China-based drugmaker Innovent Biologics (Innovent) announced on 29 June 2021 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved the combination drug Tyvyt (sintilimab) plus bevacizumab copy biological Byvasda (IBI-305).
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.
Sintilimab is an innovative immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells.
Byvasda (IBI-305) was approved by the NMPA back in June 2020 [2].
The approval of the combination therapy is based on the phase III ORIENT-32 study, positive results of which were announced at the European Society of Medical Oncology Asia (ESMO Asia) Virtual Congress 2020 [1]. The randomized, open-label, multicentre study evaluated the efficacy and safety of sintilimab in combination with IBI305 (anti-vascular endothelial growth factor (VEGF), monoclonal antibody) compared to sorafenib as the first-line treatment for advanced hepatocellular carcinoma (HCC).
Based on an interim analysis, the study met the pre-defined efficacy criteria, showing significant improvement in overall survival (OS) and progression-free survival (PFS) as assessed by an Independent Radiographic Review Committee (IRRC). The combination regimen also ‘showed an acceptable safety profile with no new safety signals’.
The approval by the NMPA marks the first regulatory approval of a PD-1 inhibitor-based combination therapy as a first line treatment for HCC and the fourth NMPA-approved indication for Tyvyt, as well as for Byvasda.
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety, and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘copy biologicals’ approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for sintilimab plus copy biological Byvasda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 23]. Available from: www.gabionline.net/biosimilars/research/Positive-phase-III-results-for-sintilimab-plus-copy-biological-Byvasda
2. GaBI Online - Generics and Biosimilars Initiative. China approves bevacizumab copy biological Byvasda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 23]. Available from: www.gabionline.net/biosimilars/news/China-approves-bevacizumab-copy-biological-Byvasda
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