefits of therapies.

In the current study, the risk differences in best ORR by weeks 11 and 17 was 2.2% (95% CI, –4.6% to 9.1%) and 2.4% (95% CI, –5.1% to 10.0%), respectively.

The mean reduction in tumor burden by week 24 was –27.8% for Aybintio and –27.3% for reference bevacizumab, with a difference of 0.59% (P = .7452).

Samsung Bioepis said the results of the phase 3 exploratory analyses would be presented in an e-poster at ESMO during the virtual event’s Science Weekend on Thursday, September 17 at 9 AM Central European Summer Time.