Shots:

• The P-III trial evaluates the safety, efficacy, immunogenicity, and PK of BI 695502 vs bevacizumab RP (Avastin) in patients with recurrent or metastatic NSCLC
• The results showed an ORR (54% vs 63.1%) @18wks. & showed 90% CI for the primary efficacy, patients had ECOG PS of 1 (63.0% vs 60.4%) & more patients had brain lesions (6.6% vs 3.7%), m-PFS (8.3mos. vs 9.0mos.), m-OS (15.6mos. vs 19.5), Plasma concentrations were higher in the bevacizumab RP group
• Additionally, similar efficacy and toxicity in clinical studies of other bevacizumab biosimilars over bevacizumab RP while two biosimilars i.e., Pfizer’s Zirabev and Amgen’s Mvasi have been approved for unresectable, LA NSCLC and recurrent or metastatic nonsq. NSCLC

Ref: Center for Biosimilars | Image: Pharmaceutical Technology