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Recent publication in the
The Lancet Gastroenterology and Hepatology on the mAbxience bevacizumab biosimilar(BEVZ92)1

Resultados del ensayo clínico bevacizumab biosimilar BEVZ92 para cáncer colorrectal

The results of a clinical trial comparing the bevacizumab biosimilar BEVZ92 versus the original bevacizumab as the reference product, in combination with chemotherapy, in patients receiving first-line treatment for metastatic colorectal cancer were recently published in the prestigious journal, The Lancet Gastroenterology and Hepatology.

We give an overview of the most important data from the study below, with a brief introduction to what bevacizumab is and how it works.

1. Creation of blood vessels in tumours

Tumour growth depends on the formation of new blood vessels in the vascular system2, which is known as angiogenesis2. This is regulated by chemical substances, including “vascular endothelial growth factor” (VEGF), which stimulates the proliferation, displacement and survival of blood vessels3. VEGF is a protein found in our body and which is also produced by tumours. Therefore, it is a target for anticancer therapies1.

2. Bevacizumab

One of these therapies is bevacizumab, a monoclonal antibody that binds to VEGF1, thus reducing the growth of the tumour’s blood vessels and limiting the blood supply to the tumour3.

It was approved in 2004 in the USA and in 2005 in Europe for the treatment of colorectal cancer in combination with standard chemotherapy, and is currently the standard treatment for this disease1. It is currently used in combination with chemotherapy in lung, kidney, breast, ovarian and brain cancer, etc.1.

The more patients that benefit from the use of bevacizumab, the more the costs for health systems increase. In Europe, the estimated cost per year of life gained by colorectal cancer patients is €80,0003 per patient. Bevacizumab biosimilars could provide an effective and well-tolerated treatment option at a lower cost1, which could contribute to the sustainability of health systems.

3. BEVZ92, bevacizumab biosimilar developed by mAbxience

mAbxience, in line with its philosophy of providing biosimilars that increase accessibility to various treatments and that contribute to the sustainability of health systems at a global level4, has developed BEVZ92, a bevacizumab biosimilar that, when used in the same way as the reference bevacizumab, produces the same clinical benefits with no difference in safety. BEVZ92 is a more accessible alternative for the treatment of patients with colorectal cancer1.

In a clinical trial in patients with colorectal cancer that was recently published in the prestigious scientific journal The Lancet Gastroenterology and Hepatology, the bevacizumab biosimilar BEVZ92 demonstrated pharmacokinetic equivalence and comparable efficacy, safety and immunogenicity when compared to the reference product1.

The study was carried out in 15 hospitals in Argentina, Brazil, India, Spain and Ukraine, and 142 patients who met the inclusion criteria (age, grade of disease, prior treatments and physical status) participated1.

The patients were divided into two groups: 71 received the reference product and 71 received BEVZ92. In addition, all the patients received the routine chemotherapy1.

The primary objective of the study was to investigate whether BEVZ92 and the reference product achieved the same blood levels and were eliminated at the same speed when administered at the same dose and in combination with the same chemotherapy. The other objectives of the trial were to investigate whether the clinical benefits, level of response to the treatment, progression-free survival, safety and immunogenicity were similar (bioequivalence)1.

Results showed that BEVZ92 is bioequivalent to the reference product. Moreover, its efficacy, safety and immunogenicity are also similar1.

The conclusions from this study are good news for patients, doctors and health authorities, as the development of high-quality, effective and safe biosimilars provides better access to the treatment options and, at the same time, reduces healthcare costs and promotes competition1.

Access to BEVZ92 will increase the number of biological treatments available, and will contribute to the treatment of cancer, to the accessibility and sustainability of healthcare systems1.

4. 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. Lancet Gastroenterol Hepatol. September 2018. doi:10.1016/S2468-1253(18)30269-3

2. Ranieri G, Patruno R, Ruggieri E, Montemurro S, Valerio P, Ribatti D. Vascular Endothelial Growth Factor (VEGF) as a Target of Bevacizumab in Cancer: From the Biology to the Clinic. Curr Med Chem. 2006;13(16):1845-1857. doi:10.2174/092986706777585059

3. Kazazi-Hyseni F, Beijnen JH, Schellens JHM. Bevacizumab. The Oncologist. 2010;15(8):819-825. doi:10.1634/theoncologist.2009-0317

4. UNA APUESTA SÓLIDA EN BIOSIMILARES. http://www.mabxience.com/es/acerca-de-mabxience/nuestra-mision-una-apuesta-solida-biosimilares/. Accessed October 2, 2018.