Hervelous (trastuzumab biosimilar)

This final analysis of the TROIKA trial further confirms the comparable efficacy and safety of HD201 and trastuzumab.

Eligible patients received 4 cycles of docetaxel, 75 mg/m2, followed by 4 cycles of epirubicin, 75 mg/m2, and cyclophosphamide, 500 mg/m2 with either HD201 or referent trastuzumab (loading dose, 8 mg/kg; maintenance dose, 6 mg/kg) every 3 weeks in the neoadjuvant setting and then, 10 cycles of HD201 or referent trastuzumab after surgery, according to their initial randomization. During the post-treatment follow up period, AEs were reported for 64 (27.4%) and 72 (29.8%) patients in the HD201 and the referent trastuzumab groups respectively and no serious event was related to study treatment. Conclusions This final analysis of the TROIKA trial further confirms the comparable efficacy and safety of HD201 and referent trastuzumab.

Patients with ERBB2-positive early breast cancer were randomly assigned to receive HD201 or referent trastuzumab in the neoadjuvant setting for 8 cycles, concurrently with 4 cycles of docetaxel, which was followed by 4 cycles of epirubicin and cyclophosphamide. The results of this randomized clinical trial found that HD201 demonstrated equivalence to referent trastuzumab in terms of efficacy for the end point of tpCR, with a similar safety profile. ClinicalTrials.gov Identifier: NCT03013504.

P3, N=503, Completed, Prestige Biopharma Limited | Active, not recruiting --> Completed

Methods 503 patients with HER2+ EBC were randomised in a 1:1 ratio to receive either HD201 or Herceptin in neoadjuvant settings for 8 cycles in combination with chemotherapy (4 cycles of docetaxel followed by 4 cycles of epirubicin/cyclophosphamide). Funding: Prestige Biopharma Ltd. Clinical trial identification: Eudract: 2016-004019-11.

The overall comparison exercise demonstrated the equivalence of HD201 to Herceptin. Research Funding: Private funding

P3, N=500, Active, not recruiting, Prestige Biopharma Pte Ltd | Trial completion date: Dec 2019 --> Mar 2022 | Trial primary completion date: Dec 2019 --> Apr 2019