Shots:

• The P-III AVANA trial compares the efficacy and safety of FKB238 (IV- 15 mg/kg) vs Avastin in a ratio (1:1) in patients with advanced/recurrent non-sq.NSCLC
• Results: ORR (51.6% vs 53.7%); m-PFS (7.72 vs 7.62 mos.); m-OS (14.13 vs 16.95 mos.)- TEAEs was 94.2% and 95.1%- patients experienced grade 3 or higher TEAEs (53.6% and 55.5%) respectively
• Currently- two bevacizumab biosimilars have been available in the US i.e.- Mvasi (Amgen) and Zirabev (Pfizer) that launched in July’19 & Dec’19 respectively. FKB238 is currently under FDA’s review while the P-I study demonstrated PK properties & good tolerability without antidrug Ab development

Ref: Center for biosimilar| Image: Centus