Generics
Innovent's phase III clinical trial of anti-PD-1 antibody Tyvyt reports first patient dosing
2 January 2019 -

Innovent Biologics Inc (Innovent) (HKEX: 01801), a biopharmaceutical company that develops and commercialises high quality medicines, announced on Tuesday the dosing of the first patient in a phase III clinical trial (ORIENT-15) that is to evaluate Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody) (generic name: sintilimab injection), in combination with paclitaxel and cisplatin, as first-line treatment in patients with advanced, recurrent or metastatic oesophageal squamous cell carcinoma (ESCC).

The company said its ORIENT-15 study is a randomised, double-blind, multi-centre, phase III trial conducted in China to evaluate the efficacy and safety of Tyvyt (sintilimab injection) or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic ESCC.

This phase III study will enrol 640 patients. The study follows a phase Ib study that evaluated Tyvyt (sintilimab injection) in patients with oesophageal cancer and a phase II study that evaluated Tyvyt (sintilimab injection) versus paclitaxel/irinotecan as second-line therapy for patients with advanced/metastatic ESCC.

According to the company, based on the preliminary result or the ongoing phase II study, it has decided to conduct ORIENT-15, a phase III study as a first-line treatment for patients with oesophageal squamous cell carcinoma. The goal is to provide more effective cancer treatment options for these patients and for their families.

Tyvyt (sintilimab injection) is an innovative drug jointly developed by Innovent and Eli Lilly and Company in China. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to the PD-1 molecule on the surface of T-cells, blocks the PD-L1(Programmed Cell Death-1 Ligand-1, PD-L1 pathway) and reactivates T-cells to kill cancer cells. Currently, Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company.

Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent) had in March 2015 announced one of the largest biotechnology drug development collaborations in China to date between a multi-national and domestic company. Under the terms of the agreement, Lilly and Innovent shall collaborate on the development and potential commercialisation of at least three cancer treatments over the next decade. In October 2015, they announced an expansion of their drug development collaboration. These collaborations represent that Innovent has struck one of the most comprehensive strategic collaborations of any Chinese company with a multinational partner in terms of the scope and breadth ranging from discovery to commercialisation and involving up to six therapeutic antibodies for cancers.

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