P6 trial
Results showed that the pCR rates and breast pCR rates continued to be comparable between treatment arms, regardless of patient characteristics that included age, region, or clinical stage and were similar to the neoadjuvant data. Future analyses will explore disease-free survival and progression-free survival. Follow-up will continue post-treatment for ≤3 years from the enrollment date of the last patient.Įndpoints assessed during the adjuvant setting included progressive disease, and the proportion of patients receiving post-surgery radiation or hormonal therapy. Additionally, patients received radiation therapy or hormonal therapy in the adjuvant setting at the investigator’s discretion. Then, patients received adjuvant treatment with CT-P6 (n = 271) or reference trastuzumab (n = 278) at 6 mg/kg at 90-minute intravenous infusions every 3 weeks until ≤1 year from the initial neoadjuvant dose or ≤10 cycles after surgery. Neoadjuvant therapy comprised eight 3-week cycles of CT-P6 (n = 258) or trastuzumab (n = 261) at a loading dose of 8 mg/kg followed by 6 mg/kg for cycles 2 through 8, along with a chemotherapy regimen of docetaxel and fluorouracil, epirubicin, and cyclophosphamide. Patients were recruited from 112 centers in 23 countries and patient characteristics were similar between arms. In the study, patients were female and aged&thinsp ≥18 years with pathologically confirmed, newly diagnosed, operable, HER2-positive early breast cancer that was clinical stage I, II, or IIIA, which was classified according to the American Joint Committee on Cancer Breast Cancer Staging 7th edition. 3 In the updated findings, researchers reported on pathological complete response (pCR), breast pCR, and efficacy and safety measures of a subgroup analysis in the adjuvant setting.
P6 TRIAL TRIAL
Prior data from the double-blind, parallel group, active-controlled phase III trial showed that the biosimilar demonstrated equivalent efficacy to reference trastuzumab in the neoadjuvant setting. The decision was based on an extensive review of a comprehensive data package, which included foundational analytical similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data. The FDA approved the biosimilar in December 2018 for the treatment of patients with HER2-overexpressing breast cancer. Adjuvant treatment with the trastuzumab (Herceptin) biosimilar CT-P6 (Herzuma trastuzumab-pkrb) demonstrated comparable efficacy and safety to the reference product in patients with HER2-positive early breast cancer, according to results of posthoc analyses of a phase III trial (NCT02162667).