Innovent and Lilly Jointly Announce Results of Seven Clinical Studies of TYVYT® (sintilimab injection) to Be Presented at the ESMO ASIA Congress 2020

On November 4, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for treatment of oncology, metabolic, autoimmune and other major diseases, and Eli Lilly and Company ("Lilly",NYSE: LLY) reported that results of seven clinical studies of TYVYT (sintilimab injection) will be presented during the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) ASIA ("ESMO ASIA") Virtual Congress 2020 from November 20th to 22nd (Press release, Innovent Biologics, NOV 4, 2020, View Source [SID1234569889]).

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The seven studies of TYVYT (sintilimab injection) to be presented on ESMO (Free ESMO Whitepaper) ASIA include one Proffered Paper Oral Presentation (a Phase 3 study) and six e-posters, covering indications including lung cancer, liver cancer, gastric cancer, and esophageal cancer.

1.
Cancer Type:Liver cancer
Presentation Type:Proffered Paper Oral Presentation
Title: Sintilimab plus bevacizumab biosimilar vs. sorafenib as first-line treatment for advanced hepatocellular carcinoma (ORIENT-32)
Presentation #:523
Presenter:Professor Zhenggang Ren
Date of Presentation: 21 November 2020

2.
Cancer Type:Liver cancer
Presentation Type:E-poster
Title:Sintilimab plus anlotinib as first-line therapy in patients (pts) with advanced hepatocellular carcinoma (aHCC)
Presentation #:170P
Leading PI:Professor Xiaofeng Chen

3.
Cancer Type:Non–Small Cell Lung Cancer
Presentation Type:E-poster
Title: Efficacy and Safety of Sintilimab Plus Docetaxel in Patients with Previously Treated Advanced Non–Small Cell Lung Cancer
Presentation #:402P
Leading PI:Professor Zhehai Wang

4.
Cancer Type:Non–Small Cell Lung Cancer
Presentation Type:E-poster
Title:A Single-Arm Phase Ib Study of Autologous Cytokine-Induced Killer (CIK) Cell Immunotherapy in Combination with Sintilimab plus Chemotherapy in Patients with Advanced Non-Small-Cell Lung Cancer
Presentation #:386P
Leading PI:Professor Xiubao Ren

5.
Cancer Type:Esophageal cancer
Presentation Type:E-poster
Title:A study of neoadjuvant sintilimab combined with triplet chemotherapy of lipo-paclitaxel, cisplatin, and S-1 for resectable esophageal squamous cell carcinoma(ESCC)
Presentation #:175P
Leading PI:Professor Yanhong Gu

6.
Cancer Type:Gastric cancer
Presentation Type:E-poster
Title:Phase II study of sintilimab combined with FLOT regimen for neoadjuvant treatment of gastric or gastroesophageal junction (GEJ) adenocarcinoma
Presentation #:160P
Leading PI: Professor Suxia Luo, Ning Li

7.
Cancer Type:Gastric cancer
Presentation Type:E-poster
Title: Perioperative sintilimab in combination with concurrent chemoradiotherapy for patients with locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma
Presentation #:196TiP
Leading PI: Professor Baorui Liu

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT (sintilimab injection) is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the Phase 3 ORIENT-32 study.

TYVYT (sintilimab injection) is a type of 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. Innovent is currently conducting more than 20 clinical studies for TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, Innovent is conducting clinical research studies on TYVYT (sintilimab injection) worldwide.