Blog Big Molecule Watch September 22, 2021

Tanvex and Biocad announce Phase III results at ESMO Congress

Last week, results of Tanvex’s phase III study on its trastuzumab biosimilar candidate (TX05) were published in connection with the European Society for Medical Oncology’s (ESMO’s) Congress 2021.  The study compared the efficacy and safety of TX05 to Herceptin in patients with HER2+ early breast cancer.  The poster provides the following conclusions:  “The pCR risk ratio was within the predefined equivalence margins, confirming therapeutic equivalence of TX05 and Herceptin.  Secondary endpoints including ORR, safety and immunogenicity were comparable and support the conclusion of biosimilarity.”

As part of the same ESMO Congress, Biocad announced results of its phase III study for its bevacizumab biosimilar candidate (BCD-021).  The study compared the efficacy and safety of BCD-021 to Avastin in patients with stage IIIB or IV non-squamous non-small cell lung cancer.  The poster reports that the study “demonstrated equivalence between BCD-021 and [Avastin] in terms of ORR risk difference and risk ratio,” noting that “[s]afety, PK, and immunogenicity parameters were comparable between BCD-021 and [Avastin].”

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