1 research outputs found
A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer
Objectives: Efficacy, safety, pharmacokinetics (PK), and immunogenicity of the biosimilar candidate SB8 was
compared to its reference product bevacizumab (BEV) in patients with metastatic or recurrent nonsquamous
non―small cell lung cancer.
Methods: Patients were randomized (1:1) in a phase III, double-blind study to receive intravenous SB8 or BEV
15 mg/kg with paclitaxel/carboplatin every 3 weeks for 24 weeks, followed by SB8 or BEV maintenance
monotherapy. The primary endpoint was best overall response rate (ORR) by 24 weeks. Secondary endpoints
included survival outcomes, safety, PK, and immunogenicity.
Results: 763 patients (SB8, n = 379; BEV, n = 384) were randomized; baseline characteristics were well balanced. Best ORR in the FAS was 47.6% and 42.8%, and best ORR in the PPS was 50.1% and 44.8% for SB8 and
BEV, respectively. The risk ratio of best ORR was 1.11 (90% CI, 0.975−1.269), and the risk difference in best
ORR was 5.3% (95% CI, −2.2%–12.9%). Median survival outcomes were comparable between SB8 and BEV:
progression-free survival was 8.50 vs 7.90 months, respectively (HR [95% CI], 0.99 [0.83–1.18]; p = 0.9338);
overall survival was 14.90 vs 15.80 months, respectively (HR [95% CI], 1.03 [0.83–1.28]; p = 0.7713); and
duration of response was 7.70 vs 7.00 months, respectively (HR [95% CI], 1.05 [0.81–1.37]; p = 0.6928).
Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
Conclusion: This study demonstrated equivalence between SB8 and BEV in terms of best ORR risk ratio, with
comparable safety, PK, and immunogenicity