Efficacy and safety of BCD-022, trastuzumab biosimilar candidate, compared to herceptin: Results of international multicenter randomized double blind study in patients with HER2+ mBC

Shustova, M.; Burdaeva, Olga; Alexeev, Sergey; Shelepen, Konstantin; Khorinko, Andrey V.; Mukhametshina, Guzel; Sheveleva, Ludmila P.; Ivanov, Roman

doi:10.1093/annonc/mdw365.03

Cited by 9 publications

(19 citation statements)

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“…In addition to the current study, MBC has been used as the setting for comparative clinical studies of other trastuzumab biosimilars. 25,26 One of these, MYL-1401O, was licensed by the US Food and Drug Administration in December 2017, as trastuzumab-dkst. 27 In a randomised trial of 500 patients without previous treatment for HER2+ MBC, this biosimilar demonstrated equivalence to reference trastuzumab in ORR at 24 weeks, when both treatments were administered 3-weekly and in combination with a taxane.…”

Section: Discussionmentioning

confidence: 99%

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PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study

et al. 2018

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Background This randomised, double-blind study compared PF-05280014 (a trastuzumab biosimilar) with reference trastuzumab (Herceptin®) sourced from the European Union (trastuzumab-EU), when each was given with paclitaxel as first-line treatment for HER2-positive metastatic breast cancer. Methods Between 4 April 2014 and 22 January 2016, 707 participants were randomised 1:1 to receive intravenous PF-05280014 plus paclitaxel (PF-05280014 group; n = 352) or trastuzumab-EU plus paclitaxel (trastuzumab-EU group; n = 355). PF-05280014 or trastuzumab-EU was administered weekly (first dose 4 mg/kg, subsequent doses 2 mg/kg), with the option to change to a 3-weekly regimen (6 mg/kg) from Week 33. Treatment with PF-05280014 or trastuzumab-EU could continue until disease progression. Paclitaxel (starting dose 80 mg/m 2 ) was administered on Days 1, 8 and 15 of 28-day cycles for at least six cycles or until maximal benefit of response. The primary endpoint was objective response rate (ORR), evaluating responses achieved by Week 25 and confirmed by Week 33, based on blinded central radiology review. Results The risk ratio for ORR was 0.940 (95% CI: 0.842–1.049). The 95% CI fell within the pre-specified equivalence margin of 0.80–1.25. ORR was 62.5% (95% CI: 57.2–67.6%) in the PF-05280014 group and 66.5% (95% CI: 61.3–71.4%) in the trastuzumab-EU group. As of data cut-off on 11 January 2017 (using data up to 378 days post-randomisation), there were no notable differences between groups in progression-free survival (median: 12.16 months in the PF-05280014 group vs. 12.06 months in the trastuzumab-EU group; 1-year rate: 54% vs. 51%) or overall survival (median: not reached in either group; 1-year rate: 89.31% vs. 87.36%). Safety outcomes and immunogenicity were similar between the treatment groups. Conclusion When given as first-line treatment for HER2-positive metastatic breast cancer, PF-05280014 plus paclitaxel demonstrated equivalence to trastuzumab-EU plus paclitaxel in terms of ORR. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT01989676

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Section: Discussionmentioning

confidence: 99%

“…25 Another product, BCD-022, demonstrated non-inferiority to reference trastuzumab in ORR when each treatment was given 3-weekly in combination with paclitaxel in a randomised trial of 126 patients with HER2+ MBC. 26…”

Section: Discussionmentioning

confidence: 99%

PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study

et al. 2018

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“…To date, results from some of these trials have only been disclosed at international oncology congresses. 78,82,84,94,95,98,99 A study in patients with HER2 þ EBC comparing neoadjuvant treatment with the proposed trastuzumab biosimilar ABP 980 and originator trastuzumab, each after run-in anthracycline-based chemotherapy, The 2-sided 90% CIs for RD and RR of pCR were contained within the equivalence margins (AE13.0% and 0.759-1.318, respectively). c The 95% CI for the treatment difference was within the equivalence margin (AE0.15).…”

Section: Kimberly Blackwell Et Almentioning

confidence: 99%

“…84 In a study conducted in patients with HER2 þ MBC, the proposed trastuzumab biosimilar BCD-022 showed noninferiority in efficacy to originator trastuzumab on the basis of ORRs of 53.57% and 53.70%, respectively. 82 Two studies have compared the proposed trastuzumab biosimilar PF-05280014 and originator trastuzumab sourced from the European Union (trastuzumab-EU) in patients with HER2 þ MBC or EBC. 94,95 A comparative safety and efficacy study of PF-05280014 versus originator trastuzumab, each in combination with paclitaxel as first-line treatment for HER2 þ MBC, showed equivalence in the primary end point of ORR, with the 95% CI (0.842-1.049) for the risk ratio for ORR (0.940 for PF-05280014/trastuzumab-EU) being within the prespecified equivalence margin (0.80-1.25).…”

Section: Kimberly Blackwell Et Almentioning

confidence: 99%

The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer

Blackwell

Gligorov

Jacobs

et al. 2018

Clinical Breast Cancer

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Trastuzumab improves survival outcomes for patients with HER2-positive (HER2) breast cancer, yet not all such women receive this important therapy. Trastuzumab was approved by the US Food and Drug Administration in 1998 and the European Medicines Agency in 2000 as treatment for HER2 metastatic breast cancer (MBC). Observational studies between 2000 and 2015 in patients with HER2 MBC suggest that nearly 12% in the United States, 27% to 54% in Europe, and 27.1% to 49.2% in China did not receive trastuzumab or any other HER2-targeted agent as first- and/or later-line for treatment of metastatic disease. In 2006, both agencies approved trastuzumab as adjuvant therapy for patients with HER2 early breast cancer (EBC). Observational studies on real-world treatment patterns for HER2 EBC between 2005 and 2015 suggest that 19.1% to 59.5% of patients across regions of North America, Europe, Australia, New Zealand, and China did not receive (neo)adjuvant trastuzumab. Data suggest that some patient subgroups, including older patients, those with HER2/hormone receptor-positive disease, and women with small and/or node-negative HER2 tumors, were less likely to receive anti-HER2 therapy. Barriers to accessing trastuzumab are multifactorial and include issues related to drug funding and high treatment costs for patients that have been reported worldwide. Herein, we review available literature on the use of, and barriers to, treatment with trastuzumab in patients with HER2 breast cancer. We also discuss how the availability of safe and effective biosimilars might increase access to trastuzumab and allow greater use of anti-HER2 therapy, potentially improving patient outcomes.

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“…Basing our investigation on the Italian Health System key principles of equitable and sustainable care, we evaluated the resource utilization associated with the administration of SC trastuzumab compared with IV trastuzumab in patients with HER2-positive EBC. Advanced settings were not considered, as an IV trastuzumab biosimilar [ 9 , 10 ], whose direct costs are still unknown, will soon be available.…”

Section: Introductionmentioning

confidence: 99%

Resource utilization and cost saving analysis of subcutaneous versus intravenous trastuzumab in early breast cancer patients

et al. 2017

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We conducted an economic evaluation of intravenous (IV) vs subcutaneous (SC) trastuzumab for the treatment of patients with early breast cancer (EBC). Data of patients receiving adjuvant IV trastuzumab at our institute in 2014 were used to study three different treatment scenarios: 1) IV trastuzumab, 2) SC trastuzumab, and 3) IV trastuzumab during chemotherapy followed by SC trastuzumab. Our cohort included 114 patients with a median weight of 63.75 kg. Scenario 2 was the most time-saving treatment, with 71.7% reduction in preparation time and 89.3% reduction in chair time compared to scenario 1. Considering full costs, the mean costs per patient/year were € 14,233 ± 8,698 for scenario 1, € 14,272 ± 8,312 for scenario 2, and € 14,535 ± 8,646 for scenario 3 (p = 0.959). When mean body weight was > 65.2 kg, the mean cost was lower in scenario 2 than in scenario 1. Scenario 2 proved a valuable time-saving and cost-saving option. A shift from IV to SC trastuzumab should be considered, especially in capacity-constrained oncology departments.

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Efficacy and safety of BCD-022, trastuzumab biosimilar candidate, compared to herceptin: Results of international multicenter randomized double blind study in patients with HER2+ mBC

Cited by 9 publications

References 0 publications

PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study

PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study

The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer

Resource utilization and cost saving analysis of subcutaneous versus intravenous trastuzumab in early breast cancer patients

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