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 has 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.
Ahmed Salah, Vice President International Markets BIOCAD said,
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