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Bioequivalence of bevacizumab biosimilar (BEVZ92) versus Avastin in mCRC patients Posted 28/09/2018

Researchers from mAbxience presented data that supports the pharmacokinetic (PK) bioequivalence between bevacizumab biosimilar BEVZ92 and originator bevacizumab (Avastin) as first-line treatment in combination with fluorouracil, leucovorin and oxaliplatin (FOLFOX) or fluorouracil, leucovorin, and irinotecan (FOLFIRI).  in patients with metastatic colorectal cancer (mCRC) [1].

The randomized, phase I, open-label trial was carried out at 15 centres in Argentina, Brazil, India, Spain and the Ukraine. It compared the PK and safety profile between BEVZ92 and Avastin (NCT02069704). A total of 142 patients were randomized 1:1 to receive BEVZ92
(n = 71) or Avastin (n = 71). BEVZ92 or Avastin was administered at 5 mg/kg on day 1 of each cycle every 2 weeks, in combination with FOLFOX or FOLFIRI. The primary endpoint was the area under the concentration-versus-time curve after a single infusion (AUC0–336h) and at steady state (AUCss) – i.e. at cycle 7 - in the assessable population, which comprised all treated patients for whom serum concentration measurements were available during the first seven cycles. Bioequivalence was established if the 90% CIs for the ratio of BEVZ92 to reference bevacizumab of the geometric means for AUC0-336h and AUCss were within the acceptance interval of 80−125%.

The geometric mean ratio of AUC0-336h in the BEVZ92 versus the control group was 99.4% (90% CI 90.5−109.0) and of AUCss was 100.0% (90.2−112.0). Objective response (35 [49%] of 71 vs 40 [56%] of 71), clinical benefit (62 [87%] vs 65 [92%]), and progression-free survival (median 10.8 months [95% CI 7.4−11.5] vs 11.1 months [95% CI 8.0−12.8]) were similar in the BEVZ92 and reference bevacizumab groups. No relevant differences were noted between the safety profiles of the two study treatments. The occurrence of anti-drug antibodies was low and similar in both treatment groups (two patients in the BEVZ92 group and one in the reference bevacizumab group).

The authors concluded that their ‘results suggest that BEVZ92 and reference bevacizumab are pharmacokinetically bioequivalent and have no appreciable differences in safety profiles as first-line treatment in combination with FOLFOX or FOLFIRI in patients with metastatic colorectal cancer’.

mAbxience announced in May 2018 a deal with US generics maker Amneal Pharmaceuticals (Amneal) which gives Amneal exclusive licensing and supply rights in the US for mAbxience’s candidate bevacizumab biosimilar [2].

Conflict of interest
The authors of the research paper [1] reported conflict of interest, including being an employee of mAbxience. For full details of the authors’ conflict of interest, see the research paper [1].

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References
1.  Romera A, Peredpaya S, Shparyk Y, et al. Bevacizumab biosimilar BEVZ92 versus reference bevacizumab in combination with FOLFOX or FOLFIRI as first-line treatment for metastatic colorectal cancer: a multicentre, open-label, randomised controlled trial. The Lancet. 2018 Sep 24. doi: https://doi.org/10.1016/S2468-1253(18)30269-3
2.  GaBI Online - Generics and Biosimilars Initiative. Amneal and mAbxience make deal for bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Pharma-News/Amneal-and-mAbxience-make-deal-for-bevacizumab-biosimilar

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