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Prestige BioPharma Published Results of HD201 (biosimilar, trastuzumab) for the Treatment of ERBB2+ Breast Cancer in JAMA Oncology

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Prestige BioPharma Published Results of HD201 (biosimilar, trastuzumab) for the Treatment of ERBB2+ Breast Cancer in JAMA Oncology

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  • 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

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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