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Biosimilar’s Efficacy and Safety Comparable to Bevacizumab in Study
Amgen and Allergan say a phase III study of their biosimilar candidate ABP 215 met primary and secondary endpoints for efficacy and safety compared with bevacizumab (Avastin, Genentech) in adults with advanced nonsquamous non–small-cell lung cancer (NSCLC).
The primary endpoint, an assessment of objective response rates (ORR), was within the prespecified margin for ABP 215 compared with 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 is being developed as a biosimilar to bevacizumab, a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2. This inhibits establishment of the new blood vessels necessary for the maintenance and growth of solid tumors.
This randomized, double-blind, active-controlled study (study number 20120265) evaluated safety and efficacy of ABP 215 compared to bevacizumab in adults with advanced nonsquamous NSCLC receiving first-line chemotherapy with carboplatin and paclitaxel. There were 642 patients enrolled and randomized (1:1) to receive ABP 215 (n = 328) or bevacizumab (n = 314) at a dose of 15 mg/kg administered as an intravenous infusion every three weeks for up to six cycles.
The duration of the treatment included a screening period of up to four weeks, followed by up to six three-week treatment cycles and an end-of-treatment visit 21 days after the last dose of the investigational product or study-specified chemotherapy. Following the end-of-treatment visit, patients were followed for disease progression and overall survival (OS) until the end of the clinical study, consent was withdrawn, they were lost to follow-up or death, or they had proscribed therapy (e.g., commercial bevacizumab, nonstudy anticancer treatment).
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.
Source: Amgen; September 23, 2015.