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. The primary endpoint was an assessment of
pathologic complete response (pCR) following neoadjuvant therapy and definitive
surgery in the per protocol population. Based on the study design, TX05 was
considered equivalent for pCR if the 95% CI of the risk ratio TX05: Herceptin was within
0.755 to 1.325.
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. The pCR risk ratio
was 1.0783 (95% CI, 0.9185 to 1.2659), which was entirely within the predefined
equivalence margins, demonstrating therapeutic equivalence.
Tanvex BioPharma, Inc. (TWSE: 6541) is a biopharmaceutical company focused on the
biosimilar market. The Company is vertically integrated with end-to-end in-house
development, manufacturing and commercialization capabilities. Tanvex BioPharma, Inc.
is registered in Cayman Islands and has operations and facilities in Irvine, CA, San Diego,
CA, and Taipei, Taiwan. Tanvex is publicly traded on the Taiwan Stock Exchange.