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ePoster Display

1338P - A phase III study comparing BCD-021, a bevacizumab biosimilar, and reference bevacizumab in patients with stage IIIB or IV non-squamous NSCLC


16 Sep 2021


ePoster Display


Cytotoxic Therapy;  Clinical Research

Tumour Site

Non-Small Cell Lung Cancer


Natalia Fadeeva


Annals of Oncology (2021) 32 (suppl_5): S949-S1039. 10.1016/annonc/annonc729


N. Fadeeva1, B. Roy2, R. Nagarkar3, H. Adamchuk4, M. Matrosova5, S. Tjulandin6, D. Stroyakovskiy7, D. Zhuravleva8, G. voevodin9, M. Shustova10, K.A. Kryukov10, V. Chistiakov11

Author affiliations

  • 1 Chemotherapy, Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine, 454087 - Chelyabinsk/RU
  • 2 Department Of Clinical Research, Netaji Subhas Chandra Bose Cancer Hospital, 3081 - Nayabad/IN
  • 3 Surgical Oncology, HCG Manavata Cancer Centre, Nashik/IN
  • 4 Oncology, Krivoy Rog City Oncology Center, 50048 - Krivoy Rog/UA
  • 5 Chemotherapy, Nizhny Novgorod Regional Clinical Oncological Dispensary, 603126 - Nizhny Novgorod/RU
  • 6 Chemotherapy, N.N. Blokhin National Medical Research Center of Oncology, 115478 - Moscow/RU
  • 7 Chemotherapy, Moscow City Oncology Hospital №62 of Moscow Department of Health, Moscow/RU
  • 8 System Biology Devision, Biocad, 191011 - Saint Petersburg/RU
  • 9 Sas Analytics Team, Biocad, 191011 - Saint Petersburg/RU
  • 10 Clinical Development Department "oncology", BIOCAD, 198515 - Saint-Petersburg/RU
  • 11 Clinical Development Department "oncology", Biocad, 191011 - Saint Petersburg/RU


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Abstract 1338P


BCD-021 (JSC BIOCAD) is a biosimilar of the reference bevacizumab (Avastin®). This study compared the efficacy, safety, pharmacokinetics (PK), and immunogenicity of BCD-021 to BEV in patients with stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC).


In this randomised, double-blind, multicentre study, patients were randomised in a ratio 1:1 (for Russia, Belarus and Ukraine) and 2:1 (for India) to receive BCD-021 or BEV 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. Primary PK endpoint was AUC(0-t) after first infusion. Secondary endpoints were safety, PK, and immunogenicity.


A total of 357 patients were randomized and 341 patients (BCD-021, n=205; BEV, n=136) were treated and had at least 1 CT scan after initiation of study treatment (mITT population). Baseline characteristics were balanced between BCD-021 and BEV with the exception for race. In the, the ORR was 34.6% in BCD-021 and 33.8% in BEV; the risk difference was 0.8% and its 95% CI was [-9.5 %, 11.1 %]. The 90% CI for risk ratio was [79.6%, 131.7%]. CIs were within the pre-defined equivalence margins of [-18%, 18%] for risk difference and [67%, 150%] for risk ratio. Sensitivity analysis for ORR with race as covariate resulted in 90% CI for risk ratio [79.2%, 132.1%]. The 90% CIs for the ratios of geometric means of AUC(0-t) values for BCD-021 and BEV were within the pre-defined equivalence margin of [80%, 125%] for Indian and non-Indian patient populations. The overall incidence of adverse events (AEs) was comparable between BCD-021 vs BEV (91.3% vs 93.4%). The most frequently occurring AEs were anaemia, neutropenia and alopecia. PK parameters (Ctrough and Cmax) and the incidence of anti-drug antibodies were comparable between BCD-021 and BEV.


This study demonstrated equivalence between BCD-021 and BEV in terms of ORR risk difference and risk ratio. Safety, PK, and immunogenicity parameters were comparable between BCD-021 and BEV.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

JSC Biocad.


JSC Biocad.


D. Zhuravleva: Financial Interests, Institutional, Full or part-time Employment: Biocad. G. Voevodin: Non-Financial Interests, Institutional, Full or part-time Employment: Biocad. M. Shustova: Financial Interests, Institutional, Full or part-time Employment: Biocad. K.A. Kryukov: Financial Interests, Institutional, Full or part-time Employment: Biocad. V. Chistiakov: Financial Interests, Institutional, Full or part-time Employment: Biocad. All other authors have declared no conflicts of interest.

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