Efficacy and safety of bevacizumab biosimilar ABP 215 Posted 12/04/2019

Authors from the US and Europe report data from a phase III study comparing the clinical efficacy and safety of the bevacizumab biosimilar ABP 215 (Mvasi) with originator bevacizumab Avastin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1].

NSCLC is the leading cause of cancer death in both men and women in the US and the European Union (EU). Bevacizumab is approved in the US, EU, and elsewhere for first-line treatment in patients with advanced or recurrent non-squamous NSCLC in combination with platinum-based chemotherapy. Bevacizumab biosimilar Mvasi (ABP 215) was approved in the US in September 2017 [2] and in Europe in January 2018 [3].

This study was a randomized, double-blind, active-controlled study in adult patients with non-squamous NSCLC receiving first-line chemotherapy with carboplatin and paclitaxel. The study was conducted at 101 study centres in 17 countries in Asia/Pacific, Europe, North America, and Latin America.

Patients were randomized 1:1 to receive ABP 215 or Avastin at a dose of 15 mg/kg administered by intravenous infusion every 3 weeks for 6 cycles. All patients received carboplatin and paclitaxel every 3 weeks for ≥ 4 and ≤ 6 cycles.

The primary efficacy endpoint was risk ratio of objective response rate (ORR); clinical equivalence was confirmed if the 2-sided 90% CI of the risk ratio was within the margin of 0.67, 1.5. Secondary endpoints included risk difference of ORR, duration of response (DOR), progression-free survival (PFS), and overall survival (OS); pharmacokinetics, adverse events (AEs), and incidence of anti-drug antibodies (ADAs) were monitored.

A total of 820 patients were screened; 642 were randomized to ABP 215 (n = 328) and Avastin (n = 314). Of the randomized patients, 128 (39.0%) and 131 (41.7%) patients in the ABP 215 and Avastin groups, respectively, had objective responses (ORR risk ratio: 0.93 [90% CI: 0.80, 1.09]). ‘Clinical equivalence was also supported’, according to the authors, by comparing the risk difference of ORR and 90% confidence interval between ABP 215 and Avastin.

In the ABP 215 and Avastin groups, 308 (95.1%) and 289 (93.5%) patients, respectively, had at least one adverse event (AE); 13 (4.0%) and 11 (3.6%) experienced a fatal AE. Anti-VEGF toxicity was low and comparable between treatment groups. At Week 19, median trough serum drug concentration was 132 μg/mL (ABP 215 group) and 129 μg/mL (Avastin group). No patient tested positive for neutralizing antibodies.

The authors concluded that ‘ABP 215 is similar to [Avastin] with respect to clinical efficacy, safety, immunogenicity and pharmacokinetics. The totality of evidence supports clinical equivalence of ABP 215 and [Avastin]’.

Conflict of interest
The authors of the research paper [1] reported conflict of interest, including having acted as a consultant or investigator for various pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper [1].

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References
1. Thatcher N, Goldschmidt JH, Thomas M, et al. Efficacy and safety of the biosimilar ABP 215 compared with bevacizumab in patients with advanced nonsquamous non-small cell lung cancer (MAPLE): a randomized, double-blind, phase III study. Clin Cancer Res. 2019 Jan 7. doi:10.1158/1078-0432.CCR-18-2702. [Epub ahead of print]
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 12]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-bevacizumab-biosimilar-Mvasi 
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 12]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-bevacizumab-biosimilar-Mvasi

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