Positive phase III results for bevacizumab biosimilar

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Positive phase III results for bevacizumab biosimilar

Biosimilares/Investigación | Posted 25/09/2015 0 Post your comment

Results of a phase III trial have demonstrated the similarity of partners Amgen and Allergan’s biosimilar bevacizumab candidate (ABP 215) to Avastin in patients with advanced non-small cell lung cancer (NSCLC).

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian cancer.

According to ClinicalTrials.gov, the trial was a multicentre, double-blind, randomized, active-controlled, parallel-group study. The main objectives of the study were to compare the efficacy and safety of ABP 215 and Avastin in subjects with advanced NSCLC, which is the leading cause of cancer death in both men and women in the US and the European Union.

The trial, which was completed in September 2015, planned to enrol 642 patients aged 18–80 years across 139 sites in Australia, Bulgaria, Canada, Czech Republic, Germany, Greece, Hong Kong, Hungary, Italy, Mexico, Poland, Romania, Russia, Spain, Taiwan, The Netherlands and the US. Patients were randomized to receive a solution of ABP 215 or Avastin intravenously at a dose of 15 mg/kg on day 1 of each 21 day cycle, for a total of six cycles.

The primary efficacy endpoint of objective response rate (ORR) after 19 weeks of treatment was within the pre-specified equivalence margin for ABP 215 compared to Avastin. The safety and immunogenicity of ABP 215 were also found to be comparable to Avastin. Secondary endpoint results were also consistent with the primary finding and included risk difference of ORR, duration of response and progression-free survival (PFS).

The patents on the originator product, Roche’s Avastin (bevacizumab) are set to expire in Europe in January 2022 and in the US in July 2019 [1]. Avastin had 2014 sales of US$7.4 billion making it a popular target for biosimilar developers.

Biologicals major Amgen has a total of nine biosimilars in development, including adalimumab biosimilar candidate (ABP 501), for which it has announced the results of two positive phase III studies. The first in psoriasis was announced in October 2014 [2] and the second in rheumatoid arthritis in February 2015.

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References
1. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 25]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
2. GaBI Online - Generics and Biosimilars Initiative. Phase III study of biosimilar adalimumab meets primary endpoint [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 25]. Available from: www.gabionline.net/Biosimilars/Research/Phase-III-study-of-biosimilar-adalimumab-meets-primary-endpoint

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Source: Allergan, Amgen, ClinicalTrials.gov