New results for Phase III study of BCD-021, a bevacizumab biosimilar, were presented as a poster at the European Society for Medical Oncology (ESMO) Congress 2021. The study have shown that BCD-021 and reference bevacizumab have equivalent efficacy in terms of objective response rate when assessed both as risk difference and risk ratio. Importantly, equivalence was within the limits that are accepted by European Medicines Agency (EMA) and Chinese National Medical Products Administration (NMPA) for bevacizumab biosimilars. Safety and immunogenicity parameters were comparable between BCD-021 and reference bevacizumab.
In order to evaluate the efficacy, safety and immunogenicity of therapy with BCD-021, a randomized, double-blind, multicenter Phase III study was performed in Russia, Belarus, Ukraine, and India. 357 patients with stage IIIB or IV non-squamous non-small cell lung cancer participated in the study. A total of 357 patients were randomized and 341 patients (BCD-021, n=205; reference bevacizumab, n=136) were treated and had at least 1 CT scan after initiation of study treatment (mITT population). Study treatment included BCD-021 or reference bevacizumab with paclitaxel and carboplatin Q3W for 6 cycles. Patients with stable disease, complete or partial responses at Week 18 were offered BCD-021 until disease progression, death, or unacceptable toxicity. The primary efficacy endpoint was objective response rate (ORR) based on responses achieved by Week 19 and confirmed 4 weeks thereafter.
Baseline characteristics were balanced between BCD-021 and reference bevacizumab with rare exceptions. The ORR was achieved in 34.6% and 33.8% of patients that received BCD-021 and reference bevacizumab respectively. The 95% confidence interval for ORR difference was ‑9.5%; 11.1% while criteria for acceptance by EMA are considered to be -12.5%; 12.5%. The 95% confidence interval for ORR ratio was 79.6%; 131.7% while criteria for acceptance by NMPA are considered to be 75.00%; 133.33%. The most frequently occurring adverse effects were anemia, neutropenia and alopecia. PK parameters and the incidence of anti-drug antibodies were comparable between BCD-021 and reference bevacizumab.
“Development of biosimilars opens an opportunity to make life-saving therapy available for patients with limited opportunities, including those in low-income countries who suffer from insufficient healthcare resources. More than 40 000* patients from 22 countries in Africa, Latin America and Southeast Asia have already been treated with BCD-021 by BIOCAD”, told Ahmed Salah, Vice President International Markets BIOCAD.
In order to grow, a tumor needs good blood supply. Therefore, the development of tumor is always accompanied with enhanced angiogenesis – the growth of the new blood vessels. Bevacizumab is a drug the precisely targets this process. It is a monoclonal antibody that slowers an angiogenesis by inhibiting vascular endothelial growth factor A which is crucial for growth of new blood vessels. It was first approved in 2004 in the US as a therapy against metastatic colon cancer. Since then, it was approved in 134 countries for a number of other types of cancer but its high costs resulted in it being excluded from the national healthcare plans even in developed countries based on cost-benefit calculations. Therefore, the use of more affordable biosimilars significantly broadens the access of various populations to bevacizumab therapy.
About lung cancer
Lung cancer is responsible for one out of five cancer deaths in the world. The number of lung cancer patients is growing every year: new cases per year are expected to nearly double from 2018 to 2040 (2 093 876 vs 3 610 896). Moreover, more than a half of them are diagnosed with the stages III and IV, and a half of them lose their lives during the first year with this disease.