Biotech giant Amgen, and its partner Allergan, announced on 22 August 2019 positive data from a ‘top-line’ phase III study of its rituximab biosimilar (ABP 798) compared to Rituxan (rituximab) in non-Hodgkin's lymphoma (NHL) patients.
Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.
This is the second of two studies intended to support regulatory submissions for ABP 798. The first study was conducted in patients with moderate-to-severe rheumatoid arthritis (RA) and met the primary endpoint of pharmacokinetic similarity [1]. This RA study, according to Amgen, ‘demonstrated clinical equivalence within the pre-specified efficacy margin and a similar safety and immunogenicity profile’.
This second study (JASMINE) was carried out to assess if ABP 798 is safe and effective in treating NHL compared to the originator biological, Roche’s MabThera/Rituxan (rituximab). The randomized, double-blind, study (NCT02747043) evaluated the efficacy, safety and immunogenicity of ABP 798 compared to Rituxan in patients with CD20-positive B-cell NHL. A total of 256 patients were enrolled and randomized to receive either ABP 798 or Rituxan, at a dose of 375 mg/m2 administered as an intravenous (IV) infusion once weekly for four weeks followed by dosing at Weeks 12 and 20. It was carried out at 98 centres in Australia, Bulgaria, Canada, Colombia, Czechia, France, Georgia, Germany, Greece, India, Israel, Italy, Japan, Mexico, Poland, Romania, South Korea, Spain, Ukraine and the US. The trial was completed in June 2019.
The results were reported by Amgen to have met the primary objective of the study, which was to show that the overall response rate (ORR) by Week 28 was within the prespecified margin for ABP 798 compared to Rituxan. This, according to Amgen, showed the ‘clinical equivalence’ of ABP 798. The company added that the ‘safety and immunogenicity of ABP 798 were comparable to Rituxan’.
According to Amgen’s executive vice president of Research and Development, Dr David M Reese, the results ‘demonstrate another positive development from Amgen’s robust pipeline of biosimilar medicines’. He added that the company is looking forward ‘to working with regulatory agencies to bring this treatment to patients’.
Amgen has 10 biosimilars in its portfolio. These include two that are approved in the US, Amjevita (adalimumab-atto) and Mvasi (bevacizumab-awwb) [2], and three that are approved in the European Union (EU), Amgevita (adalimumab), Mvasi (bevacizumab) and Solymbic (adalimumab) [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for rituximab biosimilar ABP 798 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 13]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-rituximab-biosimilar-ABP-798
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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