Results of a phase III clinical study of Biocad’s non-originator bevacizumab candidate BCD-021 demonstrated ‘equivalence’ compared to the originator biological (Avastin) in patients with non-small cell lung cancer (NSCLC) [1].
The international, multicentre, double-blind, randomized, clinical trial compared the efficacy of BCD-021 (bevacizumab) and paclitaxel + carboplatin to Avastin (bevacizumab) and paclitaxel + carboplatin in 138 patients with inoperable or advanced non-squamous NSCLC patients. A pharmacokinetics sub-study was also performed.
The results of the study were presented at the American Society of Clinical Oncology (ASCO) Annual Conference ASCO 2015 held in Chicago, USA on 29 May–2 June 2015.
Patients were randomly assigned into two groups at a ratio of 1:1 to receive BCD-021 or Avastin at a dose of 15 mg/kg in combination with paclitaxel (175 mg/m2) and carboplatin (AUC 6 mg/mL/min) every 3 weeks up to 6 cycles of therapy or until progression or unbearable toxicity.
The results showed no statistically significant differences between the two groups for the primary endpoint of overall response rate (ORR): 42.59% (95% CI 30.33-55.83) in the BCD-021 group and 39.29% (95% CI 27.58-52.27) in the Avastin group. The lower limit of 95% CI for ORR difference between the groups (-14.96%) did not exceed the non-inferiority margin, leading the authors to conclude that BCD-021 is non-inferior to Avastin.
There were also no differences between the groups for all other efficacy parameters: complete response rate (CRR): 1.85% vs 1.79%, partial response rate (PRR): 40.74% vs 37.50%, stable disease: 51.85% vs 51.79% and progression rate: 5.56% vs 8.93% in the BCD-021 and Avastin groups, respectively.
The adverse event (AE) profiles of BCD-021 and Avastin were equivalent. The rate of all observed AEs including severe AEs had no statistically significant difference between the groups. Most AEs were associated with chemotherapy, e.g. neutropenia, anaemia, leukopenia, thrombocytopenia, hyperglycaemia.
Reactions specific for bevacizumab included arterial hypertension: 26.47% vs 22.73%, weakness: 17.65% vs 16.67%, lung bleeding: 5.88% vs 3.03%, proteinuria 2.94% vs 0%, GIT perforation: 0% vs 1.52% and VTE: 0% vs 1.52%, for BCD-021 and Avastin, respectively. Binding and neutralizing antibodies were transient and detected only in 1 patient in each group, indicating the ‘low immunogenic potential of both drugs’, according to the authors.
The authors therefore concluded that ‘BCD-021 demonstrated non-inferiority to Avastin in patients with NSCLC’.
Conflict of interest
One of the authors of the abstract [1] has received grant/research support or travel expenses from AstraZeneca, Boehringer Ingelheim, Eisai, Merck Serono, Pfizer and Sanofi. The other authors declared no conflict of interest. For full details of the authors’ conflicts of interest, see the abstract [1].
Editor’s comment
It should be noted that data of the study presented in this article were published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
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Reference
1. Filon O, Orlov S, Burdaeva O, et al. Efficacy and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin: results of international multicenter randomized double blind phase III study in patients with advanced non-squamous NSCLC. ASCO 2015, Chicago, USA; 29 May–2 June 2015.
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Source: ClinicalTrials.gov, ASCO
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