Blog Big Molecule Watch September 15, 2020

Samsung Bioepis Announces Phase 3 Exploratory Analyses Results of AYBINTIO (Bevacizumab)

Samsung Bioepis announced positive results yesterday from its exploratory analyses of the Phase 3 study of its biosimilar product, AYBINTIO (bevacizumab).  The study compared AYBINTIO’s efficacy to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).  According to Vice President and Team Lead of Medical & Lifecycle Safety Seongwon Han, the results “reinforce equivalent clinical efficacy between AYBINTIO and reference bevacizumab.”

 The study enrolled 665 patients, 337 of whom received AYBINTIO and 328 of whom received reference bevacizumab with paclitaxel and Q3W carboplatin up to six cycles followed by AYBINTIO or reference bevacizumab maintenance monotherapy.  The primary endpoint was overall response rate (ORR) by 24 weeks of induction treatment.  The analysis of the current study showed the risk difference in best ORR by 11 and 17 weeks was 2.2%  (95% CI, –4.6% to 9.1%) and 2.4% (95% CI, –5.1% to 10.0%), respectively.  The mean of maximum percentage change in tumor burden by week 24 was -27.8% for AYBINTIO and -27.3% for reference bevacizumab.

 Samsung Bioepsis will present the results of the AYBINTIO Phase 3 exploratory analyses in e-poster format during ESMO’s Science Weekend on Thursday, September 17, 2020.

 

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