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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | TX05 (trastuzumab biosimilar) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
137P - Trial comparing the safety, efficacy and immunogenicity of trastuzumab biosimilar candidate (TX05) with originator trastuzumab in HER2+ early breast cancer
Published date:
09/13/2021
Excerpt:
Demographic and baseline characteristics were well balanced between the two arms...48.8% of patients achieved pCR in the TX05 arm versus 45.3% in the Herceptin®arm….The pCR risk ratio was within the predefined equivalence margins, confirming therapeutic equivalence of TX05 and Herceptin.
Trial ID:
Title:
Positive top-line efficacy and safety data from global Phase III clinical trial of Tanvex trastuzumab biosimilar candidate, TX05
Published date:
02/20/2021
Excerpt:
Tanvex BioPharma, Inc. (TWSE: 6541) today announced results from a Phase III study evaluating efficacy and safety of its trastuzumab biosimilar candidate, TX05, compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer...Based on independent central review, in the per-protocol population, 48.8% of patients achieved pCR in the TX05 arm versus 45.3% in the Herceptin group.
