Multicenter randomized double blind phase III clinical trial comparing safety and efficacy of BCD-022 (CJSC BIOCAD, Russia) used with paclitaxel to HerceptinÂ® (F. Hoffmann-La Roche Ltd, Switzerland) used with paclitaxel in the first-line treatment of HER2-positive metastatic breast cancer patients.

Start Date02 Jul 2014

Sponsor / Collaborator-

100 Clinical Results associated with Trastuzumab biosimilar(Biocad Medical, Inc.)

100 Translational Medicine associated with Trastuzumab biosimilar(Biocad Medical, Inc.)

100 Patents (Medical) associated with Trastuzumab biosimilar(Biocad Medical, Inc.)

Literatures (Medical) associated with Trastuzumab biosimilar(Biocad Medical, Inc.)

01 Dec 2022·BMC cancerQ2 · MEDICINE

Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-021 with reference bevacizumab

Q2 · MEDICINE

ArticleOA

Author: Matrosova, Marina P ; Kryukov, Fedor ; Shustova, Mariya S ; Adamchuk, Grigoriy A ; Shelepen, Konstantin G ; Kalloli, Mahesh ; Fadeeva, Natalya V ; Nagarkar, Rajnish ; Zhuravleva, Daria ; Roy, Bodhisatta ; Voevodin, Georgiy D ; Stroyakovskiy, Daniil L

Abstract:

Background:

BCD-021 is a bevacizumab biosimilar which was shown to be equivalent to reference bevacizumab in a wide panel of physicochemical studies as well as preclinical studies in vitro and in vivo. International multicenter phase III clinical trial was conducted to compare efficacy and safety of BCD-021 and reference bevacizumab in combination with paclitaxel and carboplatin in a first-line treatment of inoperable or advanced non-squamous non-small-cell lung cancer (NSCLC).

Methods:

Patients with no previous treatment for advanced non-squamous NSCLC were randomly assigned 3:2 to BCD-021 or reference bevacizumab and were treated with bevacizumab + paclitaxel + carboplatin. Therapy continued for 6 cycles (every 3 weeks), until progression of the disease or unbearable toxicity. The primary study endpoint was the overall response rate. The study goal was to prove the equivalent efficacy of BCD-021 and reference bevacizumab. Equivalence margins for 95% CI for the difference in the overall response rates were set at [-18%; 18%], for 90% CI for the ratio of overall response rate were set at [67%; 150%].

Results:

In total 357 patients were enrolled in the study, 212 in the BCD-021 group and 145 in the reference bevacizumab group. The ORR was 34.63% in the BCD-022 group and 33.82% in the reference bevacizumab group. Limits of 95% CI for the difference in overall response rates between the groups were [-9.47%; 11.09%]. Limits of 90% CI for the ratio of overall response rate between the groups were [79.6%; 131.73%]. For both approaches CI lied within predetermined equivalence margins. Profile of adverse events (AEs) was similar between the groups (any AEs were reported in 86.89% of patients in BCD-021 group and 89.05% of patients in reference group). No unexpected adverse reactions were reported throughout the study. No statistically significant differences regarding anti-drug antibody occurrence rate was found between BCD-022 (n=4; 1.96%) and comparator (n=5; 3.65%). Both drug products showed low occurrence rate and short life of anti-bevacizumab antibodies. Pharmacokinetics assessment after 1st and 6th study drug injection also demonstrated equivalent PK parameters by all outcome measures.

Conclusions:

Thus, the results of this study demonstrated therapeutic equivalence of bevacizumab biosimilar BCD-021 and referent bevacizumab drug.

Trial registration:

The trial was registered with ClinicalTrials.gov (Study Number NCT01763645, date of registration 09/01/2013).

02 Nov 2022·Immunopharmacology and immunotoxicology

Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer: a systematic review and network meta-analysis

Review

Author: Dong, Mei ; Liu, Tong ; Jin, Yao ; Liu, Duo

AIM:

Breast cancer is the most frequently diagnosed cancer in women and ranks second among causes for cancer related death in women. Trastuzumab originator (Herceptin) is a monoclonal antibody used as a standard treatment for breast and metastatic gastric cancer when the cancer cells over-express human epidermal growth factor receptor type 2 (HER2). As the patent of Trastuzumab has now expired, biosimilars are moving into the market. It is still controversial to chose which trastuzumab biosimilar has the best treatment of HER2-positive breast cancer patients. We conducted this network meta-analysis to explore the best trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.

METHODS:

PubMed, Cochrane library databases, China National Knowledge infrastructure (CNKI) and WanFang database up to November 2021 were systematically searched. The following search terms were used: 'trastuzumab originator', and 'trastuzumab biosimilar'. No language restriction was imposed. The reference lists of all retrieved articles were also reviewed to identify additional articles missed by using these search terms.

RESULTS:

We got 10 studies to conduct network meta-analysis to evaluate efficacy and serious adverse reactions among various trastuzumab biosimilars and trastuzumab originator. The overall response rate (ORR) and pathological complete response (pCR) of SB3 were worse than trastuzumab originator significantly, while the ORR and pCR of other trastuzumab biosimilars had not yet reached statistical differences compared with each other. The cumulative ranking curve (SUCRA) probability indicated that the ORR from best to worst was CT-P6, Herceptin, HLX02, PF-05280014, R-TPR-016, BCD-022, MYL-1401O, SB3, and the pCR from best to worst was PF-05280014, CT-P6, Herceptin, ABP-980, SB3. The serious adverse events (SAEs) of CT-P6 were more than Herceptin and MYL-1401O significantly, while the SAEs of other trastuzumab biosimilars had not statistical differences. The SUCRA probability indicated that the SAEs from best to worst was MYL-1401O, Herceptin, PF-05280014, SB3, HLX02, BCD-22, CT-P6.

CONCLUSION:

There was no statistical difference in both ORR and pCR of various trastuzumab biosimilars and Herceptin except SB3. The ORR and pCR of SB3 were worse than Herceptin. Both CT-P6 and PF-05280014 are better in the overall curative effect, but CT-P6 had the highest serious adverse reactions when compared with others. The PF-05280014 might be a better trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.

01 Dec 2020·BMC cancerQ2 · MEDICINE

Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-022 with reference trastuzumab

Q2 · MEDICINE

ArticleOA

Author: Kulik, Sergey A ; Shelepen, Konstantin G ; Burdaeva, Olga N ; Srivastava, Kirti ; Khorinko, Andrey V ; Paltusova, Anastasia N ; Mukhametshina, Guzel Z ; Ivanov, Roman A ; Vikranth, Mummaneni ; Kryukov, Fedor ; Shustova, Mariya S ; Satheesh, Chiradoni Thugappa ; Alexeev, Sergey M

Abstract:

Background:

BCD-022 is a trastuzumab biosimilar which was shown to be equivalent to reference trastuzumab in a wide panel of physicochemical studies as well as preclinical studies in vitro and in vivo. International multicenter phase III clinical trial was conducted to comparatively assess efficacy and safety of BCD-022 and reference trastuzumab in combination with paclitaxel used as the therapy of metastatic HER2(+) breast cancer. Pharmacokinetics and immunogenicity were also studied.

Methods:

Patients with no previous treatment for metastatic HER2(+) breast cancer were randomly assigned 1:1 to BCD-022 or reference trastuzumab and were treated with trastuzumab + paclitaxel. Therapy continued for 6 cycles of therapy (every 3 weeks), until progression of the disease or unbearable toxicity. Primary study endpoint was overall response rate. Study goal was to prove equivalent efficacy of BCD-022 and reference trastuzumab. Equivalence margins for 95% CI for difference in overall response rates were set at [− 20%; 20%].

Results:

In total 225 patients were enrolled into the study, 115 in BCD-022 arm and 110 in reference trastuzumab arm. Overall response rate was 49.6% in BCD-022 arm and 43.6% in reference trastuzumab arm. Limits of 95% CI for difference of overall response rates between arms were [(− 8.05)-19.89%], thus, they lied within predetermined equivalence margins [− 20%; 20%]. Profile of adverse events was similar between groups (any AEs were reported in 93.81% of patients in BCD-022 arm and 94.55% of patients in reference arm). No unexpected adverse reactions were reported throughout the study. No statistically significant differences regarding antibody occurrence rate (either BAb or NAb) was found between BCD-022 (n = 3; 2.65%) and comparator (n = 4; 3.64%). Both drug products are characterized with low occurrence rate and short life of anti-trastuzumab antibodies. Pharmacokinetics assessment after 1st and 6th study drug injection also demonstrated equivalent PK parameters by all outcome measures: AUC0–504, Сmах, Тmax, T1/2. Analysis of Ctrough did not reveal any significant inter-group differences as well.

Conclusions:

Thus, results of this study have demonstrated therapeutic equivalence of trastuzumab biosimilar BCD-022 and referent trastuzumab drug.

Trial registration:

The trial was registered with ClinicalTrials.gov (Study Number NCT01764022). The date of registration was January 9, 2013.

News (Medical) associated with Trastuzumab biosimilar(Biocad Medical, Inc.)

14 Apr 2021

·www.globenewswire.com

New York, April 14, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Biosimilar Monoclonal Antibodies Forecast 2020-2030" - • Along with revenue prediction for the overall world market for biosimilar monoclonal antibodies, our investigation shows forecasts to 2027 for the market segmented by compound: • Infliximab • Rituximab • Abciximab • Trastuzumab • Adalimumab • Bevacizumab • This report also shows revenue to 2027 for individual biosimilar mAb products in the market: • Remsima/Inflectra • Infimab • Reditux • BI695500 • CT-P10 • BI695501 • FKB327 • FKB238 • Mabtas • AcellBia • Maball • Clotinab • Abcixirel • BCD-022 • BCD-021 • Herzuma • CANMAB/Hertraz • Our analyses show individual revenue forecasts to 2027 for these regional and national markets: • The US Biosimilar mAb Market • Japanese Biosimilar mAb Market • EU5 Biosimilar mAb Markets • BRIC and South Korea Biosimilar mAb Markets • Rest of the World Biosimilar mAb Market • This report profiles 10 leading companies either with biosimilar mAbs already on the market or in the pipeline • Our study discusses strengths, weaknesses, opportunities and threats affecting the biosimilar monoclonal antibodies market Read the full report: About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. __________________________

BiosimilarAntibody

100 Deals associated with Trastuzumab biosimilar(Biocad Medical, Inc.)

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Indication	Country/Location	Organization	Date
Breast Cancer	RU	Biocad Medical, Inc.	01 Jan 2016

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