Shots:
- Prestige has reported the topline P-III (SAMSON-II) trial results evaluating HD204, a biosimilar version of Avastin (bevacizumab), vs Avastin in 625 adults with advanced non-squamous NSCLC
- Trial showed an ORR of 48.7% vs 46.5% at 18wks., meeting its 1EP & showing clinical equivalence between HD204 & Avastin; 2EPs supported the primary analysis, with similar Wk. 12 ORR responses & no significant differences in PFS or OS between groups
- SAMSON-II outcomes were consistent with strong analytical & PK similarity between HD204 & Avastin, supporting Prestige’s advancement of regulatory pathways based on robust analytical & clinical PK data
Ref: PRnewswire | Image: Prestige Biopharma | Press Release
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