Key clinical point: HD201, a trastuzumab biosimilar, and reference trastuzumab display equivalence in terms of efficacy (along with a similar safety profile) in patients with human epidermal growth factor receptor 2 (ERBB2)-positive early breast cancer (BC) treated in the neoadjuvant setting.
Major finding: At the time of surgery, the rate of total pathological complete response with HD201 vs. referent trastuzumab was 45% vs. 48.7%, respectively, with the difference between the groups within the predefined equivalence margin (−3.8%; 95% CI −12.8% to 5.4%). Treatment-emergent adverse events of special interest for trastuzumab were reported by 88% and 84.5% of patients receiving HD201 and trastuzumab, respectively.
Study details: Findings are from the phase 3 TROIKA study including 502 women with ERBB2-positive early BC who were randomly assigned to receive HD201 or trastuzumab in a neoadjuvant setting along with chemotherapy.
Disclosures: This study was funded by Prestige BioPharma Ltd. Some of the authors declared serving as unpaid advisors or receiving personal fees and grants from several sources, including Prestige BioPharma Ltd. Three authors declared being employees of DICE Ltd.
Source: Pivot X et al. Efficacy of HD201 vs referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting: A multicenter phase 3 randomized clinical trial. JAMA Oncol. 2022 (Mar 3). Doi: 10.1001/jamaoncol.2021.8171