The phase III global, randomized, double-blind, parallel-arm, equivalence trial (Troika: NCT03013504) was designed to compare the efficacy, safety, and pharmacokinetics of HD201 to Herceptin (originator trastuzumab) in patients with human epidermal growth factor receptor 2 positive (HER2+) early breast cancer (EBC) and enrolled 502 patients. Patients were randomized (1:1) to receive either HD201 or Herceptin in combination with chemotherapy. HD201 or Herceptin was administered every 3 weeks for 8 cycles (24 weeks). After administration of the final neoadjuvant study drug dose, surgery was performed within 3−8 weeks followed by an adjuvant treatment period for 10 cycles.

The primary efficacy endpoint of the study was total pathological complete response (tpCR) whereas the secondary endpoints were breast pCR, pCR without ductal carcinoma in situ (DCIS), overall response (ORR), breast conservation rate, disease- free survival (DFS), progression-free survival (PFS), overall survival (OS), pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers and safety.

These results, according to Dr Lisa S Park, CEO of Prestige BioPharma, ‘demonstrate that HD201 is the most equivalent biosimilar of Herceptin’. She added that ‘Troika has broken many records - fastest recruitment, lowest screening failure and drop-out, most exceptional similarity, and the fastest dossier generation and filing’.

These data were used to support the submission of HD201 to the European Medicines Agency in May 2019 [1].

Prestige says that it will present the 24-week data from this study at the European Society for Medical Oncology Congress 2019, which will be held on 31 September–1 October 2019 in Barcelona, Spain.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilar from Prestige accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-biosimilar-from-Prestige-accepted-for-review-by-EMA 

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