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
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