3-year follow-up of a phase III trial comparing the efficacy and safety of neoadjuvant and adjuvant trastuzumab and its biosimilar CT-P6 in HER2 positive early breast cancer (EBC)

Stebbing, Justin; Baranau, Y.; Baryash, V.; Manikhas, A.; Moiseyenko, Vladimir; Dzagnidze, Giorgi; Zhavrid, Edvard; Boliukh, Dmytro; Stroyakovskiy, Daniil; Pikiel, Joanna; Eniu, Alexandru; Комов, Д. В.; Lee, S.J.; Kim, M.J.; Kim, S.; Park, S.; Bae, Jihun; Esteva, FJ

doi:10.1093/annonc/mdz240.016

Cited by 4 publications

(7 citation statements)

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“…Forty‐one studies reporting on RCTs were identified and included in the analysis, with 34 studies reporting efficacy outcomes (Table 1). Among all included studies, seven reported on ABP 980, 12,22–24,28–30 two on BCD‐022, 11,27 seven on CT‐P6, 31–34,43–45 two on HD201, 14,50 five on HLX02, 15–17,48,49 four on MYL‐1401O, 51–54 five on PF‐05280014, 13,25,26,46,47 eight on SB3, 35–42 and one on Trasturel 21 . All studies contained data in treatment‐naïve patients, and seven studies 12,22–24,28–30 reported data on switching patients; however, these data were obtained from a single studied population, so these data points were collated.…”

Section: Resultsmentioning

confidence: 99%

“…All studies contained data in treatment‐naïve patients, and seven studies 12,22–24,28–30 reported data on switching patients; however, these data were obtained from a single studied population, so these data points were collated. The outcomes of included studies 11–17,21–33,35–53,54 are summarised in Table 2.…”

Section: Resultsmentioning

confidence: 99%

“…Overall, nine brands of trastuzumab (BCD-022, ABP980, SB3, CT-P6, PF-05280014, HD201, TrastuRel, MYL-1401O, HLX02) were examined (Table 1). All studies on trastuzumab were conducted with either paclitaxel [11][12][13][14][21][22][23][24][25][26][27][28][29][30] or docetaxel (with 5 fluorouracil epirubicin cyclophosphamide (FEC) [31][32][33][34][35][36][37][38][39][40][41][42][43][44][45] or carboplatin, 46,47 or as monotherapy [15][16][17]48,49 ) or 'taxane' [50][51][52][53][54] (Table 2). One study, by Apsangikar et al, was conducted independently, 21 while all other studies were funded by the innovator company or by an unknown source.…”

Section: Included Studiesmentioning

confidence: 99%

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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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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Included Studiesmentioning

confidence: 99%

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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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“…54,55 The investigators of the SB3 study stated that they selected bpCR to eliminate potential confounding factors related to tpCR determination that are not attributable to productrelated differences, such as the extent of axillary dissection (tpCR was assessed as a secondary end point, however). 50 Longer-term survival-related end points included EFS and OS in the ABP 980 and SB3 studies and DFS, PFS, and OS in the CT-P6 study; planned follow-up durations differed across the trials 46,47,50,[56][57][58][59][60][61] (see Table 2 for selected results available at the time of writing). The first-line MBC studies for MYL-1401O and PF-05280014 each used the primary end point of ORR on the basis of complete or partial responses achieved by week 24 and week 25, respectively.…”

Section: Which Study Settings and End Points Have Been Used?mentioning

confidence: 99%

Understanding the Role of Comparative Clinical Studies in the Development of Oncology Biosimilars

Stebbing

Mainwaring

Curigliano

et al. 2020

JCO

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Biosimilars have the potential to broaden patient access to biologics and provide cost savings for health care systems. During the development of a biosimilar, data that directly compare the proposed biosimilar with the reference product are required. Such comparative data are generated in a stepwise hierarchical process that begins with extensive laboratory-based structural analyses and functional assays. This initial analytical phase serves as the foundation for the demonstration of biosimilarity and is followed by nonclinical in vivo testing (if required) and then clinical evaluation, including a comparative pharmacokinetics/pharmacodynamics study that is usually conducted in healthy volunteers. The development program typically culminates with a comparative clinical efficacy study. The aim of this study is to confirm clinical equivalence of the potential biosimilar and reference product on the basis of prespecified margins, using a study population and efficacy end point that are sufficiently sensitive for detecting potential product-related differences. Such studies also include detailed analyses of safety as well as evaluation of immunogenicity. As biosimilars become more widely available in oncology, especially with recent regulatory approvals of rituximab, trastuzumab, and bevacizumab biosimilars, it is critically important that clinicians understand how the comparative clinical study differs from a traditional phase III efficacy and safety study in the development of a novel biologic originator product. Here, we review the role of comparative clinical studies in biosimilar development, with a focus on trials conducted to support approved trastuzumab biosimilars. We discuss the study populations and end points used, extrapolation of indications, and the confirmatory nature of these studies within the totality of evidence supporting biosimilarity.

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“…[16,17] Data from a 3-year follow-up study have subsequently con rmed that disease-free survival and OS are similar in patients treated with CT-P6 and RTZ. [18] Real-world studies are an important supplement to clinical trials, by revealing the long-term safety and effectiveness of drugs in broader patient populations, as well as in other settings and in combination with other treatments. For example, RTZ is now increasingly used in combination with pertuzumab (Perjeta®; Genentech) as part of dual HER2-targeted therapy.…”

Section: Introductionmentioning

confidence: 99%

Real-World Comparison of CT-P6 and Reference Trastuzumab for the Treatment of HER2-Positive Early-Stage and Metastatic Breast Cancer

Bae¹,

Kim²,

Ahn³

et al. 2021

Preprint

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Background: Here, we present the first real-world comparison of CT-P6 versus reference trastuzumab (RTZ) for the neoadjuvant treatment of patients with HER2-positive EBC, and for the palliative first-line treatment of patients with HER2-positive metastatic breast cancer (MBC).Methods: We retrospectively identified patients with HER2-positive EBC who had received neoadjuvant treatment with RTZ or CT-P6, plus pertuzumab, carboplatin, and docetaxel, followed by surgery, alongside patients with newly diagnosed HER2-positive MBC who had received palliative treatment with RTZ or CT-P6, plus pertuzumab and docetaxel. The primary endpoints were pathologic complete response (pCR) in the EBC cohort, and progression-free survival (PFS) in the MBC cohort. Results: A similar percentage of patients with EBC achieved a pCR with CT-P6 (74.4% [93/125]) and RTZ (69.8% [90/129]) (p=0.411). For patients with MBC, median PFS did not differ significantly between the two groups (CT-P6: 13.9 months [95% confidence intervals (CIs) not available]; RTZ: 18.4 months [95% CIs 12.5–24.3]; p=0.653). The cardiac safety profiles of CT-P6 and RTZ were similar. Conclusions: These real-world data suggest that CT-P6 has similar effectiveness and cardiac safety to RTZ in patients with HER2-positive EBC and MBC, when administered as part of dual HER2-targeted therapy with pertuzumab plus chemotherapy in the neoadjuvant or palliative setting.

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3-year follow-up of a phase III trial comparing the efficacy and safety of neoadjuvant and adjuvant trastuzumab and its biosimilar CT-P6 in HER2 positive early breast cancer (EBC)

Cited by 4 publications

References 0 publications

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

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

Understanding the Role of Comparative Clinical Studies in the Development of Oncology Biosimilars

Real-World Comparison of CT-P6 and Reference Trastuzumab for the Treatment of HER2-Positive Early-Stage and Metastatic Breast Cancer

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