224PD - Efficacy and safety of BCD-022, trastuzumab biosimilar candidate, compared to herceptin: Results of international multicenter randomized double bli...

Date 09 October 2016
Event ESMO 2016 Congress
Session Breast cancer, metastatic
Topics Breast Cancer
Presenter Maria Shustova
Citation Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365
Authors M. Shustova1, O. Burdaeva2, S. Alexeev3, K. Shelepen4, A. Khorinko5, G. Mukhametshina6, L. Sheveleva7, R. Ivanov1
  • 1Medical Department, JSC "BIOCAD", 198515 - St. Petersburg/RU
  • 2Chemotherapy Department, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk/RU
  • 3Therapeutic Oncology, N.N.Petrov Research Inst. of Oncology, St. Petersburg/RU
  • 4Oncology Department, Brest Regional Oncologic Dispensary, Brest/BY
  • 5Chemotherapy Department, Perm Regional Oncological Dispensary, Perm/RU
  • 6Chemotherapy Department, Kazan Clinical Oncology Center, Kazan/RU
  • 7Chemotherapy Department, Volgograd Regional Oncologic Dispensary, Volgograd/RU



BCD-022 demonstrated equivalence to Herceptin in a comprehensive comparability physicochemical, non-clinical PK and PD studies, as well as phase I PK clinical study in patients with HER2+ mBC.


126 patients with HER2-positive metastatic BC were randomly assigned into 2 groups at a ratio of 1:1 to receive BCD-022 or Herceptin at a loading dose of 8 mg/kg and then in maintenance dose of 6 mg/kg in combination with paclitaxel (175 mg/m2) every 3 weeks up to 6 cycles of therapy or until progression or unbearable toxicity.


ORR (primary endpoint) in both groups had no statistically significant differences: 53.57% (95% CI 40.70 – 65.98%) in BCD-022 group and 53.70% (95% CI 40.60 – 66.31%) in Herceptin group. The lower limit of 95% CI for ORR difference between the groups (-19.83%) did not exceed the non-inferiority margin, hence BCD-022 is non-inferior to Herceptin. There were also no differences between the groups for all other efficacy parameters: CR (5.36 vs 3.70%), PR (48.21 vs 50.00%), SD (25.00 vs 25.93%) and progression rate (21.43 vs 20.37%) in BCD-022 and Herceptin group, respectively. AEs profiles of BCD-022 and Herceptin were equivalent. Rate of all observed AEs including severe AEs had no statistically significant difference between the groups. Most AEs were associated with chemotherapy: neutropenia (73.02 vs 73,77%), anemia (82.54 vs 77.05%), leukopenia (73.02 vs 68.85%), lymphopenia (69.84 vs. 65.57%), thrombocytopenia (17.46 vs 29.51%), hyperglycemia (57.14 vs 70.49%), ALP increase (38.68 vs 42.62%), AST increase (42.86 vs 42.62%), ALT increase (33.33 vs 40.98%), alopecia (33.33 vs 34.43%), arthralgia (17.46 vs 18.03%) etc. Cardiovascular events specific for trastuzumab included: tachycardia (34.92 vs 19.67%), arterial hypertension (20.63 vs 18.03%), atrial fibrillation (0 vs 3.28%), extrasystoles (0% vs 1.64%), CAD gr.1 (1.59 vs 0%) and aggravated myocardiodystrophy (1.59 vs 0%). Binding antibodies with neutralizing activity were detected only in 1 patient in each group that indicated to low immunogenic potential of both drugs.


BCD-022 demonstrated non-inferiority to Herceptin in patients with HER2+ mBC.

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All authors have declared no conflicts of interest.