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Celltrion Reports P-II Study Results of Herzuma (biosimilar, trastuzumab) for the Treatment of HER2-Positive Breast Cancer

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Celltrion Reports P-II Study Results of Herzuma (biosimilar, trastuzumab) for the Treatment of HER2-Positive Breast Cancer

Shots:

  • The P-II study evaluating trastuzumab biosimilar + TPC in 109 patients with HER2+ MBC who had failed 2 HER2 directed chemotherapies
  • The results showed ORR (18.7%) after the median follow-up of 13.3mos., m-PFS was 4.6mos. & m-OS was 18.6mos. In the subgroup analyses, m-PFS (5.6 vs 4.2mos. in historical control) and in patients who had a response duration to prior anti-HER2 therapy of ≥6mos. (5.8 vs 3.3mos.), patients with liver metastasis had a non-statistically significant shorter PFS, was effective and safe & showed comparable efficacy & safety to the reference product
  • The study highlighted the genetic biomarkers & showed DoR to prior anti-HER2 therapy,  patients with mutations of PIK3CA (23%) or ERBB2 (7.0%) had shorter PFS

Ref: centerforbiosimilars | Image: Celltrion

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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