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Clinical Trial
. 2019 Oct;84(4):839-847.
doi: 10.1007/s00280-019-03920-4. Epub 2019 Aug 19.

Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial

F J Esteva  1   2 , Y V Baranau  3 , V Baryash  3 , A Manikhas  4 , V Moiseyenko  5 , G Dzagnidze  6 , E Zhavrid  7 , D Boliukh  8 , D Stroyakovskiy  9 , J Pikiel  10 , A E Eniu  11 , R K Li  12 , A V Rusyn  13 , B Tiangco  14 , S J Lee  15 , S Young Lee  15 , S Y Yu  15 , J Stebbing  16   17
Affiliations
Clinical Trial

Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial

F J Esteva et al. Cancer Chemother Pharmacol. 2019 Oct.

Abstract

Purpose: Neoadjuvant CT-P6, a trastuzumab biosimilar, demonstrated equivalent efficacy to reference trastuzumab in a phase 3 trial of HER2-positive early-stage breast cancer (EBC) (NCT02162667). We report post hoc analyses evaluating pathological complete response (pCR) and breast pCR alongside additional efficacy and safety measures.

Methods: Following neoadjuvant treatment and surgery, patients received adjuvant CT-P6 or trastuzumab (6 mg/kg) every 3 weeks for ≤ 1 year.

Results: In total, 271 and 278 patients received CT-P6 and trastuzumab, respectively. pCR and breast pCR rates were comparable between treatment groups regardless of age, region, or clinical stage. Overall, 47.6% (CT-P6) and 52.2% (trastuzumab) of patients experienced study drug-related treatment-emergent adverse events (TEAEs), including 17 patients reporting heart failure (CT-P6: 10; trastuzumab: 7). Two CT-P6 and three trastuzumab patients discontinued adjuvant treatment due to TEAEs.

Conclusion: Adjuvant CT-P6 demonstrated comparable efficacy and safety to trastuzumab at 1 year in patients with HER2-positive EBC, supporting CT-P6 and trastuzumab comparability.

Keywords: Adjuvant; Biosimilar; Breast cancer; CT-P6; HER2 positive; Trastuzumab.

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Conflict of interest statement

FJE has received personal fees from Celltrion during the conduct of this study and personal fees from Celltrion, Genentech/Roche, Novartis, and Pfizer outside of the submitted work. YB, VB, and AE have received grants from Celltrion during the conduct of this study. YB has also received non-financial support from Roche and Pfizer outside of the submitted work, and personal fees from Roche outside of the submitted work. AE has also received grants from Roche during the conduct of this study and grants from AstraZeneca and Pfizer outside of the submitted work. SJL, SYL, and SYY are employees of CELLTRION, Inc. In 2018 - present Professor Stebbing, the Editor-in-Chief of Oncogene sat on scientific advisory boards for Celltrion, Singapore Biotech, Vor Biopharma, TLC Biopharmaceuticals and Benevolent AI, has consulted with Lansdowne partners, Vitruvian and Social Impact Capital and he Chairs the Board of Directors for BB Biotech Healthcare Trust and Xerion Healthcare. AM, VM, GD, EZ, DB, DS, JP, RKL, AR, and BT have nothing to disclose.

Figures

Fig. 1
Fig. 1
Patient flow diagram. aOne patient each from the CT-P6 and trastuzumab treatment groups completed the neoadjuvant period, underwent surgery, and initiated the adjuvant period, but did not complete pCR assessment due to lost pathological samples. bDue to relocation (n = 1) and due to being unable to visit treatment site within the visit window (n = 1). GCP good clinical practice, pCR pathological complete response
Fig. 2
Fig. 2
Overall significant decrease in left ventricular ejection fraction. aIf LVEF decreased by ten ejection fraction points from baseline and decreased below an absolute value of 50%, LVEF decrease was confirmed by reassessment within 3 weeks to consider treatment discontinuation. LVEF left ventricular ejection fraction
See this image and copyright information in PMC

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