The phase III, randomised MAPLE study confirms biosimilarity between ABP 215 and bevacizumab RP in patients with NSCLC
ABP 215 is a novel biosimilar for bevacizumab. In this phase III randomised study its clinical efficacy and safety were compared versus reference product in patients with non-small cell lung cancer (NSCLC).
Bevacizumab is approved in the USA and EU for the treatment of several malignancies including NSCLC. ABP 215 is the first approved biosimilar for bevacizumab. Similarity between ABP 215 and bevacizumab reference product (RP) has been demonstrated in multiple, rigorous non-clinical and pre-clinical evaluations. To add further evidence in support of the clinical value of ABP 215, the phase III, randomised MAPLE study was conducted to compare its efficacy, safety, immunogenicity, and pharmacokinetic profiles versus bevacizumab RP in patients with NSCLC.
Eligible patients starting first-line chemotherapy for NSCLC were randomly assigned to receive add-on ABP 215 or bevacizumab for up to six 3-weekly cycles. In ABP 215 and bevacizumab RP groups, objective responses (defined as complete or partial response) were recorded in 39% and 42% of patients, respectively. Since this result was within the prespecified equivalence margin, clinical efficacy of the two treatments was concluded similar. Secondary endpoints such as progression-free survival and overall survival were also comparable in both treatment groups. Adverse events, pharmacokinetic values (i.e., trough serum concentrations), and immunogenicity assessments (i.e., anti-drug antibodies) were also similar between the two groups.
This phase III equivalence study comparing ABP 215 and bevacizumab RP completes the totality of evidence recommended by regulatory agencies for biosimilars development. Together with the results of previous studies, this study confirms biosimilarity between ABP 215 and bevacizumab RP.
The biosimilarity between the bevacizumab RP and the biosimilar ABP 215 was confirmed by the totality of evidence from previous studies and a phase III equivalence study in patients with NSCLC.