(Hong Kong, 22 November 2020) TOT BIOPHARM International Company Limited (“TOT BIOPHARM” or the “Company”; stock code: 1875.HK) announced that the Company has published the phase III clinical research results of its self-developed bevacizumab biosimilar TAB008 (intended product name: 朴欣汀®Pusintin®) at the 2020 European Society for Medical Oncology Asia Congress (ESMO ASIA). The results were shown by way of E-Poster.
The research was a randomized, double-blind, parallel-controlled and multi-center Phase III clinical study. It was conducted with the aim of evaluating the efficacy, safety and immunogenicity of TAB008 in combination with paclitaxel and carboplatin as first-line or partial treatment for patients with advanced or recurrent non-squamous non-small cell lung cancer. The results were compared with reference bevacizumab. The primary endpoint is the best Objective Response Rate (ORR) within six treatment cycles. The research was conducted and completed by teams led by Professor Lu Shun of Lung Cancer Center, Shanghai Chest Hospital and Professor Qin Shukui of Oncology Center, Nanjing Jinling Hospital.
549 patients were enrolled in the research, with 277 people allocated to the TAB008 group and 272 people allocated to the reference bevacizumab group (one of the patients was not provided drug treatment after randomization and was not included in FAS). No notable differences in baseline characteristics were found between the two groups of patients tested.
The experiments showed that:
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The ORR for TAB008 group and reference bevacizumab were 55.957% and 55.720% respectively, demonstrating similarity in primary efficacy endpoint;
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The efficacy–secondary endpoints including six-cycle DCR, DoR, PFS, one-year OSR and OSR, showed similarity;
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Adverse and serious effects of TAB008 group and reference bevacizumab group were basically similar, with the differences between the two groups being statistically insignificant, while the most adverse effects can be easily controlled clinically. Three people (1.08%) in the TAB008 group and five people (1.85%) in the reference bevacizumab group tested positive for an anti-drug antibody;
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The steady-state concentration given to TAB008 group or reference bevacizumab has bioequivalency.
Conclusion:
The results of this clinical trial prove that TAB008 and reference bevacizumab used for the first-line treatment of advanced or recurrent non-squamous non-small-cell lung cancer have similar efficacy, safety, immunogenicity profiles and pharmacokinetic characteristics.
For details of the research results, please refer to the following link:
https://reurl.cc/MdmXnK
About TAB008 (Pusintin®)
TAB008 (Pusintin®) is a biosimilar drug candidate to Avastin®, a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF). It can specifically bind to VEGF and block the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth. In April 2020, phase III clinical trial of TAB008 commenced in combination with paclitaxel and carboplatin as first-line treatment for patients with advanced or recurrent non-squamous non-small cell lung cancer, and in comparison with reference bevacizumab mAb in combination with paclitaxel and carboplatin chemotherapy met primary endpoint. On 3 September 2020, the Biologics License Application for TAB008 was accepted by the National Medical Products Administration.