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

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.

• Authors: F J Esteva, Y V Baranau, V Baryash, A Manikhas, V Moiseyenko, G Dzagnidze, E Zhavrid, D Boliukh, D Stroyakovskiy, J Pikiel, A E Eniu, R K Li, A V Rusyn, B Tiangco, S J Lee, S Young Lee, S Y Yu, J Stebbing
• Journal: Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 84 Issue 4 Pg. 839-847 (10 2019) ISSN: 1432-0843 [Electronic] Germany
• PMID: 31428820 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Immunological
• Biosimilar Pharmaceuticals
• CT-P6
• ERBB2 protein, human
• Receptor, ErbB-2
• Trastuzumab

Topics

• Antineoplastic Agents, Immunological (administration & dosage, adverse effects, pharmacokinetics)
• Biosimilar Pharmaceuticals (administration & dosage, adverse effects, pharmacokinetics)
• Breast Neoplasms (drug therapy, metabolism, pathology)
• Drug Monitoring (methods)
• Female
• Heart Failure (chemically induced, diagnosis)
• Humans
• Middle Aged
• Neoplasm Staging
• Receptor, ErbB-2 (antagonists & inhibitors)
• Trastuzumab (administration & dosage, adverse effects, pharmacokinetics)
• Treatment Outcome