Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display session 2

719 - 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)

Date

29 Sep 2019

Session

Poster Display session 2

Presenters

Justin Stebbing

Citation

Annals of Oncology (2019) 30 (suppl_5): v55-v98. 10.1093/annonc/mdz240

Authors

J. Stebbing1, Y. Baranau2, V. Baryash2, A. Manikhas3, V. Moiseyenko4, G. Dzagnidze5, E. Zhavrid6, D. Boliukh7, D. Stroyakovskiy8, J. Pikiel9, A. Eniu10, D. Komov11, S.J. Lee12, M.J. Kim13, S. Kim13, S. Park13, J.H. Bae14, F.J. Esteva15

Author affiliations

  • 1 Medical Oncology, Imperial College London, Imperial College NHS Healthcare Trust, W6 8RF - London/GB
  • 2 Medical Oncology, Minsk City Clinical Oncological Dispensary, 220013 - Minsk/BY
  • 3 Oncology, St. Petersburg SBIH City Clinical Oncology Dispensary, 197022 - St. Petersburg/RU
  • 4 Medical Oncology, GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology), 197758 - Saint Petersburg/RU
  • 5 Oncology, S. Khechinashvili University Clinic, Ltd.,, 0179 - Tbilisi/GE
  • 6 Chemotherapy, N.N. Alexandrov Research Institute, 223040 - Minsk/BY
  • 7 Oncology, Vinnytsya Regional Clinical Oncology Dispensary, 21029 - Vinnytsya/UA
  • 8 Chemotherapy, Moscow City Oncology Hospital No. 62, 143423 - Moscow/RU
  • 9 Oncology, Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii, 80-219 - Gdansk/PL
  • 10 Dept Of Breast Tumours - Head Of The Day Hospital Unit, The Oncology Institute Prof. Dr. Ion Chiricuta, 400015 - Cluj-Napoca/RO
  • 11 Surgery, N.N. Blokhin Russian Cancer Research Center, 115478 - Moscow/RU
  • 12 Clinical Development, Celltrion, 22006 - Incheon/KR
  • 13 Clinical Planning, Celltrion, 22006 - Incheon/KR
  • 14 Biometrics, Celltrion, 22006 - Incheon/KR
  • 15 Medical Oncology, NYU Langone Health, 10012 - New York/US
More

Resources

Abstract 719

Background

CT-P6 was approved by both US FDA and European Commission as a biosimilar to reference trastuzumab (RTZ). Here we report updated long term efficacy and safety.

Methods

549 patients with HER2 positive EBC were randomized 1:1 to CT-P6 (n = 271) or RTZ (n = 278) with docetaxel (Cycles 1-4) and 5-fluorouracil, epirubicin and cyclophosphamide (Cycles 5-8). After surgery, patients received CT-P6 or RTZ monotherapy to complete a total of 1 year and were followed up to 3 years from enrollment of the last patient. Stratified Cox regression and Kaplan-Meier methods were used for time to event (TTE) analyses.

Results

528 patients (259 in CT-P6 and 269 in RTZ) were followed up. The median duration of follow-up was 39 months. Overall, the rates of disease-free survival (DFS) and overall survival (OS) were similar between CT-P6 and RTZ in both PPS and ITT set. The number of DFS events (42 [16.3%] in CT-P6 and 36 [13.8%] in RTZ) and OS events (18 [6.6%] in CT-P6 and 18 [6.5%] in RTZ) were comparable in ITT set. Median DFS and OS have not been reached due to an insufficient number of events. The mean LVEF was more than 60% in both groups, and no new cases of heart failure were reported during the follow-up period. Table. Summary of Long Term Efficacy EndpointsTable:

190P

PPSITT set
CT-P6 n = 248RTZ n = 256CT-P6 n = 258RTZ n = 261
DFS rate
1 year (95% CI)0.95 (0.91 – 0.97)0.96 (0.93 – 0.98)0.95 (0.91 – 0.97)0.96 (0.93 – 0.98)
2 years (95% CI)0.87 (0.81 – 0.90)0.89 (0.85 – 0.92)0.87 (0.82 – 0.90)0.89 (0.85 – 0.93)
3 years (95% CI)0.82 (0.77 – 0.87)0.82 (0.75 – 0.88)0.83 (0.77 – 0.87)0.83 (0.76 – 0.88)
Hazard ratio (95% CI)1.23 (0.78 – 1.94)1.23 (0.78 – 1.93)
p-value0.38080.3807
CT-P6 n = 248RTZ n = 256CT-P6 n = 271RTZ n = 278
OS rate
1 year (95% CI)1.00 (1.00 – 1.00)1.00 (0.97 – 1.00)0.99 (0.97 – 1.00)0.99 (0.97 – 1.00)
2 years (95% CI)0.98 (0.95 – 0.99)0.98 (0.96 – 0.99)0.97 (0.93 – 0.98)0.98 (0.96 – 0.99)
3 years (95% CI)0.95 (0.91 – 0.97)0.94 (0.90 – 0.96)0.93 (0.90 – 0.96)0.94 (0.90 – 0.96)
Hazard ratio (95% CI)0.87 (0.42 – 1.82)1.10 (0.57 – 2.13)
p-value0.71810.7710
.

Conclusions

DFS and OS rates and cardiotoxicity at a median follow-up of 39 months support the similarity of CT-P6 and reference trastuzumab in early-stage breast cancer.

Clinical trial identification

NCT02162667.

Editorial acknowledgement

Legal entity responsible for the study

Celltrion.

Funding

Celltrion.

Disclosure

J. Stebbing: Officer / Board of Directors, Editer-in-Chief: Oncogene; Advisory / Consultancy: Celltrion; Advisory / Consultancy: Vor Biopharma; Advisory / Consultancy: Benevolent AI; Officer / Board of Directors: BB Biotech Healthcare Trust; Officer / Board of Directors: Xerion Healthcare. Y. Baranau: Honoraria (self), Travel / Accommodation / Expenses: Roche; Honoraria (self), Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Novatis. V. Moiseyenko: Speaker Bureau / Expert testimony: AstraZeneca. J. Pikiel: Travel / Accommodation / Expenses: Roche. A. Eniu: Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): Celltrion; Research grant / Funding (self): Pfizer. S.J. Lee: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment, Stock option: Celltrion. M.J. Kim: Full / Part-time employment: Celltrion. S. Kim: Full / Part-time employment: Celltrion. S. Park: Full / Part-time employment: Celltrion. J.H. Bae: Full / Part-time employment: Celltrion. F.J. Esteva: Advisory / Consultancy: Celltrion; Advisory / Consultancy: Roche; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings