Amgen and Allergan announced that their biosimilar candidate ABP 215 met its primary and secondary endpoints in a Phase 3 study evaluating its efficacy and safety compared with Avastin (bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC).
The study was a randomized, double-blind, active-controlled trial in 642 patients with advanced non-squamous NSCLC receiving first-line chemotherapy with carboplatin and paclitaxel. Patients were randomized (1:1) to receive either ABP 215 or bevacizumab at a dose of 15mg/kg administered as an IV infusion every three weeks (Q3W) for up to six cycles. The primary endpoint was an assessment of objective response rates (ORR). Clinical equivalence of the primary endpoint was demonstrated by comparing the confidence interval of the risk ratio in ORR between ABP 215 and bevacizumab to a prespecified margin. Response was determined by independent review based on RECIST criteria.
The primary endpoint was within the prespecified margin for ABP 215 compared to bevacizumab, showing clinical equivalence. Safety and immunogenicity of ABP 215 were comparable to bevacizumab. Secondary endpoint results were consistent with the primary finding and included risk difference of ORR, duration of response and progression-free survival (PFS).
ABP 215, a potential biosimilar to bevacizumab, is a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that inhibits vascular endothelial growth factor (VEGF).
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