Efficacy and safety of the proposed bevacizumab biosimilar BAT1706 compared with reference bevacizumab in patients with advanced nonsquamous non-small cell lung cancer: A randomized, double-blind, phase III study.

BACKGROUND: BAT1706 is a proposed biosimilar of bevacizumab (Avastin®). We aimed to compare the efficacy and safety of BAT1706 with that of EU-sourced reference bevacizumab (EU-bevacizumab) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC). METHODS: Patients were randomized 1:1 to BAT1706 plus paclitaxel and carboplatin (BAT1706 arm) or EU-bevacizumab plus paclitaxel and carboplatin (EU-bevacizumab arm) given every 3 weeks for six cycles, followed by maintenance therapy with BAT1706 or EU-bevacizumab. The primary endpoint was overall response rate at week 18 (ORR18 ). Clinical equivalence was demonstrated if the 90% confidence interval (CI) of the BAT1706:EU-bevacizumab ORR18 risk ratio was contained within the predefined equivalence margins of 0.75-1.33 (China National Medical Products Administration requirements), or 0.73-1.36 (US Food and Drug Administration), or if the 95% CI of the ORR18 risk difference between treatments was contained within the predefined equivalence margin of -0.12 to 0.15 (EMA requirements). RESULTS: In total, 649 randomized patients (BAT1706, n = 325; EU-bevacizumab, n = 324) received at least one cycle of combination treatment. The ORR18 was comparable between the BAT1706 and EU-bevacizumab arms (48.0% and 44.5%, respectively). The ORR18 risk ratio of 1.08 (90% CI: 0.94-1.24) and the ORR18 risk difference of 0.03 (95% CI: -0.04 to 0.11) were within the predefined equivalence margins, demonstrating the biosimilarity of BAT1706 and EU-bevacizumab. The safety profile of BAT1706 was consistent with that of EU-bevacizumab and no new safety signals were observed. CONCLUSION: In patients with advanced nonsquamous NSCLC, BAT1706 demonstrated clinical equivalence to EU-bevacizumab in terms of efficacy, safety, pharmacokinetics, and immunogenicity.

Utilization of brewery wastewater for culturing yeast cells for use in river water remediation.

Successful in situ bio-augmentation of contaminated river water involves reducing the cost of the bio-agent. In this study, brewery wastewater was used to culture yeast cells for degrading the COD(Cr) from a contaminated river. The results showed that 15 g/L of yeast cells could be achieved after being cultured in the autoclaved brewery wastewater with 5 mL/L of saccharified starch and 9 g/L of corn steep liquor. The COD(Cr) removal efficiency was increased from 22% to 33% when the cells were cultured using the mentioned method. Based on the market price of materials used in this method, the cost of the medium for remediating 1 m3 of river water was 0.0076 US dollars. If the additional cost of field implementation is included, the total cost is less than 0.016 US dollars for treating 1 m3 of river water. The final cost was dependent on the size of remediation: the larger the scale, the lower the cost. By this method, the nutrient in the brewery wastewater was reused, the cost of brewery wastewater treatment was saved and the cost of the remediation using bio-augmentation was reduced. Hence, it is suggested that using brewery wastewater to culture a bio-agent for bio-augmentation is a cost-effective method.