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Good news!TOT BIOPHARM announced the results of phase I clinical trial of the biosimilar drug TAB008 bevacizumab


On May 16, 2018, the 9th Annual Biosimilars Asia 2018 announced the phase I clinical trial results of TAB008 bevacizumab developed and manufactured by the company. Beacizumab bead sheet resistance is a kind of humanized anti - VEGF monoclonal antibody, as early as 2004 by the us food and drug administration approved, commodity called Avastin ®, abroad have made metastatic colorectal cancer, non-small cell lung cancer, malignant glioma, metastatic renal cell carcinoma, ovarian cancer, breast cancer, cervical cancer and other 7 kinds of indications. At present, only roche's bevacizumab injection has been approved for import in China, and the product name is anwetin ®. Currently, no similar biological drug has been approved for production.

The phase I clinical trial design of the TAB008 bevacizumab biosimilar drug was designed to compare the pharmacokinetics and safety of the original Avastin® with a total of 100 healthy male subjects. The results showed that TAB008 was highly similar to Avastin® in terms of pharmacokinetics and safety, and the report of the results was accepted by ASCO.

Arithmetic Mean (± SD) Bevacizumab Serum Concentration-Time Profiles for TAB008 versus Avastin on Linear Scales (Pharmacokinetic Analysis Set)

Arithmetic Mean (± SD) Bevacizumab Serum Concentration-Time Profiles for TAB008 versus Avastin on Semi logarithmic Scales (Pharmacokinetic Analysis Set)

Statistical Comparison of Primary Pharmacokinetic Parameters (Pharmacokinetic Analysis Set)
Abbreviations: CI = confidence interval, LS = least-squares

All Treatment Emergent Adverse Event (TEAE, Safety Analysis Set)

As a broad-spectrum anti-tumor monoclonal antibody, bevacizumab has unique advantages in the field of combination therapy. In the treatment of colorectal cancer, renal cancer, non-small cell lung cancer and other indications, bevacizumab has shown good clinical data in combination with chemotherapy, erotinib, pd-1 / pd-l1 monoclonal antibody and other drugs. The JO25567 study evaluated the efficacy and safety of Avastin®+Tarceva® combination therapy versus Tarceva® monotherapy. Data from 154 patients showed that the median progression-free survival (PFS) was significantly extended by 6.3 months in the Avastin®+Tarceva® combination group compared to the Tarceva® monotherapy group. The phase II clinical data published by ASCO in 2017 showed that the data of Atezolizumab combined with bevacizumab was superior to that of sunitinib. In the treatment of NSCLC, the roche phase III IMpower150 study showed that Tecentriq® (atezolizumab) and Avastin® combined chemotherapy reduced the risk of disease progression or death by 38% in patients with advanced lung cancer. The treatment regimen of pd-1 plus bevacizumab increases the immune system's potential to fight a wide range of cancers, including advanced NSCLC and other cancers for which pd-1 is effective in first-line treatment. In addition to its antiangiogenic effect, bevacizumab can also inhibit vegf-related immunosuppression, including "vascular normalization" of vessel around tumors to promote T cell tumor infiltration and activate T cell response against tumor antigens, so as to further enhance the effect of pd-1. In the future, bevacizumab will play an important role in the combined drug system of tumor therapy. In addition, bevacizumab was included in medical insurance through national price negotiation in 2017, and it is expected that the market penetration rate of this product will soon increase rapidly.