Prestige BioPharma Published Results of HD201 (biosimilar, trastuzumab) for the Treatment of ERBB2+ Breast Cancer in JAMA Oncology
Shots:
- The P-III (TROIKA) study evaluates the efficacy and safety of patients who received HD201 vs Herceptin in 502 patients with ERBB2+ breast cancer across 70 centers in 12 countries & completed the median follow-up period of 31mos. Additionally, 251 were randomized to receive the biosimilar, and 252 were assigned to receive the reference product
- The results showed that tpCR rates (45.0% vs 48.7%) & demonstrated an equivalant efficacy & safety profiles, 2232 treatment-related AEs were reported in 433 patients (86.1%), 220 were in the biosimilar group (88.0%) & 213 in Herceptin. (84.5%)
- Additionally, serious treatment-related AEs were reported in 24 vs 17 patients, treatment discontinuation in 16 vs 12 patients. Since June 2019, EMA has been reviewing Prestige Biopharma’s MAA application for HD201
Ref: Center for biosimilars | Image: Prestige
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