Double-blind, randomized phase III study to compare the efficacy and safety of trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer (EBC)

Esteva, FJ; Baranau, Y.; Baryash, V.; Manikhas, Alexey; Moiseyenko, Vladimir; Dzagnidze, Giorgi; Zhavrid, Edvard; Boliukh, Dmytro; Stroyakovskiy, Daniil; Pikiel, Joanna; Eniu, Alexandru; Комов, Д. В.; Zautashvili, Z.; Morar-Bolba, Gabriela; Li, R.K.; Lifirenko, Igor; Rusyn, A.; Lee, S.J.; Yu, Sunyoung; Stebbing, Justin

doi:10.1093/annonc/mdx362.003

Cited by 6 publications

(11 citation statements)

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“…84 CT-P6 and originator trastuzumab also had similar safety profiles (7.4% vs. 11.9% of patients, respectively, reported !1 serious adverse event). 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.…”

Section: Kimberly Blackwell Et Almentioning

confidence: 79%

“…78 The efficacy and safety of neoadjuvant CT-P6 and originator trastuzumab, each in combination with chemotherapy, were compared in patients with HER2 þ EBC. 84 The pCR rate was 46.8% for CT-P6 and 50.4% for originator trastuzumab, and the 95% CI (À0.1238 to 0.0516) for the estimate of treatment difference (À0.0362) was within the equivalence margin (AE0.15), showing equivalence in efficacy between the 2 treatments. 84 CT-P6 and originator trastuzumab also had similar safety profiles (7.4% vs. 11.9% of patients, respectively, reported !1 serious adverse event).…”

Section: Kimberly Blackwell Et Almentioning

confidence: 87%

“…84 The pCR rate was 46.8% for CT-P6 and 50.4% for originator trastuzumab, and the 95% CI (À0.1238 to 0.0516) for the estimate of treatment difference (À0.0362) was within the equivalence margin (AE0.15), showing equivalence in efficacy between the 2 treatments. 84 CT-P6 and originator trastuzumab also had similar safety profiles (7.4% vs. 11.9% of patients, respectively, reported !1 serious adverse event). 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.…”

Section: Kimberly Blackwell Et Almentioning

confidence: 87%

“…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%

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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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Section: Kimberly Blackwell Et Almentioning

confidence: 79%

Section: Kimberly Blackwell Et Almentioning

confidence: 87%

Section: Kimberly Blackwell Et Almentioning

confidence: 87%

Section: Kimberly Blackwell Et Almentioning

confidence: 99%

See 2 more Smart Citations

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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“…With the expiry of the patent for trastuzumab, a number of biosimilar studies of anti-HER2 antibodies were presented at this yearʼs conferences 46 , 47 , 48 , 49 , 50 , 51 , 52 . Four different antibodies are expected to be introduced in Germany in 2018.…”

Section: Biosimilarsmentioning

confidence: 99%

Update Breast Cancer 2017 – Implementation of Novel Therapies

Lux

Janni

Hartkopf

et al. 2017

Geburtshilfe Frauenheilkd

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In recent years, numerous new therapy options for patients with breast cancer have been developed in clinical studies, with some options already approved for routine treatment. As the speed at which innovations are introduced increases, the importance of conferences also increases, as conferences are where the data underpinning new therapies are usually presented for the first time. This review looks at publications of the ASCO (American Society of Clinical Oncology) and ESMO (European Society of Medical Oncology) conferences in 2017, summarizes them and evaluates them in the context of existing data. The focus is on new insights for neoadjuvant therapy and new treatment options in the metastatic setting, such as the use of CDK4/6 inhibitors or PARP inhibitors. The first results of treatments with checkpoint inhibitors are presented. With the patent expiry of trastuzumab, a number of study results for trastuzumab biosimilars have also been published. The digitization of patient care provides the first results on quality of life and prognosis of patients with advanced cancer. Digital communications between patients and physicians are being evaluated in several studies in Germany. As the discussion about patient-relevant endpoints for patients in the metastatic setting continues, overall survival rates from studies of big endocrine-based therapies are urgently needed. Preliminary analyses of small study cohorts offer initial insights. In the context of improving patient care, in the coming years, questions will center on which patients particularly benefit from certain therapies and which patients need particular protection from specific side effects. Questions about these predictors are raised in many scientific projects as attention increasingly focuses on this topic.

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Safety and efficacy comparisons of intravenous trastuzumab biosimilars to the reference product medicine in treatment‐naïve and switch‐over patients with breast cancer: a systematic and meta‐analysis

Song,

Musa,

Soriano

et al. 2023

Pharmacy Practice and Res

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AimTo compare the efficacy and safety of trastuzumab biosimilars to reference trastuzumab in patients with breast cancer. Trastuzumab, a biologic pharmaceutical product, has improved survival in hormone‐oestrogen receptor 2 positive breast cancer. However, due to its high economic burden, ‘highly similar’ products known as biosimilars have been developed. Yet, concerns remain around the equivalency of efficacy and safety between biosimilars and their reference biologic.Data SourcesA systematic review with meta‐analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) guidelines. MEDLINE, EMBASE, and Cochrane Central databases were searched from inception to 26 April 2021 to obtain all randomised control trial data reporting on safety and efficacy outcomes of patients with breast cancer treated with trastuzumab biosimilars.Study SelectionStudies were required to investigate and report on the safety and/or efficacy of trastuzumab. No restrictions were placed on study setting or intervention type and any study which reported at least one efficacy or safety outcome was included. A head‐to‐head comparison between the biosimilar and its reference biologic was not required for inclusion in the results. Only studies using randomised control trials were included. There was no restriction on the language the study was published in, and all abstracts, raw clinical trial data, and full‐text studies were eligible.ResultsForty‐one studies were identified to report on patients treated with trastuzumab. The odds of achieving an overall response rate in patients treated with a trastuzumab biosimilar compared to the reference over at least 24 weeks of treatment was 1.10 (95% confidence interval [CI] 0.94–1.29). The proportion of patients experiencing any treatment emergent adverse events were comparable between the two study arms, 1.07 (95% CI 0.87–1.32). The switching group contained one study with 342 patients in the meta‐analysis.ConclusionTrastuzumab biosimilars have comparable efficacy and safety to reference trastuzumab in treatment‐naïve patients. However, evidence is lacking for switching patients from reference trastuzumab to biosimilars, so further work is required in the switch‐over population.

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Double-blind, randomized phase III study to compare the efficacy and safety of trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer (EBC)

Cited by 6 publications

References 0 publications

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

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

Update Breast Cancer 2017 – Implementation of Novel Therapies

Safety and efficacy comparisons of intravenous trastuzumab biosimilars to the reference product medicine in treatment‐naïve and switch‐over patients with breast cancer: a systematic and meta‐analysis

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