Positive phase III results for sintilimab plus copy biological Byvasda

Biosimilars/Research | Posted 15/01/2021 post-comment0 Post your comment

Chinese biopharmaceutical firm Innovent Biologics (Innovent) announced on 23 November 2020 positive results for its copy bevacizumab biological Byvasda (IBI-305) in combination with sintilimab.

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The results of the phase III ORIENT-32 study were released in a late-breaking oral presentation at the European Society of Medical Oncology Asia (ESMO Asia) Virtual Congress 2020.

The phase III, randomized, open-label,multi-centre ORIENT-32 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).

A total of 571 patients were enrolled in the trial. Based on an interim analysis Tyvyt (sintilimab injection) in combination with Byvasda demonstrated significantly improved overall survival (OS) and Independent Radiographic Review Committee (IRRC) progression-free survival (PFS) versus sorafenib. Compared to sorafenib, Tyvyt plus Byvasda demonstrated a 43.1% decreased risk of all-cause mortality (HR 0.569, 95%CI: 0.431‒0.751, p < 0.0001); the median OS was not reached in the Tyvyt plus Byvasda arm versus 10.4 months in the sorafenib arm. Tyvyt plus Byvasda also demonstrated 43.5% decreased risk of progression as assessed by the IRRC (HR 0.565 95%CI: 0.455‒0.701, p < 0.0001); median PFS was 4.6 months in the Tyvyt plus Byvasda arm versus 2.8 months in the sorafenib arm.

The primary outcome measures of the study (OS and PFS) were ‘significantly improved’ and ‘generally consistent across all subgroups’, according to Innovent. Innovent also said that the combination regimen also ‘showed an acceptable safety profile with no new safety signals’. The company concluded that ‘with these results, Tyvyt plus Byvasda could potentially provide a new option for the first-line treatment of patients with advanced HCC’.

Innovent announced that it had received approval for Byvasda from China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), back in June 2020 [1].

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1. GaBI Online - Generics and Biosimilars Initiative. China approves bevacizumab copy biological Byvasda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 15]. Available from: www.gabionline.net/Biosimilars/News/China-approves-bevacizumab-copy-biological-Byvasda 

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Source: ClinicalTrials.gov, Innovent

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