Efficacy and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin: Results of international multicenter randomized double blind phase III study in patients with advanced non-squamous NSCLC.

8057 Background: BCD-021 demonstrated equivalence to Avastin in a comprehensive comparability exercise that included physicochemical, PK and PD studies, as well as phase I PK clinical study in patients with non-squamous NSCLC. Methods: 138 patients with advanced non-squamous NSCLC (stage IIIb/IV) were randomly assigned into 2 groups at a ratio of 1:1 to receive BCD-021 or Avastin at a dose of 15 mg/kg in combination with paclitaxel (175 mg/m2) and carboplatin (AUC 6 mg/ml×min) every 3 weeks up to 6 cycles of therapy or until progression or unbearable toxicity. Results: ORR (primary endpoint) in both groups had no statistically significant differences: 42.59 % (95% CI 30.33 – 55.83) in BCD-021 group and 39.29% (95% CI 27.58 – 52.27%) in Avastin group. The lower limit of 95% CI for ORR difference between the groups (-14.96%) did not exceed the non-inferiority margin, hence BCD-021 is non-inferior to Avastin. There were also no differences between the groups for all other efficacy parameters: CR (1.85% vs 1....