[{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tyvyt (Sintilimab Injection) Combined with ALIMTA (Pemetrexed) and Platinum Met Predefined Primary Endpoint in Phase 3 ORIENT-11 Study as First-Line Therapy in Nonsquamous NSCLC","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innovent and Eli Lilly Announce NMPA Acceptance of Supplemental New Drug Application for Sintilimab in Combination with ALIMTA and Platinum","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large 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Find Clinical Drug Pipeline Developments & Deals for 00669_FLUKA
Tyvyt (sintilimab), an investigational PD-1 inhibitor a type of immunoglobulin G4 monoclonal antibody, binds to PD-1 molecules on surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.
Tyvyt (sintilimab),is a novel PD-1 inhibitor, is under review for the first-line treatment of people with non-squamous non-small cell lung cancer based on the ORIENT-11 trial conducted exclusively in China.
TYVYT (sintilimab injection), is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-L1 pathway, and reactivates T-cells to kill cancer cells.
KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
A total of 397 patients were enrolled and randomized 2:1 to receive either sintilimab 200mg or placebo in combination with pemetrexed and platinum chemotherapy every 3 weeks for up to four cycles, followed by either sintilimab or placebo plus pemetrexed maintenance therapy.
The ORIENT-11 primary clinical results were released during the IASLC World Conference on Lung Cancer (WCLC) 2020 Virtual Presidential Symposium as an oral presentation and simultaneously published by the Journal of Thoracic Oncology.
ORIENT-12 is the first randomized, double-blind, Phase 3 clinical trial evaluating TYVYT® or placebo in combination with GEMZAR® and platinum chemotherapy as first-line treatment for advanced or metastatic squamous non-small cell lung cancer.
TYVYT is the only PD-1 inhibitor to be included in China's National Reimbursement Drug List (NRDL) and is included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies.
National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application for TYVYT® (sintilimab injection) in combination with Gemzar® (gemcitabine) and platinum as first-line therapy in squamous non-small cell lung cancer (squamous NSCLC).
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